A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age
Phase: PHASE3
Conditions: Respiratory Syncytial Virus
Sponsor: ModernaTX, Inc.

ModernaTX, Inc. 
mRNA-1345-P302 Protocol Amendment 5 
mRNA-1345 
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Page 1 
CLINICAL STUDY PROTOCOL 
Protocol Title: 
A Phase 3 Randomized, Observer-Blind, Study to Evaluate 
Safety, Tolerability, and Immunogenicity of mRNA-1345, 
an mRNA Vaccine Targeting Respiratory Syncytial Virus 
(RSV), When Given Alone or Coadministered with a 
Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and 
When Given as an Open-label Boost at 1 Year Following a 
Primary Dose in Adults ≥ 50 Years of Age  
Protocol Number: 
mRNA-1345-P302 
Sponsor Name: 
ModernaTX, Inc.  
Legal Registered Address: 
200 Technology Square 
Cambridge, MA 02139 
Sponsor Contact and Medical 
Monitor: 
 
 
ModernaTX, Inc. 
200 Technology Square Cambridge, MA 02139 
Telephone: 
  
e-mail: 
Regulatory Agency Identifier 
Number(s): 
Investigational New Drug: 23342 
Amendment Number: 
5  
Date of Amendment 5: 
16 Jun 2023 
Date of Amendment 4: 
14 Feb 2023 
Date of Amendment 3 
17 Jun 2022 
Date of Amendment 2: 
10 May 2022 
Date of Amendment 1: 
17 Mar 2022 
Date of Original Protocol: 
01 Feb 2022 
CONFIDENTIAL  
All financial and nonfinancial support for this study will be provided by ModernaTX, Inc. The 
concepts and information contained in this document or generated during the study are 
considered proprietary and may not be disclosed in whole or in part without the expressed 
written consent of ModernaTX, Inc. The study will be conducted according to the 
International Council for Harmonisation (ICH) of Technical Requirements for Registration of 
Pharmaceuticals for Human Use, E6(R2) Good Clinical Practice (GCP) Guidance. 
NCT #: NCT05330975
PPD
PPD
PPD

ModernaTX, Inc. 
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PROTOCOL APPROVAL – SPONSOR SIGNATORY  
Study Title: 
A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, 
Tolerability, and Immunogenicity of mRNA-1345, an mRNA 
Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given 
Alone or Coadministered with a Seasonal Influenza Vaccine or 
SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 
Year Following a Primary Dose in Adults ≥ 50 Years of Age 
Protocol Number: 
mRNA-1345-P302 
Amendment Number: 
5 
Amendment Date: 
16 Jun 2023 
 
Protocol accepted and approved by: 
See eSignature and date signed on 
last page of the document 
 
 
 
  
ModernaTX, Inc.  
200 Technology Square 
Cambridge, MA 02139 
Telephone:
 
e-mail: 
 
 
Date 
 
 
 
 
PPD
PPD
PPD

ModernaTX, Inc. 
mRNA-1345-P302 Protocol Amendment 5 
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Page 3 
DECLARATION OF INVESTIGATOR  
I have read and understood all sections of the protocol entitled “A Phase 3 Randomized, 
Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an 
mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or 
Coadministered with a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as 
an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age” dated 
16 Jun 2023 and the most recent version of the Investigator’s Brochure (IB). 
I agree to supervise all aspects of the protocol and to conduct the clinical investigation in 
accordance with the current Protocol, the International Council for Harmonisation (ICH) of 
Technical Requirements for Registration of Pharmaceuticals for Human Use, E6(R2) Good 
Clinical Practice (GCP) Guidance, and all applicable government regulations. I will not make 
changes to the protocol before consulting with ModernaTX, Inc. or implement protocol changes 
without Institutional Review Board (IRB) approval except to eliminate an immediate risk to 
participants.  
I agree to administer study treatment only to participants under my personal supervision or the 
supervision of a sub-investigator. I will not supply study treatment to any person not authorized 
to receive it. I also agree that persons debarred from conducting or working on clinical studies by 
any court or regulatory agency will not be allowed to conduct or work on studies for the Sponsor 
or a partnership in which the Sponsor is involved. I will immediately disclose it in writing to the 
Sponsor if any person who is involved in the study is debarred, or if any proceeding for 
debarment is pending, or, to the best of my knowledge, threatened. 
I will not disclose confidential information contained in this document including participant 
information, to anyone other than the recipient study staffs and members of the IRB. I agree to 
ensure that this information will not be used for any purpose other than the evaluation or conduct 
of the clinical investigation without the prior written consent from ModernaTX, Inc. I will not 
disclose information regarding this clinical investigation or publish results of the investigation 
without authorization from ModernaTX, Inc. 
The signature below provides the necessary assurance that this study will be conducted 
according to all stipulations of the protocol, including statements regarding confidentiality, and 
according to local legal and regulatory requirements, US federal regulations, and ICH E6(R2) 
GCP guidelines. 
 
Signature of Principal Investigator 
 
 
Date 
 
 
 
 
Printed Name of Principal Investigator  
 
 

ModernaTX, Inc. 
mRNA-1345-P302 Protocol Amendment 5 
mRNA-1345 
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Page 4 
PROTOCOL AMENDMENT SUMMARY OF CHANGES  
Document History 
Document 
Date 
Amendment 5 
16 Jun 2023 
Amendment 4 
14 Feb 2023 
Amendment 3 
17 June 2022 
Amendment 2 
10 May 2022 
Amendment 1 
17 Mar 2022 
Original Protocol 
01 Feb 2022 
Amendment 5, 16 Jun 2023: Current Amendment: 
CCI

ModernaTX, Inc. 
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mRNA-1345 
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CCI

ModernaTX, Inc. 
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mRNA-1345 
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CCI

ModernaTX, Inc. 
mRNA-1345-P302 Protocol Amendment 5 
mRNA-1345 
Confidential 
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CCI

ModernaTX, Inc. 
mRNA-1345-P302 Protocol Amendment 5 
mRNA-1345 
Confidential 
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TABLE OF CONTENTS 
CLINICAL STUDY PROTOCOL ..................................................................................................1 
PROTOCOL APPROVAL – SPONSOR SIGNATORY ................................................................2 
DECLARATION OF INVESTIGATOR .........................................................................................3 
PROTOCOL AMENDMENT SUMMARY OF CHANGES ..........................................................4 
TABLE OF CONTENTS .................................................................................................................8 
LIST OF TABLES .........................................................................................................................18 
LIST OF FIGURES .......................................................................................................................18 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ..................................................19 
1. 
INTRODUCTION ......................................................................................................22 
1.1. 
Background and Overview .........................................................................................22 
1.1.1. 
mRNA-1345 ...............................................................................................................24 
1.1.2. 
Afluria® Quadrivalent Influenza Vaccine ...................................................................24 
1.1.3. 
mRNA-1273.214 ........................................................................................................24 
1.1.4. 
Study Rationale ...........................................................................................................24 
1.1.5. 
Nonclinical Studies .....................................................................................................25 
1.1.6. 
Clinical Studies ...........................................................................................................25 
1.2. 
Benefit/Risk Assessment ............................................................................................26 
1.2.1. 
Known Potential Benefits ...........................................................................................26 
1.2.2. 
Risks From Study Participation and Their Mitigation ................................................26 
1.2.3. 
Overall Benefit/Risk Conclusion ................................................................................27 
2. 
PART A ......................................................................................................................28 
2.1. 
Protocol Summary ......................................................................................................28 
2.1.1. 
Synopsis (Part A) ........................................................................................................28 
2.1.2. 
Schema (Part A) ..........................................................................................................32 
2.1.3. 
SoA (Part A) ...............................................................................................................33 
2.2. 
Objectives and Endpoints (Part A) .............................................................................35 
2.3. 
Study Design ...............................................................................................................36 
2.3.1. 
General Design (Part A) .............................................................................................36 
2.3.2. 
Scientific Rationale for Study Design ........................................................................37 
2.3.3. 
Choice of Vaccine Dose .............................................................................................38 
2.3.4. 
EoS Definition ............................................................................................................38 

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2.4. 
Study Population (Part A) ...........................................................................................38 
2.4.1. 
Inclusion Criteria (Part A) ..........................................................................................38 
2.4.2. 
Exclusion Criteria (Part A) .........................................................................................39 
2.4.3. 
Lifestyle Restrictions ..................................................................................................41 
2.4.4. 
Screen Failures ............................................................................................................41 
2.5. 
Study Treatment ..........................................................................................................41 
2.5.1. 
Investigational Products Administered .......................................................................41 
2.5.2. 
Randomization and Blinding ......................................................................................41 
2.5.2.1. 
Blinding ......................................................................................................................42 
2.5.2.2. 
Unblinding ..................................................................................................................42 
2.5.3. 
Preparation, Handling, Storage, and Accountability ..................................................42 
2.5.3.1. 
Preparation of Study Vaccine .....................................................................................42 
2.5.3.2. 
Study Vaccine Administration ....................................................................................42 
2.5.3.3. 
Study Vaccine Delivery and Receipt ..........................................................................43 
2.5.3.4. 
Study Vaccine Packaging and Labeling .....................................................................43 
2.5.3.5. 
Study Vaccine Storage ................................................................................................43 
2.5.3.6. 
Study Vaccine Accountability ....................................................................................44 
2.5.3.7. 
Study Vaccine Handling and Disposal .......................................................................44 
2.5.4. 
Study Intervention Compliance ..................................................................................44 
2.5.5. 
Prior and Concomitant Medications ...........................................................................44 
2.5.5.1. 
Prior Medications and Therapies ................................................................................44 
2.5.5.2. 
Concomitant Medications and Therapies ...................................................................44 
2.5.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination of 
a Participant from the Per-Protocol Analyses ..............................................................45 
2.5.6. 
Intervention After the End of the Study .....................................................................46 
2.6. 
Delay or Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal .......................................................................................46 
2.6.1. 
Criteria for Delay of Vaccine Administration ............................................................46 
2.6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination .................................46 
2.6.2. 
Participant Discontinuation/Withdrawal from the Study ...........................................46 
2.6.3. 
Lost to Follow-Up.......................................................................................................47 
2.7. 
Study Assessments and Procedures ............................................................................48 
2.7.1. 
Safety Assessments and Procedures ...........................................................................49 

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2.7.1.1. 
Use of Electronic Diaries ............................................................................................49 
2.7.1.2. 
Safety Telephone Call .................................................................................................50 
2.7.1.3. 
Vital Sign Measurements ............................................................................................50 
2.7.1.4. 
Physical Examinations ................................................................................................51 
2.7.2. 
Immunogenicity Assessments ....................................................................................51 
2.7.3. 
Efficacy Assessments .................................................................................................52 
2.7.4. 
Safety Definitions and Related Procedures ................................................................52 
2.7.4.1. 
Adverse Event .............................................................................................................52 
2.7.4.2. 
Serious Adverse Events ..............................................................................................52 
2.7.4.3. 
Solicited Adverse Reactions .......................................................................................53 
2.7.4.4. 
Medically Attended Adverse Events ..........................................................................55 
2.7.4.5. 
Adverse Event of Special Interest ...............................................................................55 
2.7.4.6. 
Eliciting and Documenting Adverse Events ...............................................................57 
2.7.4.7. 
Assessment of Intensity ..............................................................................................57 
2.7.4.8. 
Assessment of Causality .............................................................................................58 
2.7.4.9. 
Reporting Adverse Events ..........................................................................................58 
2.7.4.10. 
Reporting Serious Adverse Events .............................................................................59 
2.7.4.11. 
Reporting of Adverse Events of Special Interest ........................................................59 
2.7.4.12. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information .........................................................................................59 
2.7.4.13. 
Method of Detecting AEs and SAEs ..........................................................................60 
2.7.4.14. 
Follow-up of AEs and SAEs .......................................................................................61 
2.7.4.15. 
Regulatory Reporting Requirements for SAEs ...........................................................61 
2.7.5. 
Pregnancy ...................................................................................................................61 
2.7.6. 
Safety Monitoring .......................................................................................................61 
2.7.7. 
Treatment of Overdose ...............................................................................................62 
2.7.8. 
Pharmacokinetics ........................................................................................................62 
2.7.9. 
Pharmacodynamics .....................................................................................................62 
2.7.10. 
Biomarkers ..................................................................................................................62 
2.7.11. 
Health Economics .......................................................................................................62 
2.8. 
Statistical Considerations ............................................................................................62 
2.8.1. 
Blinding and Responsibility for Analyses ..................................................................62 
2.8.1.1. 
Breaking the Blind ......................................................................................................63 

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2.8.2. 
Statistical Hypotheses .................................................................................................64 
2.8.3. 
Sample Size Determination ........................................................................................65 
2.8.4. 
Analysis Sets ...............................................................................................................67 
2.8.5. 
Statistical Methods ......................................................................................................68 
2.8.5.1. 
Immunogenicity Analysis ...........................................................................................68 
2.8.5.2. 
Safety Analyses ..........................................................................................................69 
2.8.5.3. 
Exploratory Analyses ..................................................................................................70 
2.8.6. 
Planned Analyses ........................................................................................................70 
2.8.6.1. 
Primary Analysis ........................................................................................................70 
2.8.6.2. 
Final Analysis .............................................................................................................70 
2.8.7. 
Multiplicity .................................................................................................................71 
3. 
PART B ......................................................................................................................72 
3.1. 
Protocol Summary ......................................................................................................72 
3.1.1. 
Synopsis (Part B) ........................................................................................................72 
3.1.2. 
Schema (Part B) ..........................................................................................................76 
3.1.3. 
SoA (Part B) ...............................................................................................................77 
3.2. 
Objectives and Endpoints (Part B) .............................................................................80 
3.3. 
Study Design ...............................................................................................................81 
3.3.1. 
General Design (Part B) ..............................................................................................81 
3.3.2. 
Scientific Rationale for Study Design ........................................................................83 
3.3.3. 
Choice of Vaccine Dose .............................................................................................83 
3.3.4. 
EoS Definition ............................................................................................................83 
3.4. 
Study Population .........................................................................................................83 
3.4.1. 
Inclusion Criteria (Part B) ..........................................................................................83 
3.4.2. 
Exclusion Criteria (Part B) .........................................................................................84 
3.4.3. 
Lifestyle Restrictions ..................................................................................................86 
3.4.4. 
Screen Failures ............................................................................................................86 
3.5. 
Study Treatment ..........................................................................................................86 
3.5.1. 
Investigational Products Administered .......................................................................86 
3.5.2. 
Randomization and Blinding ......................................................................................86 
3.5.2.1. 
Blinding ......................................................................................................................86 
3.5.2.2. 
Unblinding ..................................................................................................................87 
3.5.3. 
Preparation, Handling, Storage, and Accountability ..................................................87 

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3.5.3.1. 
Preparation of Study Vaccine .....................................................................................87 
3.5.3.2. 
Study Vaccine Administration ....................................................................................87 
3.5.3.3. 
Study Vaccine Delivery and Receipt ..........................................................................87 
3.5.3.4. 
Study Vaccine Packaging and Labeling .....................................................................88 
3.5.3.5. 
Study Vaccine Storage ................................................................................................88 
3.5.3.6. 
Study Vaccine Accountability ....................................................................................88 
3.5.3.7. 
Study Vaccine Handling and Disposal .......................................................................88 
3.5.4. 
Study Intervention Compliance ..................................................................................88 
3.5.5. 
Prior and Concomitant Medications ...........................................................................88 
3.5.5.1. 
Prior Medications and Therapies ................................................................................88 
3.5.5.2. 
Concomitant Medications and Therapies ...................................................................89 
3.5.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination of 
a Participant from the Per-Protocol Analyses ..............................................................89 
3.5.6. 
Intervention After the End of the Study .....................................................................89 
3.6. 
Delay or Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal .......................................................................................90 
3.6.1. 
Criteria for Delay of Vaccine Administration ............................................................90 
3.6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination .................................90 
3.6.2. 
Participant Discontinuation/Withdrawal From the Study ...........................................90 
3.6.3. 
Lost to Follow-Up.......................................................................................................90 
3.7. 
Study Assessments and Procedures ............................................................................90 
3.7.1. 
Safety Assessments and Procedures ...........................................................................90 
3.7.1.1. 
Use of Electronic Diaries ............................................................................................90 
3.7.1.2. 
Safety Telephone Call .................................................................................................90 
3.7.1.3. 
Vital Sign Measurements ............................................................................................90 
3.7.1.4. 
Physical Examinations ................................................................................................90 
3.7.2. 
Immunogenicity Assessments ....................................................................................91 
3.7.3. 
Efficacy Assessments .................................................................................................91 
3.7.4. 
Safety Definitions and Related Procedures ................................................................91 
3.7.4.1. 
Adverse Event .............................................................................................................91 
3.7.4.2. 
Serious Adverse Events ..............................................................................................91 
3.7.4.3. 
Solicited Adverse Reactions .......................................................................................91 
3.7.4.4. 
Medically Attended Adverse Events ..........................................................................91 

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3.7.4.5. 
Adverse Event of Special Interest ...............................................................................91 
3.7.4.6. 
Eliciting and Documenting Adverse Events ...............................................................92 
3.7.4.7. 
Assessment of Intensity ..............................................................................................92 
3.7.4.8. 
Assessment of Causality .............................................................................................92 
3.7.4.9. 
Reporting Adverse Events ..........................................................................................92 
3.7.4.10. 
Reporting Serious Adverse Events .............................................................................92 
3.7.4.11. 
Reporting of Adverse Events of Special Interest ........................................................92 
3.7.4.12. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information .........................................................................................92 
3.7.4.13. 
Method of Detecting AEs and SAEs ..........................................................................92 
3.7.4.14. 
Follow-up of AEs and SAEs .......................................................................................92 
3.7.4.15. 
Regulatory Reporting Requirements for SAEs ...........................................................92 
3.7.5. 
Pregnancy ...................................................................................................................92 
3.7.6. 
Safety Monitoring .......................................................................................................92 
3.7.7. 
Treatment of Overdose ...............................................................................................93 
3.7.8. 
Pharmacokinetics ........................................................................................................93 
3.7.9. 
Pharmacodynamics .....................................................................................................93 
3.7.10. 
Biomarkers ..................................................................................................................93 
3.7.11. 
Health Economics .......................................................................................................93 
3.8. 
Statistical Considerations ............................................................................................93 
3.8.1. 
Statistical Methods ......................................................................................................93 
3.8.1.1. 
Immunogenicity Analysis ...........................................................................................93 
3.8.1.2. 
Safety Analyses ..........................................................................................................95 
3.8.1.3. 
Exploratory Analyses ..................................................................................................95 
3.8.2. 
Blinding and Responsibility for Analyses ..................................................................95 
3.8.2.1. 
Breaking the Blind ......................................................................................................95 
3.8.3. 
Statistical Hypotheses .................................................................................................95 
3.8.4. 
Sample Size Determination ........................................................................................97 
3.8.5. 
Analysis Sets ...............................................................................................................99 
3.8.6. 
Planned Analyses ........................................................................................................99 
3.8.6.1. 
Primary Analysis ........................................................................................................99 
3.8.6.2. 
Final Analysis .............................................................................................................99 
3.8.7. 
Multiplicity .................................................................................................................99 

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4. 
PART C ....................................................................................................................100 
4.1. 
Protocol Summary ....................................................................................................100 
4.1.1. 
Synopsis (Part C) ......................................................................................................100 
4.1.2. 
Schema (Part C) ........................................................................................................104 
4.1.3. 
SoA (Part C) .............................................................................................................105 
4.2. 
Objectives and Endpoints (Part C) ...........................................................................108 
4.3. 
Study Design .............................................................................................................109 
4.3.1. 
General Design (Part C) ............................................................................................109 
4.3.2. 
Scientific Rationale for Study Design ......................................................................110 
4.3.3. 
Choice of Vaccine Dose ...........................................................................................110 
4.3.4. 
EoS Definition ..........................................................................................................110 
4.4. 
Study Population (Part C) .........................................................................................111 
4.4.1. 
Inclusion Criteria (Part C) ........................................................................................111 
4.4.2. 
Exclusion Criteria (Part C) .......................................................................................112 
4.4.3. 
Lifestyle Restrictions ................................................................................................114 
4.4.4. 
Screen Failures ..........................................................................................................114 
4.5. 
Study Treatment ........................................................................................................114 
4.5.1. 
Investigational Products Administered .....................................................................114 
4.5.2. 
Randomization and Blinding ....................................................................................114 
4.5.2.1. 
Blinding ....................................................................................................................114 
4.5.2.2. 
Unblinding ................................................................................................................114 
4.5.3. 
Preparation, Handling, Storage, and Accountability ................................................114 
4.5.3.1. 
Preparation of Study Vaccine ...................................................................................114 
4.5.3.2. 
Study Vaccine Administration ..................................................................................114 
4.5.3.3. 
Study Vaccine Delivery and Receipt ........................................................................115 
4.5.3.4. 
Study Vaccine Packaging and Labeling ...................................................................115 
4.5.3.5. 
Study Vaccine Storage ..............................................................................................115 
4.5.3.6. 
Study Vaccine Accountability ..................................................................................115 
4.5.3.7. 
Study Vaccine Handling and Disposal .....................................................................115 
4.5.4. 
Study Intervention Compliance ................................................................................116 
4.5.5. 
Prior and Concomitant Medications .........................................................................116 
4.5.5.1. 
Prior Medications and Therapies ..............................................................................116 
4.5.5.2. 
Concomitant Medications and Therapies .................................................................116 

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4.5.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination of 
a Participant from the Per-Protocol Analyses ............................................................117 
4.5.6. 
Intervention After the End of the Study ...................................................................117 
4.6. 
Delay or Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal .....................................................................................117 
4.6.1. 
Criteria for Delay of Vaccine Administration ..........................................................117 
4.6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination ...............................117 
4.6.2. 
Participant Discontinuation/Withdrawal from the Study .........................................117 
4.6.3. 
Lost to Follow-Up.....................................................................................................117 
4.7. 
Study Assessments and Procedures ..........................................................................117 
4.7.1. 
Safety Assessments and Procedures .........................................................................118 
4.7.1.1. 
Use of Electronic Diaries ..........................................................................................118 
4.7.1.2. 
Safety Telephone Call ...............................................................................................119 
4.7.1.3. 
Vital Sign Measurements ..........................................................................................119 
4.7.1.4. 
Physical Examinations ..............................................................................................119 
4.7.2. 
Immunogenicity Assessments ..................................................................................120 
4.7.3. 
Efficacy Assessments ...............................................................................................120 
4.7.4. 
Safety Definitions and Related Procedures ..............................................................120 
4.7.4.1. 
Adverse Event ...........................................................................................................120 
4.7.4.2. 
Serious Adverse Events ............................................................................................120 
4.7.4.3. 
Solicited Adverse Reactions .....................................................................................120 
4.7.4.4. 
Medically Attended Adverse Events ........................................................................120 
4.7.4.5. 
Adverse Event of Special Interest .............................................................................120 
4.7.4.6. 
Eliciting and Documenting Adverse Events .............................................................120 
4.7.4.7. 
Assessment of Intensity ............................................................................................121 
4.7.4.8. 
Assessment of Causality ...........................................................................................121 
4.7.4.9. 
Reporting Adverse Events ........................................................................................121 
4.7.4.10. 
Reporting Serious Adverse Events ...........................................................................121 
4.7.4.11. 
Reporting of Adverse Events of Special Interest ......................................................121 
4.7.4.12. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information .......................................................................................121 
4.7.4.13. 
Method of Detecting AEs and SAEs ........................................................................121 
4.7.4.14. 
Follow-up of AEs and SAEs .....................................................................................121 

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4.7.4.15. 
Regulatory Reporting Requirements for SAEs .........................................................121 
4.7.5. 
Pregnancy .................................................................................................................121 
4.7.6. 
Safety Monitoring .....................................................................................................121 
4.7.7. 
Treatment of Overdose .............................................................................................121 
4.7.8. 
Pharmacokinetics ......................................................................................................122 
4.7.9. 
Pharmacodynamics ...................................................................................................122 
4.7.10. 
Biomarkers ................................................................................................................122 
4.7.11. 
Health Economics .....................................................................................................122 
4.8. 
Statistical Considerations ..........................................................................................122 
4.8.1. 
Blinding and Responsibility for Analyses ................................................................122 
4.8.1.1. 
Breaking the Blind ....................................................................................................122 
4.8.2. 
Statistical Hypotheses ...............................................................................................122 
4.8.3. 
Sample Size Determination ......................................................................................123 
4.8.4. 
Analysis Sets .............................................................................................................124 
4.8.5. 
Statistical Methods ....................................................................................................124 
4.8.5.1. 
Immunogenicity Analysis .........................................................................................124 
4.8.5.2. 
Safety Analyses ........................................................................................................125 
4.8.5.3. 
Exploratory Analyses ................................................................................................126 
4.8.6. 
Planned Analyses ......................................................................................................126 
4.8.6.1. 
Primary Analysis ......................................................................................................126 
4.8.6.2. 
Final Analysis ...........................................................................................................126 
4.8.7. 
Multiplicity ...............................................................................................................126 
5. 
REFERENCES .........................................................................................................127 
6. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................................130 
6.1. 
APPENDIX 1: Study Governance Considerations ...................................................130 
6.1.1. 
Regulatory and Ethical Considerations ....................................................................130 
6.1.2. 
Study Monitoring ......................................................................................................130 
6.1.3. 
Audits and Inspections ..............................................................................................131 
6.1.4. 
Financial Disclosure .................................................................................................132 
6.1.5. 
Recruitment Procedures ............................................................................................132 
6.1.6. 
Informed Consent/Assent Process ............................................................................132 
6.1.7. 
Protocol Amendments ..............................................................................................133 

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6.1.8. 
Protocol Deviations ..................................................................................................133 
6.1.9. 
Data Protection .........................................................................................................134 
6.1.10. 
Sample Retention and Future Biomedical Research ................................................134 
6.1.11. 
Safety Oversight .......................................................................................................134 
6.1.12. 
Dissemination of Clinical Study Data ......................................................................135 
6.1.13. 
Data Quality Assurance and Quality Control ...........................................................135 
6.1.14. 
Data Collection and Management ............................................................................136 
6.1.15. 
Source Documents ....................................................................................................136 
6.1.16. 
Retention of Records ................................................................................................136 
6.1.17. 
Study and Site Closure..............................................................................................137 
6.1.18. 
Publication Policy .....................................................................................................137 
6.2. 
APPENDIX 2: Contraceptive Guidance and Collection of Pregnancy 
Information ...............................................................................................................138 
6.3. 
APPENDIX 3: Adverse Events of Special Interest ..................................................140 
6.3.1. 
AESIs for RSV and Influenza ...................................................................................140 
6.3.2. 
AESIs for COVID (Part B only) ...............................................................................140 
6.4. 
APPENDIX 4: CDC Working Case Definition of Pericarditis, Myocarditis, 
and Myopericarditis Occurring After Receipt of COVID-19 mRNA 
Vaccines ....................................................................................................................144 
6.5. 
APPENDIX 5: Protocol Amendment History ..........................................................146 
6.5.1. 
Protocol Amendment 4 .............................................................................................146 
6.5.2. 
Protocol Amendment 3 .............................................................................................147 
6.5.3. 
Protocol Amendment 2 .............................................................................................148 
6.5.4. 
Protocol Amendment 1 .............................................................................................150 
 
 
 

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LIST OF TABLES  
Table 1: 
SoA (Part A) ...............................................................................................................33 
Table 2: 
Study Objectives and Endpoints (Part A) ...................................................................35 
Table 3: 
Randomized Groups ...................................................................................................37 
Table 4: 
Solicited Adverse Reactions and Grades ....................................................................54 
Table 5: 
Sample Size Justification for the Co-primary Endpoints ...........................................66 
Table 6: 
Analysis Sets ...............................................................................................................67 
Table 7: 
SoA (Part B) ...............................................................................................................77 
Table 8: 
Study Objectives and Endpoints (Part B) ...................................................................80 
Table 9: 
Randomized Groups (Part B)......................................................................................82 
Table 10: Sample Size Justification for the Co-primary Endpoints ...........................................98 
Table 11: SoA (Part C) .............................................................................................................105 
Table 12: Study Objectives and Endpoints (Part C) .................................................................108 
Table 13: Analysis Sets for Part C ............................................................................................124 
Table 14: Adverse Events of Special Interest ...........................................................................140 
Table 15: AESIs for COVID .....................................................................................................141 
Table 16: CDC Working Case Definition of Pericarditis, Myocarditis, and 
Myopericarditis Occurring After Receipt of COVID-19 mRNA Vaccines .............144 
 
LIST OF FIGURES  
Figure 1: 
Study Schema (Part A) ...............................................................................................32 
Figure 2: 
Study Schema (Part B) ................................................................................................76 
Figure 3: 
Study Schema (Part C) ..............................................................................................104 
 
 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS  
The following abbreviations and terms are used in this study protocol. 
Abbreviation or Specialist Term 
Definition 
Ab 
antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
ANCOVA 
analysis of covariance 
AR 
adverse reaction 
bAb 
binding antibody 
BD 
booster dose 
CDC 
Centers for Disease Control and Prevention 
CEAC 
Cardiac Event Adjudication Committee 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CoV 
coronavirus 
COVID-19 
coronavirus disease 2019 
CRO 
contract research organization 
CSR 
clinical study report 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eDiary 
electronic diary 
EoS 
end of study 
FAS 
full analysis set 
FluSurv-NET 
Influenza Hospitalization Surveillance Network 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GLSM 
geometric least squares mean 
GM 
geometric mean 
GMC  
geometric mean concentration 
GMFR 
geometric mean fold rise 
GMR 
geometric mean titer ratio 

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Abbreviation or Specialist Term 
Definition 
GMT 
geometric mean titer 
HA 
hemagglutinin  
HAI 
hemagglutination inhibition 
HCP 
healthcare practitioner 
HIV 
human immunodeficiency virus 
IA 
interim analysis 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use 
Ig 
immunoglobulin 
IM 
intramuscular 
IP 
investigational product 
IST 
Internal Safety Team 
IRB 
Institutional Review Board 
IRT 
interactive response technology 
LB 
lower bound 
LLOQ 
lower limit of quantification 
LNP 
lipid nanoparticle 
LTFU 
lost to follow-up 
MAAE 
medically attended adverse event 
MedDRA 
Medical Dictionary for Regulatory Activities 
mRNA 
messenger ribonucleic acid 
nAb 
neutralizing antibody 
NH 
Northern Hemisphere  
PP 
per protocol 
RSV 
respiratory syncytial virus  
RSV-LRTD 
respiratory syncytial virus-associated lower respiratory tract 
disease 
S-2P 
prefusion stabilized spike glycoprotein 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 

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Abbreviation or Specialist Term 
Definition 
SH 
Southern Hemisphere  
SoA 
schedule of assessments  
SCR 
seroconversion rate 
SRR 
seroresponse rate 
ULOQ 
upper limit of quantification 
US 
United States 
USP 
United States Pharmacopeia 
WHO 
World Health Organization 
 
 

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1. INTRODUCTION  
This study is divided into Part A (Section 2), Part B (Section 3), and Part C (Section 4). 
Part A is a Phase 3 randomized, observer-blind, study to evaluate safety, tolerability, and 
immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or 
coadministered with a seasonal influenza vaccine in adults ≥50 years of age. 
Part B utilizes a similar study design to Part A with a severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) vaccine (mRNA-1273.214) in place of the seasonal influenza 
vaccine. The differences in the Part B study design are discussed in Section 3. 
Part C is a Phase 3 single arm, open-label study to evaluate safety, tolerability, and 
immunogenicity of a BD of mRNA-1345 given at 1 year following a primary dose in adults 
≥50 years of age. 
1.1. Background and Overview  
Lower respiratory tract infections, including pneumonia, represent a substantial burden of illness 
in older adults. It is estimated that lower respiratory infections caused approximately 
1.27 million deaths (95% confidence interval [CI]: 1.15-1.34 million) in older adults across 
195 countries in 2015 (Global Burden of Disease 2015).  
Respiratory syncytial virus 
RSV is a single-stranded, enveloped, RNA virus that belongs to the Pneumoviridae family. The 
fusion glycoprotein of the RSV envelope is a conserved target of protective nAbs for both 
serotypes of RSV: RSV-A and RSV-B. RSV has been identified as one of the important 
etiologies of acute respiratory disease in older adults and is increasingly recognized as a major 
cause of illness in adults with certain comorbidities (“high risk”), including those with chronic 
lung and heart disease (Falsey et al 2000, Falsey et al 2005, Shi et al2020). 
A 4-year prospective cohort study indicated that RSV infection developed annually in 3% to 7% 
of healthy older adults and in 4% to 10% of high-risk adults, translating to an estimated 
177,000 hospital admissions, 14,000 deaths, and hospitalization costs exceeding $1 billion each 
year in the US (Falsey et al 2005). An active surveillance study across multiple centers in the US 
estimated that the hospital admission rate of RSV-associated community-acquired pneumonia in 
adults aged 50 to 64 years was 0.8 cases/10,000 persons per year, with higher rates in adults aged 
65 to 79 years (2.5 cases/10,000 persons per year) and ≥80 years (5.0 cases/10,000 persons per 
year) (Jain et al 2015). Globally, there are an estimated 336,000 hospitalizations (95% CI: 
186,000-614,000) and 14,100 in-hospital deaths (95% CI: 4,800-50,500) in older adults each 
year related to RSV-associated acute respiratory infection (Shi et al 2020). 
While most adults have been previously infected with RSV and therefore demonstrate some level 
of RSV protective immunity, the immune requirements for protection in older adults are not well 
understood. The level of humoral response is a strong correlate of immune protection, as 
decreased serum neutralizing activity and/or decreased nasal RSV-specific immunoglobulin 
(Ig)A are risk factors for RSV infection, including more severe disease (Duncan et al 2009; 
Falsey et al 2000; Luchsinger et al 2012; Piedra et al 2003; Walsh et al 2013). Waning cellular 
immunity may also play a role in the susceptibility of the elderly to RSV infections, as healthy 
adults older than 60 years of age have increased numbers of regulatory (immunosuppressive) 

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T cells and fewer RSV-specific CD8+ T cells (Cherukuri et al 2013; Cusi et al 2010; de Bree et 
al 2005; Kurzweil et al 2013; Looney et al 2002). 
Therefore, with no existing approved vaccine or specific therapy for RSV infection, RSV 
remains a significant unmet medical need globally. 
Influenza 
Influenza is a respiratory virus that has a segmented RNA genome, allowing for new strains to 
arise by genetic reassortment (Bartoszko et al 2021). Seasonal influenza viruses are estimated by 
the World Health Organization (WHO) to cause 3 million to 5 million cases of severe illness and 
up to 650,000 deaths each year resulting in a severe challenge to public health (WHO 2018). 
Influenza epidemics occur each year and follow a seasonal circulation pattern with increased 
cases during the winter months in the Northern Hemisphere (NH) and Southern Hemisphere 
(SH) (Riedel et al 2019). Since influenza viruses continuously change through a process termed 
antigenic drift, the circulating viruses are actively monitored by a worldwide monitoring network 
coordinated by the WHO (Monto et al 2018). Based on the observed circulation patterns and 
antigenic changes, an expert panel recommends influenza virus strains to be used for vaccine 
manufacturing twice per year (once for the NH and once for the SH). Influenza A and 
influenza B viruses are the most relevant influenza viruses for human infection. Therefore, 
current vaccine recommendations include 1 influenza A H1N1 strain, 1 influenza A H3N2 strain, 
and 2 influenza B strains (covering the B/Victoria and B/Yamagata lineages). 
It is well accepted that the risk of complications due to influenza increases with age 
(Bartoszko et al 2021). An analysis of the US Influenza Hospitalization Surveillance Network 
(FluSurv-NET) showed that hospitalization rates among adults aged 75–84 years and ≥85 years 
were 1.4–3.0 and 2.2–6.4 times greater, respectively, than rates for adults aged 65–74 years. 
In-hospital death or transfer to hospice occurred in 3.8% of patients aged 65–74 years, 5.3% of 
patients aged 75–84 years, and 8.7% of patients aged ≥85 years (Czaja et al 2019). Similarly, 
data from 33 countries demonstrated that the highest excess mortality rates were found among 
patients aged 75 years and older (17.9–223.5 per 100,000) (Iuliano et al 2018).  
Respiratory syndrome coronavirus 2 (SARS-CoV-2) 
Coronaviruses (CoVs) are a large family of viruses that cause illness ranging from the common 
cold to more severe diseases, such as Middle East respiratory syndrome and severe acute 
respiratory syndrome. An outbreak of a novel CoV (later designated SARS-CoV-2, the causative 
agent of coronavirus disease 2019 [COVID-19]) initially emerged in Wuhan, Hubei Province, 
China in December 2019. The WHO declared COVID-19 a pandemic on 11 Mar 2020, and 
COVID-19 continues to have a major global public health impact, with more than 500 million 
cases and 6.2 million deaths as of 27 Apr 2022. ModernaTX, Inc. (Sponsor), leveraged its 
foundational understanding of messenger ribonucleic acid (mRNA) vaccine approaches against 
CoV to develop a rapid response proprietary vaccine platform and the mRNA-1273 
(SPIKEVAX™) vaccine, which is a lipid nanoparticle (LNP) encapsulated, mRNA-based 
vaccine against SARS-CoV-2. 
Of major public health concern is whether immunity to early pandemic strains, developed via 
vaccination (or natural infection), confers protection against newly circulating variants. With the 
Omicron variant [B.1.1.529] as the predominant variant circulating since November 2021, public 
health experts have observed cases of breakthrough infection, although most such cases have 

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been mild to moderate. The US Centers for Disease Control and Prevention (CDC) and European 
Centre for Disease Prevention and Control have identified and concurred with the use of booster 
vaccinations of the prototype vaccine to bridge the gap until a variant-matched vaccine which 
confers superior protection can be available. 
1.1.1. mRNA-1345  
ModernaTX, Inc. (the Sponsor) has developed a rapid response, proprietary vaccine platform 
based on a messenger RNA (mRNA) delivery system. The platform is based on the principle and 
observations that cells in vivo can take up mRNA, translate it, and then express protein viral 
antigen(s) on the cell surface. The delivered mRNA does not enter the cellular nucleus or interact 
with the genome, is nonreplicating and transient, and delivers only the elements required for 
expression of the encoded protein. 
mRNA-1345 is a lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine to prevent disease 
associated with RSV infection. 
mRNA-1345 encodes the RSV fusion glycoprotein that is stabilized in the prefusion 
conformation. The fusion protein exists in 2 primary conformational states, the metastable 
prefusion state drives fusion of the virus and host cell membranes through a conformational 
change to the stable postfusion state. The prefusion conformation is the primary target of the 
natural immune response to RSV, displays all the epitopes known to elicit nAbs, and induces a 
higher nAb response than the postfusion conformation, both in animal models and humans 
(Crank et al 2019, Graham 2019, McLellan et al 2013, Ngwuta et al 2015). 
1.1.2. Afluria® Quadrivalent Influenza Vaccine  
Afluria® Quadrivalent is an egg-based, inactivated influenza vaccine indicated for active 
immunization against influenza disease. The vaccine will be provided to the study site in its 
commercial packaging, containing the recommended influenza strains for the 2021-2022 
influenza season in the NH. 
1.1.3. mRNA-1273.214  
mRNA-1273.214 is based on the same platform described in Section 1.1.1. mRNA-1273.214 
contains CX-024414, the mRNA that encodes for the prefusion stabilized spike glycoprotein 
(S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-031302, the mRNA that encodes for 
the S-2P of the SARS-CoV-2 B.1.1.529 variant. 
1.1.4. Study Rationale  
Part A: 
The Sponsor’s position is that the coadministration of mRNA-1345 with a seasonal influenza 
vaccine will allow people to receive both vaccines at once to reduce the number of visits and add 
to the uptake/convenience in the elderly population that is at risk for both severe RSV and 
influenza diseases. 
Part B: 
The Sponsor’s position is that the coadministration of mRNA-1345 with vaccines that are 
recommended for older adults, including SARS-CoV-2 vaccines, will allow people to receive 

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both vaccines at once to reduce the number of visits and add to the uptake/convenience in the 
elderly population that is at risk for both severe RSV and COVID. 
Part C: 
The Sponsor’s position is that administering a booster at 1 year following initial mRNA-1345 
vaccination will allow for the assessment of whether re-vaccination increases RSV antibody 
titers to comparable levels observed after initial administration of mRNA-1345. 
1.1.5. Nonclinical Studies  
Nonclinical immunogenicity and safety studies have been completed by the Sponsor with 
mRNA-1345 or similar mRNA-based vaccines formulated in SM-102 (heptadecan-9-yl 8 
((2 hydroxyethyl) (6 oxo-6-(undecyloxy) hexyl) amino) octanoate), the custom manufactured 
lipid used in the mRNA-1345 LNP formulation. 
In an in vivo dose-response study, the immunogenicity of mRNA-1345 was evaluated in female 
BALB/c mice at 4 dose levels (
 µg) after intramuscular (IM) injections on Day 1 
and Day 22. mRNA-1345 induced a dose-dependent RSV-nAb and bAb response and a balanced 
Ig G2a:IgG1 response, indicating a T helper 1 response. 
In addition, in a non-Good Laboratory Practice immunogenicity and safety study in Sprague 
Dawley rats, mRNA-1345 was administered at clinically relevant dose levels of 
 
 µg/dose via IM injections on Day 1 and Day 22. Respiratory syncytial virus-nAbs were 
detected in the serum of all animals administered mRNA-1345, and a dose-dependent nAb 
response was observed. Administration of mRNA-1345 was well tolerated up to 
 µg/dose. 
There were no mRNA-1345 –related mortalities or changes in body weight or body weight gains. 
Clinical signs consisted of transient local effects of edema and impaired limb functions at the 
injection site. Changes in clinical pathology parameters were consistent with an inflammatory 
response, in addition to a mild liver effect in individual animals. 
A detailed review of nonclinical experience with the mRNA-1345 vaccine is provided in the IB. 
For a detailed review of nonclinical experience with the mRNA-1273.214/1273 vaccine, please 
refer to the most recent version of the mRNA-1273 IB. 
1.1.6. Clinical Studies  
The mRNA-1345 vaccine is currently being evaluated for safety and immunogenicity in a 
Phase 1 study (NCT04528719) and a Phase 2/3 study (NCT05127434). 
The Phase 1 study (mRNA-1345-P101) is an observer-blind, placebo-controlled, dose-escalation 
study of mRNA-1345 in healthy younger adults aged 18 to 49 years, women of childbearing 
potential aged 18 to 40 years, healthy older adults aged 65 to 79 years, Japanese older adults 
aged ≥60 years, and RSV seropositive children aged 12 to 59 months. Five dose levels of 
mRNA-1345 are to be evaluated in the Phase 1 study, first 
 µg, 
 µg, and 
 µg dose levels 
in healthy younger adults aged 18 to 49 years, and then 
 µg, 
 µg, and 
 µg dose levels in 
women of childbearing potential and 
 µg, 
 µg, 
 µg, 
 µg, and 
 µg dose levels in 
healthy older adults aged 65 to 79 years (
 µg dose level in Japanese healthy older adults aged 
≥60 years), as well as 
 µg and 
 µg dose levels in RSV seropositive children aged 12 to 
59 months. Older adult participants enrolled in the US who initially received mRNA-1345 on 
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Day 1 will also receive the same dose level of mRNA-1345 or placebo as a BD at Month 12. The 
results from this initial study will be used to support and inform subsequent evaluations of the 
mRNA-1345 vaccine in future clinical studies. 
The Phase 2/3 study (mRNA-1345-P301) is a randomized, observer-blind, placebo-controlled 
study to evaluate the safety, efficacy, and immunogenicity of mRNA-1345 in adults ≥60 years of 
age. In Phase 2 part between 400 and 2,000 participants will be randomly assigned to receive a 
single injection of 
 µg of the mRNA-1345 vaccine or a placebo in a 1:1 randomization ratio. 
Enrollment in the Phase 3 part of the study will be triggered by the DSMB’s review of the 
Day 29 safety data from the first 400 participants in the Phase 2 part of the study. In Phase 3, 
between 32,000 and 33,600 participants will be randomly assigned to receive a single injection 
of either 
 µg of the mRNA-1345 vaccine or a placebo in a 1:1 randomization ratio. Overall, 
approximately 37,000 participants will be enrolled in the Phase 2/3 study. 
mRNA-1273 (SPIKEVAX) booster is marketed globally. mRNA-1273.214 is currently under 
investigation as a single 
 μg booster dose in adults ≥18 years of age who have previously 
received the mRNA-1273 primary series as well as a booster dose (mRNA-1273-P205). 
mRNA-1273.214 is also under investigation in a Phase 3 study as a single 
 μg booster dose in 
adults ≥16 years of age in the UK (mRNA-1273-P305). For a detailed review of clinical 
experience with the mRNA-1273.214/1273 vaccine, please refer to the most recent version of the 
mRNA-1273 IB. 
1.2. Benefit/Risk Assessment  
Summaries of the potential risks and benefits of mRNA-1345 and mRNA-1273 are provided in 
the most recent versions of the IBs. 
1.2.1. Known Potential Benefits  
Participants who receive mRNA-1345 may or may not directly benefit from the vaccination, as 
the efficacy of mRNA-1345 is yet to be established. 
Participants will be contributing to the process of developing a new potentially prophylactic 
measure in an area of unmet medical need (the prevention of RSV-LRTD). 
Participants who receive the mRNA-1273.214 vaccine as a booster dose in Part B of the study 
may be provided with improved protection against COVID-19 variants of concern. 
1.2.2. Risks From Study Participation and Their Mitigation  
Immediate systemic allergic reactions (eg, anaphylaxis) can occur following any vaccination. 
These reactions are very rare and are estimated to occur once per 450,000 vaccinations for 
vaccines that do not contain allergens such as gelatin or egg protein (Zent et al 2002). As a 
precaution, all participants will remain under observation at the study site for at least 30 minutes 
after study injection. 
Vasovagal syncope (fainting) can occur before or after any vaccination, is usually triggered by 
the pain or anxiety caused by the injection and is not related to the substance injected. Therefore, 
it is important that standard precautions and procedures be followed to avoid injury from 
fainting. 
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Intramuscular vaccination commonly precipitates a transient and self-limiting local inflammatory 
reaction. This typically includes pain, erythema (redness), or swelling (hardness) at the injection 
site, which are mostly mild to moderate in severity and usually occur within 24 hours of the 
vaccination. 
Most systemic AE) observed after vaccination do not exceed mild-to-moderate severity. The 
most commonly reported systemic ARs are anticipated to be fever, fatigue, chills, headache, 
myalgia, and arthralgia. 
Laboratory abnormalities (including increases in liver function tests and serum lipase levels) 
following vaccination were observed in some clinical studies with similar mRNA-based 
vaccines. These abnormalities were without clinical symptoms or signs and returned toward 
baseline (Day 1) values over time. The clinical significance of these observations is unknown. 
In the post-authorization setting, there have been very rare reports of myocarditis and pericarditis 
occurring after vaccination with COVID-19 mRNA vaccines. The majority of the cases have 
been reported in young males shortly after the second dose of the vaccine. These are typically 
mild cases, and individuals tend to recover within a short time following standard treatment and 
rest. Investigators and participants should be alert to the signs and symptoms of myocarditis and 
pericarditis (Gargano et al 2021). 
1.2.3. Overall Benefit/Risk Conclusion  
Appropriate eligibility criteria, as well as specific criteria for delaying the vaccination, are 
included in this protocol. The risk to participants in this study may be minimized by compliance 
with the eligibility criteria and study assessments and procedures. 
All safety findings will be closely monitored and reviewed by the study team as well as an 
Internal Safety Team (IST) and an independent DSMB (Part A and Part B) to evaluate the safety 
and treatment status of all participants. The DSMB will review and assess the safety data as 
described in a separate charter. 
The proposed Phase 3 clinical study (Part A) evaluating the coadministration of mRNA-1345 
and Afluria Quadrivalent in adults ≥50 years of age is supported by nonclinical safety and 
immunogenicity studies and a Phase 1 clinical study. 
Considering the measures used to minimize the risk to individuals participating in this study and 
oversight by the study team, an IST, and independent DSMB (Part A and Part B), the potential 
risks to the participants are justified by the potential benefits linked to the development of the 
RSV vaccine and its coadministration with a commercially available influenza vaccine (Part A) 
or approved/investigational SARS-CoV-2 vaccine (Part B) or as a booster dose at 1 year 
following a primary dose (Part C). 
For participants who receive mRNA-1273.214 (Part B), considering the nonclinical data for 
mRNA-1273.214 and clinical trial safety data for mRNA-1273 (and other mRNA vaccines 
manufactured to date by the Sponsor that contain the proprietary SM-102 lipid formulation), the 
Sponsor considers the potential benefits of participation to exceed the risks. 

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2. PART A  
Part A is a Phase 3 randomized, observer-blind, study to evaluate safety, tolerability, and 
immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or 
coadministered with a seasonal influenza vaccine in adults ≥50 years of age. 
2.1. Protocol Summary  
2.1.1. Synopsis (Part A)  
Protocol Title: 
A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and 
Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus 
(RSV), When Given Alone or Coadministered with a Seasonal Influenza Vaccine or SARS-
CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in 
Adults ≥50 Years of Age 
Regulatory Agency Identifier Numbers: 
Investigational New Drug: 23342 
Rationale: 
This study is designed as a randomized, observer-blind study to evaluate the safety and 
immunogenicity of mRNA-1345 when coadministered with a commercial influenza vaccine 
(Afluria Quadrivalent) compared with either vaccine alone in older adults ≥50 years of age who 
are medically stable. Participants will receive either mRNA-1345 + placebo, mRNA-1345 + 
Afluria Quadrivalent, or Afluria Quadrivalent + placebo in contralateral arms.  
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and tolerability of 
mRNA-1345 coadministered with a 
seasonal influenza vaccine (Afluria® 
Quadrivalent) 
• 
Numbers and percentages of participants with 
solicited local and systemic adverse reactions 
(ARs) over the 7 days postinjection 
• 
Numbers and percentages of unsolicited adverse 
events (AEs) through 28 days postinjection 
• 
Numbers and percentages of medically attended 
AEs (MAAEs), serious AEs (SAEs), adverse 
events of special interest (AESIs) and AEs 
leading to withdrawal Day 1 (baseline) to 
Day 181/ EoS 
• 
To evaluate the impact of 
coadministered influenza vaccine on the 
immune response to RSV-A 
• 
Geometric mean titer (GMT) of serum RSV-A 
neutralizing Abs at Day 29  
• 
Seroresponse rate (SRR) in RSV-A neutralizing 
Abs at Day 29 

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Objectives 
Endpoints 
• 
To evaluate the impact of 
coadministered RSV vaccine on the 
immune response to influenza 
• 
GMT of serum Ab level as measured by 
hemagglutination inhibition (HAI) assay for 
influenza at Day 29 
Key Secondary 
• 
To evaluate the impact of 
coadministered influenza vaccine on the 
immune response to RSV-B 
 
• 
GMT of serum RSV-B neutralizing Abs at Day 
29 
• 
SRR in RSV-B neutralizing Abs at Day 29 
• 
To evaluate the impact of 
coadministered RSV vaccine on the 
immune response to influenza based on 
seroconversion from baseline 
• 
Seroconversion rate (SCR) in influenza A and B 
strains at Day 29 
Secondary 
• To evaluate Ab response to mRNA-
1345 with and without a seasonal 
influenza vaccine (Afluria® 
Quadrivalent) 
• GMT and geometric mean fold rise (GMFR) 
of post-injection/baseline titers to RSV-A 
neutralizing Abs up to Day 181/EoS 
• GMT and GMFR of post-injection/baseline 
titers to RSV-B neutralizing Abs up to 
Day 181/EoS  
• Proportion of participants with ≥2-fold 
increases in RSV-A neutralizing Ab titers up 
to Day 181/EoS 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in RSV-B neutralizing Ab 
titers up to Day 181/EoS 
• To evaluate the Ab response to 
seasonal influenza vaccine (Afluria® 
Quadrivalent) with and without 
mRNA-1345 
• SCR at Day 181/EoS in anti-HA Abs 
measured by HAI assay 
• GMT and GMFR of serum Ab level as 
measured by HAI assay for influenza up to 
Day 181/EoS 
Exploratory (may be performed) 
• To further characterize the immune 
response across study vaccines  
• Geometric mean concentration (GMC) and GMFR 
of post-injection/baseline titers to RSV-binding 
Abs up to Day 181/EoS 
• Proportion of participants with ≥2-fold and ≥4-fold 
increases in RSV-binding Ab concentration up to 
Day 181/EoS 

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Objectives 
Endpoints 
• Frequency, specificities, or other endpoints to be 
determined for the further characterization of 
immune responses  
Overall Design: 
Part A is a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and 
immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or 
coadministered with a seasonal influenza vaccine (Afluria Quadrivalent) in adults ≥ 50 years of 
age. 
All participants will participate in a Screening period (up to 14 days before Day 1), treatment 
period (vaccine and/or placebo administration on Day 1 [Baseline]), and a follow-up period (up 
to 6 months after vaccination). 
The study will enroll approximately 1620 adults ≥50 years of age who are medically stable. On 
Day 1, each participant will receive 2 injections administered IM, one in each arm, in the deltoid 
muscle. Participants will be randomized as shown in the below table to receive either 
(1) mRNA-1345 (
 μg) + placebo (0.9% sodium chloride [normal saline]); (2) mRNA-1345 
(
 μg) + Afluria® Quadrivalent; or (3) Afluria® Quadrivalent + placebo. Randomization will be 
stratified by age (50 to 59 years, 60 to 74 years, and ≥75 years). The study will target enrollment 
of approximately 20% of participants 50 to 59 years of age. 
Group Name 
Sample Size 
Vaccine Administered 
Group 1 
420 
mRNA-1345 (
 μg) + placebo in 
contralateral arms 
Group 2 
600 
mRNA-1345 (
 μg) + Afluria 
Quadrivalent in contralateral arms 
Group 3 
600 
Afluria Quadrivalent + placebo in 
contralateral arms 
Participants will have a total of 8 visits/safety telephone calls. At the dosing visit on Day 1, 
participants will be instructed how to document, and report solicited ARs in a provided 
electronic diary (eDiary). Solicited ARs will be assessed from Day 1 through Day 7 (the day of 
injection and the following 6 days), and local solicited ARs will be assessed separately for each 
injection site. Unsolicited AEs will be assessed from Day 1 through Day 28 (the day of injection 
and the following 27 days). Serious AEs, MAAEs, AEs leading to withdrawal, and AESIs will 
be assessed from Day 1 through Day 181/EoS. 
Blood sample collection for humoral immunogenicity will occur on Day 1, Day 29, and 
Day 181/EoS. The samples will be processed and analyzed per the Laboratory Manual. The 
Day 8 visit (Visit 2) may be either at the study site or a via a telephone call. The study site staff 
will perform scheduled safety telephone calls to participants on Day 57, Day 91, Day 121, and 
Day 151 to collect AEs, MAAEs, AESIs, AEs leading to withdrawal, SAEs, and information 
about concomitant medications related to those events and receipt of nonstudy vaccinations. 
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Participants may experience AEs that necessitate an unscheduled visit. There may also be 
situations in which the investigator asks a participant to attend an unscheduled visit following the 
report of an AE. Additional examinations may be conducted at these visits as necessary to ensure 
the safety and well-being of participants during the study. Electronic case report forms (eCRFs) 
should be completed for each unscheduled visit. 
Brief Summary: 
The purpose of this study is to assess the safety and immune response of mRNA-1345, an 
mRNA vaccine targeting RSV, when given alone or coadministered with a seasonal influenza 
vaccine in healthy older adults. 
Study details include: 
• The study duration will be up to 6 months. 
• The treatment is 2 injections on Day 1. 
• The visit frequency will be 3 visits in the first month (Days 1 [clinic], 8 [clinic or 
telephone call], and 29 [clinic]); 4 (one per month) safety telephone calls from 
Months 2 through 5, and a clinic visit at Month 6. 
Number of Participants: 
Approximately 1620 participants will be enrolled. 
Note: Enrolled means participants’, or their legally acceptable representatives’, agreement to 
participate in a clinical study following completion of the informed consent process. Potential 
participants who are screened for the purpose of determining eligibility for the study, but do not 
participate in the study, are not considered enrolled unless otherwise specified by the protocol. A 
participant will be considered enrolled if the informed consent is not withdrawn prior to 
participating in any study activity after screening. 
Data Monitoring/other Committee: 
Safety monitoring for this study will include the blinded study team members, inclusive of, at a 
minimum, the Sponsor’s medical monitor and a contract research organization (CRO) medical 
monitor, a blinded IST, and an unblinded DSMB. The study team will conduct ongoing blinded 
safety reviews during the study and will be responsible for notifying the IST and DSMB of 
potential safety signal events. The IST will be composed of the Sponsor’s physicians and may 
also include Sponsor-designated members from the CRO, as specified in the study IST charter. 
The IST will conduct ad hoc reviews as requested by the study medical monitor and study team. 
The DSMB, composed of external/independent subject matter experts, will conduct unblinded 
reviews of safety data on an ad hoc basis if requested by the study team and/or the IST. 
This study will be conducted in compliance with the protocol, GCP, and all applicable regulatory 
requirements. 

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2.1.2. Schema (Part A)  
Figure 1: 
Study Schema (Part A) 
 
Abbreviation: V = visit. 
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2.1.3. SoA (Part A)  
Table 1: 
SoA (Part A) 
Visit Number 
Screening 
1 
2 
3 
4, 5, 6, 7 
8 
USV 
Type of Visit 
C 
C 
C/SC 
C 
SC 
C 
C 
Month Timepoint 
N/A 
 
 
M1 
M2-M5 
M6 
Up to M6 
Visit Day  
Screeninga 
D1 
(Baseline)
a 
D8 
D29 
D57, D91, 
D121, 
D151 
D181/ 
EoS 
N/A 
Window Allowance (Days) 
-14 
- 
+3 
-7 to +2 
±5 
±14 
N/A 
Informed consent, demographics, concomitant medicationsh, and medical 
history  
X 
– 
– 
– 
– 
– 
– 
Inclusion/exclusion criteria 
X 
X 
– 
– 
– 
– 
– 
Physical examinationb 
X 
X 
– 
– 
– 
– 
– 
Vital sign measurementsc 
X 
X 
– 
– 
– 
– 
X 
Study vaccination (including a 30-minute postdose observation period)d 
– 
X 
– 
– 
– 
– 
– 
Blood sample collection for humoral immunogenicitye 
– 
X 
– 
X 
– 
X 
– 
Pregnancy testingf 
X 
X 
 
 
 
 
 
eDiary activation for recording solicited ARs (7 days)g 
– 
X 
– 
– 
– 
– 
– 
Optional blood collection for genomicse 
– 
X 
– 
– 
– 
– 
– 
Optional blood sample for transcriptomicse 
– 
X 
– 
X 
– 
X 
– 
Follow-up safety telephone callh 
– 
– 
– 
– 
X 
– 
– 
Recording of unsolicited AEs 
– 
X 
X 
X 
– 
– 
– 
Recording of SAEs, AESIs, MAAEs, AEs leading to discontinuation, 
and concomitant medications relevant to or for their treatmenti 
– 
X 
X 
X 
X 
X 
X 
Recording of nonstudy vaccinationsi 
X 
X 
X 
X 
X 
X 
X 
Study completion 
– 
– 
– 
– 
– 
X 
– 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; C = clinic visit; D = Day; eDiary = electronic diary; 
EoS = end of study; M = month; N/A = not applicable; MAAE = medically attended adverse event; SAE = serious adverse event; SC = safety telephone call; 
USV = unscheduled visit. 

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a. 
The Screening Visit and Day 1 Visit may be performed on the same day or on different days. Additionally, the Screening Visit may be performed over 
multiple visits if within the 14-day screening window. Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened 1 time within the 14-day Screening window if they will be eligible upon rescreening. 
b. 
A full physical examination, including height and weight, will be performed at the Screening Visit. Symptom-directed physical examinations will be 
performed at other study visits, if clinically indicated. Interim physical examinations will be performed at the discretion of the investigator. On the day of 
study injections, both arms should be examined, and the associated lymph nodes should be evaluated. Any clinically significant findings identified by a 
healthcare professional during study visits should be reported as an MAAE.  
c. 
Vital sign measurements include assessment of systolic and diastolic blood pressure, heart rate, respiratory rate, and body temperature (preferred route is 
oral). Fever is defined as a body temperature ≥38.0 °C/100.4 °F. The participant will be seated for at least 5 minutes before all measurements are taken. Vital 
signs will only be collected at Screening and on the day of vaccination (Day 1), once before and at least 30 minutes after vaccination. Vital signs will be 
collected at other clinical visits only in conjunction with a symptom-directed physical examination. 
d. 
All participants will be randomized to receive 2 intramuscular injections, one in each arm, in the deltoid muscle. 
e. 
Blood samples for humoral immunogenicity must be collected prior to administration of the IP on Day 1. Transcriptomic and genomic samples will be part 
of the optional biomarker assessment once consented by the study participant. 
f. 
A urine pregnancy test (β-human chorionic gonadotropin) will be performed on all female participants of childbearing potential at Screening and prior to 
study vaccination on Day 1. A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm menopausal status. 
At unscheduled visits, serum or urine pregnancy testing may be performed as needed at the discretion of the investigator. 
g. 
The eDiary entries will be recorded by the participant starting approximately 30 minutes after vaccination while at the clinic with instruction provided by 
study staff. Study participants will continue to record in the eDiary each day after they leave the clinic, preferably in the evening and at the same time each 
day, on the day of vaccination and for 6 days following vaccination. If the participant is unable to complete the eDiary on their own, a caregiver can assist 
with data entry, but the information entered in the eDiary must come from the participant. Local solicited ARs will be recorded separately for each injection. 
h. 
Medically qualified study staff will contact all participants. The participant will be interviewed according to the script. Information will be collected about 
occurrence of unsolicited AEs through 28 days post vaccination, and the occurrence of AESIs, MAAEs, SAEs, or AEs leading to study withdrawal and 
concomitant medications associated with those events, and receipt of any nonstudy vaccinations at all points of contact. 
i. 
All concomitant medications will be recorded from Day 1 through Day 28 days after vaccination; all nonstudy vaccinations and concomitant medications 
relevant to or for the treatment of an SAE, AESI, or MAAE will be recorded from Day 1 through Day 181/EoS.

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2.2. Objectives and Endpoints (Part A)  
The objectives and endpoints of this study are described in Table 2.  
Table 2: 
Study Objectives and Endpoints (Part A)  
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and tolerability of 
mRNA-1345 coadministered with a 
seasonal influenza vaccine (Afluria® 
Quadrivalent) 
• 
Numbers and percentages of participants with 
solicited local and systemic adverse reactions 
(ARs) over the 7 days post-injection 
• 
Numbers and percentages of unsolicited adverse 
events (AEs) through 28 days post-injection 
• 
Numbers and percentages of medically attended 
AEs (MAAEs), serious AEs (SAEs), adverse 
events of special interest (AESIs) and AEs 
leading to withdrawal Day 1 (baseline) to 
Day 181/ EoS 
• 
To evaluate the impact of 
coadministered influenza vaccine on the 
immune response to RSV-A 
• 
Geometric mean titer (GMT) of serum RSV-A 
neutralizing Abs at Day 29  
• 
Seroresponse rate (SRR) in RSV-A neutralizing 
Abs at Day 29 
• 
To evaluate the impact of 
coadministered RSV vaccine on the 
immune response to influenza 
• 
GMT of serum Ab level as measured by 
hemagglutination inhibition (HAI) assay for 
influenza at Day 29 
Key Secondary 
• 
To evaluate the impact of 
coadministered influenza vaccine on the 
immune response to RSV-B 
• 
GMT of serum RSV-B neutralizing Abs at Day 
29 
• 
SRR in RSV-B neutralizing Abs at Day 29 
• 
To evaluate the impact of 
coadministered RSV vaccine on the 
immune response to influenza based on 
seroconversion from baseline 
• 
Seroconversion rate (SCR) in influenza A and B 
strains at Day 29 
Secondary 
• To evaluate Ab response to mRNA-
1345 with and without a seasonal 
influenza vaccine (Afluria® 
Quadrivalent) 
• GMT and geometric mean fold rise (GMFR) 
of post-injection/baseline titers to RSV-A 
neutralizing Abs up to Day 181/EoS 
• GMT and GMFR of post-injection/baseline 
titers to RSV-B neutralizing Abs up to 
Day 181/EoS  

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Objectives 
Endpoints 
• Proportion of participants with ≥2-fold 
increases in RSV-A neutralizing Ab titers up 
to Day 181/EoS 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in RSV-B neutralizing Ab 
titers up to Day 181/EoS 
• To evaluate the Ab response to 
seasonal influenza vaccine (Afluria® 
Quadrivalent) with and without 
mRNA-1345 
• SCR at Day 181/EoS in anti-HA Abs 
measured by HAI assay 
• GMT and GMFR of serum Ab level as 
measured by HAI assay for influenza up to 
Day 181/EoS 
Exploratory (may be performed) 
• To further characterize the immune 
response across study vaccines  
• 
Geometric mean concentration (GMC) and 
GMFR of post-injection/baseline titers to 
RSV-binding Abs up to Day 181/EoS 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in RSV-binding Ab 
concentration up to Day 181/EoS 
• Frequency, specificities, or other endpoints to be 
determined for the further characterization of 
immune responses 
2.3. Study Design  
2.3.1. General Design (Part A)  
This is a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and 
immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or 
coadministered with a seasonal influenza vaccine (Afluria Quadrivalent) in adults ≥50 years of 
age. 
All participants will participate in a Screening period (up to 14 days before Day 1), treatment 
period (vaccine and/or placebo administration on Day 1 [Baseline]), and a follow-up period (up 
to 6 months after vaccination). The study schema is presented in Figure 1. 
The study will enroll approximately 1620 medically stable adults ≥50 years of age. The 
eligibility criteria are provided in Section 2.4. On Day 1, each participant will receive 2 
injections administered IM, one in each arm, in the deltoid muscle. Participants will be 
randomized as shown in Table 3 to receive either 1) mRNA-1345 (
 μg) + placebo (0.9% 
sodium chloride [normal saline]); 2) mRNA-1345 (
 μg) + Afluria® Quadrivalent; or 3) 
Afluria® Quadrivalent + placebo. Randomization will be stratified by age (50 to 59 years, 60 to 
74 years, and ≥75 years). The study will target enrollment of approximately 20% of participants 
50 to 59 years of age. 
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Table 3: 
Randomized Groups  
Group Name 
Sample Size 
Vaccine Administered 
Group 1 
420 
mRNA-1345 (
 μg) + placebo in contralateral arms 
Group 2 
600 
mRNA-1345 (
 μg) + Afluria Quadrivalent in contralateral arms 
Group 3 
600 
Afluria Quadrivalent + placebo in contralateral arms 
The Schedule of Assessments (SoA) is provided in Table 1. 
Participants will have a total of 8 visits/safety telephone calls. At the dosing visit on Day 1, 
participants will be instructed how to document, and report solicited ARs in a provided 
electronic diary (eDiary). Solicited ARs will be assessed from Day 1 through Day 7 (the day of 
injection and the following 6 days), and local solicited ARs will be assessed separately for each 
injection site. Unsolicited AEs will be assessed from Day 1 through Day 28 (the day of injection 
and the following 27 days). Serious AEs, MAAEs, AEs leading to withdrawal, and AESIs will 
be assessed from Day 1 through Day 181/EoS. 
Blood sample collection for humoral immunogenicity will occur on Day 1, Day 29, and 
Day 181/EoS. The samples will be processed and analyzed per the Laboratory Manual. The 
Day 8 visit (Visit 2) may be either at the study site or a via a telephone call. The study site staff 
will perform scheduled safety telephone calls to participants on Day 57, Day 91, Day 121, and 
Day 151 to collect AEs, MAAEs, AESIs, AEs leading to withdrawal, SAEs, and information 
about concomitant medications related to those events and receipt of nonstudy vaccinations. 
Participants may experience AEs that necessitate an unscheduled visit. There may also be 
situations in which the investigator asks a participant to attend an unscheduled visit following the 
report of an AE. Additional examinations may be conducted at these visits as necessary to ensure 
the safety and well-being of participants during the study. eCRFs should be completed for each 
unscheduled visit. 
The IST will also conduct ad hoc reviews throughout the study as requested by the study medical 
monitor and study team. An independent, unblinded DSMB will be used throughout the conduct 
of this study. This committee will be composed of independent members with relevant 
therapeutic and/or biostatistical expertise to allow for the ongoing review of safety data from this 
study population. The safety data will be reviewed according to intervals defined in the DSMB 
charter and will occur as needed when study stopping or pausing criteria are met or as otherwise 
requested by the study team and/or IST. See Section 2.7.6 for details on the IST and DSMB 
constituted in this study.  
This study will be conducted in compliance with the protocol, GCP, and all applicable regulatory 
requirements. 
2.3.2. Scientific Rationale for Study Design  
This study is designed as a randomized, observer-blind study to evaluate the safety and 
immunogenicity of mRNA-1345 when coadministered with a commercial influenza vaccine 
(Afluria Quadrivalent) compared with either vaccine alone in medically stable older adults 
≥50 years of age. Participants will receive either mRNA-1345 + placebo, mRNA-1345 + Afluria 
Quadrivalent, or Afluria Quadrivalent + placebo in contralateral arms.  
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Local solicited ARs will be recorded separately for each injection site from Day 1 through Day 7 
using eDiaries. Unsolicited AEs will be recorded from Day 1 through Day 28. Recording of 
nonstudy vaccinations and concomitant medications relevant to or for the treatment of an SAE, 
AESI, or MAAE will be recorded from Day 1 through Day 181/EoS.  
Humoral immune responses to both RSV and influenza will be examined at baseline and several 
time points throughout the study (Table 1). 
2.3.3. Choice of Vaccine Dose  
The 
-µg dose of mRNA-1345 was selected for this study based on the mRNA-1345-P101 
study data (Section 1.1.6). 
2.3.4. EoS Definition  
A participant is considered to have completed the study if he or she has completed the last 
scheduled procedure on Day 181 (ie, 6 months after administration of the investigational product 
(IP) on Day 1; Table 1). 
The EoS is defined as completion of the last visit of the last participant in the study or last 
scheduled procedure, as shown in the SoA (Table 1). 
2.4. Study Population (Part A)  
Prospective approval of protocol deviations for recruitment and enrollment criteria, also known 
as protocol waivers or exemptions, is not permitted. 
2.4.1. Inclusion Criteria (Part A)  
Participants are eligible to be included in the study only if all the following criteria apply:  
1. Adults ≥50 years of age on the day of the Randomization Visit who are primarily 
responsible for self-care and activities of daily living. Participants may have one or more 
chronic medical diagnoses, but should be medically stable as assessed by: 
– Absence of changes in medical therapy within 1 month due to treatment failure or 
toxicity, 
– Absence of medical events qualifying as SAEs within 1 month of the planned 
vaccination on Day 1, and 
– Absence of known, current, and life-limiting diagnoses which, in the opinion of 
the investigator, would make completion of the protocol unlikely. 
2. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as bilateral tubal ligation >1 year prior to Screening, 
bilateral oophorectomy, hysterectomy, or menopause. An FSH level may be measured at 
the discretion of the investigator to confirm menopausal status.  
3. Female participants of childbearing potential may be enrolled in the study, if the 
participant: (1) has a negative urine pregnancy test at Screening and on the day of 
vaccination, (2) has practiced adequate contraception or has abstained from all activities 
that could lead to pregnancy for 28 days prior to vaccination, (3) has agreed to continue 
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adequate contraception through 3 months following the last injection, and (4) is not 
currently breastfeeding. 
Adequate contraception is defined as consistent and correct use of approved 
contraceptive method in accordance with the product label. For example: 
– Barrier method (such as condoms, diaphragm, or cervical cap) used in 
conjunction with spermicide 
– Intrauterine device 
– Hormonal contraceptive in the form of a pill or patch 
– Medroxyprogesterone injection (eg, Depo-Provera®) 
– Etonogestrel implant (eg, Nexplanon®) 
– Sterilization of a female participant’s male partner prior to entry into the study 
– Vasectomy for male participants 
Note: Periodic abstinence (eg, calendar, ovulation, symptom-thermal, postovulation methods) 
and withdrawal are not acceptable methods of contraception. 
4. Willing and able (on both a physical and cognitive basis) to give informed consent prior to 
study enrollment. 
5. Able to comply with study requirements, including access to transportation for study 
visits. 
6. Access to inbound and outbound telephone communication with caregivers and study 
staff. 
2.4.2. Exclusion Criteria (Part A)  
Participants are not eligible to be included in the study if any of the following criteria apply:  
1. Participant is acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior 
to or at Day 1. Participants meeting this criterion may be rescheduled within the 14day 
Screening window and will retain their initially assigned participant number. 
2. History of a diagnosis or condition that, in the judgment of the investigator, is clinically 
unstable or may affect participant safety, assessment of safety endpoints, assessment of 
immune response, or adherence to study procedures. Clinically unstable is defined as a 
diagnosis or condition requiring significant changes in management or medication 
≤60 days prior to Screening and includes ongoing workup of an undiagnosed illness that 
could lead to a new diagnosis or condition.  
3. Reported history of congenital or acquired immunodeficiency, immunosuppressive 
condition, or immune-mediated disease. Note: Human immunodeficiency virus (HIV) 
positive participants with CD4 count ≥350 cells/mm3 and an undetectable HIV viral load 
and an undetectable HIV RNA within the past 12 months (low level variations from 50 to 
500 viral copies/mL which do not lead to changes in antiretroviral therapy is allowed) as 
determined from participant’s medical records, are permitted. 

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4. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, 
psoriasis patches affecting skin over the deltoid areas). 
5. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any 
mRNA vaccine(s) or commercially available influenza and any components of the 
mRNA or commercially available influenza vaccines. 
6. Reported history of bleeding disorder that is considered a contraindication to IM injection 
or phlebotomy. 
7. Diagnosis of malignancy within previous 10 years (excluding nonmelanoma skin cancer). 
8. Any medical, psychiatric, or occupational condition, including reported history of drug or 
alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to 
participation in the study or could interfere with the interpretation of study results. 
9. Known history of poorly controlled hypertension (per determination of the investigator), 
or systolic blood pressure >160 mmHg at the Screening or baseline (Day 1) visit. 
10. Known history of hypotension or systolic blood pressure <85 mmHg at the Screening or 
baseline (Day 1) visit. 
11. Diastolic blood pressure >90 mmHg at the Screening or baseline (Day 1) visit. 
12. Known uncontrolled disorder of coagulation.  
Note: In the setting of well-controlled atrial fibrillation, prophylaxis for cardiovascular 
thromboembolism, or stroke with the following medications are allowed (aspirin, 
clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin). 
13. Chronic administration (defined as more than 14 continuous days) of 
immunosuppressants or other immune-modifying drugs within 6 months prior to the 
administration of the study injection. An immunosuppressant dose of glucocorticoid will 
be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of 
topical, inhaled, and nasal glucocorticoids will be permitted. 
14. Participant has received or plans to receive any vaccine authorized or approved by a local 
health agency ≤28 days prior to study injections (Day 1) or plans to receive a vaccine 
authorized or approved by a local health agency within 28 days after the study injections. 
15. Prior participation in research involving receipt of any IP (drug/biologic/device including 
any investigational RSV product) within 45 days before the planned date of the Day 1 
study injection. 
16. Participant has received a seasonal influenza vaccine or any other investigational 
influenza vaccine ≤180 days prior to the Randomization Visit. 
17. Participant has tested positive for influenza by local health authority approved testing 
methods ≤180 days prior to the Screening Visit. 
18. Participant had significant exposure to someone with severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 10 days, as defined by 
the US Centers for Disease Control and Prevention (CDC) as a close contact of someone 
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19. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 
6 weeks of any prior influenza immunization. 
20. Receipt of systemic immunoglobulins or blood products ≤90 days prior to the Screening 
Visit or plans to receive systemic immunoglobulins or blood products during the study. 
21. Participant has a history of myocarditis, pericarditis, or myopericarditis within 2 months 
prior to Screening. Participants who have not returned to baseline after their convalescent 
period will also be excluded.  
22. Participant has donated ≥450 mL of blood products within 28 days prior to the Screening 
Visit or plans to donate blood products during the study. 
23. Participated in an interventional clinical study within 28 days prior to the Screening Visit 
based on the medical history interview or plans to do so while participating in this study. 
24. Participant is an immediate family member or household member of study personnel, 
study site staff, or Sponsor personnel. 
2.4.3. Lifestyle Restrictions  
Not applicable. 
2.4.4. Screen Failures  
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently assigned to treatment. A minimum set of screen failure information is required 
to ensure transparent reporting of screen failures to meet the Consolidated Standards of 
Reporting Trials publishing requirements and to respond to queries from regulatory authorities. 
The minimum information includes the date of informed consent, demography, reason(s) for 
screen failure, eligibility criteria. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened 1 time within the 14-day Screening window if they will be eligible upon rescreening.  
2.5. Study Treatment  
2.5.1. Investigational Products Administered  
mRNA-1345 is an LNP formulation consisting of mRNA sequences encoding the RSV fusion 
glycoprotein stabilized in the prefusion conformation.  
Afluria Quadrivalent is an egg-based, inactivated influenza vaccine. 
The placebo is 0.9% sodium chloride (normal saline) injection, US Pharmacopeia (USP) or 
European Pharmacopeia. 
2.5.2. Randomization and Blinding  
Randomization will be performed using an interactive response technology (IRT) system. 
Randomization is further described in Section 2.3.1. 

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2.5.2.1. 
Blinding  
The study is observer-blind, such that only designated unblinded study personnel responsible for 
vaccine preparation, administration, and/or accountability will have access to study treatment 
assignments. Neither the participant, investigator, nor clinical staff responsible for study 
assessments/safety will have access to the treatment assignment during the conduct of the study. 
The investigator may be unblinded in the event of an emergency (Section 2.5.2.2). 
2.5.2.2. 
Unblinding  
Except in the case of medical necessity, a participant’s vaccine assignment should not be 
unblinded without the approval of the Sponsor. If a participant becomes seriously ill or pregnant 
during the study, the blind will be broken only if knowledge of the vaccine assignment will 
affect that participant’s clinical management. In the event of a medical emergency requiring 
identification of individual vaccine assignment, the investigator will make every attempt to 
contact the Sponsor medical lead or designee, preferably via electronic protocol inquiry platform, 
to explain the need for unblinding within 24 hours of obtaining the treatment code. The 
investigator will be responsible for documenting the time, date, reason for unblinding, and the 
names of the personnel involved. The investigator (or designee) will have access to unblind 
participants within IRT. All unblinding instances will be tracked via an audit trail in IRT and 
documented in the final clinical study report (CSR).  
If unblinding should occur (by either accidental unblinding or emergency unblinding) before 
completion of the study, the investigator must promptly contact the Sponsor and document the 
circumstances on the appropriate forms. The Sponsor will remain blinded to the treatment 
assignment throughout the treatment period for each individual cohort/dose level of the study up 
until the specified timepoint in the interim analysis (IA), as outlined in Section 2.8.6. 
2.5.3. Preparation, Handling, Storage, and Accountability  
2.5.3.1. 
Preparation of Study Vaccine  
mRNA-1345 will be provided as a sterile liquid for injection and will be a white to off white 
dispersion at a concentration of 
 
  
Afluria Quadrivalent will be provided as a 0.5 mL, single-dose, pre-filled syringe.  
mRNA-1345 and placebo preparation instructions are detailed in the Pharmacy Manual. 
2.5.3.2. 
Study Vaccine Administration  
mRNA-1345, Afluria Quadrivalent, and/or placebo will be administered as IM injections, one in 
each deltoid muscle on Day 1, according to the procedures specified in the Pharmacy Manual. 
Each arm (left and right) and the corresponding vaccine or placebo administered will be recorded 
by the unblinded site staff and will be kept confidential from other study documents/personnel 
before unblinding is authorized. 
On Day 1, participants will be monitored for a minimum of 30 minutes after vaccination. 
Assessments will include vital sign measurements and monitoring for local or systemic ARs as 
shown in the SoA (Table 1). 
CCI

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The study site will be appropriately staffed with individuals with basic cardiopulmonary 
resuscitation training and certification. Either on-site resuscitation equipment and study 
personnel or appropriate protocols for the rapid transport of a participant to a resuscitation area 
or facility are required. 
2.5.3.3. 
Study Vaccine Delivery and Receipt  
The Sponsor (or designee) is responsible for the following: 
• Supplying mRNA-1345, Afluria Quadrivalent, and placebo (0.9% sodium chloride) to 
the study sites. 
• Confirming the appropriate labeling of the IP, so it complies with the legal 
requirements of the US. 
The investigator is responsible for acknowledging the receipt of the IP by a designated staff 
member at the site, which includes the following: 
• Confirming that the IP was received in good condition. 
• Confirming that the temperature during shipment from the Sponsor to the 
investigator’s designated storage location was appropriate. 
• Confirming that the Sponsor has authorized the IP for use. 
• Ensuring the appropriate dose of the IP is properly prepared using aseptic technique. 
Further description of the IP and instructions for the receipt, storage, preparation, administration, 
accountability, and destruction of the IP are described in the Pharmacy Manual. 
2.5.3.4. 
Study Vaccine Packaging and Labeling  
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of the IP. 
mRNA-1345 and Afluria Quadrivalent will be prepared, packaged, and labeled in accordance 
with the standard operating procedures of the Sponsor or those of its designee, Code of Federal 
Regulations (CFR) Title 21, Good Manufacturing Practice guidelines, the International Council 
for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH) GCP guidelines, guidelines for Quality System Regulations, and applicable 
regulations. 
2.5.3.5. 
Study Vaccine Storage  
mRNA-1345 should be stored at –25 to –15 ºC (–13 to 5 ºF). mRNA-1345 must be received by a 
designated unblinded study personnel at the study site, handled and stored safely, kept in a 
secure location with restricted access (unblinded study personnel only), and protected from 
moisture and light until it is prepared for administration. Additional details are found in the 
Pharmacy Manual. 
Afluria Quadrivalent should be stored at 2 to 8 ºC (36 to 47 ºF). 
The 0.9% sodium chloride injection (USP or European Pharmacopeia) should be stored at 20 to 
25 ºC (68 to 77 ºF) in a secure location with restricted access (unblinded study personnel only). 

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2.5.3.6. 
Study Vaccine Accountability  
It is the investigator’s responsibility that the IP accountability study staff maintain accurate 
records in an IP accountability log of receipt of all IP, study site IP inventory, IP dispensing, IP 
injections, and return to the Sponsor or alternative disposition of used and unused IP vials. 
An unblinded study site monitor will review the inventory and accountability log during study 
site visits and at the completion of the study. Additional details are found in the Pharmacy 
Manual. 
2.5.3.7. 
Study Vaccine Handling and Disposal  
An unblinded study site monitor will reconcile the IP inventory during the conduct of the study 
and at the EoS for compliance. Once fully reconciled at the site at the EoS, the IP can be 
destroyed on-site, if study site procedures allow, or returned to a destruction depot per instruction 
of the Sponsor. Additional details are found in the Pharmacy Manual. 
2.5.4. Study Intervention Compliance  
The IP will be administered at the study site under direct observation of medically qualified 
unblinded study personnel and appropriately recorded (date and time) in the source documents 
and eCRF. The qualified unblinded study personnel will confirm that the participant has received 
the entire dose of the IP, record the injection site (left or right deltoid) and corresponding IP 
administered, and keep the information confidential from other study documents and study 
personnel until unblinding is authorized. If a participant does not receive the IP or does not 
receive all of the planned dose, the reason for the missed dose will be recorded. The data will be 
reconciled with the study site accountability records to assess compliance. 
The study site staff are responsible for ensuring that the participants comply with the allowed 
study visit windows. If a participant misses a visit, every effort should be made to contact the 
participant and complete the visit within the defined visit window, as specified in the SoA 
(Table 1 [Part A] or Table 7 [Part B]). If a participant does not complete a visit within the 
defined time window, that visit will be classified as a missed visit, and the participant will 
continue with the subsequent scheduled visits. All safety requirements of the missed visit will be 
captured and included in the subsequent visit. 
2.5.5. Prior and Concomitant Medications  
2.5.5.1. 
Prior Medications and Therapies  
Information about prior medications (including any prescription or over-the-counter medications, 
vaccines, or blood products) taken by the participant within the 28 days before providing 
informed consent (or as designated in the inclusion/exclusion requirements) will be recorded in 
the participant’s eCRF. 
2.5.5.2. 
Concomitant Medications and Therapies  
At the study site, the study staff must question the participant regarding any medications taken 
and nonstudy vaccinations received by the participant and record the following information in 
the eCRF: 

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• All nonstudy vaccinations administered within the period starting 28 days before the 
study injection and through Day 181/EoS. 
• Seasonal influenza vaccine administered for the current influenza season (as 
appropriate for a study site depending on whether it is located in the Northern or 
Southern Hemisphere). 
• All concomitant medications taken through 28 days after vaccination. Antipyretics 
and analgesics taken prophylactically (ie, taken in the absence of any symptoms in 
anticipation of an injection reaction) will be recorded as such. 
• Any concomitant medications used to prevent or treat COVID19, RSV disease, or any 
other infectious disease symptoms. 
• Any concomitant medications relevant to or for the treatment of an SAE, AESI, or an 
MAAE from Day 1 through Day 181/EoS. 
• The participant will be asked in the eDiary if they have taken any antipyretic or 
analgesic to treat or prevent fever or pain within 7 days after vaccination, including 
the day of injection. Reported antipyretic or analgesic medications should be recorded 
in the source document by the study site staff during the postinjection study site visits 
or via other participant interactions (eg, safety telephone calls). 
• Use of facial injections or dermal fillers, for cosmetic or medical indications such as 
migraine headaches. 
Concomitant medications (including vaccinations) will be coded using the WHO Drug Global 
dictionary.  
If a participant takes a prohibited drug therapy, the investigator and the medical monitor will 
make a joint decision about continuing or withholding further assessment of the participant based 
on the time the medication was administered, the drug’s pharmacology and pharmacokinetics, 
and whether the use of the medication will compromise the participant’s safety or interpretation 
of the study data. It is the investigator’s responsibility to ensure that details regarding the 
concomitant medications are adequately recorded in the eCRF. 
2.5.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination 
of a Participant from the Per-Protocol Analyses  
The use of the following concomitant medications and/or vaccines will not require withdrawal of 
the participant from the study but may determine a participant’s evaluability in the per-protocol 
(PP) analysis (analysis sets are described in Section 2.8.4): 
• Any investigational or nonregistered product (drug or vaccine) other than the IPs used 
during the study period. 
• A nonstudy vaccine (including authorized or approved vaccines for the prevention of 
COVID-19 regardless of the type of vaccine) administered during the period from 
28 days before through 28 days after the study injection. 
• Immunoglobulins and/or any blood products administered during the study period 
(except for treatment of COVID-19). 

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• Medications that suppress the immune system (except for treatment of COVID-19). 
2.5.6. Intervention After the End of the Study  
IP will not be available to the participants following the end of the study. 
2.6. Delay or Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
2.6.1. Criteria for Delay of Vaccine Administration  
2.6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination  
Body temperature must be measured before vaccination. The following events constitute criteria 
for delay of injection, and if either of these events occur at the time scheduled for dosing, the 
participant may be injected at a later date within the time window specified in the SoA 
(Table 1 [Part A], Table 7 [Part B], or Table 11 [Part C]), or the participant may be discontinued 
from dosing at the discretion of the investigator (Section 2.6.2): 
• Acute moderate or severe infection with or without fever at the time of dosing. 
• Fever, defined as body temperature ≥38.0°C (100.4°F) at the time of dosing. 
Participants with a fever ≥38.0°C (100.4°F) will be contacted within the time window acceptable 
for participation and reevaluated for eligibility. If the investigator determines that the 
participant’s health on the day of dosing temporarily precludes injection, the visit should be 
rescheduled within the allowed interval for that visit.  
The investigator, in consultation with the Sponsor’s medical monitor, may withhold the IP 
injection if the participant meets any of the following criteria: 
• Develops symptoms or conditions listed in the exclusion criteria. 
• Experiences a clinically significant change in clinical laboratory test results, vital sign 
measurements, or general condition that, in the judgment of the investigator, requires 
withholding of vaccine. 
• Becomes pregnant. 
The reason(s) for withholding the injection will be recorded in the eCRF. 
If a participant takes a prohibited drug therapy, an injection could be delayed within the visit 
window based on the joint decision of the investigator and the medical monitor (Section 2.5.5.3). 
2.6.2. Participant Discontinuation/Withdrawal from the Study  
Participants who withdraw or are withdrawn from the study will not be replaced. 
A “withdrawal” from the study refers to a situation wherein a participant does not return for the 
final visit planned in the protocol. 
Participants can withdraw consent and withdraw from the study at any time, for any reason, 
without prejudice to further treatment the participant may need to receive. The investigator will 
request that the participant complete all study procedures pending at the time of withdrawal. 

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If a participant desires to withdraw from the study because of an AE, the investigator will 
attempt to obtain agreement to follow-up with the participant until the event is considered 
resolved or stable and will then complete the EoS eCRF. 
Information related to the withdrawal will be documented in the eCRF. The investigator will 
document whether the decision to withdraw a participant from the study was made by the 
participant or by the investigator, as well as which of the following possible reasons was 
responsible for withdrawal: 
• AE (specify). 
• Solicited AR or reactogenicity event (specify). 
• Death. 
• Lost to follow-up (LTFU). 
• Physician decision (specify). 
• Pregnancy. 
• Protocol deviation. 
• Study terminated by the Sponsor. 
• Withdrawal of consent by participant (specify). 
• Other (specify). 
Participants who are withdrawn from the study because of AEs (including solicited ARs, or 
reactogenicity events) must be clearly distinguished from participants who are withdrawn for 
other reasons. Investigators will follow-up with participants who are withdrawn from the study 
as result of an AE, pregnancy, solicited AR, or reactogenicity until resolution of the event. 
A participant withdrawing from the study may request destruction of any samples taken and not 
tested, and the investigator must document this in the site study records. 
If the participant withdraws consent for disclosure of future information, the Sponsor may retain 
and continue to use any data collected before such a withdrawal of consent (Section 6.1.6). 
The Sponsor will continue to retain and use all research results that have already been collected 
for the study evaluation, unless the participant has requested destruction of these samples. All 
biological samples that have already been collected may be retained and analyzed at a later date 
(or as permitted by local regulations). 
2.6.3. Lost to Follow-Up  
A participant will be considered LTFU if he or she repeatedly fails to return for scheduled visits 
without stating an intention to withdraw consent and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible, counsel the participant on the importance of maintaining the 

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assigned visit schedule and ascertain whether the participant wishes to and/or should 
continue in the study. 
• Before a participant is deemed LTFU, the investigator or designee must make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if 
necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts (eg, dates of telephone calls and 
registered letters) should be documented in the participant’s medical record.  
• If the registered/certified letter is signed by the participant but no other contact is 
established, the participant is considered to be noncompliant with study visits or 
procedures and will be considered to have withdrawn from the study. 
• A participant should not be considered LTFU until due diligence has been completed. 
2.7. Study Assessments and Procedures  
Before performing any study procedures, all potential participants will sign an informed consent 
form (ICF; Section 6.1.6). Participants will undergo study procedures at the time points specified 
in the SoA (Table 1 [Part A], Table 7 [Part B], or Table 11 [Part C]). A participant can also 
attend an unscheduled visit at any time during the study. Reasons for an unscheduled visit may 
include, but are not limited to, reactogenicity issues or new or ongoing AEs. The study site also 
has the discretion to make reminder telephone calls or send text messages to inform the 
participant about visits, review eDiary requirements, or follow-up on ongoing or outstanding 
issues. 
In accordance with the Food and Drug Administration guidance on the conduct of clinical trials 
of medical products during COVID-19 public health emergency (DHHS 2020), investigators 
may convert study site visits to home visits or telemedicine visits with the approval of the 
Sponsor. Such action should be taken to protect the safety and well-being of participants and 
study site staff or to comply with state or municipal mandates. 
General considerations for study assessments and procedures include the following: 
• Protocol waivers or exemptions are not allowed. The study procedures and their 
timing must be followed as presented in the SoA (Table 1 [Part A], Table 7 [Part B], 
or Table 11 [Part C]). Adherence to the study design requirements is essential and 
required for study conduct. 
• Immediate safety concerns should be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue participation 
in the study. 
• All Screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log 
to record details of all participants screened and to confirm eligibility or record 
reasons for screening failure, as applicable. 
• The Screening Visit and Day 1 Visit may be performed on the same day. 
Additionally, the Screening Visit assessments may be performed over multiple visits 
if within the 14day Screening window. 

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2.7.1. Safety Assessments and Procedures  
Safety assessments will include monitoring and recording of the following for each participant, 
according to the SoA (Table 1 [Part A], Table 7 [Part B], or Table 11 [Part C]): 
• Solicited local and systemic ARs (Section 2.7.4.3) that occur during the 7 days 
following vaccine administration (ie, the day of study injections and 6 subsequent 
days). Solicited ARs will be recorded daily using eDiaries (Section 2.7.1.1). Local 
solicited ARs will be recorded separately for each injection site. 
• Unsolicited AEs observed or reported from the day of injection and 27 subsequent 
days). Unsolicited AEs are defined in Section 2.7.4.1 and Section 2.7.4.2. 
• SAEs, AESIs, MAAEs, and AEs leading to discontinuation from study participation 
from vaccination on Day 1 through EoS or withdrawal from the study. 
• Vital sign measurements (Section 2.7.1.3). 
• Physical examination findings (Section 2.7.1.4). 
The incidence and severity of the above events will be monitored by an IST on a regular basis.  
2.7.1.1. 
Use of Electronic Diaries  
At the time of consent, the participants must confirm they will be willing to complete an eDiary 
using either an application downloaded to their smartphone or a device that will be provided at 
the time of enrollment. Before enrollment on Day 1, the participant will be instructed to 
download the eDiary application or will be provided with an eDiary device to record solicited 
ARs (Section 2.7.4.3).  
On vaccination days, participants will be instructed on thermometer usage to measure body 
temperature, ruler usage to measure injection site erythema and swelling/induration (hardness), 
and self-assessment for localized axillary swelling or tenderness on the same side as the injection 
arm. 
On vaccination days, participants will record data in the eDiary starting approximately 30 min 
after administration of the IP under supervision of the study site staff to ensure correct 
completion of the eDiary. The study site staff will perform any retraining as necessary. 
Participants will continue to record data in the eDiary after they leave the study site once per day, 
preferably in the evening and at the same time each day, on the day of vaccination and 
6 subsequent days. 
Participants will record the following data in the eDiary: 
• Solicited local and systemic reactogenicity ARs, as defined in Section 2.7.4.3, that 
occur on the day of vaccination and during the 7 days after vaccination (ie, the day of 
injection and 6 subsequent days). Local solicited ARs will be recorded separately for 
each injection site. ARs beyond Day 7 should be reviewed either at the next 
scheduled study site visit or during the safety telephone call. 
• Daily oral body temperature measurements should be performed using the 
thermometer provided by the study site. If body temperature is taken more than once 
in a given day, only the highest temperature reading should be recorded. 

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• Other measurements, as applicable, for solicited local ARs (injection site erythema 
and swelling/induration) should be performed using the ruler provided by the study 
site. 
• Whether any medications were taken to treat or prevent pain or fever on the day of 
vaccination and 6 subsequent days. 
The eDiary will be the only source document allowed for solicited systemic or local ARs 
(including body temperature measurements). Participants will be instructed to complete eDiary 
entries daily. Quantitative temperature recordings and measurement of any injection site 
erythema or swelling/induration reported on the following day may be excluded from the 
analyses of solicited ARs. 
The study site staff will review eDiary data with participants during the Day 8 visit (Visit 2) (or 
Day 37 [Visit 4] for Part B) after vaccination. 
2.7.1.1.1 Ancillary Supplies for Participant Use  
The study sites will distribute Sponsor-provided oral thermometers and rulers for use by 
participants to assess body temperature and injection site reactions, respectively, for recording 
solicited ARs in the eDiaries. Based on availability, smartphone devices may be provided to 
those participants who do not have their own device to use for eDiary activities. 
2.7.1.2. 
Safety Telephone Call  
The safety telephone call will be made to the participants by trained study site personnel. This 
call will follow a Sponsor-approved script, which will facilitate the collection of relevant safety 
information. Safety telephone calls by the study site to each participant will occur at the time 
points indicated in the SoA (Table 1 [Part A], Table 7 [Part B], or Table 11 [Part C]). The 
participant will be interviewed according to the script about the occurrence of AEs, MAAEs, 
AESIs, SAEs, AEs leading to discontinuation, concomitant medications associated with those 
events, and any nonstudy vaccinations (Section 2.7.4.6). All safety information collected from 
the telephone call must be documented in the source documents as described by the participant 
and not documented on the script used for the safety telephone call. As noted in Section 2.7.1.1, 
an unscheduled follow-up safety telephone call may be triggered if an eDiary record results in 
identification of a relevant safety event. 
2.7.1.3. 
Vital Sign Measurements  
Vital sign measurements include systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (preferred route is oral). The participant will be seated for at least 
5 minutes before all measurements are taken. Vital signs will be measured at the time points 
indicated in the SoA (Table 1 [Part A], Table 7 [Part B], or Table 11 [Part C]). On the day of IP 
administration, vital sign measurements will be collected once before and at least 30 minutes 
after vaccination. Vital signs may be collected at other study visits in conjunction with 
a symptom-directed physical examination.  
If any of the vital sign measurements meet the toxicity grading criteria for clinical abnormalities 
of Grade 3 or greater, the abnormal value and grade will be documented in the AE section of the 
eCRF (unless there is another known cause of the abnormality that would result in an AE 
classification). The investigator will continue to monitor the participant with additional 

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assessments until the vital sign value has reached the reference range, returns to the vital sign 
value at baseline, or is considered stable or until the investigator determines that follow-up is no 
longer medically necessary. 
Participants who are febrile (body temperature ≥38.0 °C/100.4 °F) before injection may be 
rescheduled within the relevant time window period to receive the injection. Afebrile participants 
with minor illnesses may be vaccinated at the discretion of the investigator. 
When procedures overlap and are scheduled to occur at the same timepoint, the order of 
procedures should be vital sign measurements and then blood collection. 
2.7.1.4. 
Physical Examinations  
A full physical examination, including height and weight, will be performed at the Screening 
Visit (Table 1 [Part A], Table 7 [Part B], or Table 11 [Part C]). The full physical examination 
will include an assessment of the skin, head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, 
cardiovascular system, abdomen, lymph nodes, and musculoskeletal system and extremities. At 
the Screening Visit, the participant’s body mass index will be calculated using the formula 
weight (kg)/(height [m])2. Any clinically significant findings identified should be reported as an 
MAAE. 
Symptom-directed physical examinations may be performed at other time points at the discretion 
of the investigator. On the day of vaccination, before injection, both arms should be examined, 
and the associated lymph nodes should be evaluated. 
2.7.2. Immunogenicity Assessments  
Blood samples for immunogenicity assessments will be collected at the time points indicated in 
the SoA (Table 1). Immunogenicity assessments will be performed for all participants. The 
following analytes will be measured: 
• RSV Abs, as measured by nAbs and binding (bAbs). 
• GMT of serum Ab level as measured by a HAI assay for influenza. 
Sample aliquots will be designed to ensure that backup samples are available and vial volumes 
are likely to be adequate for future testing needs. The actual date and time of each sample will be 
noted. Unique sample identification will be utilized to maintain the blind at the laboratory at all 
times and allow for automated sample tracking and housing. Handling and preparation of the 
samples for analysis, as well as shipping and storage requirements, will be provided in a separate 
study manual. 
Measurement of Ab levels will be performed in a laboratory designated by the Sponsor. 
According to the ICF (Section 6.1.6), excess serum from the blood samples collected for 
immunogenicity testing may be used for future research, which may be performed at the 
discretion of the Sponsor to further characterize the immune response to RSV and influenza virus 
and additional assay development. 

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2.7.3. Efficacy Assessments  
While the study will not be powered for efficacy assessments, symptoms of infection with 
respiratory pathogens will be tracked as an exploratory objective in this study. 
2.7.4. Safety Definitions and Related Procedures  
2.7.4.1. 
Adverse Event  
An AE is defined as any untoward medical occurrence associated with the use of an IP in 
humans, whether or not considered related to the IP. 
Events Meeting the Adverse Event Definition: 
• Exacerbation of a chronic or intermittent preexisting condition, including an increase 
in the frequency and/or intensity of the condition, after administration of the IP. 
• New conditions detected or diagnosed after administration of the IP even though they 
may have been present before the start of the study. 
Events NOT Meeting the Adverse Event Definition: 
• Procedures planned before enrollment in the study (eg, hospitalization for preplanned 
surgical procedure). 
• Medical or surgical procedures (eg, endoscopy or appendectomy). The condition that 
leads to the procedure should be the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
An AR is any AE for which there is a reasonable possibility that the vaccine caused the AE 
(Section 2.7.4.3). For the purposes of investigational new drug safety reporting, “reasonable 
possibility” means that there is evidence to suggest a causal relationship between the IP and AE. 
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AR in 
the protocol (Section 2.7.4.3) or specified as a solicited AR but starts outside the protocol-
defined period for reporting solicited ARs (ie, 7 days after vaccination).  
2.7.4.2. 
Serious Adverse Events  
An AE (including an AR) is considered an SAE if, in the view of either the investigator or 
Sponsor, it results in any of the following outcomes:  
• Death 
A death that occurs during the study or that comes to the attention of the investigator 
during the protocol-defined follow-up period must be reported to the Sponsor, 
whether or not it is considered related to the IP. 
• Is life-threatening  
An AE is considered life-threatening if, in the view of either the investigator or the 
Sponsor, its occurrence places the participant at immediate risk of death. It does not 
include an AE that, had it occurred in a more severe form, might have caused death. 

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• Inpatient hospitalization or prolongation of existing hospitalization 
In general, inpatient hospitalization indicates the participant was admitted to the 
hospital or emergency ward for at least one overnight stay for observation and/or 
treatment that would not have been appropriate in the physician’s office or outpatient 
setting. The hospital or emergency ward admission should be considered an SAE 
regardless of whether opinions differ as to the necessity of the admission. 
Complications that occur during inpatient hospitalization will be recorded as AEs; 
however, if a complication/AE prolongs hospitalization or otherwise fulfills SAE 
criteria, the complication/AE will be recorded as a separate SAE. Procedures planned 
before study entry (eg, hospitalization for preplanned surgical procedure) are not 
considered SAEs. 
• Persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions. This definition is not intended to include experiences 
of relatively minor medical significance such as uncomplicated headache, 
nausea/vomiting, diarrhea, influenza, and accidental trauma (eg, sprained ankle) 
which may interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
• Congenital anomaly or birth defect. 
• Medically important event 
Medical judgment should be exercised in deciding whether SAE reporting is 
appropriate in other situations, such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize 
the participant or require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These events should usually be considered 
serious. Examples of such medical events include allergic bronchospasm requiring 
intensive treatment in an emergency room or at home, blood dyscrasias or 
convulsions that do not result in inpatient hospitalization, or the development of drug 
dependency or drug abuse. 
2.7.4.3. 
Solicited Adverse Reactions  
The term “reactogenicity” refers to the occurrence and intensity of selected signs and symptoms 
(ARs) occurring after administration of the IP. The eDiary will solicit daily participant reporting 
of ARs using a structured checklist (Section 2.7.1.1). Participants will record such occurrences in 
an eDiary from the day of injection and 6 subsequent days). Local solicited ARs will be recorded 
separately for each injection site. 
Severity grading of reactogenicity will occur automatically based on participant entry in the 
eDiary according to the grading scales presented in Table 4 from the toxicity grading scale for 
healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials 
(DHHS 2007). 
If a participant reported a solicited adverse reaction during the solicited period and did not record 
the event in the eDiary, the event should be recorded on the Reactogenicity page of the eCRF. If 
the event starts during the solicited period, but continues beyond 7 days after dosing, the 
participants should notify the site to provide an end date and close out the event on the 

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Reactogenicity page of the eCRF. If the participant reported an event that started after the 
solicited period, it should be recorded as an AE on the AE page of the eCRF. All solicited ARs 
(local and systemic) will be considered causally related to dosing. 
Table 4: 
Solicited Adverse Reactions and Grades 
Reaction 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Injection site pain 
Does not 
interfere with 
activity  
Repeated use of over-
the-counter pain 
reliever > 24 hours or 
interferes with 
activity  
Any use of 
prescription pain 
reliever or 
prevents daily 
activity 
Requires emergency 
room visit or 
hospitalization 
Injection site 
erythema (redness) 
25 – 50 mm/ 
2.5 – 5 cm 
51 – 100 mm/ 
5.1 – 10 cm 
> 100 mm/ 
> 10 cm 
Necrosis or 
exfoliative 
dermatitis 
Injection site 
swelling/induration 
(hardness) 
25 – 50 mm/ 
2.5 – 5 cm 
51 – 100 mm/ 
5.1 – 10 cm  
> 100 mm/ 
> 10 cm 
Necrosis  
Axillary 
(underarm) 
swelling or 
tenderness 
ipsilateral to the 
side of injection 
No interference 
with activity 
Repeated use of 
over-the-counter 
(non-narcotic) pain 
reliever > 24 hours or 
some interference 
with activity 
Any use of 
prescription 
(narcotic) pain 
reliever or 
prevents daily 
activity 
Emergency room 
visit or 
hospitalization 
Headache 
No interference 
with activity 
Repeated use of over-
the-counter pain 
reliever > 24 hours or 
some interference 
with activity 
Significant; any 
use of 
prescription pain 
reliever or 
prevents daily 
activity 
Requires emergency 
room visit or 
hospitalization 
Fatigue 
No interference 
with activity  
Some interference 
with activity 
Significant; 
prevents daily 
activity  
Requires emergency 
room visit or 
hospitalization 
Myalgia (muscle 
aches all over 
body) 
No interference 
with activity  
Some interference 
with activity 
Significant; 
prevents daily 
activity  
Requires emergency 
room visit or 
hospitalization 
Arthralgia (joint 
aches in several 
joints) 
No interference 
with activity  
Some interference 
with activity 
Significant; 
prevents daily 
activity  
Requires emergency 
room visit or 
hospitalization 

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Reaction 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Nausea/vomiting 
No interference 
with activity or 
1-2 episodes/ 
24 hours 
Some interference 
with activity or 
> 2 episodes/24 hours 
Prevents daily 
activity, requires 
outpatient 
intravenous 
hydration 
Requires emergency 
room visit or 
hospitalization for 
hypotensive shock 
Chills 
No interference 
with activity 
Some interference 
with activity not 
requiring medical 
intervention 
Prevents daily 
activity and 
requires medical 
intervention 
Requires emergency 
room visit or 
hospitalization 
Fever (oral) 
38.0 – 38.4°C 
100.4 – 101.1°F 
38.5 – 38.9°C 
101.2 – 102.0°F 
39.0 – 40.0°C 
102.1 – 104.0°F 
> 40.0°C 
> 104.0°F 
Abbreviations: AE = adverse event; eCRF = electronic case report form. 
Note: Events listed in the table above but starting >7 days after study injection will be recorded on the AE page of 
the eCRF. Causality for each event will be determined per assessment by the investigator. 
Source: Guidance for Industry – Toxicity Grading Scale for Heathy Adult and Adolescent Volunteers Enrolled in 
Preventive Vaccine Clinical Trials (DHHS 2007). 
Any solicited AR that meets any of the following criteria must be entered into the participant’s 
source document and must also be recorded by the study site staff on the solicited AR page of the 
participant’s eCRF: 
• Solicited local or systemic AR that results in a visit to a healthcare practitioner 
(HCP), to be recorded as an MAAE (Section 2.7.4.4). 
• Solicited local or systemic AR leading to the participant withdrawing from the study 
or the participant being withdrawn from the study by the investigator (AE leading to 
withdrawal). 
• Solicited local or systemic AR lasting beyond 7 days post-injection. 
• Solicited local or systemic AR that otherwise meets the definition of an SAE. 
2.7.4.4. 
Medically Attended Adverse Events  
An MAAE is an AE that leads to an unscheduled visit to an HCP, including telephone calls. This 
would include visits to a study site for unscheduled assessments (eg, rash assessment) and visits 
to HCPs external to the study site (eg, urgent care, primary care physician). The investigators 
will review unsolicited AEs for the occurrence of any MAAEs. Unsolicited AEs will be captured 
on the AE page of the eCRF. 
2.7.4.5. 
Adverse Event of Special Interest  
An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the 
Sponsor’s product or program for which ongoing monitoring and immediate notification by the 
investigator to the Sponsor is required and documentation is in the form of a case narrative. Such 
events may require further investigation to characterize and understand them.  

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Section 6.3 provides a list of the AESIs pertinent to this study.  
All AESIs will be collected from Day 1 through EoS and must be reported to the Sponsor (or 
designee) immediately and in all circumstances within 24 hours of becoming aware of the event 
via the electronic data capture (EDC) system. If a site receives a report of a new AESI from a 
study participant or receives updated data on a previously reported AESI at a time after the eCRF 
has been taken offline, then the site can report this information on a paper AESI form using the 
SAE Mailbox or the SAE Fax line (Section 2.7.4.10). 
2.7.4.5.1 Anaphylaxis  
All suspected cases of anaphylaxis should be recorded as MAAEs and reported as an SAE, based 
on the criteria for a medically important event, unless the event meets other serious criteria. As 
an SAE, the event should be reported to the Sponsor (or designee) immediately and in all 
circumstances within 24 hours per Section 2.7.4.10. The investigator will submit any updated 
anaphylaxis case data to the Sponsor within 24 hours of it being available. For reporting 
purposes, a participant who displays signs or symptoms consistent with anaphylaxis should be 
reported as a potential case of anaphylaxis. This is provided as general guidance for investigators 
and based on the Brighton Collaboration case definition (Rüggeberg, et al 2007). 
Anaphylaxis is an acute hypersensitivity reaction with multiorgan system involvement that can 
present as, or rapidly progress to, a severe life-threatening reaction. It may occur following 
exposure to allergens from a variety of sources. 
Anaphylaxis is a clinical syndrome characterized by the following: 
• Sudden onset AND 
• Rapid progression of signs and symptoms AND 
• Involves 2 or more organ systems, as follows: 
- 
Skin/mucosal: Urticaria (hives), generalized erythema, angioedema, generalized 
pruritus with skin rash, generalized prickle sensation, and red and itchy eyes. 
- 
Cardiovascular: Measured hypotension, clinical diagnosis of uncompensated 
shock, loss of consciousness or decreased level of consciousness, and evidence of 
reduced peripheral circulation. 
- 
Respiratory: Bilateral wheeze (bronchospasm), difficulty breathing, stridor, 
upper airway swelling (lip, tongue, throat, uvula, or larynx), respiratory distress, 
persistent dry cough, hoarse voice, sensation of throat closure, sneezing, and 
rhinorrhea. 
- 
Gastrointestinal: Diarrhea, abdominal pain, nausea, and vomiting. 
2.7.4.5.2 Myocarditis/Pericarditis  
A case of suspected, probable, or confirmed myocarditis, pericarditis, or myopericarditis should 
be reported as an AESI, even if it does not meet the criteria per the CDC case definition. The 
event should also be reported as an SAE if it meets seriousness criteria (Section 2.7.4.2). The 
CDC case definition is provided in Section 6.3.2 as guidance.  

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2.7.4.6. 
Eliciting and Documenting Adverse Events  
The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF and 
reported to the Sponsor. 
Solicited ARs will be collected from the day of injection and 6 subsequent days. Other 
(unsolicited) AEs will be collected from the day of injection and 28 subsequent days. 
The MAAEs, AESIs, AE leading to withdrawal, and SAEs will be collected from participants as 
specified in the SoA (Table 1 [Part A] Table 7 [Part B], or Table 11 [Part C]) until the end of 
their participation in the study. Any AEs occurring before administration of the IP will be 
analyzed separately from the AEs occurring after administration of the IP. 
At every study site visit or safety telephone call, participants will be asked a standard question to 
elicit any medically related changes in their well-being according to the scripts provided. 
Participants will also be asked if they have been hospitalized, had any accidents, used any new 
medications, changed concomitant medication regimens (both prescription and over-the-counter 
medications), or had any nonstudy vaccinations. 
In addition to participant observations, physical examination findings or data relevant to 
participant safety classified as an AE will be documented on the AE page of the eCRF. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent study site visits, safety telephone calls, and any other contact. All AEs and SAEs 
will be treated as medically appropriate and followed until resolution, stabilization, the event is 
otherwise explained, or the participant is LTFU (Section 2.6.3). All contacts or contact attempts 
concerning the follow-up of AEs and SAEs should be recorded in the participant’s source 
documentation. 
Pregnancies occurring in participants after enrollment must be reported to Sponsor or designee 
within 24 hours of the site learning of its occurrence. If the participant agrees to submit this 
information, the pregnancy must be followed to determine the outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications. This follow-up should 
occur even if the intended duration of the safety follow-up for the study has ended. Pregnancy 
report forms will be distributed to the study site to be used for this purpose. The investigator 
must immediately (within 24 hours of awareness) report to the Sponsor any pregnancy resulting 
in an abnormal outcome according to the procedures described for SAEs (Section 2.7.4.10). 
2.7.4.7. 
Assessment of Intensity  
An event is defined as “serious” when it meets at least one of the predefined criteria as described 
in the definition of an SAE (Section 2.7.4.2), NOT when it is rated as severe. 
The severity (or intensity) of an AR or AE refers to the extent to which it affects the participant’s 
daily activities. The toxicity grading scale for healthy adult and adolescent volunteers enrolled in 
preventive vaccine clinical trials (DHHS 2007) will be used to categorize local and systemic 
reactogenicity events (solicited ARs), clinical laboratory test results, and vital sign measurements 
observed during this study. Specific criteria for local and systemic reactogenicity events are 
presented in Section 2.7.4.3. 

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The determination of the severity for all unsolicited AEs should be made by the investigator 
based upon their medical judgment and the definitions of severity as follows: 
• Mild: These events do not interfere with the participant’s daily activities. 
• Moderate: These events cause some interference with the participant’s daily 
activities and require limited or no medical intervention. 
• Severe: These events prevent the participant’s daily activity and require intensive 
therapeutic intervention. 
The study staff should elicit from the participant the impact of AEs on the participant’s activities 
of daily living to assess the severity and document the AE appropriately in the participant’s 
source documentation. Changes in the severity of an AE should be documented in the 
participant’s source documentation to allow an assessment of the duration of the event at each 
level of intensity to be performed. An AE characterized as intermittent requires documentation of 
the date of onset and duration of each episode. An AE that fluctuates in severity during the 
course of the event is reported once in the eCRF at the highest severity observed. 
2.7.4.8. 
Assessment of Causality  
The investigator’s assessment of an AE’s relationship to IP is part of the documentation process 
but is not a factor in determining what is or is not reported in the study. 
The investigator will assess the causality (ie, whether there is a reasonable possibility that the IP 
caused the event) for all AEs and SAEs. The relationship will be characterized using the 
following classification: 
• Not related: There is not a reasonable possibility of a relationship to the IP. The 
participant did not receive the IP, OR temporal sequence of the AE onset relative to 
administration of the IP is not reasonable, OR the AE is more likely explained by 
another cause than the IP. 
• Related: There is a reasonable possibility of a relationship to the IP. There is 
evidence of exposure to the IP. The temporal sequence of the AE onset relative to the 
administration of the IP is reasonable. The AE is more likely explained by the IP than 
by another cause. 
2.7.4.9. 
Reporting Adverse Events  
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to IP or their clinical significance. If there is any doubt as 
to whether a clinical observation is an AE, the event should be reported. 
All unsolicited AEs reported or observed during the study will be recorded on the AE page of the 
eCRF. Information to be collected includes the type of event, time of onset, 
investigator-specified assessment of the severity (impact on activities of daily living) and 
relationship to IP, time of resolution of the event, seriousness, as well as any required treatment 
or evaluations, and outcome. The unsolicited AEs resulting from concurrent illnesses, reactions 
to concurrent illnesses, reactions to concurrent medications, or progression of disease states must 
also be reported. All AEs will be followed until they are resolved or stable or judged by the 

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investigator to be not clinically significant. The Medical Dictionary for Regulatory Activities 
(MedDRA) will be used to code all unsolicited AEs. 
Any medical condition that is present at the time that the participant is screened but does not 
deteriorate should not be reported as an unsolicited AE. However, if it deteriorates at any time 
during the study, it should be recorded as an unsolicited AE. Medical conditions that begin after 
obtaining informed consent but before the IP administration will be recorded in the medical 
history/current medical conditions section in the eCRF and not in the AE section; however, if the 
medical condition worsens at any time during the study, it will be recorded and reported as an 
AE. 
2.7.4.10. 
Reporting Serious Adverse Events  
Prompt notification by the investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a study 
intervention under clinical investigation are met. 
Any AE considered serious by the investigator or that meets SAE criteria (Section 2.7.4.2) must 
be reported to the Sponsor immediately (within 24 hours of becoming aware of the SAE) via the 
EDC system. The investigator will assess whether there is a reasonable possibility that the IP 
caused the SAE. The Sponsor will be responsible for notifying the relevant regulatory authorities 
of any SAE as outlined in 21 CFR Parts 312 and 320. The investigator is responsible for 
notifying the IRB directly. 
If the eCRF is unavailable at the time of the SAE, the following contact information is to be used 
for SAE reporting:  
• SAE Mailbox: Drugsafety@modernatx.com 
• SAE Fax Line (USA and Canada): +1-617-649-3910 
Regulatory reporting requirements for SAEs are described in Section 2.7.4.15. 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE, including SAEs, and remain responsible for 
following up AEs that are serious, considered related to the IP or study procedures, or that 
caused the participant to discontinue the study. 
2.7.4.11. 
Reporting of Adverse Events of Special Interest  
The following process for reporting an AESI ensures compliance with 21 CFR 312 and ICH 
GCP guidelines. After learning that a participant has experienced an AESI, the investigator (or 
designee) is responsible for reporting the AESI to the Sponsor, regardless of its relationship to 
the IP or expectedness, within 24 hours of becoming aware of the event. If the AESI meets the 
criteria for an SAE, the SAE reporting procedure should be followed (Section 2.7.4.10). 
2.7.4.12. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information  
Medical occurrences that begin before administration of the IP but after obtaining informed 
consent will be recorded in the “Medical History/Current Medical Conditions” section of the 

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eCRF and not in the AE section; however, if the condition worsens at any time during the study, 
it will be recorded and reported as an AE. 
Adverse events may be collected by: 
• Observing the participant. 
• Receiving an unsolicited complaint from the participant. 
• Questioning the participant in an unbiased and nonleading manner. 
Solicited ARs will be collected from the day of injection through 6 days after vaccination. Other 
(unsolicited) AEs will be collected from the day of injection through 28 days after vaccination. 
Serious AEs (including AESIs) will be collected from the start of IP dosing until the last day of 
study participation. 
All SAEs and AESIs will be recorded and reported to the Sponsor or designee immediately, and 
under no circumstance should this exceed 24 hours of becoming aware of the event via the EDC 
system. If a site receives a report of a new SAE or AESI from a study participant or receives 
updated data on a previously reported SAE or AESI and the eCRF has been taken offline, then 
the site can report this information on a paper SAE or AESI form using the SAE Mailbox or the 
SAE Fax line (Section 2.7.4.10). 
An abnormal value or result from a clinical or laboratory evaluation can also indicate an AE if it 
is determined by the investigator to be clinically significant (eg, leads to study drug 
discontinuation or meets any serious criteria). If this is the case, it must be recorded in the source 
document and as an AE on the appropriate AE form(s). The evaluation that produced the value 
or result should be repeated until that value or result returns to normal or is stabilized and the 
participant’s safety is not at risk. 
Investigators are not obligated to actively seek AEs or SAEs after EoS participation. However, if 
the investigator learns of any SAE (including a death) at any time after a participant has 
withdrawn from or completed the study and the investigator considers the event to be reasonably 
related to the IP or study participation, the investigator must promptly notify the Sponsor. 
2.7.4.13. 
Method of Detecting AEs and SAEs  
Electronic diaries have specifically been designed for this study by the Sponsor. The eDiaries 
will include prelisted AEs (solicited ARs) and intensity scales; they will also include blank space 
for the recording of information on other AEs (unsolicited AEs) and concomitant 
medications/vaccinations. 
The investigator is responsible for the documentation of AEs regardless of study arm or 
suspected causal relationship to IP. For all AEs, the investigator must pursue and obtain 
information adequate to determine the outcome of the AE and to assess whether the AE meets 
the criteria for classification as an SAE requiring immediate notification to the Sponsor or its 
designated representative. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences. 

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2.7.4.14. 
Follow-up of AEs and SAEs  
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits and contacts. 
All AEs and SAEs will be treated as medically appropriate and followed until resolution, 
stabilization, the event is otherwise explained, or the participant is LTFU, as defined in 
Section 2.6.3. 
In the case of any SAE/AESI, the participant must be followed up until clinical recovery is 
complete or until the outcome has been stabilized. This may imply that follow-up could continue 
after the participant discontinues the trial, or after the intended duration of the safety follow-up 
for the study has been completed. In the case of any SAE or AESI brought to the attention of the 
investigator at any time after the end of the study for the participant and considered to be cause 
by mRNA-1345, the event must be reported to the SAE Mailbox, SAE Hotline, or SAE Fax 
Line, as noted in Section 2.7.4.10. 
2.7.4.15. 
Regulatory Reporting Requirements for SAEs  
• Prompt notification by the investigator to the Sponsor of an SAE is essential so that 
legal obligations and ethical responsibilities toward the safety of participants and the 
safety of a study intervention under clinical investigation are met. 
• The Sponsor has a legal responsibility to notify both the local regulatory authority 
and other regulatory agencies about the safety of a study intervention under clinical 
investigation. The Sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, IRBs, and investigators. 
• Investigator safety reports must be prepared for suspected unexpected serious ARs 
according to local regulatory requirements and Sponsor policy and forwarded to 
investigators as necessary. 
• An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will 
review and then file it along with the IB and will notify the IRB, if appropriate 
according to local requirements. 
2.7.5. Pregnancy  
Details of all pregnancies occurring in participants after the start of injection must be reported to 
the Sponsor or designee within 24 hours of learning of the pregnancy following the procedures 
outlined in Section 2.7.4.6. Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal 
death, stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs. 
Further information on the collection of pregnancy information is given in Section 2.7.4.6. 
2.7.6. Safety Monitoring  
Safety monitoring for this study will include the blinded study team members, inclusive of, at a 
minimum, the Sponsor’s medical monitor and a CRO medical monitor, a blinded IST, and an 
unblinded DSMB. The study team will conduct ongoing blinded safety reviews during the study 
and will be responsible for notifying the IST and DSMB of potential safety signal events. The 

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IST will be composed of the Sponsor’s physicians and may also include Sponsor-designated 
members from the CRO, as specified in the study IST charter. The IST will conduct ad hoc 
reviews as requested by the study medical monitor and study team. The DSMB, composed of 
external/independent subject matter experts, will conduct unblinded reviews of safety data on an 
ad hoc basis if requested by the study team and/or the IST. 
2.7.7. Treatment of Overdose  
As the study treatment is to be administered by an HCP, it is unlikely that an overdose will 
occur. Dose deviations will be tracked as protocol deviations (Section 6.1.8). 
2.7.8. Pharmacokinetics  
Pharmacokinetic parameters are not evaluated in this study. 
2.7.9. Pharmacodynamics  
Pharmacodynamic parameters are not evaluated in this study. 
2.7.10. Biomarkers  
Immunogenicity assessments are described in Section 2.7.2. Biomarker assessment may include 
genomic and transcriptomics samples. 
2.7.11. Health Economics  
Health economics are not evaluated in this study. 
2.8. Statistical Considerations  
This section summarizes the planned statistical analysis strategy and procedures for the study. 
The details of statistical analysis will be provided in a statistical analysis plan (SAP), which will 
be finalized before the database lock for the study. If changes are made to primary and/or 
secondary objectives or related statistical methods after the study has begun, then the protocol 
will be amended (consistent with ICH Guideline E9). Changes to other secondary or exploratory 
analyses made after the protocol has been finalized, along with an explanation as to when and 
why they occurred, will be listed in the SAP or CSR for the study. Ad hoc exploratory analyses, 
if any, will be clearly identified in the CSR. 
2.8.1. Blinding and Responsibility for Analyses  
This is an observer-blind study. The investigator, study staff, study participants, site monitors, 
and Sponsor personnel (or its designees) will be blinded to the IP administered until the study 
database is locked and unblinded, with the following exceptions: 
• Unblinded personnel (of limited number) will be assigned to vaccine accountability 
procedures and will prepare the IP for all participants. These personnel will have no 
study functions other than IP management, documentation, accountability, 
preparation, and administration. They will not be involved in participant evaluations 
and will not reveal the identity of the IP to either the participant or the blinded study 

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site personnel involved in the conduct of the study unless this information is 
necessary in the case of an emergency. 
• Unblinded medically qualified study site personnel will administer the IP. They will 
not be involved in assessments of any study endpoints. 
• Unblinded site monitors, not involved in other aspects of monitoring, will be assigned 
as the IP accountability monitors. They will have responsibilities to ensure that sites 
are following all proper IP accountability, preparation, and administration procedures. 
• An independent unblinded statistical and programming team will perform the 
preplanned IA (Section 2.8.6). Sponsor team members will be prespecified to be 
unblinded to the IA results and will not communicate the results to the blinded 
investigators, study site staff, clinical monitors, or participants. 
• The DSMB will review the IA data to safeguard the interests of clinical study 
participants and to help ensure the integrity of the study. The DSMB will review 
unblinded IA results provided by the independent unblinded statistician. Section 2.7.6 
provides additional information on DSMB and safety review. 
The treatment assignment, including the injection site and the corresponding vaccine or placebo 
administered, will be concealed by having the unblinded pharmacy personnel prepare the IP in a 
secure location that is not accessible or visible to other study staff. An opaque sleeve over the 
syringe used for injection will maintain the blind at the time of injection, as the doses containing 
mRNA will look different from those of placebo. Only delegated unblinded study site staff will 
conduct the injection procedure. Once the injection is completed, only the blinded study staff 
will perform further assessments and interact with the participants. Access to the randomization 
code will be strictly controlled at the pharmacy. 
2.8.1.1. 
Breaking the Blind  
Except in the case of medical necessity, a participant’s vaccine assignment should not be 
unblinded without the approval of the Sponsor. If a participant becomes seriously ill or pregnant 
during the study, the blind will be broken only if knowledge of the vaccine assignment will 
affect that participant’s clinical management. In the event of a medical emergency requiring 
identification of individual vaccine assignment, the investigator will make every attempt to 
contact the Sponsor medical lead or designee, preferably via electronic protocol inquiry platform, 
to explain the need for unblinding within 24 hours of obtaining the treatment code. The 
investigator will be responsible for documenting the time, date, reason for unblinding, and the 
names of the personnel involved. The investigator (or designee) will have access to unblind 
participants within IRT) All unblinding instances will be tracked via an audit trail in IRT and 
documented in the final CSR. 
If unblinding should occur (by either accidental unblinding or emergency unblinding) before 
completion of the study, the investigator must promptly contact the Sponsor and document the 
circumstances on the appropriate forms. 
In addition to the aforementioned situations where the blind may be broken, the data will also be 
unblinded to a statistical team at specified timepoint(s) for analysis as outlined in Section 2.8.1. 

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2.8.2. Statistical Hypotheses  
The immunogenicity primary objectives are to evaluate the effect of coadministered influenza 
vaccine with mRNA-1345 on the immune response to RSV-A virus and influenza A and B 
strains included in Afluria Quadrivalent. There are 6 co-primary endpoints to support the primary 
objectives.  
Primary Objective to Evaluate the Impact on the Immune Response to RSV-A: 
Co-primary endpoints based on GMT at Day 29:  
The null hypothesis H10: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with Afluria Quadrivalent, as measured by GMT at Day 29 using 
RSV-A nAb assay, is inferior compared with that in participants who received mRNA-1345 plus 
placebo. The noninferiority in the GMT in participants who received mRNA-1345 
coadministered with Afluria Quadrivalent compared with that of participants who received 
mRNA-1345 plus placebo will be demonstrated by the lower bound (LB) of the 95% CI of the 
geometric mean titer ratio (GMR) of ruling out 0.667 (ie, LB > 0.667) using a noninferiority 
margin of 1.5. The GMR is the ratio of the GMT of RSV-A nAbs in participants who received 
mRNA-1345 coadministered with Afluria Quadrivalent compared with the GMT of RSV-A 
nAbs in participants who received mRNA-1345 plus placebo. 
Co-primary endpoints based on Seroresponse Rate at Day 29: 
The null hypothesis H20: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with Afluria Quadrivalent, as measured by seroresponse rate (SRR) 
of RSV-A nAbs at Day 29, is inferior compared with that in participants who received 
mRNA-1345 plus placebo. The noninferiority in the SRR in participants who received 
mRNA-1345 coadministered with Afluria Quadrivalent compared with that of participants who 
received mRNA-1345 plus placebo will be demonstrated by the LB of the 95% CI of the SRR 
difference of ruling out -10% (ie, LB > -10%) using a noninferiority margin of 10%. The SRR 
difference is the SRR of RSV-A nAb in participants who received mRNA-1345 coadministered 
with Afluria Quadrivalent minus the SRR of RSV-A nAbs in participants who received 
mRNA-1345 plus placebo. 
Primary Objective to Evaluate the Impact on the Immune Response to Influenza: 
Co-primary endpoints based on GMT at Day 29: 
The null hypotheses H30 to H60: immunogenicity response to Afluria Quadrivalent in participants 
who received Afluria Quadrivalent coadministered with mRNA-1345, as measured by GMT of 
influenza anti-HA Abs for each of the 4 influenza strains at Day 29 using HAI assay, is inferior 
compared with that in participants who received Afluria Quadrivalent plus placebo. For each of 
the 4 influenza strains, the noninferiority in the GMT in participants who received mRNA-1345 
coadministered with Afluria Quadrivalent compared with that of participants who received 
Afluria Quadrivalent plus placebo will be demonstrated by the LB of the 95% CI of the GMR of 
ruling out 0.667 (ie, LB > 0.667) using a noninferiority margin of 1.5. The GMR is the ratio of 
the GMT of anti-HA Abs in participants who received mRNA-1345 coadministered with Afluria 
Quadrivalent compared with the GMT of anti-HA Abs in participants who received Afluria 
Quadrivalent plus placebo. 

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Key Secondary Objective to Evaluate the Impact on the Immune Response to RSV-B: 
Key secondary endpoint based on GMT at Day 29: 
The null hypothesis H70: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with Afluria Quadrivalent, as measured by GMT at Day 29 using 
RSV-B nAb assay, is inferior compared with that in participants who received mRNA-1345 plus 
placebo. The noninferiority in the GMT in participants who received mRNA-1345 
coadministered with Afluria Quadrivalent compared with that of participants who received 
mRNA-1345 plus placebo will be demonstrated by the LB of the 95% CI of the GMR of ruling 
out 0.667 (ie, LB > 0.667) using a noninferiority margin of 1.5. The GMR is the ratio of the 
GMT of RSV-B nAbs in participants who received mRNA-1345 coadministered with Afluria 
Quadrivalent compared with the GMT of RSV-A nAbs in participants who received mRNA-
1345 plus placebo. 
Key secondary endpoint based on SRR at Day 29:  
The null hypothesis H80: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with Afluria Quadrivalent, as measured by SRR of RSV-B nAbs at 
Day 29, is inferior compared with that in participants who received mRNA-1345 plus placebo. 
The noninferiority in the SRR in participants who received mRNA-1345 coadministered with 
Afluria Quadrivalent compared with that of participants who received mRNA-1345 plus placebo 
will be demonstrated by the LB of the 95% CI of the SRR difference of ruling out -10% (ie, LB 
> -10%) using a noninferiority margin of 10%. The SRR difference is the SRR of RSV-B nAb in 
participants who received mRNA-1345 coadministered minus the SRR of RSV-B nAb in 
participants who received mRNA-1345 plus placebo. 
Key Secondary Objective to Evaluate the Impact on the Immune Response to Influenza 
Based on Seroconversion from Baseline: 
Key secondary endpoint based on SCR at Day 29:  
The null hypotheses H90 to H120: immunogenicity response to Afluria Quadrivalent in 
participants who received mRNA-1345 coadministered with Afluria Quadrivalent, as measured 
by seroconversion rate (SCR) of influenza anti-HA Abs for each influenza strain at Day 29 using 
HAI assay, is inferior compared with that in participants who received Afluria Quadrivalent plus 
placebo. The noninferiority in SCR in participants who received mRNA-1345 coadministered 
with Afluria Quadrivalent compared with that of participants who received Afluria Quadrivalent 
plus placebo will be demonstrated by the LB of the 95% CI of the SCR difference of ruling out -
10% (ie, LB > -10%) using a noninferiority margin of 10%. The SCR difference is the SCR of 
anti-HA Abs in participants who received mRNA-1345 coadministered with Afluria 
Quadrivalent minus the SCR of anti-HA Abs in participants who received Afluria Quadrivalent 
plus placebo. 
2.8.3. Sample Size Determination  
The study will plan to randomize approximately 1620 participants, with approximately 
420 participants receiving mRNA-1345 plus placebo (Group 1), 600 participants receiving 
mRNA-1345 plus Afluria Quadrivalent (Group 2), and 600 participants receiving Afluria 
Quadrivalent plus placebo (Group 3). 

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With approximately 420 participants exposed to mRNA-1345 plus placebo, the study has 
approximately 95% probability to observe at least 1 participant with an AE at a true 0.7% AE 
rate. With approximately 600 participants exposed to mRNA-1345 plus Afluria Quadrivalent and 
Afluria Quadrivalent plus placebo, respectively, the study has approximately 95% probability to 
observe at least 1 participant with an AE at a true 0.5% AE rate.  
Assuming approximately 10% of participants are ineligible to be included in the PP Set; 
540 participants receiving mRNA-1345 plus Afluria Quadrivalent (Group 2) and 378 participants 
receiving mRNA-1345 plus placebo (Group 1): 
• There is at least 98% power to demonstrate the noninferiority of the immune response 
to RSV-A, as measured by GMT of RSV-A nAb at Day 29 in participants receiving 
mRNA-1345 plus Afluria Quadrivalent compared with that in mRNA-1345 plus 
placebo group, at a 2-sided alpha of 0.05, assuming a noninferiority margin of 1.5 and 
an underlying GMR of 1. The standard deviation of the natural log-transformed level 
is assumed to be 1.5. 
• There is at least 96% power to demonstrate the noninferiority of the immune 
response, as measured by SRR of RSV-A nAbs at Day 29 in participants receiving 
mRNA-1345 plus Afluria Quadrivalent compared with that in mRNA-1345 plus 
placebo group, at a 2-sided alpha of 0.05, assuming an SRR of RSV-A nAbs of 80% 
in both groups (a true SRR difference is 0), and a noninferiority margin of 10%. 
With 540 participants to be included in PP Set in either mRNA-1345 plus Afluria Quadrivalent 
group (Group 2) or Afluria Quadrivalent plus placebo group (Group 3), there is at least 99% 
power to demonstrate noninferiority of the immune response to each of the 4 influenza strains, as 
measured by GMT of influenza anti-HA Abs for each strain in participants receiving 
mRNA-1345 plus Afluria Quadrivalent compared with that in Afluria Quadrivalent plus placebo 
group, at a 2-sided alpha of 0.05, assuming a noninferiority margin of 1.5 and an underlying 
GMR of 1. The standard deviation of the natural log-transformed level is assumed to be 1.5. 
The global power considering meeting the primary objectives to evaluate the immune responses 
to RSV-A and influenza is at least 90%. Sample size justification for the co-primary endpoints is 
shown in Table 5. 
Table 5: 
Sample Size Justification for the Co-primary Endpoints 
Co-primary 
Endpoints 
Number of 
Evaluable 
Participants (with 
10% ineligible for 
the PP Set) 
α 
Standard 
Deviation 
GMR/SRR 
Assumed 
NI 
Margin 
Power 
mRNA-1345 noninferiority (2-sided test) 
Day 29 GMT 
Coadministration 
(Group 2) vs. alone 
(Group 1) 
378 (Group 1) 
540 (Group 2) 
0.05 
1.5 
GMR=1 
1.5 
98% 
Day 29 SRR  
378 (Group 1) 
540 (Group 2) 
0.05 
 
SRR=0.8 in 
both groups 
10% 
96% 

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Co-primary 
Endpoints 
Number of 
Evaluable 
Participants (with 
10% ineligible for 
the PP Set) 
α 
Standard 
Deviation 
GMR/SRR 
Assumed 
NI 
Margin 
Power 
Coadministration 
(Group 2) vs. alone 
(Group 1) 
Afluria® Quadrivalent noninferiority (2-sided test) for each influenza strain 
Day 29 GMT  
Coadministration 
(Group 2) vs. alone 
(Group 3) 
540 (Group 2) 
540 (Group 3) 
0.05 
1.5 
GMR=1 
1.5 
99% 
Global power to show noninferiority of the co-primary immunogenicity endpoints 
90% 
Abbreviations: GMR = geometric mean titer ratio; GMT = geometric mean titer; PP = per protocol; 
SRR = seroresponse rate. 
With 540 and 378 participants to be included in the PP Set in Group 2 and Group 1, respectively: 
• There is at least 98% power to demonstrate the noninferiority of the immune response 
to RSV-B, as measured by GMT of RSV-B nAb at Day 29 in participants from 
Group 2 compared with that from Group 1, at a 2-sided alpha of 0.05, assuming a 
noninferiority margin of 1.5 and an underlying GMR of 1. The standard deviation of 
the natural log-transformed level is assumed to be 1.5. 
• There is at least 96% power to demonstrate the noninferiority of the immune 
response, as measured by SRR of RSV-B nAbs at Day 29 in participants from 
Group 2 compared with that from Group 1, at a 2-sided alpha of 0.05, assuming a 
SRR of 80% in both groups (a true SRR difference is 0) and a noninferiority margin 
of 10%.  
With 540 participants to be included in the PP Set in Group 2 and Group 3, respectively, there is 
approximately 95% power to demonstrate the noninferiority of the immune response to each of 
the 4 influenza strains, as measured by SCR of influenza anti-HA Abs for each strain at Day 29 
in participants from Group 2 compared with that from Group 3, at a 2-sided alpha of 0.05, 
assuming an SCR of 70% in both groups (a true SCR difference is 0) and a noninferiority margin 
of 10%. Under the same assumptions, the overall power to demonstrate the noninferiority of the 
immune response to 4 influenza strains is approximately 80%. 
2.8.4. Analysis Sets  
The analysis sets are described in Table 6 for Parts A and B and Table 13for Part C. 
Table 6: 
Analysis Sets 
Set 
Description 
Randomized Set 
Includes all participants who are randomized in the study, 
regardless of the participant’s treatment status in the study. 

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Set 
Description 
Participants will be included in the vaccination group to which 
they are randomized. 
Full Analysis Set (FAS) 
All randomized participants who received any IP. Participants 
will be included in the vaccination group to which they are 
randomly assigned. 
Per Protocol (PP) Set 
Includes all participants in the FAS that received the assigned IP 
dose according to protocol, complied with immunogenicity 
blood sampling to have a baseline and at least 1 post-injection 
assessment, and have no major protocol deviations that impact 
the immune response. The PP Set will be the primary 
population used for the analysis of immunogenicity data. 
Participants will be included in the vaccination group to which 
they are randomly assigned. 
Solicited Safety Set 
Includes all randomized participants who received any study 
vaccination and contributed any solicited AR data. The 
Solicited Safety Set will be used for the analyses of solicited 
ARs and participants will be included in the vaccination group 
corresponding to the IP they actually received. 
Safety Set 
Includes all randomized participants who receive any study 
injection. Participants will be included in the vaccination group 
corresponding to the IP they actually received for the analysis of 
safety data using the Safety Set. 
Abbreviations: AR = adverse reaction; FAS = full analysis set; IP = investigational product; PP = per protocol. 
2.8.5. Statistical Methods  
2.8.5.1. 
Immunogenicity Analysis  
The immunogenicity endpoints will be analyzed using the PP Set, by vaccination group. If the 
number of participants in the full analysis set (FAS) and PP Set differs (defined as the difference 
divided by the total number of participants in the PP Set) by more than 10%, supportive analyses 
of immunogenicity may be conducted using the FAS. 
The co-primary and key secondary endpoints include the GMT of RSV-A/RSV-B nAb titers at 
Day 29 and GMT of anti-HA Ab titers for each influenza strain, as measured by HAI at Day 29. 
For each co-primary and key secondary endpoint regarding GMT, the GMR will be estimated 
using an analysis of covariance (ANCOVA) model on the log-transformed titers at Day 29, with 
the vaccination group as the fixed variable, log-transformed baseline titers as a fixed covariate, 
adjusted for stratified age group used for randomization. The geometric least square mean 
(GLSM) and its corresponding 95% CI in a log-transformed scale estimated from the model will 
be back-transformed to obtain these estimates in the original scale as an estimate of the GMT and 
its 95% CI. The GMR, estimated by the ratio of the GLSM and the corresponding 2-sided 95% 
CI, will be provided to assess the treatment difference. The corresponding 2-sided 95% CI of the 
GMR will be provided to assess the difference in the immune response between the 

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2 vaccination groups. For each co-primary and key secondary endpoint regarding GMT, the 
noninferiority of the GMT will be demonstrated if the LB of the 95% CI of the GMR is > 0.667.  
SRR of RSV-A/RSV-B nAbs is defined as proportion of participants with post-vaccination titers 
≥4 × LLOQ if baseline is <LLOQ or a ≥4-fold increase from baseline if baseline is ≥LLOQ. 
SCR of an influenza strain is defined as proportion of participants with a post-vaccination titer 
≥1:40 if baseline is <1:10 or a ≥4-fold rise in post-vaccination HAI Ab titer if baseline is ≥1:10.  
The number and percentage of participants with seroresponse or seroconversion at each 
postbaseline timepoint will be provided with 2-sided 95% CIs using the Clopper-Pearson 
method. For the co-primary endpoint and key secondary endpoints regarding SRR and SCR, the 
Miettinen-Nurminen’s method will be used to calculate the 95% CI for the difference in the SRR 
or SCR at Day 29 between the vaccination groups. The noninferiority of the SRR at Day 29 for 
RSV-A/RSV-B nAbs will be demonstrated if the LB of the 95% CI of the SRR difference 
between mRNA-1345 + Afluria Quadrivalent coadministered and mRNA-1345 plus placebo 
groups is > –10%. The noninferiority of the SCR at Day 29 will be demonstrated if the LB of the 
95% CI of the SCR difference between mRNA-1345 + Afluria Quadrivalent coadministered and 
Afluria Quadrivalent plus placebo groups is > –10%. 
Data from quantitative immunogenicity assays will be summarized for each vaccination group 
using positive response rates and geometric means with 95% CIs for each timepoint an 
assessment is performed. 
For the immunogenicity endpoints, the GMT/GMC ratio of specific Abs, with the corresponding 
95% CI at each timepoint, and geometric mean fold rise of specific Ab titers, with the 
corresponding 95% CI at each postbaseline timepoint over preinjection baseline on Day 1, will 
be provided by vaccination group. The 95% CIs will be calculated based on the t-distribution of 
the log-transformed values then back-transformed to the original scale descriptive summary 
statistics, including the median, minimum, and maximum values, will also be provided. 
For summarizations of the GMT/GMC ratios, Ab titers reported as below the LLOQ will be 
replaced by 0.5 × LLOQ. Values that are greater than the upper limit of quantification (ULOQ) 
will be converted to the ULOQ if actual values are not available. 
The proportion of participants with at least 2-fold and at least 4-fold increases in 
titers/concentration (relative to baseline) will be provided by timepoint with the 2-sided 95% CI 
using the Clopper-Pearson method at Day 29. The number and percentage of participants with 
2- and 4-fold increases will be provided with the 2-sided 95% CI using the Clopper-Pearson 
method. To compare the 2- and 4-fold increase rates between the vaccination groups, the 
Miettinen-Nurminen’s method will be used to calculate the 95% CI for the difference in the 
fold-rise increase rates. The 2- and 4-fold rate difference, with the corresponding 95% CI at 
Day 29, will be provided.  
Descriptive statistics (including 95% CIs) of the immunogenicity endpoints will also be provided 
by vaccination group and age group (50 to 59 years, 60 to 74 years, and ≥75 years). 
2.8.5.2. 
Safety Analyses  
Safety and reactogenicity will be assessed by clinical review of all relevant parameters, including 
solicited ARs (local and systemic events), unsolicited AEs, SAEs, AESIs, MAAEs, AEs leading 
to discontinuation, vital signs, and physical examination findings. 

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Solicited ARs will be coded according to the MedDRA for AR terminology and unsolicited AEs 
will be coded by system organ class and preferred term according to the MedDRA. The Toxicity 
Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine 
Clinical Trials (DHHS 2007) will be used in this study. 
All safety analyses will be based on the Safety Set, except summaries of solicited ARs, which 
will be based on the Solicited Safety Set. All safety analyses will be provided by the vaccination 
group corresponding to the IP the participants actually received, unless otherwise specified. 
Local solicited reactogenicity analyses will be presented by injection content and vaccination 
group corresponding to the IP the participants actually received. 
The number and percentage of participants with any solicited local AR, solicited systemic AR, 
and solicited AR during the 7-day follow-up period after administration of the IP will be 
summarized. A 2-sided 95% exact CI using the Clopper-Pearson method will be provided for the 
percentage of participants with any solicited AR. 
The number and percentage of participants with unsolicited AEs, SAEs, AESIs, MAAEs, severe 
AEs, and AEs leading to discontinuation from study participation in the study will be 
summarized. 
The number of events of unsolicited AEs, SAEs, and MAAEs will be summarized. 
For all other safety parameters, descriptive summary statistics will be provided. 
The number and percentage of participants who have vital signs results below or above the 
normal ranges will be summarized by timepoint. 
2.8.5.3. 
Exploratory Analyses  
Exploratory analyses not addressed in Section 2.8.5.3 will be described in the SAP before 
database lock. 
2.8.6. Planned Analyses  
A primary analysis and a final analysis will be conducted in this study. Further details can be 
found in the SAP. 
2.8.6.1. 
Primary Analysis  
The primary analysis of safety and immunogenicity will be performed after all participants have 
completed the Day 29 Visit. All data relevant to the primary study analysis through the Day 29 
visit will be cleaned and locked for the primary analysis (ie, data that are as clean as possible) 
and a report may be generated. The primary analysis will be performed by a separate team of 
unblinded programmers and statisticians. 
2.8.6.2. 
Final Analysis  
The final analysis of all endpoints will be performed after all participants have completed 
Day 181/EoS. Results of this analysis will be presented in a final CSR. The final CSR will 
include full analyses of all safety and immunogenicity data through Day 181/EoS. 

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2.8.7. Multiplicity  
A sequential/hierarchical testing procedure will be used to control the overall Type 1 error rate at 
0.05 (2 sided) over the primary endpoints, key secondary efficacy endpoints, and selected 
secondary endpoints.  
The co-primary endpoints will be tested at the planned primary analysis at a 2-sided Type 1 error 
rate of 0.05. The success criteria of all 6 co-primary endpoints need to be met successfully in 
order to declare the study a success to achieve noninferiority of coadministration.  
The key secondary endpoints will be tested at the primary analysis at a 2-sided Type 1 error rate 
of 0.05 when all co-primary endpoints have achieved statistical significance. 

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3. PART B  
Part B is a Phase 3 randomized, observer-blind, study to evaluate safety, tolerability, and 
immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or 
coadministered with mRNA-1273.214 in adults ≥50 years of age. 
3.1. Protocol Summary  
3.1.1. Synopsis (Part B)  
Protocol Title: 
A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and 
Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus 
(RSV), When Given Alone or Coadministered with a Seasonal Influenza Vaccine or 
SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1Year Following a Primary 
Dose in Adults ≥ 50 Years of Age 
Regulatory Agency Identifier Numbers: 
Investigational New Drug: 23342 
Rationale: 
This study is designed as a randomized, observer-blind study to evaluate the safety and 
immunogenicity of mRNA-1345 when coadministered with mRNA-1273.214 compared with 
either vaccine alone in medically stable older adults ≥50 years of age. Participants will receive 
either mRNA-1345 + placebo, mRNA-1345 + mRNA-1273.214, or mRNA-1273.214 + placebo 
in contralateral arms. If not received on Day 1, all remaining participants will receive 
mRNA-1273.214 on Day 29. 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and tolerability of 
mRNA-1345 coadministered with 
mRNA-1273.214 
• 
Numbers and percentages of participants with 
solicited local and systemic ARs over the 7 days 
after each injection. 
• 
Numbers and percentages of unsolicited AEs 
through 28 days after each injection. 
• 
Numbers and percentages of MAAEs, SAEs, 
AESIs, and AEs leading to discontinuation from 
Day 1 (baseline) to EoS. 
• 
To evaluate the effect of coadministered 
mRNA-1273.214 on the immune 
response to RSV-A 
• 
GMT of serum RSV-A neutralizing Abs at 
Day 29. 
• 
SRR in RSV-A neutralizing Abs at Day 29. 

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Objectives 
Endpoints 
• 
To evaluate the effect of coadministered 
RSV vaccine on the immune response to 
SARS-CoV-2 
• 
GMC of serum Ab level as measured by 
neutralization assay for SARS-CoV-2 at Day 29. 
• 
SRR for SARS-CoV-2 at Day 29. 
Key Secondary 
• 
To evaluate the effect of coadministered 
mRNA-1273.214 on the immune 
response to RSV-B 
• 
GMT of serum RSV-B neutralizing Abs at Day 
29. 
• 
SRR in RSV-B neutralizing Abs at Day 29. 
Secondary 
• To evaluate Ab response to mRNA-
1345 with and without mRNA-
1273.214 
• GMT and GMFR of postinjection/baseline 
titers to RSV-A neutralizing Abs up to EoS. 
• GMT and GMFR of postinjection/baseline 
titers to RSV-B neutralizing Abs up to EoS. 
• Proportion of participants with ≥2-fold 
increases in RSV-A neutralizing Ab titers up 
to EoS. 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in RSV-B neutralizing Ab 
titers up to EoS. 
• To evaluate the Ab response to 
mRNA-1273.214 with and without 
mRNA-1345 
• GMC and GMFR as measured by 
neutralization assay for SARS-CoV-2 up to 
EoS. 
• SRR up to EoS as measured by neutralization 
assay for SARS-CoV-2. 
Exploratory (may be performed) 
• To further characterize the immune 
response across study vaccines  
• GMC and GMFR of postinjection/baseline titers 
to RSV-binding Abs up to EoS. 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in RSV-binding Ab 
concentration up to EoS. 
• GMC and GMFR of postinjection/baseline titers 
to SARS-CoV-2 binding Abs up to EoS. 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in SARS-CoV-2 binding Ab 
concentration up to EoS. 
• Frequency, specificities, or other endpoints to be 
determined for the further characterization of 
immune responses. 

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Overall Design: 
Part B is a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and 
immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or 
coadministered with mRNA-1273.214 in adults ≥50 years of age. 
All participants will participate in a Screening period (up to 14 days before Day 1), treatment 
period (vaccine and/or placebo administration on Day 1 [Baseline] and on Day 29), and a follow-
up period (up to 7 months after first vaccination).  
The study will enroll approximately 1680 medically stable adults ≥50 years of age. On Day 1, 
each participant will receive 2 injections administered IM, one in each arm, in the deltoid 
muscle. Participants will be randomized as shown in the below table to receive either 1) mRNA-
1345 (
 μg) + placebo (0.9% sodium chloride [normal saline]); 2) mRNA-1345 (
 μg) + 
mRNA-1273.214 (
 μg); or 3) mRNA-1273.214 (
 μg) + placebo. Randomization will be 
stratified by age (50 to 59 years, 60 to 74 years, and ≥75 years). The study will target enrollment 
of approximately 35% of participants 50 to 59 years of age. On Day 29, participants will receive 
an additional injection as outlined in the table below, to allow all study participants to receive an 
mRNA-1273.214 booster vaccination. 
Group 
Name 
Sample Size Vaccines Administered 
Group 4 
560 
Day 1: mRNA-1345 (
 μg) + placebo in contralateral arms 
Day 29: mRNA-1273.214 (
 μg) 
Group 5 
560 
Day 1: mRNA-1345 (
 μg) + mRNA-1273.214 (
 μg) in contralateral 
arms 
Day 29: placebo 
Group 6 
560 
Day 1: mRNA-1273.214 (
 μg) + placebo in contralateral arms 
Day 29: placebo 
At the dosing visit on Day 1 and Day 29, participants will be instructed how to document, and 
report solicited ARs in a provided eDiary. Solicited ARs will be assessed from the day of 
injection and the following 6 days, and local solicited ARs will be assessed separately for each 
injection site. Unsolicited AEs will be assessed from the day of injection and the following 
27 days. Serious AEs, MAAEs, AEs leading to withdrawal, and AESIs will be assessed from 
Day 1 through EoS. 
Participants may experience AEs that necessitate an unscheduled visit. There may also be 
situations in which the investigator asks a participant to attend an unscheduled visit following the 
report of an AE. Additional examinations may be conducted at these visits as necessary to ensure 
the safety and well-being of participants during the study. eCRFs should be completed for each 
unscheduled visit. 
Brief Summary: 
The purpose of this study is to assess the safety and immune response of mRNA-1345, an 
mRNA vaccine targeting RSV when given alone or coadministered with a SARS-CoV-2 vaccine 
in healthy older adults. 
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI

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Study details include: 
• The study duration will be up to 7 months. 
• The treatment is 2 injections on Day 1 and 2 injections on Day 29. 
• The visit frequency will be 3 visits in the first month (Days 1 [clinic], 8 [clinic or 
telephone call], and 29 [clinic]); a clinic or safety telephone call on Day 37; a clinic 
visit at Month 2, and 3 (one per month); safety telephone calls from Months 3 through 
5, and clinic visits at Month 6 and 7. 
Number of Participants: 
Approximately 1680 participants will be enrolled. 
Note: Enrolled means participants’, or their legally acceptable representatives’, agreement to 
participate in a clinical study following completion of the informed consent process. Potential 
participants who are screened for the purpose of determining eligibility for the study, but do not 
participate in the study, are not considered enrolled unless otherwise specified by the protocol. A 
participant will be considered enrolled if the informed consent is not withdrawn prior to 
participating in any study activity after screening. 
Data Monitoring/other Committee: 
Safety monitoring for this study will include the blinded study team members, inclusive of, at a 
minimum, the Sponsor’s medical monitor and a CRO medical monitor, a blinded IST, and an 
unblinded DSMB. The study team will conduct ongoing blinded safety reviews during the study 
and will be responsible for notifying the IST and DSMB of potential safety signal events. The 
IST will be composed of the Sponsor’s physicians and may also include Sponsor-designated 
members from the CRO, as specified in the study IST charter. The IST will conduct ad hoc 
reviews as requested by the study medical monitor and study team. The DSMB, composed of 
external/independent subject matter experts, will conduct unblinded reviews of safety data on an 
ad hoc basis if requested by the study team and/or the IST. This study will be conducted in 
compliance with the protocol, GCP, and all applicable regulatory requirements. 
In addition, the following will be performed for Part B because of the inclusion of 
mRNA-1273.214 in the study design: 
An independent Cardiac Event Adjudication Committee (CEAC) that includes cardiologists will 
review suspected cases of myocarditis, pericarditis, or myopericarditis to determine if they meet 
CDC criteria of “probable” or “confirmed” events and to assess severity. Any cases that the 
CEAC assesses as representing probable or confirmed cases of myocarditis, pericarditis, or 
myopericarditis will be referred to the Sponsor, who will then make a final decision on whether 
to suspend further enrollment and/or study dosing based on an assessment of the overall potential 
risk to study participants. The CEAC will operate under the rules of an approved charter that will 
be written and reviewed at the organizational meeting of the CEAC. Details regarding the CEAC 
composition, responsibilities, procedures, and frequency of data review will be defined in its 
charter. 

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3.1.2. Schema (Part B)  
Figure 2: 
Study Schema (Part B) 
 
 
 
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3.1.3. SoA (Part B)  
Table 7: 
SoA (Part B) 
Visit Number 
Screening 
1 
2 
3 
4 
5 
6, 7, 8 
9 
10 
USV 
Type of Visit 
C 
C 
C/SC 
C 
C/SC 
C 
SC 
C 
C 
C 
Month Timepoint 
N/A 
 
 
M1 
 
M2 
M3-M5 
M6 
M7 
Up to M7 
Visit Day  
Screeninga 
D1 
(Baseline)a 
D8 
D29 
D37 
D57 
D91, 
D121, 
D151 
D181 
D211/ 
EoS 
N/A 
Window Allowance (Days) 
-14 
- 
+3 
-7 + 2 
+3 
±5 
±5 
±14 
±14 
N/A 
Informed consent, demographics, 
concomitant medications, medical history 
(including COVID), and SARS-Cov-2 
vaccination historyh  
X 
– 
– 
– 
 
 
– 
– 
 
– 
Inclusion/exclusion criteria 
X 
X 
– 
– 
 
 
– 
– 
 
– 
Physical examinationb 
X 
X 
– 
– 
 
 
– 
– 
 
– 
Vital sign measurementsc 
X 
X 
– 
X 
 
 
– 
– 
 
X 
Study vaccination (including a 30-minute 
postdose observation period)  
– 
Xd 
– 
 
 
 
– 
– 
 
– 
Day 29 mRNA.214 vaccination or placebo 
 
 
 
X 
 
 
 
 
 
 
Blood sample collection for humoral 
immunogenicitye 
– 
X 
– 
X 
 
X 
– 
X 
X 
– 
Pregnancy testingf 
X 
X 
 
X 
 
 
 
 
 
 
eDiary activation for recording solicited ARs 
(7 days)g 
– 
X 
– 
X 
 
 
– 
– 
 
– 
Optional blood collection for genomicse 
– 
X 
– 
– 
 
 
– 
– 
 
– 
Optional blood sample for transcriptomicse 
– 
X 
– 
X 
 
X 
– 
X 
X 
– 
Follow-up safety telephone callh 
– 
– 
– 
– 
 
 
X 
– 
 
– 
Recording of unsolicited AEs (for confirmed 
cases of RSV or COVID, see Section 3.7.1 
– 
X 
X 
X 
X 
X 
– 
– 
 
– 

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Visit Number 
Screening 
1 
2 
3 
4 
5 
6, 7, 8 
9 
10 
USV 
Type of Visit 
C 
C 
C/SC 
C 
C/SC 
C 
SC 
C 
C 
C 
Month Timepoint 
N/A 
 
 
M1 
 
M2 
M3-M5 
M6 
M7 
Up to M7 
Visit Day  
Screeninga 
D1 
(Baseline)a 
D8 
D29 
D37 
D57 
D91, 
D121, 
D151 
D181 
D211/ 
EoS 
N/A 
Window Allowance (Days) 
-14 
- 
+3 
-7 + 2 
+3 
±5 
±5 
±14 
±14 
N/A 
Recording of SAEs, AESIs, MAAEs, AEs 
leading to discontinuation, and concomitant 
medications relevant to or for their treatmenti 
– 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of nonstudy vaccinationsi 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study completion 
– 
– 
– 
– 
 
 
– 
 
X 
– 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; C = clinic visit; D = Day; eDiary = electronic diary; 
EoS = end of study; M = month; mRNA = messenger RNA; N/A = not applicable; MAAE = medically attended adverse event; RSV = respiratory syncytial 
virus; SAE = serious adverse event; SC = safety telephone call; USV = unscheduled visit. 
a. 
The Screening Visit and Day 1 Visit may be performed on the same day or on different days. Additionally, the Screening Visit may be performed over 
multiple visits if within the 14-day Screening window. Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened 1 time within the 14-day Screening window if they will be eligible upon rescreening. 
b. 
A full physical examination, including height and weight, will be performed at the Screening Visit. Symptom-directed physical examinations will be 
performed at other study visits if clinically indicated. Interim physical examinations will be performed at the discretion of the investigator. On the day of 
study injections, both arms should be examined, and the associated lymph nodes should be evaluated. Any clinically significant findings identified by a 
healthcare professional during study visits should be reported as an MAAE.  
c. 
Vital sign measurements include assessment of systolic and diastolic blood pressure, heart rate, respiratory rate, and body temperature (preferred route is 
oral). Fever is defined as a body temperature ≥38.0 °C/100.4 °F. The participant will be seated for at least 5 minutes before all measurements are taken. Vital 
signs will only be collected at Screening and on the days of vaccination, once before and at least 30 minutes after vaccination. Vital signs will be collected at 
other clinical visits only in conjunction with a symptom-directed physical examination. 
d. 
All participants will be randomized to receive 2 intramuscular injections, one in each arm, in the deltoid muscle. 
e. 
Blood samples for humoral immunogenicity must be collected prior to administration of the IP on vaccination days. Transcriptomic and genomic samples 
will be part of the optional biomarker assessment once consented by the study participant. 
f. 
A urine pregnancy test (β-human chorionic gonadotropin) will be performed on all women of childbearing potential at Screening and prior to study 
vaccination. A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm menopausal status. At unscheduled 
visits, serum or urine pregnancy testing may be performed as needed at the discretion of the investigator. 
g. 
The eDiary entries will be recorded by the participant starting approximately 30 minutes after vaccination while at the clinic with instruction provided by 
study staff. Study participants will continue to record in the eDiary each day after they leave the clinic, preferably in the evening and at the same time each 
day, on the day of vaccination and for 6 days following vaccination. If the participant is unable to complete the eDiary on their own, a caregiver can assist 
with data entry, but the information entered in the eDiary must come from the participant. Local solicited ARs will be recorded separately for each injection 
site (Sections 2.7.1.1 and 2.7.4.3). 

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h. 
Medically qualified study staff will contact all participants. The participant will be interviewed according to the script. Information will be collected about 
occurrence of unsolicited AEs through 28 days postvaccination and the occurrence of AESIs, MAAEs, SAEs, or AEs leading to study withdrawal and 
concomitant medications associated with those events, and receipt of any nonstudy vaccinations at all points of contact. All concomitant medications will be 
recorded from the days of vaccination and the following 27 days; all nonstudy vaccinations and concomitant medications relevant to or for the treatment of 
an SAE, AESI, or MAAE will be recorded from Day 1 through EoS. Demographic information relating to the participant’s sex, age, and race will be 
recorded at the Screening visit on the appropriate eCRF page. Medical history of each participant will be obtained by interviewing the participant or by 
reviewing the participant’s medical records and recorded on the Medical History eCRF page. Significant findings that were present prior to the signature of 
the informed consent will also be included in the Medical History eCRF page. 
 

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3.2. Objectives and Endpoints (Part B)  
The objectives and endpoints of this study are described in Table 2. 
Table 8: 
Study Objectives and Endpoints (Part B)  
Objectives 
Endpoints 
Primary 
• To evaluate the safety and 
tolerability of messenger RNA 
(mRNA)-1345 coadministered with 
mRNA-1273.214 
• Numbers and percentages of participants 
with solicited local and systemic adverse 
reactions (ARs) over the 7 days after each 
injection 
• Numbers and percentages of unsolicited 
AEs through 28 days after each injection 
• Numbers and percentages of MAAEs, 
SAEs, AESIs, and AEs leading to 
discontinuation Day 1 (baseline) to EoS 
• To evaluate the effect of 
coadministered mRNA-1273.214 
on the immune response to 
respiratory syncytial virus (RSV)-A 
• GMT of serum RSV-A neutralizing Abs at 
Day 29  
• Seroresponse rate (SRR) in RSV-A 
neutralizing Abs at Day 29 
• To evaluate the effect of 
coadministered RSV vaccine on the 
immune response to SARS-CoV-2 
• GMC of serum Ab level as measured by 
neutralization assay for SARS-CoV-2 at 
Day 29 
• SRR for SARS-CoV-2 at Day 29 
Key Secondary 
• To evaluate the effect of 
coadministered mRNA-1273.214 
on the immune response to RSV-B 
• GMT of serum RSV-B neutralizing Abs at 
Day 29 
• SRR in RSV-B neutralizing Abs at Day 29 
Secondary 
• To evaluate Ab response to 
mRNA-1345 with and without 
mRNA-1273.214 
• GMT and GMFR of postinjection/baseline 
titers to RSV-A neutralizing Abs up to EoS 
• GMT and GMFR of postinjection/baseline 
titers to RSV-B neutralizing Abs up to EoS  
• Proportion of participants with ≥2-fold 
increases in RSV-A neutralizing Ab titers 
up to EoS 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in RSV-B neutralizing 
Ab titers up to EoS 

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Objectives 
Endpoints 
• To evaluate the Ab response to 
mRNA-1273.214 with and without 
mRNA-1345 
• GMC and GMFR as measured by 
neutralization assay for SARS-CoV-2 up 
to EoS 
• SRR up to EoS as measured by 
neutralization assay for SARS-CoV-2 
Exploratory (may be performed) 
• To further characterize the immune 
response across study vaccines  
• GMC and GMFR of postinjection/baseline 
titers to RSV-binding Abs up to EoS 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in RSV-binding Ab 
concentration up to EoS 
• GMC and GMFR of postinjection/baseline 
titers to SARS-CoV-2 binding Abs up to 
EoS 
• Proportion of participants with ≥2-fold and 
≥4-fold increases in SARS-CoV-2 binding 
Ab concentration up to EoS 
• Frequency, specificities, or other endpoints 
to be determined for the further 
characterization of immune responses  
3.3. Study Design  
3.3.1. General Design (Part B)  
Part B is a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and 
immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or 
coadministered with mRNA-1273.214 in adults ≥50 years of age. 
All participants will participate in a Screening period (up to 14 days before Day 1), treatment 
period (vaccine and/or placebo administration on Day 1 [Baseline] and on Day 29), and a 
follow-up period (up to 7 months after first vaccination). The study schema is presented in 
Figure 2. 
The study will enroll approximately 1680 medically stable adults ≥50 years of age. The 
eligibility criteria are provided in Section 3.4. On Day 1, each participant will receive 
2 injections administered IM, one in each arm, in the deltoid muscle. Participants will be 
randomized as shown in Table 9 to receive either (1) mRNA-1345 (
 μg) + placebo 
(0.9% sodium chloride [normal saline]); (2) mRNA-1345 (
 μg) + mRNA-1273.214 (
 μg); or 
(3) mRNA-1273.214 (
 μg) + placebo. Randomization will be stratified by age (50 to 59 years, 
60 to 74 years, and ≥75 years). The study will target enrollment of approximately 35% of 
participants 50 to 59 years of age. On Day 29, participants will receive an additional injection as 
outlined in Table 9 to allow all study participants to receive an mRNA-1273.214 booster 
vaccination. 
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Table 9: 
Randomized Groups (Part B) 
Group 
Name 
Sample Size Vaccines Administered 
Group 4 
560 
Day 1: mRNA-1345 (
 μg) + placebo in contralateral arms 
Day 29: mRNA-1273.214 (
 μg) 
Group 5 
560 
Day 1: mRNA-1345 (
 μg) + mRNA-1273.214 (
 μg) in 
contralateral arms 
Day 29: placebo 
Group 6 
560 
Day 1: mRNA-1273.214 (
 μg) + placebo in contralateral arms 
Day 29: placebo 
The SoA is provided in Table 7 and outlines all study visits. 
At the dosing visits on Day 1 and Day 29, participants will be instructed how to document, and 
report solicited ARs in a provided eDiary. Solicited ARs will be assessed from the day of 
injection and the following 6 days, and local solicited ARs will be assessed separately for each 
injection site. Unsolicited AEs will be assessed from the days of injection and the following 
27 days. Serious AEs, MAAEs, AEs leading to withdrawal, and AESIs will be assessed from 
Day 1 through EoS. 
All study visit procedures and timing are described in the SoA (Table 7). 
Participants may experience AEs that necessitate an unscheduled visit. There may also be 
situations in which the investigator asks a participant to attend an unscheduled visit following the 
report of an AE. Additional examinations may be conducted at these visits as necessary to ensure 
the safety and well-being of participants during the study. eCRFs should be completed for each 
unscheduled visit. 
Safety Oversight 
An IST, inclusive of, at a minimum, the Sponsor’s medical monitor, Sponsor’s safety physician, 
and a CRO medical monitor, will be formed to review interim and cumulative blinded safety data 
on a regular basis with a remit to escalate concerns to the data safety monitoring board (DSMB). 
The IST will conduct a scheduled review of safety data after at least 30 participants (10 in each 
group in Part B) have completed the Day 8 visit. The IST will also conduct ad hoc reviews 
throughout the study as requested by the study medical monitor and study team. 
An independent, unblinded DSMB will be used throughout the conduct of this study. This 
committee will be composed of independent members with relevant therapeutic and/or 
biostatistical expertise to allow for the ongoing review of safety data from this study population. 
The safety data will be reviewed according to intervals defined in the DSMB charter and will 
occur as needed when study stopping or pausing criteria are met or as otherwise requested by the 
study team and/or IST. See Section 2.7.6 for details on the IST and DSMB constituted in this 
study. 
This study will be conducted in compliance with the protocol, GCP, and all applicable regulatory 
requirements. 
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3.3.2. Scientific Rationale for Study Design  
This study is designed as a randomized, observer-blind study to evaluate the safety and 
immunogenicity of mRNA-1345 when coadministered with mRNA-1273.214 compared with 
either vaccine alone in medically stable older adults ≥50 years of age. Participants will receive 
either mRNA-1345 + placebo, mRNA-1345 + mRNA-1273.214, or mRNA-1273.214 + placebo 
in contralateral arms. If not received on Day 1, all remaining participants will receive 
mRNA-1273.214 on Day 29 (Table 9).  
3.3.3. Choice of Vaccine Dose  
The 
-µg dose of mRNA-1345 was selected for this study based on the mRNA-1345-P101 
study data (Section 1.1.6). 
The 
-µg booster dose of mRNA-1273.214 was selected for this study based on the dose chosen 
for other Phase 3 mRNA-1273/1273.214 clinical studies. 
3.3.4. EoS Definition  
A participant is considered to have completed the study if he or she has completed the last 
scheduled procedure on Day 211 (ie, 6 months after administration of the last IP injection on 
Day 29; Table 7). 
The EoS is defined as completion of the last visit of the last participant in the study or last 
scheduled procedure, as shown in the SoA (Table 7). 
3.4. Study Population  
Prospective approval of protocol deviations for recruitment and enrollment criteria, also known 
as protocol waivers or exemptions, is not permitted. 
3.4.1. Inclusion Criteria (Part B)  
Participants are eligible to be included in the study only if all the following criteria apply:  
1. Adults ≥50 years of age on the day of the Randomization Visit who are primarily 
responsible for self-care and activities of daily living. Participants may have one or more 
chronic medical diagnoses but should be medically stable as assessed by: 
– Absence of changes in medical therapy within 1 month due to treatment failure or 
toxicity, 
– Absence of medical events qualifying as SAEs within 1 month of the planned 
vaccination on Day 1, and 
– Absence of known, current, and life-limiting diagnoses, which, in the opinion of 
the investigator, would make completion of the protocol unlikely. 
2. Fully vaccinated for COVID-19 with an approved primary series according to the locally 
authorized or approved regimen. If the most recent COVID-19 vaccine was part of a 
primary series, it must be ≥150 days before (or less per local guidance) Day 1. If the most 
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recent COVID-19 vaccine was a booster dose, it must be ≥120 days before (or less per 
local guidance) Day 1. 
3. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as bilateral tubal ligation >1 year prior to Screening, 
bilateral oophorectomy, hysterectomy, or menopause. An FSH level may be measured at 
the discretion of the investigator to confirm menopausal status.  
4. Female participants of childbearing potential may be enrolled in the study if the 
participant: (1) has a negative urine pregnancy test at Screening and on the day of 
vaccination, (2) has practiced adequate contraception or has abstained from all activities 
that could lead to pregnancy for 28 days prior to vaccination, (3) has agreed to continue 
adequate contraception through 3 months following the last injection, and (4) is not 
currently breastfeeding. 
Adequate contraception is defined as consistent and correct use of approved 
contraceptive method in accordance with the product label. For example: 
– Barrier method (such as condoms, diaphragm, or cervical cap) used in 
conjunction with spermicide 
– Intrauterine device 
– Hormonal contraceptive in the form of a pill or patch 
– Medroxyprogesterone injection (eg, Depo-Provera®) 
– Etonogestrel implant (eg, Nexplanon®) 
– Sterilization of a female participant’s male partner prior to entry into the study 
– Vasectomy for male participants 
Note: Periodic abstinence (eg, calendar, ovulation, symptom-thermal, postovulation methods) 
and withdrawal are not acceptable methods of contraception. 
5. Willing and able (on both a physical and cognitive basis) to give informed consent prior 
to study enrollment. 
6. Able to comply with study requirements, including access to transportation for study 
visits. 
7. Access to inbound and outbound telephone communication with caregivers and study 
staff. 
3.4.2. Exclusion Criteria (Part B)  
Participants are not eligible to be included in the study if any of the following criteria apply:  
1. Participant is acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior 
to or at Day 1. Participants meeting this criterion may be rescheduled within the 14-day 
Screening window and will retain their initially assigned participant number. 
2. History of a diagnosis or condition that, in the judgment of the investigator, is clinically 
unstable or may affect participant safety, assessment of safety endpoints, assessment of 

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immune response, or adherence to study procedures. Clinically unstable is defined as a 
diagnosis or condition requiring significant changes in management or medication 
≤30 days prior to Screening and includes ongoing workup of an undiagnosed illness that 
could lead to a new diagnosis or condition.  
3. Reported history of congenital or acquired immunodeficiency, immunosuppressive 
condition, or immune-mediated disease. Note: Participants who are HIV positive with 
CD4 count ≥350 cells/mm3, an undetectable HIV viral load, and an undetectable HIV 
RNA within the past 12 months (low level variations from 50 to 500 viral copies/mL 
which do not lead to changes in antiretroviral therapy is allowed) as determined from 
participant’s medical records, are permitted. 
4. Conditions that could affect local solicited AR assessments as determined by the 
investigator (eg, tattoos, psoriasis patches affecting skin over either deltoid area). 
5. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any 
mRNA vaccine(s) or any components of the mRNA vaccines. 
6. Reported history of bleeding disorder that is considered a contraindication to IM injection 
or phlebotomy. 
7. Diagnosis of malignancy within previous 10 years (excluding nonmelanoma skin cancer). 
8. Any medical, psychiatric, or occupational condition, including reported history of drug or 
alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to 
participation in the study or could interfere with the interpretation of study results. 
9. Known history of poorly controlled hypertension (per determination of the investigator), 
or systolic blood pressure >160 mm Hg at the Screening or baseline (Day 1) visit. 
10. Known history of hypotension or systolic blood pressure <85 mm Hg at the Screening or 
baseline (Day 1) visit. 
11. Diastolic blood pressure >90 mm Hg at the Screening or baseline (Day 1) visit. 
12. Known uncontrolled disorder of coagulation.  
Note: In the setting of well-controlled atrial fibrillation, prophylaxis for cardiovascular 
thromboembolism, or stroke with the following medications are allowed: aspirin, 
clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin. 
13. Chronic administration (defined as more than 14 continuous days) of 
immunosuppressants or other immune-modifying drugs within 6 months prior to the 
administration of the study injection. An immunosuppressant dose of glucocorticoid will 
be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of 
topical, inhaled, and nasal glucocorticoids will be permitted. 
14. Participant has received or plans to receive any vaccine authorized or approved by a local 
health agency ≤28 days prior to study injections (Day 1) or plans to receive a vaccine 
authorized or approved by a local health agency within 28 days after the study injections 
(with the exception of SARS-Cov-2 vaccination as defined in Inclusion Criterion 2). 

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15. Prior participation in research involving receipt of any IP (drug/biologic/device with the 
exception of RSV investigation products [see exclusion criterion 16]) within 45 days 
before the planned date of the Day 1 study injection. 
16. Prior receipt of any investigational/approved RSV product within 1 year of the Day 1 
study injection. 
17. Participant had significant exposure to someone with SARS-CoV-2 infection or 
COVID-19 in the past 10 days, as defined by the US CDC as a close contact of someone 
who has had COVID19. 
18. Has known history of SARS-CoV-2 infection within 90 days prior to enrollment. 
19. Receipt of systemic immunoglobulins or blood products ≤90 days prior to the Screening 
Visit or plans to receive systemic immunoglobulins or blood products during the study. 
20. Participant has a history of myocarditis, pericarditis, or myopericarditis.  
21. Participant has donated ≥450 mL of blood products within 28 days prior to the Screening 
Visit or plans to donate blood products during the study. 
22. Participant is an immediate family member or household member of study personnel, 
study site staff, or Sponsor personnel. 
23. Participant has a history of dermatological filler injections. 
3.4.3. Lifestyle Restrictions  
Not applicable. 
3.4.4. Screen Failures  
See Section 2.4.4 for details. 
3.5. Study Treatment  
3.5.1. Investigational Products Administered  
mRNA-1345 is an LNP formulation consisting of mRNA sequences encoding the RSV fusion 
glycoprotein stabilized in the prefusion conformation.  
mRNA-1273.214 is based on the same platform as mRNA-1345. mRNA-1273.214 contains 
CX-024414, the mRNA that encodes for the S-2P of the Wuhan-Hu-1 isolate of SARS-CoV-2 
and CX-031302, the mRNA that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 variant. 
The placebo is 0.9% sodium chloride (normal saline) injection, USP or European Pharmacopeia. 
3.5.2. Randomization and Blinding  
Randomization will be performed using an IRT system. Randomization is further described in 
Section 3.3.1. 
3.5.2.1. 
Blinding  
See Section 2.5.2.1 for details. 

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3.5.2.2. 
Unblinding  
See Section 2.5.2.2 for details. 
3.5.3. Preparation, Handling, Storage, and Accountability  
3.5.3.1. 
Preparation of Study Vaccine  
mRNA-1345 will be provided as a sterile liquid for injection and will be a white to off white 
dispersion at a concentration of 
 
  
mRNA-1273.214 will be provided as a sterile liquid for injection and will be a white to off white 
dispersion at a concentration of 
 
 
mRNA-1345, mRNA-1273.214, and placebo preparation instructions are detailed in the 
Pharmacy Manual. 
3.5.3.2. 
Study Vaccine Administration  
mRNA-1345, mRNA-1273.214, and/or placebo will be administered as IM injections, one in 
each deltoid muscle at the times indicated in the SoA (Table 7), according to the procedures 
specified in the Pharmacy Manual. Each arm (left and right) and the corresponding vaccine or 
placebo administered will be recorded by the unblinded site staff and will be kept confidential 
from other study documents/personnel before unblinding is authorized. 
Participants will be monitored for a minimum of 30 minutes after any injection. Assessments 
will include vital sign measurements and monitoring for local or systemic ARs as shown in the 
SoA (Table 7). 
The study site will be appropriately staffed with individuals with basic cardiopulmonary 
resuscitation training and certification. Either on-site resuscitation equipment and study 
personnel or appropriate protocols for the rapid transport of a participant to a resuscitation area 
or facility are required. 
3.5.3.3. 
Study Vaccine Delivery and Receipt  
The Sponsor (or designee) is responsible for the following: 
• Supplying mRNA-1345, mRNA-1273.214, and placebo (0.9% sodium chloride) to 
the study sites. 
• Confirming the appropriate labeling of the IP, so it complies with the legal 
requirements of the US. 
The investigator is responsible for acknowledging the receipt of the IP by a designated staff 
member at the site, which includes the following: 
• Confirming that the IP was received in good condition. 
• Confirming that the temperature during shipment from the Sponsor to the 
investigator’s designated storage location was appropriate. 
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• Confirming that the Sponsor has authorized the IP for use. 
• Ensuring the appropriate dose of the IP is properly prepared using aseptic technique. 
Further description of the IP and instructions for the receipt, storage, preparation, administration, 
accountability, and destruction of the IP are described in the Pharmacy Manual. 
3.5.3.4. 
Study Vaccine Packaging and Labeling  
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of the IP. 
mRNA-1345 and mRNA-1273.214, will be prepared, packaged, and labeled in accordance with 
the standard operating procedures of the Sponsor or those of its designee, CFR Title 21, Good 
Manufacturing Practice guidelines, the ICH GCP guidelines, guidelines for Quality System 
Regulations, and applicable regulations. 
3.5.3.5. 
Study Vaccine Storage  
mRNA-1345 should be stored at –25 ºC to –15 ºC (–13 ºF to 5 ºF). mRNA-1273.214 must be 
stored at -90 °C to -60°C (-130 °F to -76 °F). mRNA-1345 and mRNA-1273.214 must be 
received by a designated unblinded study personnel at the study site, handled and stored safely, 
kept in a secure location with restricted access (unblinded study personnel only), and protected 
from moisture and light until it is prepared for administration. Additional details are found in the 
Pharmacy Manual. 
The 0.9% sodium chloride injection (USP or European Pharmacopeia) should be stored at 15ºC 
to 25ºC (68ºF to 77ºF) in a secure location with restricted access (unblinded study personnel 
only). 
3.5.3.6. 
Study Vaccine Accountability  
See Section 2.5.3.6 for details. 
3.5.3.7. 
Study Vaccine Handling and Disposal  
See Section 2.5.3.7 for details. 
3.5.4. Study Intervention Compliance  
See Section 2.5.4 for details. 
3.5.5. Prior and Concomitant Medications  
3.5.5.1. 
Prior Medications and Therapies  
Information about prior medications (including any prescription or over-the-counter medications, 
vaccines, or blood products) taken by the participant within the 28 days before providing 
informed consent (or as designated in the inclusion/exclusion requirements) will be recorded in 
the participant’s eCRF. A complete history (at any time prior to informed consent) about prior 
COVID-19 vaccination will also be collected. 

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3.5.5.2. 
Concomitant Medications and Therapies  
At the study site, the study staff must question the participant regarding any medications taken 
and nonstudy vaccinations received by the participant and record the following information in 
the eCRF: 
• All nonstudy vaccinations administered within the period starting 28 days before the 
study injection and through EoS. 
• All concomitant medications taken through 28 days after vaccination. Antipyretics 
and analgesics taken prophylactically (ie, taken in the absence of any symptoms in 
anticipation of an injection reaction) will be recorded as such. 
• Any concomitant medications used to prevent or treat COVID-19, RSV disease, or 
any other infectious disease symptoms. 
• Any concomitant medications relevant to or for the treatment of an SAE, AESI, or an 
MAAE from Day 1 through EoS. 
• The participant will be asked in the eDiary if they have taken any antipyretic or 
analgesic to treat or prevent fever or pain within 7 days after vaccination, including 
the day of injection. Reported antipyretic or analgesic medications should be recorded 
in the source document by the study site staff during the postinjection study site visits 
or via other participant interactions (eg, safety telephone calls). 
• Use of facial injections or dermal fillers, for cosmetic or medical indications such as 
migraine headaches. 
Concomitant medications (including vaccinations) will be coded using the WHO Drug Global 
dictionary. 
If a participant takes a prohibited drug therapy, the investigator and the medical monitor will 
make a joint decision about continuing or withholding further assessment of the participant based 
on the time the medication was administered, the drug’s pharmacology and pharmacokinetics, 
and whether the use of the medication will compromise the participant’s safety or interpretation 
of the study data. It is the investigator’s responsibility to ensure that details regarding the 
concomitant medications are adequately recorded in the eCRF. 
3.5.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination 
of a Participant from the Per-Protocol Analyses  
See Section 2.5.5.3 for details. 
3.5.6. Intervention After the End of the Study  
See Section 2.5.6 for details. 

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3.6. Delay or Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
3.6.1. Criteria for Delay of Vaccine Administration  
3.6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination  
See Section 2.6.1.1 for details. 
3.6.2. Participant Discontinuation/Withdrawal From the Study  
See Section 2.6.2 for details. 
3.6.3. Lost to Follow-Up  
See Section 2.6.3 for details. 
3.7. Study Assessments and Procedures  
See Section 2.7 for details and refer to the SoA for Part B (Table 7). 
3.7.1. Safety Assessments and Procedures  
See Section 2.7.1 for details and refer to the SoA for Part B (Table 7). 
In addition, for Part B, the following will be performed: 
Any reverse transcriptase-polymerase chain reaction–confirmed case of RSV or any positive 
SARS-CoV-2 testing by an authorized/approved lateral flow/rapid antigen or polymerase chain 
reaction will be recorded as unsolicited AEs through EoS (unless they meet the definition of an 
SAE, MAAE, or AE leading to discontinuation). 
3.7.1.1. 
Use of Electronic Diaries  
See Section 2.7.1.1 for details and refer to the SoA for Part B (Table 7). 
3.7.1.1.1 Ancillary Supplies for Participant Use  
See Section 2.7.1.1.1 for details. 
3.7.1.2. 
Safety Telephone Call  
See Section 2.7.1.2 for details and refer to the SoA for Part B (Table 7). 
3.7.1.3. 
Vital Sign Measurements  
See Section 2.7.1.3 for details and refer to the SoA for Part B (Table 7). 
3.7.1.4. 
Physical Examinations  
See Section 2.7.1.4 for details and refer to the SoA for Part B (Table 7). 

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3.7.2. Immunogenicity Assessments  
Blood samples for immunogenicity assessments will be collected at the time points indicated in 
the SoA (Table 7). Immunogenicity assessments will be performed for all participants. The 
following analytes will be measured: 
• RSV Abs, as measured by neutralization assay (nAbs) and binding assay (bAbs). 
• SARS-Cov2 Abs, as measured by neutralization assay (nAbs) and binding assay 
(bAbs). 
Sample aliquots will be designed to ensure that backup samples are available and vial volumes 
are likely to be adequate for future testing needs. The actual date and time of each sample will be 
noted. Unique sample identification will be utilized to maintain the blind at the laboratory at all 
times and allow for automated sample tracking and housing. Handling and preparation of the 
samples for analysis, as well as shipping and storage requirements, will be provided in a separate 
study manual. 
Measurement of Ab levels will be performed in a laboratory designated by the Sponsor. 
According to the ICF (Section 6.1.6), excess serum from the blood samples collected for 
immunogenicity testing may be used for future research, which may be performed at the 
discretion of the Sponsor to further characterize the immune response to respiratory viruses (eg, 
RSV and SARS-CoV-2) and additional assay development. 
3.7.3. Efficacy Assessments  
While the study will not be powered for efficacy assessments, symptoms of infection with 
respiratory pathogens will be tracked as an exploratory objective in this study. 
3.7.4. Safety Definitions and Related Procedures  
3.7.4.1. 
Adverse Event  
See Section 2.7.4.1 for details and refer to the SoA for Part B (Table 7). 
3.7.4.2. 
Serious Adverse Events  
See Section 2.7.4.2 for details and refer to the SoA for Part B (Table 7). 
3.7.4.3. 
Solicited Adverse Reactions  
See Section 2.7.4.3 for details and refer to the SoA for Part B (Table 7). 
3.7.4.4. 
Medically Attended Adverse Events  
See Section 2.7.4.4 for details.  
3.7.4.5. 
Adverse Event of Special Interest  
See Section 2.7.4.5 for details. 

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3.7.4.6. 
Eliciting and Documenting Adverse Events  
See Section 2.7.4.6 for details and refer to the SoA for Part B (Table 7). 
3.7.4.7. 
Assessment of Intensity  
See Section 2.7.4.7 for details and refer to the SoA for Part B (Table 7). 
3.7.4.8. 
Assessment of Causality  
See Section 2.7.4.8 for details and refer to the SoA for Part B (Table 7). 
3.7.4.9. 
Reporting Adverse Events  
See Section 2.7.4.9 for details and refer to the SoA for Part B (Table 7). 
3.7.4.10. 
Reporting Serious Adverse Events  
See Section 2.7.4.10 for details and refer to the SoA for Part B (Table 7). 
3.7.4.11. 
Reporting of Adverse Events of Special Interest  
See Section 2.7.4.11 for details and refer to the SoA for Part B (Table 7). 
3.7.4.12. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information  
See Section 2.7.4.12 for details and refer to the SoA for Part B (Table 7). 
3.7.4.13. 
Method of Detecting AEs and SAEs  
See Section 2.7.4.13 for details and refer to the SoA for Part B (Table 7). 
3.7.4.14. 
Follow-up of AEs and SAEs  
See Section 2.7.4.14 for details and refer to the SoA for Part B (Table 7). 
3.7.4.15. 
Regulatory Reporting Requirements for SAEs  
See Section 2.7.4.15 for details and refer to the SoA for Part B (Table 7). 
3.7.5. Pregnancy  
See Section 2.7.5 for details and refer to the SoA for Part B (Table 7). 
3.7.6. Safety Monitoring  
See Section 2.7.6 for details and refer to the SoA for Part B (Table 7). In addition, the following 
will be performed for Part B because of the inclusion of mRNA-1273.214 in the study design: 
An independent CEAC that includes cardiologists will review suspected cases of myocarditis, 
pericarditis, and myopericarditis to determine if they meet CDC criteria of “probable” or 
“confirmed” events, and to assess severity (Gargano et al 2021). Any cases that the CEAC 
assesses as representing probable or confirmed cases of myocarditis, pericarditis, or 
myopericarditis will be referred to the Sponsor, who will then make a final decision on whether 

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to suspend further enrollment and/or study dosing based on an assessment of the overall potential 
risk to study participants. The CEAC will operate under the rules of an approved charter that will 
be written and reviewed at the organizational meeting of the CEAC. Details regarding the CEAC 
composition, responsibilities, procedures, and frequency of data review will be defined in its 
charter. 
3.7.7. Treatment of Overdose  
See Section 2.7.7 for details. 
3.7.8. Pharmacokinetics  
Pharmacokinetic parameters are not evaluated in this study. 
3.7.9. Pharmacodynamics  
Pharmacodynamic parameters are not evaluated in this study. 
3.7.10. Biomarkers  
Immunogenicity assessments are described in Section 3.7.2. Biomarker assessment may include 
genomic and transcriptomics samples. 
3.7.11. Health Economics  
Health economics are not evaluated in this study. 
3.8. Statistical Considerations  
This section summarizes the planned statistical analysis strategy and procedures for the study. 
The details of statistical analysis will be provided in a SAP, which will be finalized before the 
database lock for the study. If changes are made to primary and/or secondary objectives or 
related statistical methods after the study has begun, then the protocol will be amended 
(consistent with ICH Guideline E9). Changes to other secondary or exploratory analyses made 
after the protocol has been finalized, along with an explanation as to when and why they 
occurred, will be listed in the SAP or CSR for the study. Ad hoc exploratory analyses, if any, 
will be clearly identified in the CSR. 
3.8.1. Statistical Methods  
3.8.1.1. 
Immunogenicity Analysis  
The immunogenicity endpoints will be analyzed using the PP Set, by vaccination group. If the 
number of participants in the FAS and PP Set differs (defined as the difference divided by the 
total number of participants in the PP Set) by more than 10%, supportive analyses of 
immunogenicity may be conducted using the FAS. 
The co-primary and key secondary endpoints include the GMT of RSV-A/RSV-B nAb titers at 
Day 29 and GMC of nAbs for each of the 2 SARS-CoV-2 strains, as measured at Day 29. For 
each co-primary and key secondary endpoint regarding GMT, the GMR will be estimated using 
an ANCOVA model on the log-transformed titers at Day 29, with the vaccination group as the 

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fixed variable, log-transformed baseline titers as a fixed covariate, adjusted for stratified age 
group used for randomization. The GLSM and its corresponding 95% CI in a log-transformed 
scale estimated from the model will be back-transformed to obtain these estimates in the original 
scale as an estimate of the GMT and its 95% CI. The GMR, estimated by the ratio of the GLSM 
and the corresponding 2-sided 95% CI, will be provided to assess the treatment difference. The 
corresponding 2-sided 95% CI of the GMR will be provided to assess the difference in the 
immune response between the 2 vaccination groups. For each co-primary and key secondary 
endpoint regarding GMT, the noninferiority of the GMT will be demonstrated if the LB of the 
95% CI of the GMR is > 0.667.  
SRR of RSV-A nAbs, RSV-B nAbs, or a SARS-CoV-2 strain nAbs is defined as proportion of 
participants with post-vaccination titers ≥4 × LLOQ if baseline is <LLOQ or a ≥4-fold increase 
from baseline if baseline is ≥LLOQ. The number and percentage of participants with 
seroresponse at each postbaseline timepoint will be provided with 2-sided 95% CIs using the 
Clopper-Pearson method. For the co-primary endpoint and key secondary endpoints regarding 
SRR, the Miettinen-Nurminen’s method will be used to calculate the 95% CI for the difference 
in the SRR at Day 29 between the vaccination groups. The noninferiority of the SRR at Day 29 
for RSV-A nAbs or RSV-B nAbs, will be demonstrated if the LB of the 95% CI of the SRR 
difference between mRNA-1345 plus mRNA-1273.214 followed with a subsequent injection of 
placebo and mRNA-1345 plus placebo followed with a subsequent injection of mRNA-1273.214 
groups is > –10%. The noninferiority of the SRR at Day 29 for nAbs of SARS-CoV-2 
Wuhan-Hu-1 or B1.1.529 strain will be demonstrated if the LB of the 95% CI of the SRR 
difference between mRNA-1345 plus mRNA-1273.214 followed with a subsequent injection of 
placebo and mRNA-1273.214 plus placebo followed with a subsequent injection of placebo 
groups is > –10%. 
Data from quantitative immunogenicity assays will be summarized for each vaccination group 
using positive response rates and geometric means with 95% CIs for each timepoint an 
assessment is performed. 
For the immunogenicity endpoints, the GMT ratio or GMC ratio of specific Abs, with the 
corresponding 95% CI at each timepoint, and GMFR of specific Ab titers, with the 
corresponding 95% CI at each postbaseline timepoint over preinjection baseline, will be 
provided by vaccination group. The 95% CIs will be calculated based on the t-distribution of the 
log-transformed values then back-transformed to the original scale descriptive summary 
statistics, including the median, minimum, and maximum values, will also be provided. 
For summarizations of the GMT ratios or GMC ratios, Ab titers reported as below the LLOQ 
will be replaced by 0.5 × LLOQ. Values greater than the ULOQ will be converted to the ULOQ 
if actual values are not available. 
The proportion of participants with at least 2-fold and at least 4-fold increases in 
titers/concentration (relative to baseline) will be provided by timepoint with the 2-sided 95% CI 
using the Clopper-Pearson method at Day 29. The number and percentage of participants with 
2- and 4-fold increases will be provided with the 2-sided 95% CI using the Clopper-Pearson 
method. To compare the 2- and 4-fold increase rates between the vaccination groups, the 
Miettinen-Nurminen’s method will be used to calculate the 95% CI for the difference in the 
fold-rise increase rates. The 2- and 4-fold rate difference, with the corresponding 95% CI at 
Day 29, will be provided.  

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Descriptive statistics (including 95% CIs) of the immunogenicity endpoints will also be provided 
by vaccination group and age group (50 to 59 years, 60 to 74 years, and ≥75 years).  
3.8.1.2. 
Safety Analyses  
See Section 2.8.5.2 for details. In addition, for Part B, the following will be performed: 
The number and percentage of participants with any solicited local AR, solicited systemic AR, 
and solicited AR during the 7 day follow-up period after administration of the IP at Day 29 will 
also be summarized respectively. 
3.8.1.3. 
Exploratory Analyses  
See Section 2.8.5.3 for details. 
3.8.2. Blinding and Responsibility for Analyses  
See Section 2.8.1 for details. 
3.8.2.1. 
Breaking the Blind  
See Section 2.8.1.1 for details. 
3.8.3. Statistical Hypotheses  
The immunogenicity primary objectives are to evaluate the effect of coadministered 
mRNA-1273.214 with mRNA-1345 on the immune response to RSV-A virus, and SARS-CoV-2 
Wuhan-Hu-1 and B.1.1.529 strains. There are 6 co-primary endpoints to support the primary 
objectives.  
Primary Objective to Evaluate the Impact on the Immune Response to RSV-A: 
Co-primary endpoints based on GMT at Day 29:  
The null hypothesis H10: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with mRNA-1273.214 at Day 1, as measured by GMT at Day 29 
using RSV-A nAb assay, is inferior compared with that in participants who received 
mRNA-1345 plus placebo at Day 1. The noninferiority in the GMT in participants who received 
mRNA-1345 coadministered with mRNA-1273.214 at Day 1 compared with that of participants 
who received mRNA-1345 plus placebo at Day 1 will be demonstrated by the LB of the 95% CI 
of the GMR of ruling out 0.667 (ie, LB > 0.667) using a noninferiority margin of 1.5. The GMR 
is the ratio of the GMT of RSV-A nAbs in participants who received mRNA-1345 
coadministered with mRNA-1273.214 at Day 1 compared with the GMT of RSV-A nAbs in 
participants who received mRNA-1345 plus placebo at Day 1. 
Co-primary endpoints based on Seroresponse Rate at Day 29: 
The null hypothesis H20: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with mRNA-1273.214 at Day 1, as measured by SRR of RSV-A 
nAbs at Day 29, is inferior compared with that in participants who received mRNA-1345 plus 
placebo at Day 1. The noninferiority in the SRR in participants who received mRNA-1345 
coadministered with mRNA-1273.214 at Day 1 compared with that of participants who received 
mRNA-1345 plus placebo at Day 1 will be demonstrated by the LB of the 95% CI of the SRR 

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difference of ruling out 10% (ie, LB > -10%) using a noninferiority margin of 10%. The SRR 
difference is the SRR of RSV-A nAb in participants who received mRNA-1345 coadministered 
with mRNA-1273.214 at Day 1 minus the SRR of RSV-A nAbs in participants who received 
mRNA-1345 plus placebo at Day 1. 
Primary Objective to Evaluate the Impact on the Immune Response to SARS-CoV-2: 
Co-primary endpoints based on GMC at Day 29: 
The null hypotheses H30 and H40: immunogenicity response to mRNA-1273.214 in participants 
who received mRNA-1273.214 coadministered with mRNA-1345 at Day 1, as measured by 
GMC of neutralizing Abs (nAbs) for each of the 2 SARS-CoV-2 strains (Wuhan-Hu-1 and 
B.1.1.529) at Day 29, is inferior compared with that in participants who received 
mRNA-1273.214 plus placebo at Day 1. For each of the two SARS-CoV-2 strains, the 
noninferiority in the GMC in participants who received mRNA-1345 coadministered with 
mRNA-1273.214 at Day 1 compared with that of participants who received mRNA-1273.214 
plus placebo at Day 1 will be demonstrated by the LB of the 95% CI of the GMR of ruling out 
0.667 (ie, LB > 0.667) using a noninferiority margin of 1.5. The GMR is the ratio of the GMC of 
nAbs in participants who received mRNA-1345 coadministered with mRNA-1273.214 at Day 1 
compared with the GMC of nAbs in participants who received mRNA-1273.214 plus placebo at 
Day 1. 
Co-primary endpoints based on Seroresponse Rate at Day 29: 
The null hypothesis H50 and H60: immunogenicity response to mRNA-1273.214 in participants 
who received mRNA-1345 coadministered with mRNA-1273.214 at Day 1, as measured by SRR 
of nAbs for each of the 2 SARS-CoV-2 strains (Wuhan-Hu-1 and B.1.1.529) on Day 29, is 
inferior compared with that in participants who received mRNA-1273.214 plus placebo at Day 1. 
The noninferiority in the SRR in participants who received mRNA-1345 coadministered with 
mRNA-1273.214 at Day 1 compared with that of participants who received mRNA-1273.214 
plus placebo at Day 1 will be demonstrated by the LB of the 95% CI of the SRR difference of 
ruling out 10% (ie, LB > -10%) using a noninferiority margin of 10%. The SRR difference in 
each strain is the SRR of SARS-CoV-2 nAb of the strain in participants who received 
mRNA-1345 coadministered with mRNA-1273.214 at Day 1 minus the SRR of SARS-CoV-2 
nAb of the strain in participants who received mRNA-1273.214 plus placebo at Day 1. 
Key Secondary Objective to Evaluate the Impact on the Immune Response to RSV-B: 
Key secondary endpoint based on GMT at Day 29: 
The null hypothesis H70: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with mRNA-1273.214 at Day 1, as measured by GMT at Day 29 
using RSV-B nAb assay, is inferior compared with that in participants who received 
mRNA-1345 plus placebo at Day 1. The noninferiority in the GMT in participants who received 
mRNA-1345 coadministered with mRNA-1273.214 at Day 1 compared with that of participants 
who received mRNA-1345 plus placebo at Day 1 will be demonstrated by the LB of the 95% CI 
of the GMR of ruling out 0.667 (ie, LB > 0.667) using a noninferiority margin of 1.5. The GMR 
is the ratio of the GMT of RSV-B nAbs in participants who received mRNA-1345 
coadministered with mRNA-1273.214 at Day 1 compared with the GMT of RSV-A nAbs in 
participants who received mRNA-1345 plus placebo at Day 1. 

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Key secondary endpoint based on SRR at Day 29:  
The null hypothesis H80: immunogenicity response to mRNA-1345 in participants who received 
mRNA-1345 coadministered with mRNA-1273.214 at Day 1, as measured by SRR of RSV-B 
nAbs at Day 29, is inferior compared with that in participants who received mRNA-1345 plus 
placebo at Day 1. The noninferiority in the SRR in participants who received mRNA-1345 
coadministered with mRNA-1273.214 at Day 1 compared with that of participants who received 
mRNA-1345 plus placebo at Day 1 will be demonstrated by the LB of the 95% CI of the SRR 
difference of ruling out -10% (ie, LB > -10%) using a noninferiority margin of 10%. The SRR 
difference is the SRR of RSV-B nAb in participants who received mRNA-1345 coadministered 
with mRNA-1273.214 at Day 1 minus the SRR of RSV-B nAb in participants who received 
mRNA-1345 plus placebo at Day 1. 
3.8.4. Sample Size Determination  
The study will plan to randomize approximately 1680 participants, with approximately 
560 participants receiving mRNA-1345 plus placebo at Day 1 and receiving mRNA-1273.214 at 
Day 29 (Group 4), 560 participants receiving mRNA-1345 plus mRNA-1273.214 at Day 1 and 
receiving placebo at Day 29 (Group 5), and 560 participants receiving mRNA-1273.214 plus 
placebo at Day 1 and receiving placebo at Day 29 (Group 6). 
With approximately 560 participants in each group, the study has approximately 94% probability 
to observe at least 1 participant in the group with an AE at a true 0.5% AE rate.  
Assuming approximately 10% of participants are ineligible to be included in the PP Set, there are 
504 eligible participants in each group: 
• There is at least 99% power to demonstrate the noninferiority of the immune response 
to RSV-A, as measured by GMT of RSV-A nAb at Day 29 in participants receiving 
mRNA-1345 plus mRNA-1273.214 at Day 1 compared with that in participants 
receiving mRNA-1345 plus placebo at Day 1, at a 2-sided alpha of 0.05, assuming a 
noninferiority margin of 1.5 and an underlying GMR of 1. The SD of the natural log-
transformed level is assumed to be 1.5. 
• There is at least 97.8% power to demonstrate the noninferiority of the immune 
response, as measured by SRR of RSV-A nAbs at Day 29 in participants receiving 
mRNA-1345 plus mRNA-1273.214 at Day 1 compared with that in participants 
receiving mRNA-1345 plus placebo at Day 1, at a 2-sided alpha of 0.05, assuming an 
SRR of RSV-A nAbs of 80% in both groups (a true SRR difference is 0), and a 
noninferiority margin of 10%. 
• There is at least 99% power to demonstrate the noninferiority of the immune response 
to SARS-CoV-2, as measured by GMC of nAbs for each of the 2 SARS-CoV-2 
strains (Wuhan-Hu-1 and B.1.1.529) at Day 29 in participants receiving mRNA-1345 
plus mRNA-1273.214 at Day 1 compared with that in participants receiving mRNA-
1345 plus placebo at Day 1, at a 2-sided alpha of 0.05, assuming a noninferiority 
margin of 1.5 and an underlying GMR of 1. The standard deviation of the natural log-
transformed level is assumed to be 1.5.  

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• There is at least 97.8% power to demonstrate the noninferiority of the immune 
response to SARS-CoV-2, as measured by SRR of nAbs for each of the 2 SARS-
CoV-2 strains (Wuhan-Hu-1 and B.1.1.529) at Day 29 in participants receiving 
mRNA-1345 plus mRNA-1273.214 at Day 1 compared with that in participants 
receiving mRNA-1273.214 plus placebo at Day 1, at a 2-sided alpha of 0.05, 
assuming an SRR of SARS-CoV-2 nAbs of 80% in both groups (a true SRR 
difference is 0), and a noninferiority margin of 10%.  
• The global power considering meeting the primary objectives to evaluate the immune 
responses to RSV-A and SARS-CoV-2 is at least 90%. Sample size justification for 
the co-primary endpoints is shown in Table 10. 
Table 10: 
Sample Size Justification for the Co-primary Endpoints  
Co-primary Endpoints 
Number of 
Evaluable 
Participants 
(with 10% 
ineligible for the 
PP Set) 
α 
Standard 
Deviation 
GMR/SRR 
Assumed 
NI 
Margin 
Power 
mRNA-1345 noninferiority (2-sided test) 
Day 29 GMT 
Coadministration (Group 5) 
vs mRNA-1345 alone at Day 
1 (Group 4) 
504 per group 
0.05 
1.5 
GMR = 1 
1.5 
99% 
Day 29 SRR  
Coadministration (Group 5) 
vs mRNA-1345 alone at Day 
1 (Group 4) 
504 per group 
0.05 
 
SRR = 0.8 
in both 
groups 
10% 
97.8% 
mRNA-1273.214 NI (2-sided test) for each SARS-CoV-2 strain (Wuhan-Hu-1 and B.1.1.529) 
Day 29 GMC 
Coadministration (Group 5) 
vs mRNA-1273.214 alone at 
Day 1 (Group 6) 
504 per group 
0.05 
1.5 
GMR = 1 
1.5 
99% 
Day 29 SRR  
Coadministration (Group 5) 
vs mRNA-1273.214 at Day 1 
(Group 6) 
504 per group 
0.05 
 
SRR = 0.8 
in both 
groups 
10% 
97.8% 
Global power to show NI of the co-primary immunogenicity endpoints 
90% 
Abbreviations: GMR = geometric mean ratio; GMT = geometric mean titer; GMC = geometric mean concentration; 
NI = noninferiority PP = per protocol; SRR = seroresponse rate. 
Assuming approximately 10% of participants are ineligible to be included in the PP Set; 
504 participants in each group for sample size in key secondary endpoints: 
• There is at least 99% power to demonstrate the noninferiority of the immune response 
to RSV-B, as measured by GMT of RSV-B nAb at Day 29 in participants from 

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Group 5 compared with that from Group 4, at a 2-sided alpha of 0.05, assuming a 
noninferiority margin of 1.5 and an underlying GMR of 1. The standard deviation of 
the natural log-transformed level is assumed to be 1.5. 
• There is at least 97.8% power to demonstrate the noninferiority of the immune 
response, as measured by SRR of RSV-B nAbs at Day 29 in participants from Group 
5 compared with that from Group 4, at a 2-sided alpha of 0.05, assuming a SRR of 
80% in both groups (a true SRR difference is 0) and a noninferiority margin of 10%.  
3.8.5. Analysis Sets  
See Section 2.8.4 for details. 
3.8.6. Planned Analyses  
A primary analysis and a final analysis will be conducted in this study. Further details can be 
found in the SAP. 
3.8.6.1. 
Primary Analysis  
See Section 2.8.6.1 for details. 
3.8.6.2. 
Final Analysis  
The final analysis of all endpoints will be performed after all participants have completed 
Day 211/EoS. Results of this analysis will be presented in a final CSR. The final CSR will 
include full analyses of all safety and immunogenicity data through Day 209/EoS. 
3.8.7. Multiplicity  
A sequential/hierarchical testing procedure will be used to control the overall Type 1 error rate at 
0.05 (2 sided) over the primary endpoints, key secondary efficacy endpoints, and selected 
secondary endpoints. 
The co-primary endpoints will be tested at the planned primary analysis at a 2-sided Type 1 error 
rate of 0.05. The success criteria of all 6 co-primary endpoints in Part B need to be met 
successfully to declare the study a success in Part B to achieve noninferiority of 
coadministration. 
The key secondary endpoints will be tested at the primary analysis at a 2-sided Type 1 error rate 
of 0.05 when all co-primary endpoints have achieved statistical significance. 

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4. PART C  
Part C is a Phase 3 single arm, open-label study to evaluate safety, tolerability, and 
immunogenicity of a booster dose (BD) of mRNA-1345 given at 1 year following a primary dose 
in adults ≥50 years of age. 
4.1. Protocol Summary  
4.1.1. Synopsis (Part C)  
Protocol Title: 
A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and 
Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus 
(RSV), When Given Alone or Coadministered with a Seasonal Influenza Vaccine or SARS-
CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary 
Dose in Adults ≥ 50 Years of Age.  
Regulatory Agency Identifier Numbers: 
Investigational New Drug: 23342 
Rationale: 
This study is designed as a single arm, open-label study to evaluate safety, tolerability, and 
immunogenicity of a BD of mRNA-1345 in adults ≥50 years of age who have previously 
received a primary dose of mRNA-1345. The mRNA-1345 recipients in the PP set in Part B 
(Group 4 [mRNA-1345 + placebo] and Group 5 [mRNA-1345 + mRNA-1273.214]) of this study 
who are willing to enroll in Part C will be screened accordingly. In Part C, eligible participants 
will receive mRNA-1345 boost at 1 Year following the primary dose. 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and tolerability of 
a BD of mRNA-1345 administered at 
1 Year following a primary dose. 
• 
Numbers and percentages of participants with 
solicited local and systemic ARs through 7 days 
postBD. 
• 
Numbers and percentages of unsolicited AEs 
through 28 days postBD. 
• 
Numbers and percentages of MAAEs from BD 
Day 1 through BD Day 181. 
• 
Numbers and percentages of SAEs, AESIs, and 
AEs leading to discontinuation from BD Day 1 
through BD Day 361/EoS. 
• 
To evaluate the immune response to 
RSV-A of a BD of mRNA-1345 
administered at 1 Year following a 
primary dose. 
• 
GMT ratio of serum RSV-A neutralizing Abs at 
BD Day 29 over serum RSV-A-neutralizing Abs 
at Day 29 post primary dose. 

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Objectives 
Endpoints 
• 
To evaluate the immune response to 
RSV-B of a BD of mRNA-1345 
administered at 1 Year following a 
primary dose. 
• 
GMT ratio of serum RSV-B neutralizing Abs at 
BD Day 29 over serum RSV-B-neutralizing Abs 
at Day 29 post primary dose. 
Secondary 
• 
To evaluate the immune response to 
RSV-A and RSV-B of a BD of mRNA-
1345 administered at 1 Year following a 
primary dose based on seroresponse  
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary dose) 
in RSV-A neutralizing Abs at BD Day 29.  
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary dose) 
in RSV-B neutralizing Abs at BD Day 29. 
• 
To evaluate the immune response to 
RSV-A and RSV-B of a BD of 
mRNA-1345 at all evaluable 
immunogenicity assessment timepoints. 
• 
GMT and GMFR of postBD/baseline titers to 
RSV-A neutralizing Abs up to BD 
Day 361/EoS. 
• 
GMT and GMFR of postBD/baseline titers to 
RSV-B neutralizing Abs up to BD Day 361/EoS. 
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary dose) 
in RSV-A neutralizing Abs up to BD Day 
361/EoS.  
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary dose) 
in RSV-B neutralizing Abs up to BD Day 
361/EoS.  
• 
Proportion of participants with ≥2-fold increase 
from baseline in RSV-A neutralizing Ab titers 
up to BD Day 361/EoS. 
• 
Proportion of participants with ≥2-fold increase 
from baseline in RSV-B neutralizing Ab titers 
up to BD Day 361/EoS. 
Exploratory (may be performed) 
• To further characterize the immune 
response of a BD of mRNA-1345. 
• 
GMC and GMFR of postBD/baseline titers to 
RSV-binding Abs up to BD Day 361/EoS. 
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary dose) 
in RSV-binding Ab concentration up to BD Day 
361/EoS. 
• 
Proportion of participants with ≥2-fold increase 
from baseline (defined as before primary dose) 
in RSV-binding Ab concentration up to BD Day 
361/EoS. 

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Objectives 
Endpoints 
• 
Frequency, specificities, or other endpoints to be 
determined for the further characterization of 
immune responses. 
Abbreviations: Ab = antibody, AE = adverse event, AR = adverse reaction, AESI = adverse event of special interest, 
BD = booster dose, EoS = end of study, GMC = geometric mean concentration, GMFR = geometric mean fold 
rise, GMT = geometric mean titer, MAAE = medically attended adverse event, RSV = respiratory syncytial virus, 
SAE = serious adverse event. 
Overall Design:  
Part C is a Phase 3 single arm, open-label, study to evaluate safety, tolerability, and 
immunogenicity of a BD of mRNA-1345 given at 1 year following a primary dose in adults 
≥50 years of age. Participants will be selected from Part B (Groups 4 and 5) of 
mRNA-1345-P302. 
All participants will participate in a Screening period and treatment period according to the 
timepoints specified in the SoA (Table 11). The study schema is presented in Figure 3.  
The study will enroll approximately 500 adults ≥50 years of age who are medically stable. The 
eligibility criteria are provided in Section 4.4. On BD Day 1, each participant will receive one 
IM injection of mRNA-1345 (
 µg) administered into the deltoid muscle of either the right or 
left arm.  
Participants will have scheduled visits and safety calls according to the timepoints specified in 
the SoA (Table 11). At the dosing visit on BD Day 1, participants will be instructed on how to 
document and report solicited ARs in a provided eDiary. Local and systemic solicited ARs will 
be assessed from BD Day 1 through BD Day 7 (the day of injection and the following 6 days). 
Unsolicited AEs will be assessed from BD Day 1 through BD Day 28 (ie, the day of injection 
and the following 27 days). MAAEs will be assessed from BD Day 1 through BD Day 181 (BD 
Month 6). Serious AEs, AEs leading to discontinuation, and AESIs will be assessed from BD 
Day 1 through EoS. 
Blood sample collection for humoral immunogenicity will occur on BD Day 1, BD Day 29, BD 
Day 181, and BD Day 361/EoS. The samples will be processed and analyzed per the Laboratory 
Manual. The scheduled safety assessment at BD Day 8 may occur either as a study site visit or a 
telephone call by the study site staff; however, a study site visit is preferred. The study site staff 
will also perform scheduled safety telephone calls to participants from BD Days 61 to 151 (BD 
Months 2 to 5), BD Day 241 (BD Month 8), and BD Day 301 (BD Month 10) to collect SAEs, 
MAAEs, AESIs, AEs leading to discontinuation, and information about concomitant medications 
related to those events and receipt of nonstudy vaccinations. 
Participants may experience AEs that necessitate an unscheduled visit. There may also be 
situations in which the Investigator asks a participant to attend an unscheduled visit following the 
report of an AE. Additional examinations may be conducted at these visits as necessary to ensure 
the safety and well-being of participants during the study. eCRFs should be completed for each 
unscheduled visit. 
Brief Summary: 
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The purpose of this study is to assess the safety, tolerability, and immunogenicity of a BD of 
mRNA-1345 given at 1 year following a primary dose in adults ≥50 years of age. 
Study details include: 
• The study duration will be up to 1 year from the injection at BD Day 1. 
• The vaccination of mRNA-1345 (
 µg) will include 1 injection on BD Day 1. 
• Details about the safety telephone call and visit frequency can be found in the SoA. 
Number of Participants: 
Approximately 500 participants will be enrolled. 
Note: Enrolled means participant agreement to participate in a clinical study following 
completion of the informed consent process. Potential participants who are screened for the 
purpose of determining eligibility for the study, but do not participate in the study, are not 
considered enrolled unless otherwise specified by the protocol. A participant will be considered 
enrolled if the informed consent is not withdrawn prior to participating in any study activity after 
screening. 
Prospective approval of protocol deviations for recruitment and enrollment criteria, also known 
as protocol waivers or exemptions, is not permitted. 
Data Monitoring/Other Committee: 
Safety monitoring for this study will include the study team members inclusive of, at a 
minimum, the Sponsor’s Medical Monitor and Safety Physician and a CRO Medical Monitor. 
The study team will conduct ongoing safety reviews during the study. This study will be 
conducted in compliance with the protocol, GCP, and all applicable regulatory requirements. 
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4.1.2. Schema (Part C)  
Figure 3: 
Study Schema (Part C) 
 
Abbreviations: BD = booster dose, d = days, V = visit. 
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4.1.3. SoA (Part C)  
Table 11: 
SoA (Part C) 
Visit Number 
Screening 
1 
2 
3 
4, 5, 6, 7 
8 
9 
10 
11 
USV 
Type of Visit 
V 
V 
Va/SC 
Va 
SC 
Va 
SC 
SC 
Va 
Va 
Month Timepoint 
N/A 
 
 
BD M1 
BD M2, M3, M4, M5 
BD M6 
BD M8 
BD M10 
BD 
M12/EoS 
Up to BD  
M12 
Visit Day  
Screeningb 
BD D1b,c BD D8 BD D29 BD D61, D91, D121, D151 
BD D181 BD D241 
BD D301 
BD D361 
N/A 
Window Allowance 
(Days) 
-14 
– 
+3 
±7 
±5 
±7 
±5 
±5 
±14 
N/A 
Informed consent, 
concomitant medicationsk 
and review of medical 
history  
X 
– 
– 
– 
– 
– 
– 
– 
– 
– 
Inclusion/exclusion 
criteria 
X 
X 
– 
– 
– 
– 
– 
– 
– 
– 
Physical examinationd 
X 
X 
– 
– 
– 
– 
– 
– 
– 
X 
Vital sign measurementse 
X 
X 
– 
– 
– 
– 
– 
– 
– 
X 
IRT registration of 
participant 
– 
X 
– 
– 
– 
– 
– 
– 
– 
– 
Study injection (including 
a 30-minute postdose 
observation period)f 
– 
X 
– 
– 
– 
– 
– 
– 
– 
– 
Blood sample collection 
for humoral 
immunogenicityg 
– 
X 
– 
X 
– 
X 
– 
– 
X 
– 
Optional blood sample for 
transcriptomicsg  
– 
X 
– 
X 
– 
X 
– 
– 
X 
– 

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Visit Number 
Screening 
1 
2 
3 
4, 5, 6, 7 
8 
9 
10 
11 
USV 
Type of Visit 
V 
V 
Va/SC 
Va 
SC 
Va 
SC 
SC 
Va 
Va 
Month Timepoint 
N/A 
 
 
BD M1 
BD M2, M3, M4, M5 
BD M6 
BD M8 
BD M10 
BD 
M12/EoS 
Up to BD  
M12 
Visit Day  
Screeningb 
BD D1b,c BD D8 BD D29 BD D61, D91, D121, D151 
BD D181 BD D241 
BD D301 
BD D361 
N/A 
Window Allowance 
(Days) 
-14 
– 
+3 
±7 
±5 
±7 
±5 
±5 
±14 
N/A 
Pregnancy testingh 
X 
X 
– 
– 
– 
– 
– 
– 
– 
– 
eDiary activation for 
recording solicited ARs 
(7 days)i 
– 
X 
– 
– 
– 
– 
– 
– 
– 
– 
Follow-up safety 
telephone callj 
– 
– 
– 
– 
X 
– 
X 
X 
– 
– 
Recording of unsolicited 
AEs 
– 
X 
X 
X 
– 
– 
– 
– 
– 
– 
Recording of MAAEs and 
concomitant medications 
relevant to or for their 
treatmentj 
– 
X 
X 
X 
X 
X 
– 
– 
– 
– 
Recording of SAEs, 
AESIs, AEs leading to 
discontinuation, and 
concomitant medications 
relevant to or for their 
treatmentj 
– 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of nonstudy 
vaccinationsk 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study completion 
– 
– 
– 
– 
– 
– 
– 
 
X 
– 

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Abbreviations: AE=adverse event; AESI=adverse event of special interest; AR=adverse reaction; BD=booster dose; D=Day; eDiary=electronic diary; EoS=end 
of study; FSH=follicle-stimulating hormone; IRT=Interactive Response Technology; M=month; N/A=not applicable; MAAE=medically attended adverse 
event; RSV=respiratory syncytial virus; SAE=serious adverse event; SC=safety telephone call; USV=unscheduled visit; V=visit. 
a.
All study visits with the exception of Screening and Visit 1 can take place at the study or mobile site or at the home of the participant, where allowed by local
regulations, and upon written Sponsor approval. If a visit cannot be scheduled within the indicated allowable window and/or the participant misses the visit,
this is considered a protocol deviation. Subsequent visits should be scheduled at the originally planned number of days after Day 1.
b.
The Screening Visit and BD Day 1 Visit may be performed on the same day or on different days. Additionally, the Screening Visit may be performed over
multiple visits if within the 14-day screening window. Individuals who do not meet the criteria for participation in this study (screen failure) may be
rescreened 1 time within the 14-day Screening window if they will be eligible upon rescreening.
c.
BD Day 1 visit should occur at least 12 months (but no later than 15 months) from the first mRNA-1345 administration on Day 1 in Part B.
d.
A full physical examination, including height and weight, will be performed at the Screening Visit and BD Day 1. Symptom-directed physical examinations
will be performed at other study visits, if clinically indicated. Interim physical examinations will be performed at the discretion of the investigator. On the
day of the study injection, both arms should be examined, and the associated lymph nodes should be evaluated. Any clinically significant findings identified
by a healthcare professional during study visits should be reported as an MAAE.
e.
Vital sign measurements include assessment of systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature (preferred route is
oral). Fever is defined as a body temperature ≥38.0°C/100.4°F. The participant will be seated for at least 5 minutes before all measurements are taken. Vital
signs will only be collected at Screening, on the day of the study injection (BD Day 1), and once before and at least 30 minutes after study injection. Vital
signs will be collected at other clinical visits only in conjunction with a symptom-directed physical examination.
f.
All participants will receive one intramuscular injection on BD Day 1, in one arm, in the deltoid muscle.
g.
Blood samples for humoral immunogenicity must be collected prior to administration of the IP on BD Day 1. Transcriptomic samples will be part of the
optional biomarker assessment once consented to by the study participant.
h.
A urine pregnancy test (β-human chorionic gonadotropin) will be performed on all participants of childbearing potential at Screening and prior to study
injection on BD Day 1. An FSH level may be measured at the discretion of the Investigator to confirm menopausal status. At USVs, serum or urine
pregnancy testing may be performed as needed at the discretion of the Investigator.
i.
The eDiary entries will be recorded by the participant starting approximately 30 minutes after study injection while at the study site with instruction provided
by study staff. Study participants will continue to record in the eDiary each day after they leave the study site, on the day of study injection and for 6 days
following study injection. If the participant is unable to complete the eDiary on their own, a caregiver can assist with data entry, but the information entered
in the eDiary must come from the participant. Local solicited ARs will be recorded for the injection site. The study site staff will review eDiary data with
participants on BD Day 8 visit (Visit 2). See Sections 4.7.1.1and 2.7.4.3.
j.
Medically qualified study staff will contact all participants. The participant will be interviewed according to the script. Information will be collected about
occurrence of unsolicited AEs through 28 days postinjection, the occurrence of MAAEs and concomitant medications associated with those events through
Day 181 postinjection, and the occurrence of SAEs, AESIs, or AEs leading to study discontinuation and concomitant medications associated with those
events, and receipt of any nonstudy vaccinations at all points of contact through Day 361/EoS.
k.
All concomitant medications will be recorded on from Screening through 28 days following injection; concomitant medications relevant to or for the
treatment of an MAAE will be recorded from BD Day 1 through BD Day 181; all nonstudy vaccinations and concomitant medications relevant to or for the
treatment of an SAE, AESI, or AE leading to study discontinuation, will be recorded from BD Day 1 through BD Day 361/EoS.

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4.2. Objectives and Endpoints (Part C)  
The objectives and endpoints of this study are described in Table 12.  
Table 12: 
Study Objectives and Endpoints (Part C)  
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and tolerability of a 
BD of mRNA-1345 administered at 1 Year 
following a primary dose. 
• 
Numbers and percentages of participants 
with solicited local and systemic ARs 
through 7 days postBD. 
• 
Numbers and percentages of unsolicited AEs 
through 28 days postBD. 
• 
Numbers and percentages of MAAEs from 
BD Day 1 through BD Day 181. 
• 
Numbers and percentages of SAEs, AESIs, 
and AEs leading to discontinuation from BD 
Day 1 through BD Day 361/EoS. 
• 
To evaluate the immune response to RSV-A 
of a BD of mRNA-1345 administered at 1 
Year following a primary dose. 
• 
GMT ratio of serum RSV-A neutralizing 
Abs at BD Day 29 over GMT of serum 
RSV-A-neutralizing Abs at Day 29 post 
primary dose. 
• 
To evaluate the immune response to RSV-B 
of a BD of mRNA-1345 administered at 1 
Year following a primary dose. 
• 
GMT ratio of serum RSV-B neutralizing 
Abs at BD Day 29 over GMT of serum 
RSV-B-neutralizing Abs at Day 29 post 
primary dose. 
Secondary 
• 
To evaluate the immune response to RSV-A 
and RSV-B of a BD of mRNA-1345 
administered at 1 Year following a primary 
dose based on seroresponse  
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary 
dose) in RSV-A neutralizing Abs at BD Day 
29.  
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary 
dose) in RSV-B neutralizing Abs at BD Day 
29. 
• 
To evaluate the immune response to RSV-A 
and RSV-B of a BD of mRNA-1345 at all 
evaluable immunogenicity assessment 
timepoints. 
• 
GMT and GMFR of postBD/baseline titers 
to RSV-A neutralizing Abs up to BD 
Day 361/EoS. 
• 
GMT and GMFR of postBD/baseline titers 
to RSV-B neutralizing Abs up to BD 
Day 361/EoS. 
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary 
dose) in RSV-A neutralizing Abs up to BD 
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Objectives 
Endpoints 
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary 
dose) in RSV-B neutralizing Abs up to BD 
Day 361/EoS.  
• 
Proportion of participants with ≥2-fold 
increase from baseline (defined as before 
primary dose) in RSV-A neutralizing Ab 
titers up to BD Day 361/EoS. 
• 
Proportion of participants with ≥2-fold 
increase from baseline (defined as before 
primary dose) in RSV-B neutralizing Ab 
titers up to BD Day 361/EoS. 
Exploratory (may be performed) 
• 
To further characterize the immune response 
of a BD of mRNA-1345. 
• 
GMC and GMFR of postBD/baseline titers 
to RSV-binding Abs up to BD Day 361/EoS. 
• 
Proportion of participants with seroresponse 
from baseline (defined as before primary 
dose) in RSV-binding Ab concentration up 
to BD Day 361/EoS. 
• 
Proportion of participants with ≥2-fold 
increase from baseline (defined as before 
primary dose) in RSV-binding Ab 
concentration up to BD Day 361/EoS. 
• 
Frequency, specificities, or other endpoints 
to be determined for the further 
characterization of immune responses. 
Abbreviations: Ab = antibody, AE = adverse event, AR = adverse reaction, AESI = adverse event of special interest, 
BD = booster dose, EoS = end of study, GMC = geometric mean concentration, GMFR = geometric mean fold 
rise, GMT = geometric mean titer, MAAE = medically attended adverse event, RSV = respiratory syncytial virus, 
SAE = serious adverse event. 
4.3. Study Design  
4.3.1. General Design (Part C)  
Part C is a Phase 3 single arm, open-label, study to evaluate safety, tolerability, and 
immunogenicity of a BD of mRNA-1345 given at 1 year following a primary dose in adults 
≥50 years of age. Participants will be selected from Part B (Groups 4 and 5) of 
mRNA-1345-P302. 
All participants will participate in a Screening period and treatment period according to the 
timepoints specified in the SoA (Table 11). The study schema is presented in Figure 3. 
The study will enroll approximately 500 adults ≥50 years of age who are medically stable. The 
eligibility criteria are provided in Section 4.4. On BD Day 1, each participant will receive one 
IM injection of mRNA-1345 (
 µg), administered into the deltoid muscle of either the right or 
left arm.  
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Participants will have scheduled visits and safety calls according to the timepoints specified in 
the SoA (Table 11). At the dosing visit on BD Day 1, participants will be instructed on how to 
document and report solicited ARs in a provided eDiary. Local and systemic solicited ARs will 
be assessed from BD Day 1 through BD Day 7 (the day of injection and the following 6 days). 
Unsolicited AEs will be assessed from BD Day 1 through BD Day 28 (ie, the day of injection 
and the following 27 days). MAAEs will be assessed from BD Day 1 through BD Day 181 (BD 
Month 6). Serious AEs, AEs leading to discontinuation, and AESIs will be assessed from BD 
Day 1 through EoS. 
Blood sample collection for humoral immunogenicity will occur on BD Day 1, BD Day 29, BD 
Day 181, and BD Day 361/EoS. The samples will be processed and analyzed per the Laboratory 
Manual. The scheduled safety assessment at BD Day 8 may occur either as a study site visit or a 
telephone call by the study site staff; however, a study site visit is preferred. The study site staff 
will also perform scheduled safety telephone calls to participants from BD Days 61 to 151 (BD 
Months 2 to 5), BD Day 241 (BD Month 8), and BD Day 301 (BD Month 10) to collect SAEs, 
MAAEs, AESIs, AEs leading to discontinuation, and information about concomitant medications 
related to those events and receipt of nonstudy vaccinations. 
Participants may experience AEs that necessitate an unscheduled visit. There may also be 
situations in which the Investigator asks a participant to attend an unscheduled visit following the 
report of an AE. Additional examinations may be conducted at these visits as necessary to ensure 
the safety and well-being of participants during the study. eCRFs should be completed for each 
unscheduled visit. 
Safety monitoring for this study will include the study team members inclusive of, at a 
minimum, the Sponsor’s Medical Monitor and Safety Physician and a CRO Medical Monitor. 
The study team will conduct ongoing safety reviews during the study. This study will be 
conducted in compliance with the protocol, GCP, and all applicable regulatory requirements. 
4.3.2. Scientific Rationale for Study Design  
This study is designed as a single arm, open-label study to evaluate safety, tolerability, and 
immunogenicity of a BD of mRNA-1345 in adults ≥50 years of age who have previously 
received a primary dose of mRNA-1345. The mRNA-1345 recipients in the PP set in Part B 
(Group 4 [mRNA-1345 + placebo] and Group 5 [mRNA-1345 + mRNA-1273.214]) of this study 
who are willing to enroll in Part C will be screened accordingly. In Part C, eligible participants 
will receive mRNA-1345 boost at 1 Year following the primary dose (Table 11). 
4.3.3. Choice of Vaccine Dose  
The 
-µg dose of mRNA-1345 was selected for this study based on the mRNA-1345-P101 
study data (Section 1.1.6). 
4.3.4. EoS Definition  
A participant is considered to have completed the study if they have completed the last scheduled 
procedure on BD Day 361 (ie, 12 months after administration of mRNA-1345 on BD Day 1; 
Table 11). The EoS is defined as completion of the last visit of the last participant in the study or 
last scheduled procedure, as shown in the SoA (Table 11). 
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4.4. Study Population (Part C)  
Approximately 500 participants will be enrolled. 
Note: Enrolled means participant agreement to participate in a clinical study following 
completion of the informed consent process. Potential participants who are screened for the 
purpose of determining eligibility for the study, but do not participate in the study, are not 
considered enrolled unless otherwise specified by the protocol. A participant will be considered 
enrolled if the informed consent is not withdrawn prior to participating in any study activity after 
screening. 
Prospective approval of protocol deviations for recruitment and enrollment criteria, also known 
as protocol waivers or exemptions, is not permitted. 
4.4.1. Inclusion Criteria (Part C)  
Participants are eligible to be included in the study only if all the following criteria apply:  
1. Participants at Part C study sites who have been enrolled in Part B (Groups 4 and 5) of 
this study; have immunogenicity blood sampling at Part B baseline and Day 29; 
completed the Day 211/EoS visits for Part B; were included in the PP set; and received 1 
dose of mRNA-1345 at least 12 months (but no later than 15 months) prior to the time of 
enrollment. 
2. Investigator assessment that participant understands and is willing and physically able to 
comply with protocol-mandated follow-up, including all procedures, and is in general 
good health according to the Investigator’s assessment. 
3. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as bilateral tubal ligation >1 year prior to Screening, 
bilateral oophorectomy, hysterectomy, or menopause. An FSH level may be measured at 
the discretion of the Investigator to confirm menopausal status.  
4. Female participants of childbearing potential may be enrolled in the study if the 
participant: (1) has a negative urine pregnancy test at Screening and on the day of 
injection, (2) has practiced adequate contraception or has abstained from all activities that 
could lead to pregnancy for 28 days prior to vaccination, (3) has agreed to continue 
adequate contraception through 3 months following the BD injection, and (4) is not 
currently breastfeeding. 
Adequate contraception is defined as consistent and correct use of approved 
contraceptive method in accordance with the product label. For example: 
– Barrier method (such as condoms, diaphragm, or cervical cap) used in 
conjunction with spermicide. 
– Intrauterine device. 
– Hormonal contraceptive in the form of a pill or patch. 
– Medroxyprogesterone injection (eg, Depo-Provera®). 
– Etonogestrel implant (eg, Nexplanon®). 
– Sterilization of a female participant’s male partner prior to entry into the study. 

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– Vasectomy for male participants. 
Note: Periodic abstinence (eg, calendar, ovulation, symptom-thermal, postovulation 
methods,) and withdrawal are not acceptable methods of contraception. 
5. Willing and able (on both a physical and cognitive basis) to give informed consent prior 
to study enrollment. 
6. Able to comply with study requirements, including access to transportation for study visits. 
7. Access to inbound and outbound telephone communication with caregivers and study staff. 
4.4.2. Exclusion Criteria (Part C)  
Participants are not eligible to be included in the study if any of the following criteria apply:  
1. Participation in another interventional clinical research study where participant has 
received any IP (drug/biologic/device) within 6 months before the planned date of the BD 
Day 1 study injection. Any prior receipt of an investigational or approved vaccine against 
RSV, except as part of mRNA-1345 Study P302 Part B, is exclusionary.  
2. Participant is acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior 
to Screening Visit or BD Day 1. Participants meeting this criterion may be rescheduled 
within the 14-day Screening window and will retain their initially assigned participant 
number. 
3. History of a diagnosis or condition, that in the judgment of the Investigator, is clinically 
unstable or may affect participant safety, assessment of safety endpoints, assessment of 
immune response, or adherence to study procedures. Clinically unstable is defined as a 
diagnosis or condition requiring significant changes in management or medication 
≤60 days prior to Screening and includes ongoing workup of an undiagnosed illness that 
could lead to a new diagnosis or condition.  
Asymptomatic conditions and conditions with no evidence of end-organ involvement 
(eg, mild hypertension, dyslipidemia) are not exclusionary if they are being appropriately 
managed and are clinically stable (ie, unlikely to result in symptomatic illness within the 
time course of this study). Illnesses or conditions may be exclusionary, even if otherwise 
stable, because of therapies used to treat them (eg, immune-modifying treatments), at the 
discretion of the Investigator. 
Participants who have undergone surgical procedures within 7 days prior to BD Day 1 or 
are scheduled to undergo a surgical procedure within 28 days after study injection are 
also excluded. However, minor surgical procedures under local anesthesia (eg, excision 
of skin lesion) or diagnostic procedures (eg, colonoscopy) are allowed. 
4. Reported history of congenital or acquired immunodeficiency; asplenia or recurrent 
infections; or an immunocompromizing/immunosuppressive condition that requires 
systemic treatment with immunosuppressive therapy, including cytotoxic agents, 
radiotherapy, or monoclonal antibodies for cancer or an autoimmune disorder with the 
following exceptions. 
a. Participants who are HIV positive with CD4 count ≥350 cells/mm3 and an 
undetectable HIV viral load within the past year (low level variations from 50 to 

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500 viral copies, which do not lead to changes in antiretroviral therapy) as determined 
from participant’s medical records are permitted. 
b. Certain immune-mediated conditions that are stable and well-controlled (eg, alopecia 
areata, Hashimoto thyroiditis, type 1 diabetes mellitus, gout, autoimmune ovarian 
failure) as well as those that do not require systemic immunosuppressants per 
Exclusion Criterion 5 (eg, asthma, psoriasis, or vitiligo) are permitted at the discretion 
of the Investigator. 
5. Participants who received systemic immunosuppressants for >14 days in total within 
180 days prior to BD Screening Visit (for glucocorticoids ≥10 mg/day of prednisone or 
equivalent) or is anticipating the need for systemic immunosuppressive treatment at any 
time during participation in the study (including intra-articular steroid injections). 
Inhaled, nasal, and topical steroids are allowed.  
6. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, 
psoriasis patches affecting skin over the deltoid areas). 
7. Any reported history of anaphylaxis or known immediate hypersensitivity to any 
component of the study product or any mRNA vaccine(s), including polyethylene glycol. 
8. Reported history of coagulopathy or bleeding disorder that is considered a 
contraindication to IM injection or phlebotomy. 
9. Any medical, psychiatric, or occupational condition, including reported history of drug or 
alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to 
participation in the study or could interfere with the interpretation of study results. 
10. Known uncontrolled disorder of coagulation.  
Note: In the setting of well-controlled atrial fibrillation, prophylaxis for cardiovascular 
thromboembolism or stroke with the following medications are allowed: aspirin, 
clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin. 
11. Participant has received or plans to receive any vaccine authorized or approved by a local 
health agency ≤28 days prior to the study injection (BD Day 1) or plans to receive a 
vaccine authorized or approved by a local health agency within 28 days after the study 
injections. 
12. History of a serious reaction to any prior vaccination or Guillain-Barré syndrome 6 weeks 
after any prior influenza immunization. 
13. Receipt of systemic immunoglobulins or blood products ≤90 days prior to the Screening 
Visit or plans to receive systemic immunoglobulins or blood products during the study. 
14. Participant has a history of myocarditis, pericarditis, or myopericarditis within 2 months 
prior to Screening. Participants who have not returned to baseline after their convalescent 
period will also be excluded.  
15. Participant has donated ≥450 mL of blood products within 28 days prior to the Screening 
Visit or plans to donate blood products during the study. 
16. Participant is an immediate family member or household member of study personnel, 
study site staff, or Sponsor personnel. 

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4.4.3. Lifestyle Restrictions  
Not applicable. 
4.4.4. Screen Failures  
See Section 2.4.4 for details. 
4.5. Study Treatment  
4.5.1. Investigational Products Administered  
mRNA-1345 is an LNP-encapsulated mRNA-based vaccine consisting of mRNA encoding the 
RSV fusion glycoprotein stabilized in the prefusion conformation. 
4.5.2. Randomization and Blinding  
Not applicable. 
4.5.2.1. 
Blinding  
Not applicable. 
4.5.2.2. 
Unblinding  
Not applicable. 
4.5.3. Preparation, Handling, Storage, and Accountability  
4.5.3.1. 
Preparation of Study Vaccine  
mRNA-1345 will be provided as a sterile liquid for injection and will be a white to off white 
dispersion at a concentration of 
 
  
mRNA-1345 preparation instructions is detailed in the Pharmacy Manual. 
4.5.3.2. 
Study Vaccine Administration  
mRNA-1345 will be administered as one IM injection on BD Day 1 in the deltoid muscle, 
according to the procedures specified in the Pharmacy Manual. The arm (left or right) in which 
the injection is administered will be recorded by the site staff.  
On BD Day 1, participants will be monitored for a minimum of 30 minutes after injection. 
Assessments will include, but are not limited to, vital sign measurements and monitoring for 
local or systemic ARs as shown in the SoA (Table 11). 
The study site will be appropriately staffed with individuals with basic cardiopulmonary 
resuscitation training and certification. Either on-site resuscitation equipment and study 
personnel or appropriate protocols for the rapid transport of a participant to a resuscitation area 
or facility are required. 
CCI

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4.5.3.3. 
Study Vaccine Delivery and Receipt  
The Sponsor (or designee) is responsible for the following: 
• Supplying mRNA-1345 to the study sites.  
• Confirming the appropriate labeling of the IP so it complies with the legal 
requirements of the US. 
The investigator is responsible for acknowledging the receipt of the IP by a designated staff 
member at the site, which includes the following: 
• Confirming that the IP was received in good condition. 
• Confirming that the temperature during shipment from the Sponsor to the 
investigator’s designated storage location was appropriate. 
• Confirming that the Sponsor has authorized the IP for use. 
• Ensuring the appropriate dose of the IP is properly prepared using aseptic technique. 
Further description of the IP and instructions for the receipt, storage, preparation, administration, 
accountability, and destruction of the IP are described in the Pharmacy Manual. 
4.5.3.4. 
Study Vaccine Packaging and Labeling  
The Sponsor will provide the Investigator (via the study site pharmacy) with adequate quantities 
of the IP. 
mRNA-1345 will be prepared, packaged, and labeled in accordance with the standard operating 
procedures of the Sponsor or those of its designee, CFR Title 21, Good Manufacturing Practice 
guidelines, the International Council for ICH GCP guidelines, guidelines for Quality System 
Regulations, and applicable regulations. 
4.5.3.5. 
Study Vaccine Storage  
mRNA-1345 should be stored at –25ºC to –15ºC (–13ºF to 5ºF). mRNA-1345 must be received 
by a designated study personnel at the study site, handled and stored safely, kept in a secure 
location with restricted access, and protected from moisture and light until it is prepared for 
administration. Additional details are found in the Pharmacy Manual. 
4.5.3.6. 
Study Vaccine Accountability  
It is the Investigator’s responsibility that the IP accountability study staff maintain accurate 
records in an IP accountability log of receipt of all IP, study site IP inventory, IP dispensing, IP 
injections, and return to the Sponsor or alternative disposition of used and unused IP vials. 
The study site monitor will review the inventory and accountability log during study site visits 
and at the completion of the study. Additional details are found in the Pharmacy Manual. 
4.5.3.7. 
Study Vaccine Handling and Disposal  
The study site monitor will reconcile the IP inventory during the conduct of the study and at the 
EoS for compliance. Once fully reconciled at the site at the EoS, the IP can be destroyed on-site, 

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if study site procedures allow, or returned to a destruction depot per instruction of the Sponsor. 
Additional details are found in the Pharmacy Manual. 
4.5.4. Study Intervention Compliance  
The IP will be administered at the study site under direct observation of medically qualified 
study personnel and appropriately recorded (date and time) in the source documents and eCRF. 
The qualified study personnel will confirm that the participant has received the entire dose of the 
IP, record the injection site (left or right deltoid) and corresponding IP administered. If a 
participant does not receive the IP or does not receive all of the planned dose, the reason for the 
missed dose will be recorded. The data will be reconciled with the study site accountability 
records to assess compliance. 
The study site staff are responsible for ensuring that the participants comply with the allowed 
study visit windows. If a participant misses a visit, every effort should be made to contact the 
participant and complete the visit within the defined visit window, as specified in the SoA 
(Table 11 [Part C]). If a participant does not complete a visit within the defined time window, 
that visit will be classified as a missed visit, and the participant will continue with the subsequent 
scheduled visits. All safety requirements of the missed visit will be captured and included in the 
subsequent visit. 
4.5.5. Prior and Concomitant Medications  
4.5.5.1. 
Prior Medications and Therapies  
Information about prior medications (including any prescription or over-the-counter medications, 
vaccines, or blood products) taken by the participant within the 28 days before providing 
informed consent (or as designated in the inclusion/exclusion requirements) will be recorded in 
the participant’s eCRF. 
4.5.5.2. 
Concomitant Medications and Therapies  
At the study site, the study staff must question the participant regarding any medications taken 
and nonstudy vaccinations received by the participant and record the following information in 
the eCRF: 
• All nonstudy vaccinations administered within the period starting 28 days before the 
study injection and through Month 12/EoS. 
• All concomitant medications taken through 28 days after injection. Antipyretics and 
analgesics taken prophylactically (ie, taken in the absence of any symptoms in 
anticipation of an injection reaction) will be recorded as such. 
• Any concomitant medications used to prevent or treat COVID-19, RSV, or any other 
infectious disease symptoms. 
• Any concomitant medications relevant to or for the treatment of MAAE from BD 
Day 1 through Month 6. 
• Any concomitant medications relevant to or for the treatment of SAE or AESI, from 
BD Day 1 through Month 12/EoS. 

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• The participant will be asked in the eDiary if they have taken any antipyretic or 
analgesic to treat or prevent fever or pain within 7 days after injection, including the 
day of injection. Reported antipyretic or analgesic medications should be recorded in 
the source document by the study site staff during the postinjection study site visits or 
via other participant interactions (eg, safety telephone calls). 
• Use of facial injections or dermal fillers for cosmetic or medical indications such as 
migraine headaches. 
Concomitant medications (including vaccinations) will be coded using the WHO Drug Global 
dictionary.  
If a participant takes a prohibited drug therapy, the Investigator and the medical monitor will 
make a joint decision about continuing or withholding further assessment of the participant based 
on the time the medication was administered, the drug’s pharmacology and pharmacokinetics, 
and whether the use of the medication will compromise the participant’s safety or interpretation 
of the study data. It is the Investigator’s responsibility to ensure that details regarding the 
concomitant medications are adequately recorded in the eCRF. 
4.5.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination 
of a Participant from the Per-Protocol Analyses  
See Section 2.5.5.3 for details. 
4.5.6. Intervention After the End of the Study  
See Section 2.5.6 for details. 
4.6. Delay or Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
4.6.1. Criteria for Delay of Vaccine Administration  
4.6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination  
See Section 2.6.1.1 for details and refer to the SoA for Part C (Table 11). 
4.6.2. Participant Discontinuation/Withdrawal from the Study  
See Section 2.6.2 for details. 
4.6.3. Lost to Follow-Up  
See Section 2.6.3 for details. 
4.7. Study Assessments and Procedures  
See Section 2.7 for details and refer to the SoA for Part C (Table 11).  

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4.7.1. Safety Assessments and Procedures  
Safety assessments will include monitoring and recording of the following for each participant, 
according to the SoA (Table 11 [Part C]): 
• Solicited local and systemic ARs (Section 2.7.4.3) that occur during the 7 days 
following vaccine administration (ie, the day of study injections and 6 subsequent 
days). Solicited ARs will be recorded daily using eDiaries (Section 4.7.1.1). Local 
solicited ARs will be recorded separately for each injection site. 
• Unsolicited AEs observed or reported from the day of injection and 27 subsequent 
days). Unsolicited AEs are defined in Section 2.7.4.1 and Section 2.7.4.2. 
• MAAEs from BD Day 1 through BD Day 181 (BD Month 6). 
• SAEs, AESIs, and AEs leading to discontinuation from study participation from 
vaccination on Day 1 through BD Day 361/EoS or withdrawal from the study. 
• Vital sign measurements (Section 2.7.1.3). 
• Physical examination findings (Section 2.7.1.4). 
The incidence and severity of the above events will be monitored by study team members 
inclusive of, at a minimum, the Sponsor’s Medical Monitor and Safety Physician and a CRO 
Medical Monitor who will conduct ongoing safety reviews during the study.  
4.7.1.1. 
Use of Electronic Diaries  
At the time of consent, the participants must confirm they will be willing to complete an eDiary 
(for 7-day reactogenicity) using either an application downloaded to their smartphone or a device 
that will be provided at the time of enrollment. If the participant is unable to complete the eDiary 
on their own, a caregiver can assist with the data entry, but the information entered in the eDiary 
must come from the participant. 
Before enrollment on BD Day 1, the participant will be instructed to download the eDiary 
application or will be provided with an eDiary device to record solicited ARs (Section 4.7.4.3). 
and to receive eDiary prompts.  
On the injection day, participants will be instructed on thermometer usage to measure body 
temperature, ruler usage to measure injection site erythema and swelling/induration (hardness), 
and self-assessment for localized axillary swelling or tenderness on the same side as the injection 
arm. 
On the injection day, participants will record data in the eDiary starting approximately 
30 minutes after administration of the injection under supervision of the study site staff to ensure 
correct completion of the eDiary. The study site staff will perform any retraining as necessary. 
Participants will continue to record data in the eDiary after they leave the study site once per day, 
preferably in the evening and at the same time each day, on the day of injection and 6 subsequent 
days. 
Participants will record the following data in the eDiary: 
• Solicited local and systemic reactogenicity ARs, as defined in Section 4.7.4.3, that 
occur on the day of injection and during the 7 days after injection (ie, the day of 

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injection and 6 subsequent days). Local solicited ARs will be recorded for the 
injection site. ARs beyond Day 7 should be reviewed either at the next scheduled 
study site visit or during the safety telephone call. 
• Daily oral body temperature measurements should be performed using the 
thermometer provided by the study site. If body temperature is taken more than once 
in a given day, only the highest temperature reading should be recorded. 
• Other measurements, as applicable, for solicited local ARs (injection site erythema 
and swelling/induration) should be performed using the ruler provided by the study 
site. 
• Whether any medications were taken to treat or prevent pain or fever on the day of 
injection and 6 subsequent days. 
The eDiary will be the only source document allowed for solicited systemic or local ARs 
(including body temperature measurements). Participants will be instructed to complete eDiary 
entries daily. Quantitative temperature recordings and measurement of any injection site 
erythema or swelling/induration reported on the following day may be excluded from the 
analyses of solicited ARs. 
If eDiary prompts result in identification of relevant safety events according to the study period, 
a follow-up safety contact will be triggered to determine whether an unscheduled visit should be 
arranged. 
For Part C, the study site staff will review eDiary data with participants on BD Day 8 visit 
(Visit 2). 
4.7.1.1.1 Ancillary Supplies for Participant Use  
See Section 2.7.1.1.1 for details. 
4.7.1.2. 
Safety Telephone Call  
The safety telephone call will be made to the participants by trained study site personnel. This 
call will follow a Sponsor-approved script, which will facilitate the collection of relevant safety 
information. Safety telephone calls by the study site to each participant will occur at the 
timepoints indicated in the SoA (Table 11). The participant will be interviewed according to the 
script about the occurrence of AEs, MAAEs, AESIs, SAEs, AEs leading to discontinuation, 
concomitant medications associated with those events, and any nonstudy vaccinations 
(Section 2.7.4.6). All safety information collected from the telephone call must be documented in 
the source documents as described by the participant and not documented on the script used for 
the safety telephone call. As noted in Section 4.7.1.1, an unscheduled follow-up safety telephone 
call may be triggered if an eDiary record results in identification of a relevant safety event. 
4.7.1.3. 
Vital Sign Measurements  
See Section 2.7.1.3 for details and refer to the SoA for Part C (Table 11). 
4.7.1.4. 
Physical Examinations  
See Section 2.7.1.4 for details and refer to the SoA for Part C (Table 11). 

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4.7.2. Immunogenicity Assessments  
Blood samples for immunogenicity assessments will be collected at the timepoints indicated in 
the SoA (Table 11). Immunogenicity assessments will be performed for all participants. The 
following analytes will be measured: 
• RSV-A and RSV-B nAbs measured by microneutralization assay. 
Sample collection, handling, and volume will be provided in the lab manual. Unique sample 
identification will be used to allow for automated sample tracking and housing. Handling and 
preparation of the samples for analysis, as well as shipping and storage requirements, will be 
provided in a separate study manual. 
Measurement of Ab levels will be performed in a laboratory designated by the Sponsor. 
According to the ICF (Section 6.1.6), excess serum from the blood samples collected for 
immunogenicity testing may be used for future research, which may be performed at the 
discretion of the Sponsor to further characterize the immune response to RSV, other related 
respiratory viruses, and additional assay development. 
4.7.3. Efficacy Assessments  
Not applicable. 
4.7.4. Safety Definitions and Related Procedures  
4.7.4.1. 
Adverse Event  
See Section 2.7.4.1 for details and refer to the SoA for Part C (Table 11). 
4.7.4.2. 
Serious Adverse Events  
See Section 2.7.4.2 for details and refer to the SoA for Part C (Table 11). 
4.7.4.3. 
Solicited Adverse Reactions  
See Section 2.7.4.3 for details and refer to the SoA for Part C (Table 11). 
4.7.4.4. 
Medically Attended Adverse Events  
See Section 2.7.4.4 for details. 
4.7.4.5. 
Adverse Event of Special Interest  
See Section 2.7.4.5 for details. 
Investigators should report events listed in Table 14, Section 6.3.1 as an AESI for Part C.  
4.7.4.6. 
Eliciting and Documenting Adverse Events  
See Section 2.7.4.6 for details and refer to the SoA for Part C (Table 11). 

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4.7.4.7. 
Assessment of Intensity  
See Section 2.7.4.7 for details and refer to the SoA for Part C (Table 11). 
4.7.4.8. 
Assessment of Causality  
See Section 2.7.4.8 for details and refer to the SoA for Part C (Table 11). 
4.7.4.9. 
Reporting Adverse Events  
See Section 2.7.4.9 for details and refer to the SoA for Part C (Table 11). 
4.7.4.10. 
Reporting Serious Adverse Events  
See Section 2.7.4.10 for details and refer to the SoA for Part C (Table 11). 
4.7.4.11. 
Reporting of Adverse Events of Special Interest  
See Section 2.7.4.11 for details and refer to the SoA for Part C (Table 11). 
4.7.4.12. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information  
See Section 2.7.4.12 for details and refer to the SoA for Part C (Table 11). 
4.7.4.13. 
Method of Detecting AEs and SAEs  
See Section 2.7.4.13 for details and refer to the SoA for Part C (Table 11). 
4.7.4.14. 
Follow-up of AEs and SAEs  
See Section 2.7.4.14 for details and refer to the SoA for Part C (Table 11). 
4.7.4.15. 
Regulatory Reporting Requirements for SAEs  
See Section 2.7.4.15 for details and refer to the SoA for Part C (Table 11). 
4.7.5. Pregnancy  
See Section 2.7.5 for details and refer to the SoA for Part C (Table 11). 
4.7.6. Safety Monitoring  
Safety monitoring for this study will include study team members inclusive of, at a minimum, 
the Sponsor’s Medical Monitor and Safety Physician and a CRO Medical Monitor. The study 
team will conduct ongoing safety reviews during the study. 
4.7.7. Treatment of Overdose  
See Section 2.7.7 for details. 

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4.7.8. Pharmacokinetics  
Pharmacokinetic parameters are not evaluated in this study. 
4.7.9. Pharmacodynamics  
Pharmacodynamic parameters are not evaluated in this study. 
4.7.10. Biomarkers  
Immunogenicity assessments are described in Section 4.7.2. Biomarker assessment may include 
genomics and transcriptomics samples. 
4.7.11. Health Economics  
Health economics are not evaluated in this study. 
4.8. Statistical Considerations  
This section summarizes the planned statistical analysis strategy and procedures for the study. 
The details of statistical analysis will be provided in the SAP which will be finalized before the 
database lock for the study. If changes are made to primary and/or secondary objectives or 
related statistical methods after the study has begun, then the protocol will be amended 
(consistent with ICH Guideline E9). Changes to other secondary or exploratory analyses made 
after the protocol has been finalized, along with an explanation as to when and why they 
occurred, will be listed in the SAP or CSR for the study. Ad hoc exploratory analyses, if any, 
will be clearly identified in the CSR. 
4.8.1. Blinding and Responsibility for Analyses  
Not applicable. 
4.8.1.1. 
Breaking the Blind  
Not applicable. 
4.8.2. Statistical Hypotheses  
The immunogenicity primary objectives are to evaluate the effect of a BD of mRNA-1345 on the 
immune response to RSV-A and RSV-B virus. There are 2 co-primary endpoints, based on GMT 
at BD Day 29, to support the primary objectives.  
The null hypothesis 𝐻0
1: immunogenicity response to a BD of mRNA-1345, as measured by 
GMT at BD Day 29 using RSV-A nAb assay, is inferior compared with the GMT at Day 29 post 
primary dose using RSV-A nAb assay. The noninferiority of the GMT at BD Day 29 will be 
demonstrated by the LB of the 95% CI of the GMR of ruling out 0.667 (ie, LB>0.667) using a 
noninferiority margin of 1.5. GMR is the ratio of GMT of RSV-A nAbs at BD Day 29 over GMT 
of RSV-A nAbs at Day 29 post primary dose, calculated as the back transformation of mean of 
paired difference of RSV-A nAbs on the logarithmic scale between BD Day 29 and Day 29 post 
primary dose.  

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The null hypothesis 𝐻0
2: immunogenicity response to a BD of mRNA-1345, as measured by 
GMT at BD Day 29 using RSV-B nAb assay, is inferior compared with the GMT at Day 29 post 
primary dose using RSV-B nAb assay. The noninferiority of the GMT at BD Day 29 will be 
demonstrated by the LB of the 95% CI of the GMR of ruling out 0.667 (ie, LB>0.667) using a 
noninferiority margin of 1.5. GMR is the ratio of GMT of RSV-B nAbs at BD Day 29 over GMT 
of RSV-B nAbs at Day 29 post primary dose, calculated as the back transformation of mean of 
paired difference of RSV-B nAbs on the logarithmic scale between BD Day 29 and Day 29 post 
primary dose. 
4.8.3. Sample Size Determination  
If there are 500 participants, Part C will have approximately 99% and 92% probability to observe 
at least 1 participant with an AE at a true 1% and 0.5% AE rate, respectively. If there are 450 
participants, Part C will have approximately 99% and 90% probability to observe at least 1 
participant with an AE at a true 1% and 0.5% AE rate, respectively.   
Assuming approximately 10% of participants are ineligible to be included in the Part C PP Set: 
• If there are 500 participants, approximately 450 participants will be included in the Part C 
PP Set.  
- 
There is approximately 86.6% power to demonstrate the noninferiority of the 
immunogenicity response in a BD of mRNA-1345 to RSV-A, as measured by 
GMT of RSV-A nAbs at BD Day 29, compared with the GMT of RSV-A nAbs at 
Day 29 post primary dose, at a 2-sided alpha of 0.05, assuming a noninferiority 
margin of 1.5, an underlying GMR of 0.8 (based on the preliminary results in 
mRNA-1345-P101 study), and the correlation between the titers of RSV-A nAb at 
BD Day 29 and the titers at Day 29 post primary dose is 0.65. The standard 
deviation of the natural log-transformed titer level is assumed to be 1.5.  
- 
There is approximately 98.3% power to demonstrate the noninferiority of the 
immunogenicity response in a BD of mRNA-1345 to RSV-B, as measured by 
GMT of RSV-B nAbs at BD Day 29, compared with the GMT of RSV-B nAbs at 
Day 29 post primary dose, at a 2-sided alpha of 0.05, assuming a noninferiority 
margin of 1.5, an underlying GMR of 0.85 (based on the preliminary results in 
mRNA-1345-P101 study), and the correlation between the titers of RSV-B nAb at 
BD Day 29 and the titers at Day 29 post primary dose is 0.65. The standard 
deviation of the natural log-transformed titer level is assumed to be 1.5.  
The overall power is approximately 85%. 
• If there are 450 participants, approximately 405 participants will be included in the Part C 
PP Set.  
- 
There is approximately 82.9% power to demonstrate the noninferiority of the 
immunogenicity response in a BD of mRNA-1345 to RSV-A, as measured by 
GMT of RSV-A nAbs at BD Day 29, compared with the GMT of RSV-A nAbs at 
Day 29 post primary dose, at a 2-sided alpha of 0.05, assuming a noninferiority 
margin of 1.5, an underlying GMR of 0.8 (based on the preliminary results in 
mRNA-1345-P101 study), and the correlation between the titers of RSV-A nAb at 

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BD Day 29 and the titers at Day 29 post primary dose is 0.65. The standard 
deviation of the natural log-transformed titer level is assumed to be 1.5.  
- 
There is approximately 97.3% power to demonstrate the noninferiority of the 
immunogenicity response in a BD of mRNA-1345 to RSV-B, as measured by 
GMT of RSV-B nAbs at BD Day 29, compared with the GMT of RSV-B nAbs at 
Day 29 post primary dose, at a 2-sided alpha of 0.05, assuming a noninferiority 
margin of 1.5, an underlying GMR of 0.85 (based on the preliminary results in 
mRNA-1345-P101 study), and the correlation between the titers of RSV-B nAb at 
BD Day 29 and the titers at Day 29 post primary dose is 0.65. The standard 
deviation of the natural log-transformed titer level is assumed to be 1.5.  
The overall power is approximately 80%. 
4.8.4. Analysis Sets  
The analysis sets are described in Table 13. 
Table 13: 
Analysis Sets for Part C  
Set 
Description 
Enrolled Set 
All participants who completed the informed consent of Part C. 
Part C PP Set 
Includes all participants who received planned BD of mRNA-1345, 
have preBD and at least 1 post-injection assessment of 
immunogenicity after a BD, complied with the immunogenicity 
testing schedule, and had no major protocol derivations that impact 
key or critical data. The Part C PP Set will be the primary population 
for the analysis of immunogenicity data.  
Part C Solicited Safety Set 
Includes all participants who received BD of mRNA-1345 and 
contributed any solicited AR data. The Part C Solicited Safety Set 
will be used for the analyses of solicited ARs. 
Part C Safety Set 
Includes all participants who received any BD of mRNA-1345. The 
Part C Safety Set will be used for the analyses of safety data, except 
for solicited ARs. 
Abbreviations: AR = adverse reaction; PP = per protocol. 
4.8.5. Statistical Methods  
4.8.5.1. 
Immunogenicity Analysis  
Unless otherwise specified immunogenicity analysis for Part C will be based on the Part C PP 
Set. 
The primary immune endpoints based on RSV-A nAbs at BD Day 29 will be presented by 
descriptive summary statistics, such as median, minimum, maximum, and 95% CI for GMT. 
GMR will also be estimated to compare the immune response at BD Day 29 with the response at 
Day 29 post primary dose (ie, the primary 
 μg of mRNA-1345). GMR will be calculated by 
back transforming the mean of paired difference of RSV-A nAbs on the logarithmic scale 
between BD Day 29 and Day 29 post primary dose. The 95% CI for the GMR will be based on 
CCI

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t-distribution of the log-transformed values then back transformed to the original scale for 
presentation.  
The primary immune endpoints that are based on RSV-B nAbs at BD Day 29 will be presented 
by the same methods as the methods for the primary immune endpoints of RSV-A nAbs at BD 
Day 29.  
SRR of RSV-A nAbs or RSV-B nAbs is defined as proportion of participants with postinjection 
titers ≥4 × LLOQ if baseline is < LLOQ or a ≥4-fold increase from baseline if baseline is 
≥LLOQ. Baseline value is defined as the most recent nonmissing immune measurements 
collected before the mRNA-1345 primary dose. The difference and 95% CI of difference in the 
SRR at BD Day 29 versus the SRR at Day 29 post primary dose in the same participant will be 
estimated through a logistic model with repeated measure (via PROC GENMOD) in SAS.   
GMT with 2-sided 95% CIs and GMFR with 2-sided 95% CIs at each postbaseline timepoint 
will be provided. The number and percentage of participants with seroresponse at each 
postbaseline timepoint will also be provided with 2-sided 95% CIs using the Clopper-Pearson 
method. The proportion of participants with at least a 2-fold increases in titers (relative to 
baseline) will also be provided at each postbaseline timepoint with the 2-sided 95% CI.  
For summarizations of the GMT, GMFR, and GMR, the Ab titers reported as below the LLOQ 
will be replaced by 0.5 × LLOQ. Titers greater than the ULOQ will be replaced by ULOQ. 
Descriptive statistics (including 95% CIs) for the immunogenicity endpoints may also be 
provided by initial vaccination group and/or by the age at enrollment (50 to 59 years, 60 to 
74 years, and ≥75) in Part B.  
4.8.5.2. 
Safety Analyses  
Safety and reactogenicity will be assessed by clinical review of all relevant parameters, including 
solicited ARs (local and systemic events), unsolicited AEs, SAEs, AESIs, MAAEs, severe AEs, 
AEs leading to discontinuation, vital signs, and physical examination findings. 
Solicited ARs will be coded according to the MedDRA for AR terminology and unsolicited AEs 
will be coded by system organ class and preferred term according to the MedDRA. The Toxicity 
Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine 
Clinical Trials (DHHS 2007) will be used in this study. 
All safety analyses will be based on the Part C Safety Set, except summaries of solicited ARs, 
which will be based on the Part C Solicited Safety Set. All safety analyses will be provided by 
the injection group corresponding to the IP the participants actually received in Part B, unless 
otherwise specified.  
The number and percentage of participants with any solicited local AR, solicited systemic AR, 
and solicited AR during the 7 days following BD Day 1 will be summarized. A 2-sided 95% 
exact CI using the Clopper-Pearson method will be provided for the percentage of participants 
with any solicited AR. 
The number and percentage of participants with unsolicited AEs, SAEs, AESIs, MAAEs, severe 
AEs, and AEs leading to discontinuation from study participation will be summarized. The 
number of events will also be summarized. 

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For all other safety parameters, descriptive summary statistics will be provided. 
The number and percentage of participants who have vital signs results below or above the 
normal ranges will be summarized by timepoint. 
4.8.5.3. 
Exploratory Analyses  
The exploratory analyses may be conducted after database lock and will be described in the SAP. 
4.8.6. Planned Analyses  
One primary analysis and one final analysis will be conducted in this Part of the study. Further 
details can be found in the SAP. 
4.8.6.1. 
Primary Analysis  
The primary analysis of immunogenicity and safety will be performed after all Part C 
participants have completed the BD Day 29 Visit. All data relevant to the primary analysis 
through the BD Day 29 visit in all participants will be cleaned (ie, data that are as clean as 
possible) and a report may be generated.  
4.8.6.2. 
Final Analysis  
The final analysis of all endpoints will be performed after all participants have completed EoS 
visit. Results of this analysis will be presented in a final CSR. The final CSR will include full 
analyses of all safety and immunogenicity data through EoS. 
4.8.7. Multiplicity  
The co-primary endpoints will be tested at the planned primary analysis at a 2-sided Type 1 error 
rate of 0.05. The success criteria of both co-primary endpoints need to be met in order to declare 
this part of the study a success to achieve noninferiority of a BD. 

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Iuliano AD, Roguski KM, Chang HH, Muscatello DJ, Palekar R, Tempia S, et al. Estimates of 
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Adelberg’s Medical Microbiology. 28th ed. New York: McGraw-Hill Education; 2019. Chapter 
39, Orthomyxoviruses (Influenza Viruses); p. 581-94. 
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case definition and guidelines for data collection, analysis, and presentation of immunization 
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of respiratory syncytial virus-associated acute respiratory infection in older adults in 2015: A 
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review boards: Conduct of clinical trials of medical products during the COVID-19 public health 
emergency. March 2020 [updated 2021 Aug 30; cited 2022 Jan 11]. Available from: 
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6. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS  
6.1. APPENDIX 1: Study Governance Considerations  
6.1.1. Regulatory and Ethical Considerations  
This study will be conducted in accordance with the protocol and with the following: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences International Ethical Guidelines. 
• Applicable ICH GCP Guidelines. 
• Applicable laws and regulatory requirements. 
• The protocol, protocol amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB by the investigator and reviewed 
and approved by the IRB before the study is initiated. 
• Any amendments to the protocol will require IRB approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an 
immediate hazard to study participants. 
• The investigator will be responsible for the following: 
- 
Providing written summaries of the status of the study to the IRB annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB 
- 
Notifying the IRB of SAEs or other significant safety findings as required by IRB 
procedures 
- 
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 
6.1.2. Study Monitoring  
Before an investigational site can enter a participant into the study, a representative of the 
Sponsor or its representatives will visit the investigational study site to: 
• Determine the adequacy of the facilities. 
• Discuss with the investigator(s) and other personnel their responsibilities with regard 
to protocol adherence, and the responsibilities of the Sponsor or its representatives. 
This will be documented in a Clinical Study Agreement between the Sponsor, the 
designated CRO, and the investigator. 
According to ICH GCP guideline, the Sponsor of the study is responsible for ensuring the proper 
conduct of the study with regard to protocol adherence and validity of data recorded on the 

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eCRFs. The study monitor’s duties are to aid the investigator and the Sponsor in the maintenance 
of complete, accurate, legible, well-organized, and easily retrievable data. The study monitor will 
advise the investigator of the regulatory necessity for study-related monitoring, audits, IRB 
review, and inspection by providing direct access to the source data and/or documents. In 
addition, the study monitor will explain to and interpret for the investigator all regulations 
applicable to the clinical evaluation of an IP as documented in ICH guidelines. 
It is the study monitor’s responsibility to inspect the eCRFs and source documentation 
throughout the study to protect the rights of the participants; to verify adherence to the protocol; 
to verify completeness, accuracy, and consistency of the data; and to confirm adherence of study 
conduct to any local regulations. Details will be outlined in the clinical monitoring plan. During 
the study, a monitor from the Sponsor or a representative will have regular contacts with the 
investigational site, for the following: 
• Provide information and support to the investigator(s). 
• Confirm that facilities remain acceptable. 
• Confirm that the investigational team is adhering to the protocol, that the data are 
being accurately recorded in the eCRFs, and that IP accountability checks are being 
performed. 
• Perform source data verification. This includes a comparison of the data in the eCRFs 
with the participant’s medical records at the hospital or practice, and other records 
relevant to the study. This will require direct access to all original records for each 
participant (eg, clinical charts or electronic medical record system). 
• Record and report any protocol deviations not previously sent. 
• Confirm that AEs and SAEs have been properly documented on eCRFs, that any 
SAEs have been forwarded to the SAE Hotline, and that those SAEs that met criteria 
for reporting have been forwarded to the IRB. 
The monitor will be available between visits if the investigator(s) or other staff needs 
information or advice. 
6.1.3. Audits and Inspections  
The Sponsor, their designee(s), the IRB, or regulatory authorities will be allowed to conduct site 
visits to the investigational facilities for the purpose of monitoring or inspecting any aspect of the 
study. The investigator agrees to allow the Sponsor, their designee(s), the IRB, or regulatory 
authorities to inspect the IP storage area, IP stocks, IP records, participant charts and study 
source documents, and other records relative to study conduct. 
Authorized representatives of the Sponsor, a regulatory authority, and the IRB may visit the site 
to perform audits or inspections, including source data verification. The purpose of a Sponsor 
audit or inspection is to systematically and independently examine all study-related activities and 
documents to determine whether these activities were conducted, and data were recorded, 
analyzed, and accurately reported according to the protocol, ICH GCP (R2), and any applicable 
regulatory requirements. The investigator should contact the Sponsor immediately if contacted 
by a regulatory agency about an inspection. 

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The principal investigator must obtain IRB approval for the investigation. Initial IRB approval 
and all materials approved by the IRB for this study, including the participant consent form and 
recruitment materials, must be maintained by the investigator and made available for inspection. 
6.1.4. Financial Disclosure  
The investigator is required to provide financial disclosure information to allow the Sponsor to 
submit the complete and accurate certification or disclosure statements required under 
21 CFR 54. In addition, the investigator must provide the Sponsor with a commitment to 
promptly update this information if any relevant changes occur during the course of the 
investigation and for 1 year following the completion of the study. 
The Sponsor, the CRO, and the study site are not financially responsible for further testing or 
treatment of any medical condition that may be detected during the screening process. In 
addition, in the absence of specific arrangements, the Sponsor, the CRO, and the study site are 
not financially responsible for further treatment of the disease under study. 
6.1.5. Recruitment Procedures  
Advertisements to be used for the recruitment of study participants and any other written 
information regarding this study to be provided to the participant should be submitted to the 
Sponsor for approval. All documents must be approved by the IRB. 
6.1.6. Informed Consent/Assent Process  
The informed consent document(s) must meet the requirements of 21 CFR 50, local regulations, 
ICH guidelines, Health Insurance Portability and Accountability Act requirements, where 
applicable, and the IRB or study center. All consent documents will be approved by the 
appropriate IRB. The actual ICF used at each center may differ, depending on local regulations 
and IRB requirements. However, all versions must contain the standard information found in the 
sample ICF provided by the Sponsor. Any change to the content of the ICF must be approved by 
the Sponsor and the IRB prior to the form being used. 
If new information becomes available that may be relevant to the participant’s willingness to 
continue participation in the study, this will be communicated to them in a timely manner. Such 
information will be provided via a revised ICF or an addendum to the original ICF. 
The investigator or his/her representative will explain the nature of the study to the participant 
and answer all questions regarding the study. 
The investigator is responsible for ensuring that the participant fully understands the nature and 
purpose of the study. Information should be given in both oral and written form whenever 
possible. 
No participant should be obliged to participate in the study. The participant must be informed 
that participation is voluntary. Participants, their relatives, guardians, or (if applicable) legal 
representatives must be given ample opportunity to inquire about details of the study. The 
information must make clear that refusal to participate in the study or withdrawal from the study 
at any stage is without any prejudice to the participant’s subsequent care. 
The participant must be allowed sufficient time to decide whether they wish to participate. 

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The participant must be made aware of and give consent to direct access to his/her source 
medical records by study monitors, auditors, the IRB, and regulatory authorities. The participant 
should be informed that such access will not violate participant confidentiality or any applicable 
regulations. The participants should also be informed that he/she is authorizing such access by 
signing the ICF. 
A copy of the signed and dated ICF(s) must be provided to the participant. 
A participant who is rescreened is not required to sign another ICF if the rescreening occurs 
within 14 days from the previous ICF signature date (within the initial Screening period). 
The ICF will also explain that excess serum from the blood samples collected for 
immunogenicity testing may be used for future research, which may be performed at the 
discretion of the Sponsor to further understand the infection and disease associated with RSV 
and related viruses, including analyses related to the immunology of this vaccine, viral infection, 
and clinical conduct. 
6.1.7. Protocol Amendments  
No change or amendment to this protocol may be made by the investigator or the Sponsor after 
the protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) 
has (have) been agreed upon by the investigator or the Sponsor. Any change agreed upon will be 
recorded in writing, and the written amendment will be signed by the investigator and the 
Sponsor. Institutional review board approval is required prior to the implementation of an 
amendment, unless overriding safety reasons warrant immediate action, in which case the IRB(s) 
will be promptly notified. 
Any modifications to the protocol or the ICF, which may impact the conduct of the study, 
potential benefit of the study, or may affect participant safety, including changes of study 
objectives, study design, participant population, sample sizes, study procedures, or significant 
administrative aspects will require a formal amendment to the protocol. Such amendment will be 
released by the Sponsor, agreed by the investigator(s), and approved by the relevant IRB(s) prior 
to implementation. A signed and dated statement that the protocol, any subsequent relevant 
amended documents and the ICF have been approved by relevant IRB(s) must be provided to the 
Sponsor before the study is initiated. 
Administrative changes to the protocol are minor corrections and/or clarifications that have no 
effect on the way the study is to be conducted. These administrative changes will be released by 
the Sponsor, agreed by the investigators, and notified to the IRB(s). 
6.1.8. Protocol Deviations  
Noncompliance may be either on the part of the participant, the investigator, or the study site 
staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations to the Sponsor or its designee. All deviations must be addressed in study source 
documents and reported to the study monitor. Protocol deviations must be sent to the reviewing 
IRB per their policies. The site investigator is responsible for knowing and adhering to the 
reviewing IRB requirements. 

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6.1.9. Data Protection  
Participants will be assigned a unique identifier by the Sponsor. Any participant records or 
datasets that are transferred to the Sponsor will contain the identifier only; participant names or 
any information that would make the participant identifiable will not be transferred. 
The participant must be informed that his/her personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant. 
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB members, and by inspectors from regulatory authorities. 
Individual participant medical information obtained as a result of this study is considered 
confidential, and disclosure to third parties is prohibited. Information will be accessible to 
authorized parties or personnel only. Medical information may be given to the participant’s 
physician or to other appropriate medical personnel responsible for the participant’s well-being. 
Each participant will be asked to complete a form allowing the investigator to notify the 
participant’s primary HCP of his/her participation in this study. 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain participant confidentiality. All records will be kept in a secure 
storage area with limited access. Clinical information will not be released without the written 
permission of the participant, except as necessary for monitoring and auditing by the Sponsor, 
its designee, the relevant regulatory authority, or the IRB. 
The investigator and all employees and coworkers involved with this study may not disclose or 
use for any purpose other than performance of the study, any data, record, or other unpublished, 
confidential information disclosed to those individuals for the purpose of the study. Prior written 
agreement from the Sponsor or its designee must be obtained for the disclosure of any 
confidential information to other parties. 
6.1.10. Sample Retention and Future Biomedical Research  
The Sponsor may store samples for the time frame specified in the ICF to achieve the study 
objectives. In addition, identifiable samples can be destroyed at any time at the request of the 
participant. During the study, or during the retention period, in addition to the analysis outlined 
in the study endpoints, exploratory analysis may be conducted, using other antibody-based 
methodologies, on any remaining blood or serum samples, including participants who provide 
samples for screening, but are not subsequently enrolled. These analyses would extend the search 
for other potentially relevant biomarkers to investigate the effect of mRNA-1345, as well as to 
determine how changes in the markers may relate to exposure and clinical outcomes. A decision 
to perform such exploratory research may arise from new scientific findings related to the drug 
class or disease, as well as reagent and assay availability. 
6.1.11. Safety Oversight  
Safety monitoring for the study is described in Section 2.7.6, Section 3.7.6, and Section 4.7.6. 

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6.1.12. Dissemination of Clinical Study Data  
The Sponsor shares information about clinical trials and results on publicly accessible websites, 
based on international and local legal and regulatory requirements, and other clinical trial 
disclosure commitments established by pharmaceutical industry associations. These websites 
include ClinicalTrials.gov and the European Union Clinical Trials Register, as well as some 
national registries. 
6.1.13. Data Quality Assurance and Quality Control  
Data collection is the responsibility of the clinical study staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
• All participant data relating to the study will be recorded in the eCRF unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The 
investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the eCRF. 
• The investigator must maintain accurate documentation (source data) that supports 
the information entered in the eCRF. 
• The investigator must permit study-related monitoring, audits, IRB review, and 
regulatory agency inspections and provide direct access to source data documents. 
• Monitoring details describing strategy (eg, risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical 
Risk-Based Monitoring), methods, responsibilities and requirements, including 
handling of noncompliance issues and monitoring techniques (central, remote, or 
on-site monitoring) are provided in the clinical monitoring plan. 
• The Sponsor or designee is responsible for the data management of this study 
including quality checking of the data. 
• The Sponsor assumes accountability for actions delegated to other individuals 
(eg, CROs). 
• Study monitors will perform ongoing source data verification to confirm that data 
entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the investigator for a period of at least 2 years after the last 
marketing application approval or, if not approved, 2 years following the 
discontinuance of the test article for investigation. If this requirement differs from any 
local regulations, the local regulations will take precedence unless the local retention 
policy is less than 2 years. No records may be destroyed during the retention period 

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without the written approval of the Sponsor. No records may be transferred to another 
location or party without written notification to the Sponsor. 
Quality assurance includes all the planned and systematic actions that are established to ensure 
that the clinical study is performed, and the data are generated, documented (recorded), and 
reported according to ICH GCP and local/regional regulatory standards. 
A quality assurance representative from Sponsor or qualified designee, who is independent of 
and separated from routine monitoring, may periodically arrange inspections/audits of the 
clinical study by reviewing the data obtained and procedural aspects. These inspections may 
include on-site inspections/audits and source data checks. Direct access to source documents is 
required for the purpose of these periodic inspections/audits. 
6.1.14. Data Collection and Management  
This study will be conducted in compliance with ICH CGP guidelines. This study will also be 
conducted in accordance with the most recent version of the Declaration of Helsinki. 
This study will use electronic data collection to collect data directly from the study site using 
eCRFs. The investigator is responsible for ensuring that all sections of each eCRF are completed 
promptly and correctly and that entries can be verified against any source data. 
Study monitors will perform source document verification to identify inconsistencies between 
the eCRFs and source documents. Discrepancies will be resolved in accordance with the 
principles of GCP. Detailed study monitoring procedures are provided in the clinical monitoring 
plan. 
AEs will be coded with MedDRA. Concomitant medications will be coded using WHO – Drug 
Global Dictionary. 
6.1.15. Source Documents  
Source documents are original documents or certified copies, and include, but are not limited to, 
eDiaries, medical and hospital records, screening logs, ICFs, telephone contact logs, and 
worksheets. Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the investigator’s 
site. 
Data reported on the case report form or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must be explained. 
The investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available. 
The Sponsor or its designee requires that the investigator prepare and maintain adequate and 
accurate records for each participant treated with the IP. Source documents such as any hospital, 
clinic, or office charts and the signed ICFs are to be included in the investigator’s files with the 
participant’s study records. 
6.1.16. Retention of Records  
The principal investigator must maintain all documentation relating to the study for a period of at 
least 2 years after the last marketing application approval or, if not approved, 2 years following 

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the discontinuance of the test article for investigation. If this requirement differs from any local 
regulations, the local regulations will take precedence unless the local retention policy is less than 2 
years. 
If it becomes necessary for the Sponsor or the regulatory authority to review any documentation 
relating to the study, the investigator must permit access to such records. No records will be 
destroyed without the written consent of the Sponsor, if applicable. It is the responsibility of the 
Sponsor to inform the investigator when these documents no longer need to be retained. 
6.1.17. Study and Site Closure  
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IRBs, the regulatory authorities, and any CRO(s) used in the study of the 
reason for termination or suspension, as specified by the applicable regulatory requirements. The 
investigator shall promptly inform the participant and should assure appropriate participant 
therapy and/or follow-up. 
The Sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the Sponsor. 
The investigator may initiate study site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or investigator may include but are 
not limited to: 
• Continuation of the study represents a significant medical risk to participants. 
• Failure of the investigator to comply with the protocol, requirements of the IRB or 
local health authorities, Sponsor's procedures, or ICH GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further mRNA-1345 development. 
Study sites will be closed upon study completion. A study site is considered closed when all required 
documents and study supplies have been collected and a study site closure visit has been performed. 
6.1.18. Publication Policy  
The results of this study may be published or presented at scientific meetings. If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. 
This allows the Sponsor to protect proprietary information and to provide comments. 
The Sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with International Committee of 
Medical Journal Editors authorship requirements. 
The clinical study plan and the results of the study will be published on www.ClinicalTrials.gov 
in accordance with 21 CFR 50.25(c). The results of and data from this study belong to the 
Sponsor. 

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6.2. APPENDIX 2: Contraceptive Guidance and Collection of Pregnancy 
Information  
Definitions: Woman of Child-bearing Potential 
Women of child-bearing potential are those who are considered fertile following menarche and 
until becoming postmenopausal unless permanently sterile (see below). If fertility is unclear 
(eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot be confirmed before the 
first dose of mRNA-1345, an additional evaluation should be considered. 
Women in the following categories are not considered women of child-bearing potential: 
• Premenarchal 
• Premenopausal, surgically sterile female with one of the following: 
- 
Documented complete hysterectomy 
- 
Documented bilateral salpingectomy 
- 
Documented bilateral oophorectomy 
For individuals with permanent infertility due to an alternate medical cause other than the above 
(eg, Müllerian agenesis, androgen insensitivity), investigator discretion should be applied to 
determining study entry. 
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
• Postmenopausal female 
A postmenopausal state is defined as no menses for 12 months without an alternative medical 
cause. The following age-specific requirements apply: 
• Women <50 years of age would be considered postmenopausal if they have been 
amenorrheic for 12 months or more following cessation of exogenous hormonal 
treatments and if they have luteinizing hormone and FSH levels in the 
postmenopausal range for the institution. 
• Women ≥50 years of age would be considered postmenopausal if they have been 
amenorrheic for 12 months or more following cessation of all exogenous hormonal 
treatments, had radiationinduced menopause with last menses >1 year ago, had 
chemotherapy-induced menopause with last menses >1 year ago. 
A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in 
women not using hormonal contraception or hormonal replacement therapy (HRT). However, in 
the absence of 12 months of amenorrhea, confirmation with more than 1 FSH measurement is 
required. 
Females on HRT and whose menopausal status is in doubt will be required to use one of the 
nonestrogen hormonal highly effective contraception methods if they wish to continue their HRT 
during the study. Otherwise, they must discontinue HRT to allow confirmation of 
postmenopausal status before study enrollment. 

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Contraception Guidance 
Female participants of child-bearing potential must be nonpregnant and nonlactating and meet 
the following criteria: 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to vaccination and agrees to consistently 
use a highly effective method of contraception through 3 months after the last 
injection (eg, barrier method with spermicide, intrauterine device, 
injectable/implanted/oral hormonal methods). Female participants should also refrain 
from breastfeeding throughout this period. 
Collection of Pregnancy Information 
Pregnancies occurring in participants after enrollment must be reported to Sponsor or designee 
within 24 hours of the site learning of its occurrence. 
Female Participants Who Become Pregnant 
• The investigator will collect pregnancy information on any female participant who 
becomes pregnant while participating in this study. Information will be recorded on 
the appropriate form and submitted to the Sponsor within 24 hours of learning of a 
participant's pregnancy. 
• The participant will be followed to determine the outcome of the pregnancy 
(including spontaneous miscarriage, elective termination, normal birth, or congenital 
abnormality). The investigator will collect follow-up information on the participant 
and the child, even if the participant is discontinued from the study, and the 
information will be forwarded to the Sponsor. Generally, follow-up will not be 
required for longer than 6 to 8 weeks beyond the estimated delivery date. Any 
termination of pregnancy will be reported, regardless of fetal status (presence or 
absence of anomalies) or indication for the procedure. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy 
complication or elective termination of a pregnancy will be reported as an AE or 
SAE. Spontaneous miscarriages, congenital anomaly, and/or birth defect abortion 
should be reported as SAEs. 
• Any poststudy, pregnancy-related SAE considered reasonably related to mRNA-1345 
by the investigator will be reported to the Sponsor as described in Section 4.7.4.6. 
While the investigator is not obligated to actively seek this information in former 
study participants, he or she may learn of an SAE through spontaneous reporting. 
Any female participant who becomes pregnant while participating in the study will discontinue 
mRNA-1345 and should be followed for safety and not withdrawn from the study. 

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6.3. APPENDIX 3: Adverse Events of Special Interest  
6.3.1. AESIs for RSV and Influenza  
Investigators should report all events that fall into the categories presented in Table 14 as an 
AESI per the reporting processes specified in Section 2.7.4.11. These AESIs are medical 
concepts that are generally of interest in vaccine safety surveillance as per the Brighton 
Collaboration and safety platform for emergency vaccines (Brighton Collaboration 2019). 
Table 14: 
Adverse Events of Special Interest  
Medical Concept 
Additional Notes 
Thrombocytopenia 
• 
Platelet counts <150 × 109 cells per liter 
• 
Including but not limited to immune thrombocytopenia, platelet 
production decreased, thrombocytopenia, thrombocytopenic 
purpura, thrombotic thrombocytopenic purpura, or HELLP 
(hemolysis, elevated liver enzymes, and low platelet count) 
syndrome 
New onset of or worsening 
of neurologic diseases 
Neurologic diseases include the following: 
• 
Guillain-Barré Syndrome 
• 
Acute disseminated encephalomyelitis 
• 
Idiopathic peripheral facial nerve palsy (Bell’s palsy) 
• 
Seizures including but not limited to febrile seizures and/or 
generalized seizures/convulsions 
Anaphylaxis 
• 
Anaphylaxis as defined per protocol Section 2.7.4.5.1 
• 
Follow the reporting procedures in protocol Section 4.7.4.9 
Myocarditis/Pericarditis 
• 
Myocarditis 
• 
Pericarditis 
• 
Myopericarditis 
6.3.2. AESIs for COVID (Part B only) 
The investigator’s medical judgment must be applied to assess an event as an AESI because most 
AESIs are based on medical concepts. The table below does not provide a comprehensive list of 
terms.  
The following table describes events/medical concepts that are of interest in COVID-19 vaccine 
safety surveillance. Some are specific to vaccines; however, some are of interest because of their 
occurrence in the context of concurrent or recent COVID-19. Events falling into the descriptions 
below should be reported as AESIs, per protocol, even when they occur during/following 
COVID infection. 

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Table 15: 
AESIs for COVID  
Please note: COVID-19 itself is not an AESI. 
Medical Concept 
Medical Concept Descriptions/Guidance 
Anosmia, Ageusia 
• 
New onset of anosmia or ageusia associated with COVID-19 or 
idiopathic etiology  
• 
DOES NOT INCLUDE anosmia or ageusia associated with sinus/nasal 
congestion, congenital, or traumatic etiologies  
Subacute thyroiditis 
• 
Acute inflammatory disease of the thyroid (immune-mediated or 
idiopathic) 
• 
DOES NOT INCLUDE new onset of chronic thyroiditis 
Acute pancreatitis 
• 
New onset of pancreatitis in the absence of a clear, alternate etiology, 
such as alcohol, gallstones, trauma, recent invasive procedure, etc. 
Appendicitis  
• 
Any event of appendicitis  
Rhabdomyolysis 
• 
New onset of rhabdomyolysis in the absence of a clear, alternate 
etiology, such as drug/alcohol abuse, excessive exercise, trauma, etc. 
Acute respiratory 
distress syndrome 
(ARDS) 
• 
New onset of ARDS/respiratory failure due to acute inflammatory lung 
injury 
• 
DOES NOT INCLUDE nonspecific symptoms of shortness of breath or 
dyspnea, nor events with underlying etiologies of heart failure or fluid 
overload 
Coagulation disorders • 
New onset of thrombosis, thromboembolic event, or non-traumatic 
hemorrhage/bleeding disorder (eg. stroke, deep vein thrombosis, 
pulmonary embolism, disseminated intravascular coagulation) 
Acute cardiovascular 
injury 
• 
New onset of clinically confirmed, acute cardiovascular injury, such as 
myocarditis, pericarditis, arrhythmia confirmed by electrocardiogram 
(eg. atrial fibrillation, atrial flutter, supraventricular tachycardia); stress 
cardiomyopathy; heart failure; acute coronary syndrome; myocardial 
infarction). 
• 
DOES NOT INCLUDE transient sinus tachycardia/bradycardia, non-
specific symptoms such as palpitations, racing heart, heart fluttering or 
pounding, irregular heartbeats, shortness of breath, chest 
pain/discomfort, etc. 
Acute kidney injury 
• 
New onset of acute kidney injury or acute renal failure in the absence of 
a clear, alternate etiology, such as urinary tract infection/urosepsis, 
trauma, tumor, nephrotoxic medications/substances, etc.; 
• 
Increase in serum creatinine by ≥0.3 mg/dl (or ≥26.5 µmol/l) within 
48 hours; OR 
• 
Increase in serum creatinine to ≥1.5 ×baseline, known or presumed to 
have occurred within prior 7 days. 

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Medical Concept 
Medical Concept Descriptions/Guidance 
Acute liver injury 
• 
New onset in the absence of a clear, alternate etiology, such as trauma, 
tumor, hepatotoxic medications/substances, etc.: 
• 
>3-fold elevation above the upper normal limit for ALT or AST; OR 
• 
>2-fold elevation above the upper normal limit for total serum bilirubin 
or GGT or ALP 
Dermatologic findings  • 
Chilblain-like lesions 
• 
Single-organ cutaneous vasculitis 
• 
Erythema multiforme 
• 
Bullous rash 
• 
Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, 
Toxic epidermal necrolysis, Drug reaction with eosinophilia and 
systemic symptoms, fixed drug eruptions, and necrotic or exfoliative 
reactions 
Systemic 
inflammatory 
syndromes  
• 
Multisystem inflammatory syndrome in adults or children 
• 
Kawasaki’s disease 
• 
Hemophagocytic lymphohistiocytosis 
Thrombocytopenia 
• 
Platelet count <150 × 109/L (thrombocytopenia) 
• 
New clinical diagnosis, or worsening, of thrombocytopenic condition, 
such as immune thrombocytopenia, thrombocytopenic purpura, or 
hemolysis, elevated liver enzymes, and low platelet count syndrome 
Acute aseptic arthritis Clinical syndrome characterized by acute onset of signs and symptoms of 
joint inflammation without recent trauma for a period of no longer than 
6 weeks, synovial increased leukocyte count and the absence of 
microorganisms on Gram stain, routine culture and/or polymerase chain 
reaction. 
• 
DOES NOT INCLUDE new onset of chronic arthritic conditions 
New onset, or 
worsening, of 
neurological disease 
• 
Immune-mediated neurological disorders 
• 
Guillain-Barré Syndrome 
• 
Acute disseminated encephalomyelitis 
• 
Peripheral facial nerve palsy (Bell’s palsy)  
• 
Transverse myelitis 
• 
Encephalitis/encephalomyelitis 
• 
Aseptic meningitis 
• 
Seizures/convulsions/epilepsy 
• 
Narcolepsy/hypersomnia 
Anaphylaxis  
• 
Anaphylaxis associated with study drug administration 

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Medical Concept 
Medical Concept Descriptions/Guidance 
Other syndromes 
• 
Fibromyalgia  
• 
Postural orthostatic tachycardia syndrome  
• 
Chronic fatigue syndrome  
• 
Myalgic encephalomyelitis  
• 
Postviral fatigue syndrome 
• 
Myasthenia gravis 
 

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6.4. APPENDIX 4: CDC Working Case Definition of Pericarditis, 
Myocarditis, and Myopericarditis Occurring After Receipt of COVID-19 
mRNA Vaccines  
The CDC working case definition of pericarditis, myocarditis, and myopericarditis to be used in 
this study is presented in Table 16. 
Table 16: 
CDC Working Case Definition of Pericarditis, Myocarditis, and 
Myopericarditis Occurring After Receipt of COVID-19 mRNA Vaccines  
Condition 
Definition 
Acute myocarditis 
Probable Case 
Confirmed Case 
Presence of ≥ 1 new or worsening of 
the following clinical symptomsa 
Presence of ≥ 1 new or worsening of 
the following clinical symptomsa 
• Chest pain, pressure, or 
discomfort. 
• Chest pain, pressure, or 
discomfort. 
• Dyspnea, shortness of breath, or 
pain with breathing. 
• Dyspnea, shortness of breath, or 
pain with breathing. 
• Palpitations. 
• Palpitations. 
• Syncope. 
• Syncope. 
OR, infants and children aged 
< 12 years might instead have ≥ 2 of 
the following symptoms: 
OR, infants and children aged 
< 12 years might instead have ≥ 2 of 
the following symptoms: 
• Irritability. 
• Irritability. 
• Vomiting. 
• Vomiting. 
• Poor feeding. 
• Poor feeding.  
• Pachypnea. 
• Tachypnea.  
• Lethargy. 
• Lethargy.  
AND 
AND 
≥ 1 new finding of 
≥ 1 new finding of 
• Troponin level above the upper 
limit of normal (any type of 
troponin). 
• Histopathologic confirmation of 
myocarditisb. 
• Abnormal ECG or rhythm 
monitoring findings consistent 
with myocarditisc. 
• Abnormal cardiac function or 
wall motion abnormalities on an 
echocardiogram. 
• cMRI findings consistent with 
myocarditis in the presence of a 
troponin level above the upper 

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Condition 
Definition 
• cMRI findings consistent with 
myocarditis. 
limit of normal (any type of 
troponin). 
AND 
AND 
• No other identifiable cause of the 
symptoms and findings. 
• No other identifiable cause of the 
symptoms and findings. 
Acute pericarditisd 
Presence of ≥2 new or worsening of the following clinical features: 
• Acute chest pain. 
• Pericardial rub on examination. 
• New ST-elevation or PR-depression on ECG. 
• New or worsening pericardial effusion on echocardiogram or magnetic 
resonance imaging. 
Myopericarditis 
This term may be used for participants who meet the criteria for both 
myocarditis and pericarditis. 
Abbreviations: AV = atrioventricular; CEAC = Cardiac Event Adjudication Committee; cMRI = cardiac magnetic 
resonance imaging; ECG = electrocardiogram. 
Note: An independent CEAC comprised of medically qualified personnel, including cardiologists, will review 
suspected cases of myocarditis, pericarditis, and myopericarditis to determine if they meet Center for Disease 
Control and Prevention criteria for “probable” or “confirmed” events, (Gargano et al 2021) and provide the 
assessment to the Sponsor. The CEAC members will be blinded to study treatment. Details regarding the CEAC 
composition, responsibilities, procedures, and frequency of data review will be defined in the CEAC charter. 
a. 
Persons who lack the listed symptoms but who meet other criteria may be classified as subclinical myocarditis 
(probable or confirmed). 
b. 
Using the Dallas criteria (Aretz et al 1987). Autopsy cases may be classified as confirmed clinical myocarditis 
on the basis of meeting histopathologic criteria if there is no other identifiable cause. 
c. 
To meet the ECG or rhythm monitoring criterion, a probable case must include at least one of 1) ST-segment or 
T-wave abnormalities; 2) Paroxysmal or sustained atrial, supraventricular, or ventricular arrhythmias; or 3) AV 
nodal conduction delays or intraventricular conduction defects. 
Using either the original or the revised Lake Louise criteria. 
https://www.sciencedirect.com/science/article/pii/S0735109718388430?via%3Dihubexternal icon 
d. 
https://academic.oup.com/eurheartj/article/36/42/2921/2293375external icon 
e. 
Typically described as pain made worse by lying down, deep inspiration, or cough and relieved by sitting up or 
leaning forward, although other types of chest pain might occur. 
Source: Gargano et al 2021. 
 
 

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6.5. APPENDIX 5: Protocol Amendment History  
6.5.1. Protocol Amendment 4  
Amendment 4, 14 Feb 2023: 
CCI

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6.5.2. Protocol Amendment 3  
Amendment 3, 17 June 2022: 
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CCI

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6.5.3. Protocol Amendment 2  
Amendment 2, 10 May 2022: 
CCI
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6.5.4. Protocol Amendment 1  
Amendment 1, 17 Mar 2022: 
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CCI

Signature Page for VV-CLIN-003910 v10.0
Signature Page for VV-CLIN-003910 v10.0
2nd Approval
(Moderna)
Medical
23-Jun-2023 18:16:49 GMT+0000
PPD