Phase 1/2, Randomized, Stratified, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1073 (SARS-CoV-2 and Influenza Vaccine) Compared to Co-administered mRNA-1010 (Influenza) and mRNA-1273 (SARS-CoV-2) Vaccines and to mRNA- 1010 Vaccine and mRNA-1273 Vaccine Alone in Healthy Adults 18-75 Years of Age
Phase: PHASE1
Conditions: SARS-CoV-2, Influenza
Sponsor: ModernaTX, Inc.

ModernaTX, Inc. 
mRNA 1073-P101 Protocol Amendment 2 
mRNA-1073 
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CLINICAL STUDY PROTOCOL 
Protocol Title: 
Phase 1/2, randomized, stratified, observer-blind study to evaluate 
the safety, reactogenicity, and immunogenicity of mRNA-1073 
(SARS-CoV-2 and influenza vaccine) compared to co-administered 
mRNA-1010 (influenza) and mRNA-1273 (SARS-CoV-2) vaccines 
and to mRNA-1010 vaccine and mRNA-1273 vaccine alone in 
healthy adults 18-75 years of age 
Protocol Number: 
mRNA-1073-P101 
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: 
IND: 28200 
Amendment Number 
2 
Date of Amendment 2 16 Aug 2022 
Date of Original 
Protocol: 
04 Nov 2021 
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. 
NCT05375838
PPD
PPD
PPD

ModernaTX, Inc. 
mRNA 1073-P101 Protocol Amendment 2 
mRNA-1073 
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PROTOCOL APPROVAL – SPONSOR SIGNATORY 
Study Title: 
Phase 1/2, randomized, stratified, observer-blind study to evaluate 
the safety, reactogenicity, and immunogenicity of mRNA-1073 
(SARS-CoV-2 and influenza vaccine) compared to co-administered 
mRNA-1010 (influenza) and mRNA-1273 (SARS-CoV-2) vaccines 
and to mRNA-1010 vaccine and mRNA-1273 vaccine alone in 
healthy adults 18-75 years of age 
Protocol Number: 
mRNA-1073-P101 
Amendment Number 
2 
Date of Amendment 2 
16 Aug 2022 
Date of Original 
Protocol: 
04 Nov 2021 
 
Protocol accepted and approved by: 
 
 
See eSignature and date at the end of 
the document 
 
 
  
 
  
ModernaTX, Inc.  
200 Technology Square  
Cambridge, MA 02139  
Telephone: 
  
e-mail: 
 
 
Date 
 
 
 
PPD
PPD
PPD

ModernaTX, Inc. 
mRNA 1073-P101 Protocol Amendment 2 
mRNA-1073 
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DECLARATION OF INVESTIGATOR 
I have read and understood all sections of the protocol entitled “Phase 1/2, randomized, stratified, 
observer-blind study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 
(SARS-CoV-2 and influenza vaccine) compared to co-administered mRNA-1010 (influenza) and 
mRNA-1273 (SARS-CoV-2) vaccines and to mRNA-1010 vaccine and mRNA-1273 vaccine 
alone in healthy adults 18-75 years of age” dated 16 Aug 2022 and the most recent version of the 
Investigator’s Brochure. 
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 1073-P101 Protocol Amendment 2 
mRNA-1073 
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Protocol Amendment Summary of Changes 
DOCUMENT HISTORY 
Document 
Date 
Amendment 2 
16 Aug 2022 
Amendment 1 
25 Feb 2022 
Original Protocol 
04 Nov 2021 
 
Amendment 2, 16 Aug 2022: Current Amendment 
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Main Rationale for the Amendment: 
The purpose of this amendment is to remove the Phase 2 expansion part of this study, which is 
now planned as part of a future Phase 2/3 trial. As originally planned, the Sponsor will use safety 
and immunogenicity data from the ~550 participants to select a dose level for Phase 2/3. The 
Phase 2 expansion part was initially planned to provide additional safety data with potential 
immunogenicity assessment at a later time. The Sponsor considers the data from 550 participants 
in mRNA-1073-P101, 729 participants who received mRNA-1010 in Study mRNA-1010-P101, 
approximately 1700 participants who received mRNA-1010 in Study mRNA-1010-P301 (as of 
16 Aug 2022), and an estimated total of 661,128,345 doses of mRNA-1273 administered (as of 
15 Jun 2022) to be supportive of advancement to Phase 2/3. The final analysis of all endpoints 
will be performed after all participants in the revised Phase 1/2 study have completed 
Day 181/End of Study (EoS). 
The summary of changes table provided below describes the major changes made in Amendment 
2 compared to Amendment 1, including the sections modified and the corresponding rationales. 
As applicable, the synopsis of Amendment 2 has been modified to correspond to changes in the 
body of the protocol. 
Summary of Major Changes From Protocol Amendment 1 to Protocol Amendment 2 
Section # and Name 
Description of Change 
Brief Rationale 
Global 
• 
Deleted wording relevant to the 
Phase 2 portion of the study. 
• 
Decreased the total number of 
participants from 1050 to 550. 
• 
The Sponsor will use safety and 
immunogenicity data from the 
550 participants to select a dose 
level for the Phase 2/3 study. 
Sections 1.1. 
(Synopsis), 
2.1.(Background and 
Overview) 
• 
Updated information of COVID-19 
cases and deaths as of 19 Apr 2022. 
• 
To update latest information in 
support to this study. 

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Section # and Name 
Description of Change 
Brief Rationale 
Sections 1.1. 
(Synopsis), 2.1.1 
(mRNA-1010), 2.2.2 
(Clinical Studies) 
• 
Modified text for background 
information on Phase 3 program for 
this vaccine and development of 
mRNA-1010 studies. 
• 
To update latest information in 
support to this study. 
Sections 1.1. 
(Synopsis), 5.2. 
(Exclusion Criteria) 
• 
To Exclusion Criterion #9, added: 
“Inhaled, nasal, and topical steroids 
are not exclusionary.” 
• 
To clarify that inhaled, nasal, and 
topical steroids are not 
considered systemic agents and 
potential participants who have 
received inhaled, nasal, and 
topical steroids do not meet 
Exclusion Criterion #9. 
Sections 1.1 
(Synopsis), 9.4. 
(Analysis Set) 
• 
Replaced “and have no major 
protocol deviations that impact the 
immune response” with “do not 
have influenza or SARS-CoV-2 
infection at baseline and post-
baseline up to Day 29 (as 
documented by positive RT-PCR 
testing result) and have no major 
protocol deviations and/or 
prohibited concomitant medication 
use (documented in the 
Section 6.5.3.) that are prespecified 
with impacts on the immune 
response and should be excluded 
from the PP set.” 
• 
Specifying criteria for PP set. 
Sections 1.1 
(Synopsis), 4.1. 
(General Design), 
9.6. (Planned 
Analysis), 9.6.1. 
(Interim Analysis) 
• 
Deleted description of the second 
interim analysis (IA2). 
• 
Clarified that one IA will be 
performed after the first 50 
participants in Group 1 and 100 
participants each in Groups 2, 3, 4, 
5, and 6 have completed their Day 
29 visit assessments and will 
include the safety and 
immunogenicity data collected up 
to Day 29. 
• 
IA2 was scheduled to be 
performed on the data from 
participants in the Phase 2 
expansion phase which will not 
occur. 
Sections 1.1 
(Synopsis), 4.4. (End 
of Study Definition), 
9.6.2. (Final 
Analyses) 
• 
Clarified that the final analysis will 
occur after 550 participants in 
Phase 1 have completed Day 
181/EoS. 
• 
The expansion of the Phase 2 part 
of the study will not occur. The 
study will be closed after the 550 
participants complete Day 
181/EoS. 
Section 4.3. (Choice 
of Vaccine Doses) 
• 
Updated mRNA-1273 booster 
guidance for older people and for 
certain immunocompromised 
individuals. 
• 
The FDA recently amended the 
emergency use authorization to 
authorize a second booster dose 
for people 50 years of age and 

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Section # and Name 
Description of Change 
Brief Rationale 
older and for certain 
immunocompromised 
individuals. 
Section 6.5.3. 
(Concomitant 
Medications and 
Vaccines That May 
Lead to the 
Elimination of a 
Participant From Per-
Protocol Analyses) 
• 
Added: “Antiviral and antiretroviral 
medications.” 
• 
Antiviral and antiretroviral 
medications interfere with SARS-
CoV-2 immunologic assays used 
in this study; participants using 
either may be excluded from PP 
analysis. 
Section 7.1.1.1. 
(Pause Rules Based 
on the Occurrence of 
a Single Event and 
Adjudicated by the 
Data and Safety 
Monitoring Board) 
• 
Replaced “Any” With “A” in Pause 
Rule 3: A systemic immediate 
hypersensitivity reaction within 
60 minutes after the study 
vaccination2 
• 
Added footnote 2: “Systemic 
immediate hypersensitivity reaction 
refers to anaphylaxis as defined in 
Section 8.4.7.1.” 
• 
To clarify that a systemic 
immediate hypersensitivity 
reaction should only trigger a 
pause if the reaction meets the 
definition of anaphylaxis as 
stated in Section 8.4.7.1: 
Anaphylaxis. 
Section 7.1.1.2. 
(Pause Rules Based 
on the Occurrence of 
Events in a 
Proportion of 
Participants) 
• 
Added “exposed” to clarify 
instructions for calculating pause 
rules based on the occurrence of 
events in a proportion of 
participants. 
• 
Updated level heading to 
Section 7.1.2 
• 
For the first 9 participants in each 
vaccination group (initial stage), 
the pause rule will be considered 
to be met if 2 of the first 
9 participants experience the 
same solicited AR or the same 
MedDRA preferred term 
unsolicited AE or laboratory 
abnormality. Following the initial 
stage, the calculation for ≥ 20% 
of participants includes exposed 
participants in the initial 
stage and the expansion stage as 
the total number of participants in 
the denominator. 
Section 7.1.1.2. 
(Pause Rules Based 
on the Occurrence of 
Events in a 
Proportion of 
Participants) 
• 
Added: “(specified in 
Section 8.1.5.).” 
• 
Updated level heading to 
Section 7.1.2 
• 
Clarifying PP laboratory 
assessments relevant to Pause 
Rule 7 
Section 8. (Study 
Assessments) 
• 
Deleted statement that the 
Screening Visit and Day 1 visit 
may be completed on the same day 
for Phase 2. 
• 
The expansion of the Phase 2 part 
of the study will not occur. 

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mRNA-1073 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 8.1.8. 
(Assessment for 
Respiratory Viral 
Infection) 
• 
Replaced “respiratory symptoms” 
with “symptoms consistent with 
protocol-defined ILI 
(Section 8.4.5.) or COVID-19 
(Section 8.4.6.).” 
• 
Clarified symptoms during the 7-
day period after vaccination that 
should trigger evaluation for 
COVID-19 and influenza. 
Section 8.2. 
(Immunogenicity 
Assessments) 
• 
Deleted language stating that blood 
samples from Phase 2 participants 
will be collected. 
• 
The expansion of the Phase 2 part 
of the study will not occur. 
Section 8.4.1. 
(Adverse Event) 
• 
Added: “An incidental, 
asymptomatic RT-PCR confirmed 
COVID-19 case (ie, workplace 
screening) should be reported as an 
unsolicited AE of “asymptomatic 
COVID-19” if occurring during the 
first 28 days post study vaccination 
unless the RT-PCR test was 
performed on the NP swab 
collected prior to study vaccination 
(Day 1).” 
• 
To clarify that asymptomatic 
COVID-19 detected prior to 
vaccination should not be 
reported as an unsolicited AE. 
Section 9.5.3. 
(Immunogenicity 
Analysis) 
• 
Added: “Between-group 
comparisons will be evaluated in 
terms of immunogenicity endpoints 
(GMR and SCR/SRR difference) in 
the PP set and will be specified in 
the SAP in greater detail.” 
• 
Clarifying immunogenicity 
analysis. 
Section 9.5.5. 
(Subgroup Analyses) 
• 
Deleted text “or previous COVID-
19 vaccine type-specific.” 
• 
Updated to remove Phase 2 
related analysis.  
Section 11.1.5. 
(Recruitment 
Procedures) 
• 
Updated title to “Recruitment 
Strategy” and text added: 
“Enrollment targets will be 
established to ensure the participant 
population reflects those that are 
most at risk for the condition, or 
those that are most reflective of the 
general population, if appropriate. 
Participant recruitment and 
retention initiatives will be 
incorporated into the trial. These 
include, but are not limited to, 
services that provide a means to 
identify potential participants and 
direct them to participating clinical 
trial sites, participant support 
services such as concierge, and trial 
information and support collateral 
for both the participant and the 
site.” 
• 
This update is to align with EU-
CTR. 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 11.1.9. (Data 
Protection) 
• 
Confidentiality information updated 
to add: “The contract between the 
Sponsor or designee and the study 
sites may specify responsibilities of 
the parties related to data 
protection, including handling of 
data security breaches and 
respective communication and 
cooperation of the parties. 
Information technology systems 
used to collect, process, and store 
study-related data are secured by 
technical and organizational 
security measures designed to 
protect such data against accidental 
or unlawful loss, alteration, or 
unauthorized disclosure or access.” 
• 
This update is to align with EU-
CTR. 
Section 11.3 
(Appendix 3) 
• 
Updated: Renamed the “Additional 
Notes” column as “Medical 
Concept Descriptions/Guidance” 
and updated the contents in that 
column. 
• 
To provide the most updated 
description of medical concepts 
of interest in COVID-19 vaccine 
safety surveillance, which should 
be reported as AESI(s). 
Table of Contents 
• 
Collapsed Pause Rules into 
Sections 7.1, 7.1.1. and 7.1.2. 
• 
Deleted Table 2 “Schedule of 
Events Phase 2.” 
• 
Deleted “Phase 1” from Table 5 
and Table 6. 
• 
Deleted Table 7 “Phase 2 Pause 
Rule Criteria Events and 
Thresholds Single Event.” 
• 
Changes to Table of Contents are 
consistent with relevant changes 
to the study described above. 
Abbreviations: AESI = adverse event of special interest; AE = adverse event; COVID-19 = coronavirus disease 
2019; DSMB = data safety monitoring board; eCRF = electronic case report form; EoS = end of study; EU-
CTR = European Union Clinical Trials Regulation; FDA = Food and Drug Administration; GMR = geometric 
mean ratio; IA = interim analysis; ILI = influenza-like illness; IST = internal safety team; MAAE = medically 
attended adverse event; MedDRA = Medical Dictionary for Regulatory Activities; NP = nasopharyngeal swab; 
PP = per-protocol; RT-PCR = reverse transcriptase polymerase chain reaction; SAP = statistical analysis plan; 
SARS-COV-2 = severe acute respiratory syndrome coronavirus 2; SCR = seroconversion rate; 
SRR = seroresponse rate. 

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1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Name of Sponsor/Company:  
ModernaTX, Inc. 
Name of Investigational 
Product:  
mRNA-1073 
Protocol Title: 
Phase 1/2, randomized, stratified, observer-blind study to 
evaluate the safety, reactogenicity, and immunogenicity of 
mRNA-1073 (SARS-CoV-2 and influenza vaccine) 
compared to co-administered mRNA-1010 (influenza) and 
mRNA-1273 (SARS-CoV-2) vaccines and to mRNA-1010 
vaccine and mRNA-1273 vaccine alone in healthy adults 18-
75 years of age 
Protocol Number: 
mRNA-1073-P101, Amendment 2 
Study Duration: 
Approximately 7 months 
Study participants will be screened up to 28 days prior to 
randomization and vaccination and followed for 6 months 
after intramuscular (IM) administration of investigational 
product (IP) 
Phase of Development:   
Phase 1/2 
Estimated Date First 
Participant Enrolled: 
May 2022 
Estimated Date Last 
Participant Completed: 
December 2022 
Proposed Country: 
Approximately 15 sites in the United States 

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mRNA-1073 
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Background and Rationale for Study: 
ModernaTX, Inc. (the Sponsor) is developing mRNA-1073, a custom manufactured 
lipid-encapsulated messenger RNA (mRNA)-based prophylactic vaccine encoding for 
antigens from influenza viruses and severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2). mRNA-1073 encodes for the respective antigens also encoded for by mRNA-1010 
and mRNA-1273 (also known as Moderna coronavirus disease 2019 [COVID-19] vaccine). 
Seasonal influenza viruses are estimated by the World Health Organization (WHO) to cause 
3 to 5 million cases of severe illness and up to 650,000 deaths each year resulting in a severe 
challenge to public health. 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). Because 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. 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). 
Currently, licensed seasonal influenza virus vaccines rarely exceed 50% overall effectiveness 
and are poorly effective during years when the circulating viruses do not match the strains 
selected for the vaccine antigens. Influenza vaccines based on mRNA technology could 
provide several benefits compared to current vaccines, including the ability to respond to 
strain changes more quickly, avoidance of mutations that may be acquired during vaccine 
production in eggs or cell culture, stronger immune responses, as well as improved protection 
in older adults. 
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 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 19 Apr 2022. 
The Sponsor has developed a rapid-response, proprietary vaccine platform based on an 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 

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mRNA-1073 
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delivered mRNA does not enter the cellular nucleus or interact with the genome, is 
nonreplicating, and is expressed transiently. 
The Sponsor is using its mRNA-based platform to develop a custom manufactured lipid 
nanoparticle-encapsulated, mRNA-based vaccine against diseases caused by influenza virus 
types A and B. The proposed development candidate mRNA-1010 is a quadrivalent vaccine 
containing mRNAs that encode for the hemagglutinins (HAs) of the 4 strains recommended by 
the WHO for cell- or recombinant-based vaccines. Equal amounts of mRNAs that encode for 
membrane-bound wild-type versions of each of the 4 different strains will be used for the HA 
components. The mRNA-1010 development candidate will be administered as a single 
intramuscular (IM) injection and aims to elicit protection from all seasonal influenza viruses 
covered by the vaccine. The Sponsor is conducting a first-in-human (FIH) Phase 1/2 study of 
mRNA-1010 (NCT04956575), a seasonal influenza vaccine, to establish preliminary safety, 
reactogenicity, and immunogenicity data that has supported the initiation of a Phase 3 program 
for this vaccine (NCT05415462).  
mRNA-1273 encodes for the full-length S protein of SARS-CoV-2, modified to introduce 
2 proline residues to stabilize the S protein (S-2P) in a prefusion conformation. The CoV-S 
protein mediates attachment and entry of the virus into host cells (by fusion), making it a 
primary target for neutralizing antibodies (nAbs) that prevent infection. It has been confirmed 
that the stabilized SARS-CoV-2 S-2P antigen presents in the correct prefusion conformation. 
In December 2020, mRNA-1273 was granted Emergency Use Authorization (EUA) in the US 
for the prevention of COVID-19 for individuals 18 years of age and older. In November 2021, 
the US Food and Drug Administration (FDA) granted EUA for an mRNA-1273 booster dose 
(
) to be given at least 5 months after the primary series with mRNA-1273 in adults aged 
18 years and older. In August 2021, the Sponsor filed a Biologics License Application (BLA) 
with the FDA for the full licensure of the mRNA-1273 vaccine for active immunization to 
prevent COVID-19 in individuals 18 years of age and older. In January 2022, the US FDA 
approved the BLA for SPIKEVAX (mRNA-1273) to prevent COVID-19 in individuals 18 
years of age and older. 
mRNA-1073 is a custom manufactured lipid-encapsulated mRNA-based prophylactic vaccine 
encoding for antigens from influenza viruses and SARS-CoV-2. 
The administration of mRNA-1073 vaccine, encoding for the respective antigens also encoded 
for by mRNA-1010 (seasonal influenza) and mRNA-1273 (SARS-CoV-2), has the potential to 
efficiently reduce the overall burden of acute viral respiratory diseases by providing 
simultaneous protection against influenza and SARS-CoV-2 viruses in a convenient dosing 
regimen. mRNA-1073 offers greater convenience and has the potential to lead to increased 
compliance with vaccine recommendations, which has been frequently utilized for pediatric 
CCI

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vaccines. Furthermore, this combined regimen could provide a public health benefit through 
synergistically increasing coverage rates against influenza and SARS-CoV-2 viruses. 
This Phase 1/2 study will collect safety and immunogenicity data to further inform the clinical 
development of mRNA-1073. 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
 
• 
To evaluate the safety and reactogenicity 
of study vaccines 
• 
Frequency and grade of each solicited local 
and systemic reactogenicity AR during a 
7-day follow-up period post vaccination 
• 
Frequency and severity of any unsolicited 
AEs during the 28-day follow-up period post 
vaccination 
• 
Frequency of any SAEs, AESIs, MAAEs, and 
AEs leading to discontinuation from Day 1 to 
Day 181/EoS 
Secondary  
  
• 
To evaluate the humoral immunogenicity 
to vaccine-matched strains for influenza 
and SARS-CoV-2 across study vaccine 
arms at Day 29 
• 
GMT and GMFR at Day 29 compared with 
Day 1 (baseline) by HAI assay for influenza 
and PsVNA (or binding antibody assay) for 
SARS-CoV-2 
• 
Influenza: Percentage of participants with 
seroconversion, defined as a Day 29 titer 
≥ 1:40 if baseline is < 1:10 or a 4-fold or 
greater rise if baseline is ≥ 1:10 in anti-HA 
antibodies measured by HAI assay 
• 
SARS-CoV-2: Percentage of participants with 
seroresponse, defined as a Day 29 titer 
≥ 4-fold if baseline is ≥ LLOQ or 
≥ 4 × LLOQ if baseline titer is < LLOQ in 
nAb titers measured by PsVNA (or binding 
antibody assay). 
• 
To evaluate the humoral immunogenicity 
to vaccine-matched strains for influenza 
and SARS-CoV-2 at all evaluable 
humoral immunogenicity time points 
• 
GMT and GMFR compared with Day 1 
(baseline) by HAI for influenza and PsVNA 
(or binding antibody assay) for SARS-CoV-2 
• 
Percentages of participants with 
seroconversion (influenza) and seroresponse 
(SARS-CoV-2) as defined above 
Exploratory (may be performed) 
 

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• 
To evaluate the humoral immunogenicity 
against vaccine mismatched strains 
• 
GMT and GMFR (compared to Day 1) to 
vaccine mismatched strains  
• 
To evaluate the humoral immunogenicity 
against vaccine-matched and mismatched 
strains using alternative methods 
• 
GMT and GMFR (compared to Day 1) to 
vaccine-matched and mismatched strains 
assayed by alternative methods (eg, 
microneutralization assay for influenza or 
ligand-binding assay for SARS-CoV-2) 
• 
To evaluate cellular immunogenicity in a 
subset of participants 
• 
Frequency, magnitude, and phenotype of 
virus-specific T-cell and B-cell responses 
measured by flow cytometry or other 
methods, and to perform targeted repertoire 
analysis of B cells and T cells after 
vaccination 
• 
To further characterize the immune 
response across study vaccines 
• 
Frequency, specificities, or other endpoints to 
be determined for the further characterization 
of immune responses 
• 
To assess the occurrence of clinical 
influenza and COVID-19 in study 
participants and characterize their 
immune response to infection and viral 
isolates 
• 
Frequency of laboratory-confirmed clinical 
influenza and COVID-19 and assessment of 
immune responses to infection and viral 
isolates 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; COVID-19 
= coronavirus disease 2019; EoS = end of study; GMFR = geometric mean fold rise; GMT = geometric mean 
titer; HA = hemagglutinin; HAI = hemagglutination inhibition; LLOQ = lower limit of quantification; MAAE = 
medically attended adverse event; nAb = neutralizing antibody; PsVNA = pseudovirus neutralization assay; SAE 
= serious adverse event; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. 
Overall Study Design:  
This is a Phase 1/2, randomized, stratified, observer-blind study to evaluate the safety, 
reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-
1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy adults 18 to 75 
years of age. 
Participants in the study will participate in a Screening period (up to 28 days before Day 1), 
treatment period (single dose of vaccine on Day 1), and a follow-up period (up to 6 months 
after vaccination). 
On Day 1, each participant will receive 2 injections administered IM, one in each arm, in the 
deltoid muscle. The vaccines to be tested include: 1) mRNA-1273 vaccine encoding for the 
full-length S protein of SARS-CoV-2, modified to introduce S-2P in a prefusion conformation; 
2) mRNA-1010 vaccine encoding for the HA surface glycoproteins of the 4 strains by the 
WHO for the 2022 SH influenza season cell- or recombinant-based vaccines; and 3) mRNA-

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1073 vaccine encoding for the respective antigens also encoded for by mRNA-1010 and 
mRNA-1273. The placebo and the diluent for mRNA-1073 vaccine will be 0.9% sodium 
chloride (normal commercial saline) injection, which meets the criteria of the US 
Pharmacopeia (USP). 
The study will enroll approximately 550 generally healthy adults 18 to 75 years of age who 
were previously fully vaccinated for COVID-19 primary series with a locally authorized and 
approved SARS-CoV-2 vaccine, and their last COVID-19 vaccine (primary series or booster) 
must be ≥ 120 days prior (or less per local guidance) to the randomization visit. Participants 
must not have received a licensed influenza vaccine within ≤ 180 days of randomization and 
have no known history of confirmed influenza infection within ≤ 180 days or SARS-CoV-2 
infection within ≤ 90 days of Screening. Randomization will be stratified by age (18 to 49 
years old and 50 to 75 years old, balanced across the 2 age groups within each vaccination 
group). The numbers of participants and groups are shown in the below table. 
Participants will have 6 visits and 4 safety phone calls. Vaccines (mRNA-1073, mRNA-1010, 
or mRNA-1273) and placebo (as indicated) will be administered as IM injections, one in each 
arm, in the deltoid muscle. Safety and/or immunogenicity and/or biomarkers study visits will 
occur on Days 4, 8, 29, and 181 (end of study [EoS]). Study visits will include scheduled 
safety phone calls at Days 57, 91, 121, and 151 to collect adverse events (AEs), medically 
attended AEs (MAAEs), AEs of special interest (AESIs), AEs leading to withdrawal, serious 
adverse events (SAEs), and information about concomitant medications and receipt of non-
study vaccinations. 
Study Arms 
# 
Group Name 
Sample Size 
(N=550) 
1 
mRNA-1273
+ placebo 
50 
2 
mRNA-1010
+ placebo 
100 
3 
mRNA-1010
+ mRNA-1273 
co-administration 
100 
4 
mRNA-1073
+ placebo 
100 
5 
mRNA-1073
 placebo 
100 
6 
mRNA-1073
 placebo 
100 
Safety Oversight: 
An internal safety team, inclusive of, at a minimum, the Sponsor’s medical monitor, Sponsor’s 
safety physician, and a contract research organization (CRO) medical monitor, will be formed 
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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 internal safety team (IST) will 
conduct a scheduled review of safety data after at least 55 participants (approximately 
5 participants in Group 1 and approximately 10 participants in Groups 2 to 6) have completed 
the Day 8 visit. Enrollment will be ongoing while this review is conducted if no pause rules 
have been met and the study team has not identified any safety concerns. The IST will also 
conduct ad hoc reviews as requested by the study medical monitor and the study team. 
The DSMB, composed of external/independent subject matter experts, will conduct scheduled 
unblinded reviews of safety data and as needed if any pause rule is met or as otherwise 
requested by the study team and/or IST as described in the DSMB charter. 
An independent Cardiac Event Adjudication Committee (CEAC) that includes pediatric and 
adult cardiologists will review suspected cases of myocarditis and pericarditis 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 or pericarditis 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. 
Study Population: 
 
Number of Participants: 
Approximately 550 participants 
Target Population: 
Healthy adults 18 to 75 years old 
Inclusion Criteria: 
Each participant must meet all of the following criteria to be enrolled in this study: 
1. Adults 18 to 75 years of age at the time of consent (Screening Visit). 
2. Investigator assessment that participant understands and is willing and physically able 
to comply with protocol-mandated follow-up, including all procedures. 
3. Participant has provided written informed consent for participation in this study, 
including all evaluations and procedures as specified in this protocol. 

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4. Body mass index (BMI) of 18 kg/m2 to 35 kg/m2 (inclusive) at the Screening Visit. 
5. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as postmenopausal or permanently sterilized. A 
follicle-stimulating hormone (FSH) level may be measured at the discretion of the 
investigator to confirm postmenopausal status. 
6. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all the following criteria: 
• Has a negative pregnancy test at the Screening Visit and on the day of vaccination 
(Day 1). 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to Day 1. 
• Has agreed to continue adequate contraception through 3 months following vaccine 
administration. Adequate female contraception is defined as consistent and correct 
use of a local health authority approved contraceptive method in accordance with 
the product label. 
• Is not currently breastfeeding. 
7. Participants must have been fully vaccinated for COVID-19 primary series according 
to the locally authorized or approved regimen, and their last COVID-19 vaccine 
(primary series or booster) was ≥ 120 days prior to the randomization visit (or less per 
local guidance). 
Exclusion Criteria: 
Participants meeting any of the following criteria at the Screening Visit, unless noted 
otherwise, will be excluded from the study: 
1. Participant is acutely ill or febrile (temperature ≥ 38.0℃ [100.4°F]) 72 hours prior to 
or at the Screening Visit or Day 1. Participants meeting this criterion may be 
rescheduled within the 28-day Screening window and will retain their initially assigned 
participant number. 
2. Participant has a 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. 

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Asymptomatic conditions and conditions with no evidence of end organ involvement 
(eg, mild hypertension, dyslipidemia) are not exclusionary, provided that 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, due to therapies used to treat them (eg, 
immune-modifying treatments), at the discretion of the investigator. 
3. Participant has a reported history of congenital or acquired immunodeficiency, 
immunosuppressive condition, or immune-mediated disease. 
4. Participant has dermatologic conditions that could affect local solicited adverse 
reaction (AR) assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid 
areas). 
5. Participant has a reported history of anaphylaxis or severe hypersensitivity reaction 
after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines. 
6. Participant has a reported history of bleeding disorder that is considered a 
contraindication to IM injection or phlebotomy. 
7. Participant has a diagnosis of malignancy within previous 10 years (excluding 
nonmelanoma skin cancer). 
8. Participant has 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. Participant has received systemic immunosuppressants or immune-modifying drugs for 
> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day 
of prednisone or equivalent) or is anticipating the need for immunosuppressive 
treatment at any time during participation in the study. Inhaled, nasal, and topical 
steroids are not exclusionary. 
10. 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 before or after 
the study injections. 
11. Participant has received a seasonal influenza vaccine or any other investigational 
influenza vaccine ≤ 180 days prior to the randomization visit. 

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12. Participant has tested positive for influenza by local health authority approved testing 
methods ≤ 180 days prior to the Screening Visit. 
13. Participant has had close contact to someone with SARS-CoV-2 infection or 
COVID-19 as defined by the US CDC in the past 10 days prior to the Screening Visit. 
14. Participant has known history of SARS-CoV-2 infection within ≤ 90 days. 
15. Participant has received systemic immunoglobulins or blood products ≤ 90 days prior 
to the Screening Visit or plans to receive systemic immunoglobulins or blood products 
during the study. 
16. Participant has a history of myocarditis, pericarditis, or myopericarditis.  
17. 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. 
18. 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. 
19. Participant is an immediate family member or household member of study personnel, 
study site staff, or Sponsor personnel. 
20. Participant has clinical screening laboratory values (total white blood cell count, 
hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase 
(AST), creatinine, alkaline phosphatase, and total bilirubin) > Grade 1. 
Treatments: 
 
Study Intervention:  
mRNA-1073 is administered as a single dose and aims to 
elicit protection from influenza and SARS-CoV-2. 
mRNA-1073 contains mRNA coding for 4 HA antigens of 
the influenza virus strains recommended for the 2022 SH 
seasonal vaccines by the WHO and the mRNA for the 
S protein of SARS-CoV-2 virus formulated in a mixture of 
4 lipids common to the Sponsor’s mRNA vaccine platform: 
SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-
phosphocholine (DSPC), and 
1-monomethoxypolyethyleneglycol-2,3-dimyristylglycerol 
with polyethylene glycol of average molecular weight 2000 
(PEG-2000-DMG). mRNA-1073 is based on the antigens 
encoded for by mRNA-1010 and mRNA-1273 and is 

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intended as a single annual dose for protection from seasonal 
influenza and SARS-CoV-2. Commercially available 0.9% 
sodium chloride, USP will be used as appropriate for dose 
preparation. 
mRNA-1010 is administered as a single dose and aims to 
elicit protection from influenza A and B viruses. mRNA-
1010 is a quadrivalent vaccine containing mRNAs encoding 
for the HAs of the 4 strains recommended by the WHO for 
2022 SH cell- or recombinant-based vaccines formulated in 
a mixture of 4 lipids common to the Sponsor’s mRNA 
vaccine platform: SM-102, cholesterol, DSPC, and PEG-
2000-DMG. Equal amounts of mRNAs encoding for each of 
the 4 different strains are used for the HA components. 
mRNA-1010 is administered as a single dose and aims to 
elicit protection from all seasonal influenza viruses covered 
by the vaccine. 
mRNA-1273 is administered as a single dose and aims to 
elicit protection from SARS-CoV-2. mRNA-1273 contains 
mRNA CX-024414 encoding for the S-2P of Wuhan-Hu-1. 
mRNA-1273 consists of the mRNA formulated in a mixture 
of 4 lipids common to the Sponsor’s mRNA vaccine 
platform: SM-102, cholesterol, DSPC, and PEG-2000-DMG. 
Dose/Route/ 
Schedule: 
mRNA-1073, mRNA-1010, or mRNA-1273 and placebo (if 
indicated) 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. 
Procedures and Assessments: 
Safety Assessments:  
Safety assessments will include monitoring and recording of the following for each 
participant: 

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• Solicited local and systemic ARs that occur during the 7 days following vaccine 
administration (ie, the day of study injections [Day 1] and 6 subsequent days). 
Solicited ARs will be recorded daily using electronic diaries. Local solicited ARs 
will be recorded separately for each injection site. 
• Unsolicited AEs observed or reported during the 28 days following vaccination 
(ie, the day of injection [Day 1] and 27 subsequent days). 
• SAEs, AESIs, MAAEs, and AEs leading to discontinuation from study 
participation from vaccination on Day 1 through Day 181/EoS or withdrawal from 
the study. 
• Results of safety laboratory tests. 
• Vital sign measurements. 
• Physical examination findings. 
• Symptom Reporting electronic diary (eDiary) for influenza-like illness (ILI) and 
COVID-19 from Day 1 through Day 181/EoS as described under assessment for 
respiratory viral infection. 
• Details of all pregnancies in female participants will be collected after the start of 
study treatment and until the end of their participation in the study. 
The incidence and severity of the above events will be monitored by an IST as per the charter.  
Immunogenicity Assessments: 
Blood samples for immunogenicity assessments will be collected per the schedule of events. 
The following analytes will be measured: 
• Influenza: Serum antibody level as measured by HAI assay 
• Influenza: Serum nAb level as measured by microneutralization assay as potential 
substitution to the HAI assay  
• SARS-CoV-2: Serum nAb titers as measured by pseudovirus neutralization assay 
(PsVNA) assay and potentially serum binding antibody titers by enzyme-linked 
immunosorbent assay (ELISA) or multiplex assay specific to the SARS-CoV-2 
proteins.  
• Cellular immunogenicity in a subset of participants 
Assessment for Respiratory Viral Infection:  

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During the study, participants might experience symptoms consistent with ILI or SARS-CoV-
2 infection. All participants will provide nasopharyngeal (NP) swab samples before the 
injection on Day 1 for assessment of infection with respiratory pathogens, including influenza 
viruses and SARS-CoV 2, as influenza or COVID-19 symptoms may confound reactogenicity 
assessments. Additionally, clinical information will be carefully collected to evaluate the 
severity of the clinical case. 
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. 
Sample Size: 
The sample size for this study is not driven by statistical assumptions for formal hypothesis 
testing. The number of proposed participants is considered sufficient to provide a descriptive 
summary of the safety and immunogenicity of different study groups. 
The study will enroll approximately 550 generally healthy adults 18 to 75 years of age who 
were previously fully vaccinated for COVID-19 primary series with a locally authorized and 
approved SARS-CoV-2 vaccine, and their last COVID-19 vaccine must be ≥ 120 days prior to 
the randomization visit (or less per local guidance). Participants must not have received a 
licensed influenza vaccine within ≤ 180 days of randomization and have not had known 
history of confirmed influenza infection within ≤ 180 days or SARS-CoV-2 infection within 
≤ 90 days of Screening. 
Approximately 550 participants will be enrolled at a 
. A sample size of 
100 participants in one group has at least an 85% (or 95%) probability to observe at least 
1 participant with an AE at a true 2% (or 3%) AE rate (see table below). 
Randomized Sample Size Calculations  
Sample Size True AE Rate Probability to Observe 0 AEs Power to Detect at Least 1 AE 
50 
0.05 
7.7% 
92.3% 
50 
0.03 
21.8% 
78.2% 
100 
0.03 
4.8% 
95.2% 
100 
0.02 
13.3% 
86.7% 
Abbreviation: AE = adverse event. 
Analysis Sets: 
Set 
Description 
Randomization Set 
The randomization set consists of all participants who are 
randomly assigned. 
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FAS1 
The FAS consists of all randomly assigned participants who 
receive the IP. 
PP Set2 
The PP set consists of all participants in the FAS who comply with 
the injection schedule, comply with the timings of immunogenicity 
blood sampling to have a baseline and at least 1 post-injection 
assessment, do not have influenza or SARS-CoV-2 infection at 
baseline and post-baseline up to Day 29 (as documented by 
positive RT-PCR testing result), and have no major protocol 
deviations and/or prohibited concomitant medication use 
(documented in Section 6.5.3) that are prespecified with impacts on 
the immune response and should be excluded from the PP set. 
Safety Set3 
The safety set consists of all randomly assigned participants who 
receive the IP. 
Solicited Safety Set4 
The solicited safety set consists of all participants in the safety set 
who contribute any solicited AR data. 
Abbreviations: AR = adverse reaction; FAS = full analysis set; IP = investigational product; PP = per-protocol. 
1  For the FAS, participants will be analyzed according to the group to which they were randomized. 
2  The PP set will be used as the primary analysis set for analyses of immunogenicity unless otherwise specified. 
Participants will be analyzed according to the group to which they were randomized. 
3 The safety set will be used for all analyses of safety, except for the solicited ARs. Participants will be included 
in the vaccination group corresponding to what they actually received. 
4 The solicited safety set will be used for the analyses of solicited ARs and participants will be included in the 
vaccination group corresponding to what they actually received. 
Safety Analyses: 
All safety analyses are descriptive in nature and 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 study arm. Participants will be included in the vaccination group 
corresponding to what they actually received. Local solicited reactogenicity analysis will be 
presented by study group and for each injection content, respectively. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters, 
including solicited ARs (local and systemic ARs); unsolicited AEs (including any clinical 
safety laboratory abnormalities); treatment-related AEs; severe AEs, SAEs, MAAEs, AESIs, 
and AEs leading to withdrawal from study participation; vital sign measurements; and 
physical examination findings. 
The number and percentage of participants with any solicited local AR, with any solicited 
systemic AR, with any solicited AR during the 7-day follow-up period after each vaccination, 
and with any Grade 3 or higher solicited AR will be summarized. A 2-sided 95% exact 
confidence interval (CI) using the Clopper-Pearson method will be provided for the percentage 
of participants with any solicited AR. 

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The number and percentage of participants with unsolicited AEs, treatment-related AEs, 
severe AEs, SAEs, MAAEs, AESIs, and AEs leading to withdrawal will be summarized. 
Unsolicited AEs will be presented by Medical Dictionary for Regulatory Activities 
(MedDRA) system organ class and preferred term. Unsolicited AEs will be coded according to 
the MedDRA Dictionary for Adverse Reaction Terminology. 
The number of events of solicited ARs, unsolicited AEs/SAEs, MAAEs, AEs leading to 
withdrawal, and AESIs will be reported in summary tables accordingly. Pregnancy outcomes 
will also be summarized. 
For all other safety parameters, descriptive summary statistics will be provided. Further details 
will be described in the statistical analysis plan (SAP). 
Immunogenicity Analyses: 
The analyses of immunogenicity will be based on the per-protocol (PP) set. 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. 
For the immunogenicity endpoints, the geometric mean of specific antibody titers with 
corresponding 95% CI at each time point and the geometric mean fold rise (GMFR) of specific 
antibody titers with the corresponding 95% CI at each post-baseline time point over pre-
injection baseline at Day 1 will be provided by treatment arm, with adjustment for baseline 
antibody titer and other potential covariates, including age group and primary vaccine type. 
Descriptive summary statistics, including median, minimum, and maximum, will also be 
provided. 
For summarizations of geometric mean titer, antibody titers reported as below the lower limit 
of quantification (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. 
For mRNA-1010, seroconversion rate from baseline will be provided with a 2-sided 95% CI 
using the Clopper-Pearson method at each post-baseline time point. Rate of seroconversion is 
defined as the proportion of participants with either a pre-vaccination HAI titer < 1:10 and a 
post-vaccination HAI titer ≥ 1:40 or a pre-vaccination HAI titer ≥ 1:10 and a minimum 4-fold 
rise in post-vaccination HAI antibody titer. 
For mRNA-1273, seroresponse is defined as either: participants with GMFR in nAb or 
(binding antibody) bAb titers of ≥ 4-fold at Day 29 compared to Day 1 in those with baseline 
titer ≥ LLOQ, or Day 29 titer ≥ 4 × LLOQ if baseline titer is < LLOQ. 

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The immunogenicity of mRNA-1073 will follow the same rules as mRNA-1010 and 
mRNA-1273. 
Planned Analyses: 
An interim analysis (IA) and a final analysis will be conducted in the study. 
The IA will be performed after all the 550 participants randomized into Group 1 through 
Group 6 have completed their Day 29 visit assessments and will include the safety and 
immunogenicity data collected up to Day 29. Either nAb or bAb assay will be used for 
assessment of immunogenicity. The IA will be performed by a separate team of unblinded 
programmers and statisticians. The analysis will be presented by vaccination groups. Except 
for a limited number of Sponsor and CRO personnel who will be unblinded to perform the IA, 
the study site staff, investigators, study monitors, and participants will remain blinded until 
after the final database lock for 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 clinical study report (CSR), 
including individual listings. The final CSR will include full analyses of all safety and 
immunogenicity data through Day 181/EoS. For immunogenicity analysis, either nAb or bAb 
assays will be used in the study. 

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1.2. 
Schema 
Figure 1 Study Schema 
 
 
Abbreviations: SoE = schedule of events; V = visit. 
 
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1.3. 
Schedule of Events 
 
Table 1 
Schedule of Events 
Visit Number 
SCRN 
1 
2 
3 
4 
5, 6, 7, 8 
9 
USV 
Type of Visit 
C 
C 
C 
C 
C 
SC 
C 
C 
Month Time Point 
N/A 
 
 
 
M1 
M2-M5 
M6 
Up to M6 
Visit Day  
Screening1 
D1 
(Baseline)1 
D4 
D8 
D29 
D57, D91, 
D121, D151 
D181/ 
EoS 
N/A 
Window Allowance (Days) 
-28 
N/A 
-2 
+3 
-7 to +2 
±5 
±14 
N/A 
Informed consent form, demographics, concomitant 
medications, medical history  
X 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
Blood collection for safety laboratory samples2 
X 
 
 
X 
 
 
 
 
Full physical examination3 
X 
 
 
 
 
 
 
 
Axillary lymph nodes assessment (both arms)4 
 
X 
 
 
 
 
 
 
Symptom-directed physical examination5 
 
X 
 
X 
X 
 
X 
X 
Vital sign measurements6 
X 
X 
 
 
 
 
 
 
Electrocardiogram (ECG)7 
 
X 
 
 
 
 
 
 
Pregnancy testing8 
X 
X 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
Study vaccination (including 60-minute, post-dose 
observation period) 
 
X9 
 
 
 
 
 
 
Blood collection for humoral immunogenicity10 
 
X 
 
X 
X 
 
X 
 
Blood collection for cellular immunogenicity10 
 
X 
 
X 
X 
 
X 
 
Optional blood collection for genomics11 
 
X 
 
 
 
 
 
 
Optional blood collection for transcriptomics11 
 
X 
 
X 
X 
 
 
 
Blood sample for potential biomarker analysis12 
 
 
X 
 
 
 
 
 
Nasopharyngeal swab for virus detection13 
 
X 
 
 
 
 
 
X 
eDiary activation for recording solicited ARs (7 days)14 
 
X 
 
 
 
 
 
 

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Visit Number 
SCRN 
1 
2 
3 
4 
5, 6, 7, 8 
9 
USV 
Type of Visit 
C 
C 
C 
C 
C 
SC 
C 
C 
Month Time Point 
N/A 
 
 
 
M1 
M2-M5 
M6 
Up to M6 
Visit Day  
Screening1 
D1 
(Baseline)1 
D4 
D8 
D29 
D57, D91, 
D121, D151 
D181/ 
EoS 
N/A 
Window Allowance (Days) 
-28 
N/A 
-2 
+3 
-7 to +2 
±5 
±14 
N/A 
Review of solicited AR eDiary 
 
 
 
X 
 
 
 
 
eDiary activation for Symptom Reporting eDiary15 
 
X 
 
 
 
 
 
 
Symptom Reporting eDiary for collection of symptoms 
of ILI and/or COVID-1916 
 
Once weekly 
 
Follow-up safety call17 
 
 
 
 
 
X 
 
 
Recording of unsolicited AEs through Day 29 
 
X 
 
X 
X 
 
 
X 
Recording of SAEs, AESIs, MAAEs, AEs leading to 
discontinuation, and concomitant medications relevant 
to or for their treatment18 
 
X 
 
X 
X 
X 
X 
X 
Recording of non-study vaccinations18 
X 
X 
 
X 
X 
X 
X 
X 
Study completion 
 
 
 
 
 
 
X 
 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; ALT = alanine aminotransferase; AR = adverse reaction; AST = aspartate 
aminotransferase; C = clinic visit; COVID-19 = coronavirus disease 2019; D = day; ECG = electrocardiogram; eDiary = electronic diary; EoS = end of study; 
ILI = influenza-like illness; IM = intramuscular; M = month; MAAE = medically attended adverse event; N/A = not applicable; NP = nasopharyngeal; SAE = 
serious adverse event; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; SC = safety (phone) call; SCRN = Screening; USV = unscheduled 
visit. 
1. Screening and Day 1 will NOT be performed on the same day. Additionally, the Screening Visit may be performed over multiple visits if within the 28-day 
Screening window. 
2. Safety laboratory tests: Total white blood cell count, hemoglobin, platelets, ALT, AST, creatinine, alkaline phosphatase, and total bilirubin. 
3. Physical examination: A full physical examination, including height and weight, will be performed at Screening. Interim physical examinations will be 
performed at the discretion of the investigator. Any clinically significant finding identified by a healthcare professional during study visits should be reported as 
an MAAE. 
4. On the day of vaccination, prior to injection, axillary lymph nodes of both arms should be examined, and any abnormalities should be documented. 
5. Symptom-directed physical examinations will be performed at all clinic visits, except at Screening, where a full physical examination will be performed. 
Interim physical examinations will be performed at the discretion of the investigator. Any clinically significant finding identified by a healthcare professional 
during study visits should be reported as an MAAE. 

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6. Vital sign measurements: Systolic and diastolic blood pressure, heart rate, respiratory rate, and body temperature. The preferred route of temperature 
assessment is oral. Vital signs will only be collected at Screening and on the day of vaccination (Day 1), once before and at least 60 minutes after vaccination. 
Vital signs will be collected at other clinical visits only in conjunction with a symptom-directed physical examination. 
7. A 12-lead ECG will be obtained, after 10 minutes of supine rest, at Visit 1/Day 1 prior to vaccination. 
8. A point-of-care urine pregnancy test will be performed at the Screening Visit and before the IM injections on Day 1. At the discretion of the investigator, a 
pregnancy test either via blood or point-of-care urine can be performed at any time. The follicle-stimulating hormone level may be measured at the Screening 
Visit, as necessary, and at the discretion of the investigator, to confirm menopausal status.  
9. All participants will be randomized to receive 2 IM injections, one in each arm, in the deltoid muscle. 
10. 
Samples for humoral immunogenicity and cellular immunogenicity must be collected prior to receipt of vaccination on Day 1. Cellular 
immunogenicity will be sampled and assessed in a subset of participants. 
11. 
Transcriptomic and genomic samples will be part of the optional biomarker assessment once consented by the study participant. Blood draws on 
Day 1 must occur prior to participants being vaccinated. 
12. 
Biomarker plasma and biomarker serum samples will be stored for potential future biomarker assessment. 
13. 
An NP swab specimen for pathogens, including influenza and SARS-CoV-2, will be collected prior to the study injections on Day 1 to document 
any pre-vaccination infection.  An NP swab will also be collected through study completion if any signs or symptoms or an MAAE suggesting influenza, 
COVID-19, or other causes of upper or lower respiratory infection occur. For signs or symptoms during the study, a participant will be instructed to contact the 
study site to have an NP swab collected for testing. If the participant cannot or is unable to come into the site to perform the NP swab, every effort should still 
be made by the site to obtain the NP swab (eg, home visits to collect NP swab for central laboratory testing). Local laboratory testing for influenza and 
SARS-CoV-2 can be performed in these cases as a backup if NP swab cannot be collected for central laboratory testing.  
14. 
The eDiary entries will be recorded by the participant starting approximately 60 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. Local solicited ARs will be recorded separately for each injection site. Please see 
Section 8.4.3 for details. 
15. 
The Symptom Reporting eDiary will be activated for collection of ILI and COVID-19 symptoms. 
16. 
Symptom Reporting eDiary: Participants will be instructed to report via eDiary or telephone calls whether ILI and/or COVID-19 symptoms have 
been experienced on the following schedule: Once weekly from Day 1 through Day 181/EoS, if symptoms occur, participants will be directed to return to the 
study site as soon as possible, but no later than 72 hours after the onset of symptoms, for medical evaluation and an NP swab. 
17. 
Trained study personnel will call all participants to collect information related to any SAEs, MAAEs, AESIs, AEs leading to discontinuation, 
information on concomitant medications associated with those events, and any non-study vaccinations. 
18. 
All concomitant medications and non-study vaccinations will be recorded through 28 days after vaccination; all concomitant medications relevant 
to or for the treatment of an SAE, AESI, or MAAE will be recorded from Screening through Day 181/EoS. Historical use of facial injections and dermal fillers 
for cosmetic or medical indications such as migraine headaches will also be collected. 

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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 
1. 
PROTOCOL SUMMARY ............................................................................... 9 
1.1. 
Synopsis ........................................................................................................... 9 
1.2. 
Schema ........................................................................................................... 25 
1.3. 
Schedule of Events ........................................................................................ 26 
TABLE OF CONTENTS .................................................................................................. 29 
LIST OF TABLES ............................................................................................................ 36 
LIST OF FIGURES .......................................................................................................... 36 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ..................................... 37 
2. 
INTRODUCTION ......................................................................................... 40 
2.1. 
Background and Overview ............................................................................ 40 
2.1.1. 
mRNA-1010 .................................................................................................. 41 
2.1.2. 
mRNA-1273 .................................................................................................. 41 
2.1.3. 
mRNA-1073 .................................................................................................. 42 
2.2. 
Study Rationale .............................................................................................. 42 
2.2.1. 
Nonclinical Studies ........................................................................................ 42 
2.2.2. 
Clinical Studies .............................................................................................. 44 
2.3. 
Benefit/Risk Assessment ............................................................................... 45 

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2.3.1. 
Potential Benefits of Study Participation ....................................................... 45 
2.3.2. 
Risks from Study Participation and Their Mitigation .................................... 45 
2.3.3. 
Overall Benefit/Risk Conclusion ................................................................... 46 
3. 
OBJECTIVES AND ENDPOINTS ............................................................... 48 
4. 
STUDY DESIGN .......................................................................................... 50 
4.1. 
General Design .............................................................................................. 50 
4.2. 
Scientific Rationale for Study Design ........................................................... 52 
4.3. 
Choice of Vaccine Doses ............................................................................... 53 
4.4. 
End of Study Definition ................................................................................. 54 
5. 
STUDY POPULATION ................................................................................ 55 
5.1. 
Inclusion Criteria ........................................................................................... 55 
5.2. 
Exclusion Criteria .......................................................................................... 56 
5.3. 
Lifestyle Restrictions ..................................................................................... 57 
5.4. 
Screen Failures ............................................................................................... 58 
6. 
STUDY TREATMENT ................................................................................. 59 
6.1. 
Investigational Products Administered .......................................................... 59 
6.2. 
Randomization and Blinding ......................................................................... 59 
6.3. 
Preparation/Handling/Storage/Accountability ............................................... 60 
6.3.1. 
Preparation of Study Vaccine ........................................................................ 60 
6.3.2. 
Study Vaccine Administration ....................................................................... 60 
6.3.3. 
Study Vaccine Delivery and Receipt ............................................................. 60 
6.3.4. 
Study Vaccine Packaging and Labeling ........................................................ 61 
6.3.5. 
Study Vaccine Storage ................................................................................... 61 

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6.3.6. 
Study Vaccine Accountability ....................................................................... 61 
6.3.7. 
Study Vaccine Handling and Disposal .......................................................... 62 
6.4. 
Study Intervention Compliance ..................................................................... 62 
6.5. 
Prior and Concomitant Medications .............................................................. 62 
6.5.1. 
Prior Medications and Therapies ................................................................... 62 
6.5.2. 
Concomitant Medications and Therapies ...................................................... 62 
6.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination of 
a Participant From Per-Protocol Analyses ...................................................... 63 
6.6. 
Intervention After the End of the Study ........................................................ 64 
7. 
DELAY OR DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL .......................... 65 
7.1. 
Pause Rules .................................................................................................... 65 
7.1.1. 
Pause Rules Based on the Occurrence of a Single Event and Adjudicated by 
the Data and Safety Monitoring Board .......................................................... 65 
7.1.2. 
Pause Rules Based on the Occurrence of Events in a Proportion of 
Participants .................................................................................................... 66 
7.2. 
Criteria for Delay of Vaccine Administration ............................................... 67 
7.2.1. 
Individual Participant Criteria for Delay of Study Vaccination .................... 67 
7.3. 
Participant Discontinuation/Withdrawal From the Study .............................. 67 
7.4. 
Lost to Follow-up .......................................................................................... 69 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................... 70 
8.1. 
Safety Assessments and Procedures .............................................................. 70 
8.1.1. 
Use of Electronic Diaries ............................................................................... 71 
8.1.2. 
Safety Telephone Call .................................................................................... 72 

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8.1.3. 
Pregnancy Testing ......................................................................................... 73 
8.1.4. 
Vital Sign Measurements ............................................................................... 73 
8.1.5. 
Safety Laboratory Assessments ..................................................................... 73 
8.1.6. 
Physical Examinations ................................................................................... 74 
8.1.7. 
Electrocardiogram (ECG) .............................................................................. 74 
8.1.8. 
Assessment for Respiratory Viral Infection .................................................. 74 
8.2. 
Immunogenicity Assessments ....................................................................... 75 
8.3. 
Efficacy Assessments .................................................................................... 76 
8.4. 
Safety Definitions and Related Procedures ................................................... 76 
8.4.1. 
Adverse Event ................................................................................................ 76 
8.4.2. 
Serious Adverse Events ................................................................................. 77 
8.4.3. 
Solicited Adverse Reactions .......................................................................... 78 
8.4.4. 
Medically Attended Adverse Events ............................................................. 80 
8.4.5. 
Influenza-like Illness ..................................................................................... 81 
8.4.6. 
Suspicion of SARS-CoV-2 Infection ............................................................. 81 
8.4.7. 
Adverse Event of Special Interest .................................................................. 82 
8.4.8. 
Recording and Follow-up of Pregnancy ........................................................ 83 
8.4.9. 
Eliciting and Documenting Adverse Events .................................................. 84 
8.4.10. 
Assessment of Intensity ................................................................................. 84 
8.4.11. 
Assessment of Causality ................................................................................ 85 
8.4.12. 
Reporting Adverse Events ............................................................................. 85 
8.4.13. 
Reporting Serious Adverse Events ................................................................ 86 
8.4.14. 
Reporting of Adverse Events of Special Interest ........................................... 86 

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8.4.15. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information ............................................................................ 87 
8.4.16. 
Method of Detecting AEs and SAEs ............................................................. 88 
8.4.17. 
Follow-up of AEs and SAEs .......................................................................... 88 
8.4.18. 
Regulatory Reporting Requirements for SAEs .............................................. 88 
8.5. 
Safety Monitoring Committees...................................................................... 89 
8.5.1. 
Internal Safety Team ...................................................................................... 89 
8.5.2. 
Data and Safety Monitoring Board ................................................................ 89 
8.5.3. 
Cardiac Event Adjudication Committee ........................................................ 89 
8.6. 
Treatment of Overdose .................................................................................. 89 
8.7. 
Pharmacokinetics ........................................................................................... 90 
8.8. 
Pharmacodynamics ........................................................................................ 90 
8.9. 
Biomarkers ..................................................................................................... 90 
8.10. 
Health Economics .......................................................................................... 90 
9. 
STATISTICAL ANALYSIS PLAN .............................................................. 91 
9.1. 
Blinding and Responsibility for Analyses ..................................................... 91 
9.1.1. 
Breaking the Blind ......................................................................................... 92 
9.2. 
Statistical Hypotheses .................................................................................... 92 
9.3. 
Sample Size Determination ........................................................................... 92 
9.4. 
Analysis Sets .................................................................................................. 93 
9.5. 
Statistical Methods ......................................................................................... 94 
9.5.1. 
Baseline Characteristics and Demographics .................................................. 94 
9.5.2. 
Safety Analyses ............................................................................................. 94 

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9.5.3. 
Immunogenicity Analysis .............................................................................. 95 
9.5.4. 
Exploratory Analyses ..................................................................................... 96 
9.5.5. 
Subgroup Analyses ........................................................................................ 96 
9.6. 
Planned Analyses ........................................................................................... 96 
9.6.1. 
Interim Analysis ............................................................................................. 96 
9.6.2. 
Final Analyses ............................................................................................... 97 
10. 
REFERENCES .............................................................................................. 98 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................... 100 
11.1. 
APPENDIX 1: Study Governance Considerations ...................................... 100 
11.1.1. 
Regulatory and Ethical Considerations ....................................................... 100 
11.1.2. 
Study Monitoring ......................................................................................... 100 
11.1.3. 
Audits and Inspections ................................................................................. 101 
11.1.4. 
Financial Disclosure .................................................................................... 102 
11.1.5. 
Recruitment Strategy ................................................................................... 102 
11.1.6. 
Informed Consent/Assent Process ............................................................... 103 
11.1.7. 
Protocol Amendments ................................................................................. 104 
11.1.8. 
Protocol Deviations ..................................................................................... 104 
11.1.9. 
Data Protection ............................................................................................ 104 
11.1.10. 
Sample Retention and Future Biomedical Research ................................... 105 
11.1.11. 
Safety Oversight .......................................................................................... 106 
11.1.12. 
Dissemination of Clinical Study Data ......................................................... 106 
11.1.13. 
Data Quality Assurance and Quality Control .............................................. 106 

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11.1.14. 
Data Collection and Management ............................................................... 107 
11.1.15. 
Source Documents ....................................................................................... 108 
11.1.16. 
Retention of Records ................................................................................... 108 
11.1.17. 
Study and Site Closure................................................................................. 108 
11.1.18. 
Publication Policy ........................................................................................ 109 
11.2. 
APPENDIX 2: Contraceptive Guidance ...................................................... 110 
11.3. 
APPENDIX 3: Adverse Events of Special Interest Terms .......................... 112 
11.4. 
APPENDIX 4: CDC Working Case Definition of Pericarditis, Myocarditis, 
and Myopericarditis Occurring After Receipt of COVID-19 mRNA 
Vaccines ....................................................................................................... 115 
11.5. 
APPENDIX 5: Protocol Amendment History ............................................. 117 
11.5.1. 
Amendment 1 (25 Feb 2022) ....................................................................... 117 
 
 
 

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LIST OF TABLES 
Table 1 
Schedule of Events .....................................................................................................26 
Table 2 
Study Objectives and Endpoints .................................................................................48 
Table 3 
Study Arms .................................................................................................................51 
Table 4 
Pause Rule Criteria, Events, and Thresholds – Single Event .....................................65 
Table 5 
Pause Rule Criteria, Events, and Thresholds – Proportion of Participants ................66 
Table 6 
Solicited Adverse Reactions and Grades ....................................................................79 
Table 7 
Randomized Sample Size Calculations ......................................................................93 
Table 8 
Analysis Sets ...............................................................................................................93 
Table 9 
Analysis Strategy for Safety Parameters ....................................................................95 
Table 10 
Adverse Events of Special Interest ...........................................................................112 
Table 11 
CDC Working Case Definition of Pericarditis, Myocarditis, and 
Myopericarditis Occurring After Receipt of COVID-19 mRNA Vaccines .............115 
  
LIST OF FIGURES 
Figure 1 
Study Schema .............................................................................................................25 
Figure 2 
Mouse Immunogenicity Data .....................................................................................43 
 

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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 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine aminotransferase 
AR 
adverse reaction 
ARDS 
acute respiratory distress syndrome 
AST 
aspartate aminotransferase 
bAb 
binding antibody 
BLA 
Biologics License Application 
BMI 
body mass index 
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 
DSMB 
data safety monitoring board 
DSPC 
1,2-distearoyl-sn-glycero-3-phosphocholine 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eDiary 
electronic diary 
ELISA 
enzyme-linked immunosorbent assay 
EoS 
end of study 
EUA 
Emergency Use Authorization 

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Abbreviation or 
Specialist Term 
Definition 
EU-CTR 
European Union Clinical Trials Regulation 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FIH 
first-in-human 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
GMFR 
geometric mean fold rise 
GMR 
geometric mean ratio 
HA 
hemagglutinin  
HAI 
hemagglutination inhibition 
HCP 
healthcare practitioner 
HELLP 
hemolysis, elevated liver enzymes, and low platelet count 
HRT 
hormone replacement therapy 
IA 
interim analysis 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
ILI 
influenza-like illness 
IM 
intramuscular 
IND 
investigational new drug 
IP 
investigational product 
IRT 
interactive response technology 
IST 
internal safety team 
IRB 
Institutional Review Board 
LLOQ 
lower limit of quantification 
LTFU 
lost to follow-up 
MAAE 
medically attended adverse event 

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Abbreviation or 
Specialist Term 
Definition 
MedDRA 
Medical Dictionary for Regulatory Activities 
mRNA 
messenger RNA 
nAb 
neutralizing antibody 
NH 
Northern Hemisphere  
NP 
nasopharyngeal 
PEG-2000-DMG 
1-monomethoxypolyethyleneglycol-2,3-dimyristylglycerol with polyethylene 
glycol of average molecular weight 2000 
PP 
per-protocol 
PsVNA 
pseudovirus neutralization assay 
RT-PCR 
reverse transcriptase polymerase chain reaction 
S-2P 
prefusion stabilized Spike protein 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SH 
Southern Hemisphere  
SCR 
seroconversion rate 
SoE 
schedule of events 
SRR 
seroresponse rate 
ULOQ 
upper limit of quantification 
US 
United States 
USP 
United States Pharmacopeia 
WHO 
World Health Organization 
 
 
 

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2. 
INTRODUCTION 
2.1. 
Background and Overview  
ModernaTX, Inc. (the Sponsor) is developing mRNA-1073, a custom manufactured lipid-
encapsulated messenger RNA (mRNA)-based prophylactic vaccine encoding for antigens from 
influenza viruses and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). mRNA-
1073 encodes for the respective antigens also encoded for by mRNA-1010 and mRNA-1273 
(also known as Moderna coronavirus disease 2019 [COVID-19] vaccine). 
Seasonal influenza viruses are estimated by the World Health Organization (WHO) to cause 3 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). Because 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 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). 
Currently, licensed seasonal influenza virus vaccines rarely exceed 50% overall effectiveness 
and are poorly effective during years when the circulating viruses do not match the strains 
selected for the vaccine antigens (CDC 2020). Influenza vaccines based on mRNA technology 
could provide several benefits compared to current vaccines, including the ability to respond to 
strain changes more quickly, avoidance of mutations that may be acquired during vaccine 
production in eggs or cell culture, stronger immune responses, as well as improved protection in 
older adults (Rockman et al 2020). 
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 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 
19 Apr 2022 (WHO 2021). 

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The Sponsor has developed a rapid-response, proprietary vaccine platform based on an 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 is expressed transiently. 
2.1.1. 
mRNA-1010 
The Sponsor is using its mRNA-based platform to develop a custom manufactured lipid 
nanoparticle-encapsulated, mRNA-based vaccine against diseases caused by influenza virus 
types A and B. The proposed development candidate mRNA-1010 is a quadrivalent vaccine 
containing mRNAs that encode for the hemagglutinins (HAs) of the 4 strains recommended by 
the WHO for cell- or recombinant-based vaccines. Equal amounts of mRNAs that encode for 
membrane-bound wild-type versions of each of the 4 different strains will be used for the HA 
components. The mRNA-1010 development candidate will be administered as a single 
intramuscular (IM) injection and aims to elicit protection from all seasonal influenza viruses 
covered by the vaccine. 
The Sponsor is conducting a first-in-human (FIH) Phase 1/2 study of mRNA-1010 
(NCT04956575), a seasonal influenza vaccine, to establish preliminary safety, reactogenicity, 
and immunogenicity data and recently initiated a pivotal Phase 3 study (NCT05415462) to 
evaluate the safety and immunological non-inferiority of mRNA-1010 to a licensed seasonal 
influenza vaccine in adults 18 years and older.  
2.1.2. 
mRNA-1273 
mRNA-1273 encodes for the full-length S protein of SARS-CoV-2, modified to introduce 
2 proline residues to stabilize the S protein (S-2P) in a prefusion conformation. The CoV-S 
protein mediates attachment and entry of the virus into host cells (by fusion), making it a primary 
target for neutralizing antibodies (nAbs) that prevent infection (Corbett et al 2020). It has been 
confirmed that the stabilized SARS-CoV-2 S-2P antigen presents in the correct prefusion 
conformation (Wrapp et al 2020). 
In December 2020, mRNA-1273 was granted Emergency Use Authorization (EUA) in the 
United States (US) for the prevention of COVID-19 for individuals 18 years of age and older. 
Additional approvals have been granted for the use of mRNA-1273 globally. mRNA-1273 is 
currently being evaluated for safety, immunogenicity, and efficacy in ongoing Phase 1 
(NCT04283461), Phase 2 (NCT04405076), and Phase 3 (NCT04470427) trials. All 3 trials have 
been modified to allow for unblinding and crossover or to assess safety and immunogenicity of 
booster doses of vaccine. In November 2021, the US Food and Drug Administration (FDA) 

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granted EUA for an mRNA-1273 booster dose (
 to be given at least 5 months after the 
primary series with mRNA-1273 in adults aged 18 years and older. 
In August 2021, the Sponsor filed a Biologics License Application (BLA) with the FDA for the 
full licensure of the mRNA-1273 vaccine for active immunization to prevent COVID-19 in 
individuals 18 years of age and older. In January 2022, the US FDA approved the BLA for 
SPIKEVAX (mRNA-1273) to prevent COVID-19 in individuals 18 years of age and older. 
2.1.3. 
mRNA-1073 
mRNA-1073 is a custom manufactured lipid-encapsulated mRNA-based prophylactic vaccine 
encoding for antigens from influenza viruses and SARS-CoV-2. 
2.2. 
Study Rationale 
The administration of mRNA-1073 vaccine, encoding for the respective antigens also encoded 
for by mRNA-1010 (seasonal influenza) and mRNA-1273 (SARS-CoV-2), has the potential to 
efficiently reduce the overall burden of acute viral respiratory diseases by providing 
simultaneous protection against influenza and SARS-CoV-2 viruses in a convenient dosing 
regimen. mRNA-1073 offers greater convenience and has the potential to lead to increased 
compliance with vaccine recommendations, which has been frequently utilized for pediatric 
vaccines (Kurosky et al 2017). Furthermore, this combined regimen could provide a public 
health benefit through synergistically increasing coverage rates against influenza and SARS-
CoV-2 viruses. The Sponsor is developing mRNA-1073, a custom manufactured lipid-
encapsulated mRNA-based prophylactic vaccine encoding for antigens from influenza viruses 
and SARS-CoV-2.  
This Phase 1/2 study will collect safety and immunogenicity data to further inform the clinical 
development of mRNA-1073. 
2.2.1. 
Nonclinical Studies 
A mouse immunogenicity study has confirmed that a combined vaccination (mixture) with 
mRNA-1010 and mRNA-1273 results in potent immune responses against all included antigens 
with no observed immune interference or synergistic or additive responses. Mice were 
immunized twice with mRNA-1010 or mRNA-1273 or a combination of both (mixed before 
administration). Antibody titers (immunoglobulin G) were measured against all antigens by 
enzyme-linked immunosorbent assay (ELISA) post prime (Day 21) and post boost (Day 36), and 
serological data are depicted in Figure 2.  
CCI

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Figure 2 
Mouse Immunogenicity Data 
 
Abbreviations: d21 = Day 21; d36 = Day 36; ELISA = enzyme-linked immunosorbent assay; HA = hemagglutinin; 
IgG = immunoglobulin G; mRNA = messenger RNA; PBS = phosphate buffered saline; S2P = stabilized 
SARS-CoV-2 spike protein; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.  
IgG binding antibody titers determined by ELISA using recombinant A/Wisconsin/588/2019 H1, A/Hong 
Kong/45/2019 H3, B/Washington/02/2019 HA, B/Phuket/3073/2013 HA and SARS-CoV-2 S2P proteins. Titers 
were determined using a 4-parameter logistic curve fit in GraphPad Prism (GraphPad Software, Inc.) and defined 
as the reciprocal dilution at approximately OD450nm = 1.5 (normalized to a mouse standard on each plate). Mice 
were immunized individually with mRNA-1010 (1 µg or 2 µg) or mRNA-1273 (1 µg) or a combination of mRNA-
1010 + mRNA-1273 (1 µg + 1 µg [1:1 ratio] or 2 µg + 1 µg [2:1 ratio]). The immunization was a prime/boost 
regimen with a 3-week interval. d21 = 3 weeks post prime, and d36 = 2 weeks post boost.  

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Immunogenicity studies in rats (not performed according to Good Laboratory Practice [GLP] 
standards) with safety endpoints (body weights, clinical observations, hematology, and clinical 
chemistry) have been completed for the individual vaccines (Seasonal Flu [mRNA-1010, 
investigational new drug (IND) 27460]; SARS-CoV-2 [mRNA-1273, IND 19635]) used in this 
study. The studies evaluated the immunogenicity and safety of the vaccine at 30, 60, or 
100 μg/dose by IM bolus injection on Days 1 and 22 in Sprague Dawley rats (reports 20287009 
and 2308-123, respectively). Both mRNA-1010 and mRNA-1273 were well tolerated at all dose 
levels and produced robust antibody responses against the target antigen(s). In both studies, there 
were no test article-related effects on mortality or body weights detected. Clinical observations 
included transient edema and erythema at the injection site that fully resolved within 4 to 5 days. 
Hematology and clinical chemistry changes on Day 23 (24 hours post last dose) were generally 
consistent between the 2 test articles, mild to moderate in magnitude, and indicative of an 
inflammatory and/or immune response (such as higher neutrophil and eosinophil counts, along 
with increases in globulin and/or decreases in albumin with a concomitant lower 
albumin/globulin ratios, compared with control) with or without signs of diminished 
erythropoiesis (for example, lower reticulocyte counts that lacked corresponding changes in red 
cell mass parameters) that were considered secondary to the inflammatory/immune response. 
Test article related, generally dose dependent clinical pathology changes were observed at 
≥ 8.9 µg/dose. Hematology changes included increases in white blood cells, neutrophils, and 
eosinophils and decreased lymphocytes; coagulation changes included increases in fibrinogen 
and activated partial thromboplastin time; and clinical chemistry changes included decreases in 
albumin, increases in globulin, and a corresponding decrease in albumin/globulin ratio. Clinical 
pathology changes generally reversed or were reversing by the end of the 2-week recovery 
period. Test article related, transient cytokine increases were observed at ≥ 8.9 µg/dose at 6 hours 
after dosing, including IP-10, MCP1, and MIP-1-α. Cytokine changes were generally reversing 
by the end of the 2-week recovery period. 
Overall, the findings of mRNA-1010 and mRNA-1273 in these non-GLP, repeat-dose rat studies 
were consistent with the aggregate GLP platform toxicology package. 
2.2.2. 
Clinical Studies 
No clinical studies of combined administration of mRNA-1010 and mRNA-1273 or with 
mRNA-1073 have been performed to date.  
Development of mRNA-1273 is outlined in Section 2.1.2. 
The Sponsor is currently evaluating mRNA-1010 in the mRNA-1010-P101 study 
(NCT04956575), the FIH Phase 1/2 clinical study to establish preliminary safety and 
immunogenicity data at 3 dose levels of vaccine (50, 100, and 200 µg) against a placebo control. 

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The study comprises 3 parts with a total of 880 participants: Phase 1/2 (placebo-controlled), 
Phase 2 NH (active-controlled), and Phase 2 Extension (active-controlled). The Phase 1/2 and 
Phase 2 NH parts are completed and have evaluated mRNA-1010 at doses of 25, 50, 100, and 
200 µg. An additional Phase 2 Extension part is intended to support shelf-life at lower doses 
(6.25, 12.5, 25 µg), and has been initiated; the Phase 2 Extension will be completed in Q4 2022. 
In June 2022, the Sponsor began enrolling adult participants ≥ 18 years of age in the mRNA-
1010-P301 study, a randomized, observer-blind, Phase 3 safety and immunogenicity of mRNA-
1010 (50 µg) vs. an active comparator (Fluarix). The selection of the 50 µg dose level is 
supported by the data from the Phase 1/2 and the Phase 2 NH interim analyses demonstrating an 
acceptable safety and reactogenicity profile and robust HAI responses for H1N1 and H3N2 
strains with Day 29 geometric mean titers (GMTs) that were higher than the licensed 
comparator.  
There is also precedence for co-administering mRNA-1273 with an influenza vaccine. Interim 
results from the co-administration study of mRNA-1273 boost (100 μg) and Fluzone High-Dose 
Quadrivalent vaccines in approximately 300 adults 65 years and older demonstrated similar 
safety, tolerability, and immunogenicity responses compared to each vaccine administered 
individually (NCT04969276). 
2.3. 
Benefit/Risk Assessment 
2.3.1. 
Potential Benefits of Study Participation 
The following benefits may accrue to participants who receive mRNA-1010 and/or mRNA-1273 
vaccine as booster doses:  
• The mRNA-1273 vaccine as a booster dose may provide improved protection against 
SARS-CoV-2 and its variants.  
• Participants will have a baseline (Day 1) evaluation for respiratory pathogens, including 
influenza virus and SARS-CoV-2, and ongoing surveillance for influenza-like illness 
(ILI) and/or COVID-19 throughout the study.  
• The study will contribute to the development of a potentially efficacious vaccine against 
seasonal influenza virus and SARS-CoV-2 given together as a single injection. 
2.3.2. 
Risks from Study Participation and Their Mitigation 
Adverse events (AEs) ranging from immediate mild allergic reactions (eg, urticaria) to systemic 
allergic reactions (eg, anaphylaxis) may occur following any vaccination. Systemic allergic 
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). Since the authorization 

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of the mRNA-1273 vaccine for COVID-19, the US Centers for Disease Control and Prevention 
(CDC) estimate of the rate of anaphylaxis based on reporting in the Vaccine Adverse Event 
Reporting System is approximately 2.5 cases/million doses administered (Shimabukuro 
et al 2021). As a precaution, all participants will remain under observation at the study site for a 
minimum of 60 minutes after injection.  
Vasovagal syncope (fainting) can occur before or after any vaccination, is usually triggered by 
pain or anxiety associated with the injection and is not related to the substance injected. 
Therefore, it is important that standard precautions and procedures are followed to avoid injury 
from fainting.  
Intramuscular injection with other mRNA vaccines manufactured by the Sponsor containing the 
proprietary SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl)(6-oxo-6-
(undecyloxy)hexyl)amino)octanoate) lipid formulation have commonly resulted in transient and 
self-limiting local inflammatory reactions. These typically included pain, erythema (redness), or 
swelling (hardness) at the injection site, which were mostly mild to moderate in severity and 
usually occurred within 24 hours of injection. Laboratory abnormalities (including increases in 
liver function tests and serum lipase levels) following injection have been observed in early 
phase clinical studies with similar mRNA-based vaccines. These abnormalities were without 
clinical symptoms or signs and returned toward baseline (Day 1) values over time.  
In an ongoing Phase 3 study of mRNA-1273 vaccine for COVID-19 in 30,346 adults, the most 
commonly reported local reactions included injection site pain, axillary lymphadenopathy, and 
injection site erythema. Most of these reactions were Grade 1 or 2 in severity and resolved within 
3 to 4 days of onset. The most commonly reported systemic reactions were fatigue, headache, 
myalgia, arthralgia, and chills. In most cases, the reactions resolved spontaneously within several 
days.  
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 study participants should be alert to the signs and symptoms of 
myocarditis and pericarditis. The risk of myocarditis after a third dose (0.5 mL, 
) or 
booster dose (0.25 mL, 
) of the Sponsor’s COVID-19 vaccine has not yet been 
characterized. 
2.3.3. 
Overall Benefit/Risk Conclusion 
Safety and immunogenicity data from the interim analyses of the mRNA-1010-P101 study 
(Phase 1/2 and Phase 2 NH study portions) demonstrated no significant safety concerns (doses 
tested ranged from 
 of mRNA-1010). Vaccination with mRNA-1010 elicited 
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hemagglutination inhibition (HAI) antibodies against all strains at all dose levels in the Phase 1/2 
portion (see Section 4.3 and the mRNA-1010 Investigator’s Brochure [IB]).  
While efficacy has been established for mRNA-1273, the combined administration of 
mRNA-1010 and mRNA-1273 as separate vaccines or as mRNA-1073 may or may not offer 
further protection against seasonal influenza and COVID-19, respectively. 
Safety findings will be monitored and periodically reviewed by the study team members, an 
internal safety team (IST), and DSMB to evaluate the safety status of all participants. The IST 
and DSMB will review and assess the safety data as described in Section 8.5. All participants 
will be followed up for 6 months after the study vaccination.  
Considering the nonclinical data for the combined administration of mRNA-1010 and 
mRNA-1273 vaccines and the safety and immunogenicity data for mRNA-1010, 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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3. 
OBJECTIVES AND ENDPOINTS 
The objectives and endpoints of this study are described in Table 2.  
Table 2 
Study Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
 
• 
To evaluate the safety and reactogenicity 
of study vaccines 
• 
Frequency and grade of each solicited local and 
systemic reactogenicity AR during a 7-day 
follow-up period post vaccination 
• 
Frequency and severity of any unsolicited AEs 
during the 28-day follow-up period post 
vaccination 
• 
Frequency of any SAEs, AESIs, MAAEs, and 
AEs leading to discontinuation from Day 1 to 
Day 181/EoS 
Secondary  
  
• 
To evaluate the humoral immunogenicity 
to vaccine-matched strains for influenza 
and SARS-CoV-2 across study vaccine 
arms at Day 29 
• 
GMT and GMFR at Day 29 compared with 
Day 1 (baseline) by HAI assay for influenza and 
PsVNA (or binding antibody assay) for SARS-
CoV-2 
• 
Influenza: Percentage of participants with 
seroconversion, defined as a Day 29 titer ≥ 1:40 
if baseline is < 1:10 or a 4-fold or greater rise if 
baseline is ≥ 1:10 in anti-HA antibodies 
measured by HAI assay 
• 
SARS-CoV-2: Percentage of participants with 
seroresponse, defined as a Day 29 titer ≥ 4-fold if 
baseline is ≥ LLOQ or ≥ 4 × LLOQ if baseline 
titer is < LLOQ in nAb titers measured by 
PsVNA (or binding antibody assay) 
• 
To evaluate the humoral immunogenicity 
to vaccine-matched strains for influenza 
and SARS-CoV-2 at all evaluable 
humoral immunogenicity time points 
• 
GMT and GMFR compared with Day 1 
(baseline) by HAI for influenza and PsVNA (or 
binding antibody assay) for SARS-CoV-2 
• 
Percentages of participants with seroconversion 
(influenza) and seroresponse (SARS-CoV-2) as 
defined above 

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Objectives 
Endpoints 
Exploratory (may be performed) 
 
• 
To evaluate the humoral immunogenicity 
against vaccine mismatched strains 
• 
GMT and GMFR (compared to Day 1) to vaccine 
mismatched strains  
• 
To evaluate the humoral immunogenicity 
against vaccine-matched and 
mismatched strains using alternative 
methods 
• 
GMT and GMFR (compared to Day 1) to 
vaccine-matched and mismatched strains assayed 
by alternative methods (eg, microneutralization 
assay for influenza or ligand-binding assay for 
SARS-CoV-2) 
• 
To evaluate cellular immunogenicity in a 
subset of participants 
• 
Frequency, magnitude, and phenotype of 
virus-specific T-cell and B-cell responses 
measured by flow cytometry or other methods, 
and to perform targeted repertoire analysis of B 
cells and T cells after vaccination 
• 
To further characterize the immune 
response across study vaccines 
• 
Frequency, specificities, or other endpoints to be 
determined for the further characterization of 
immune responses 
• 
To assess the occurrence of clinical 
influenza and COVID-19 in study 
participants and characterize their 
immune response to infection and viral 
isolates 
• 
Frequency of laboratory-confirmed clinical 
influenza and COVID-19 and assessment of 
immune responses to infection and viral isolates 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; COVID-19 = 
coronavirus disease 2019; EoS = end of study; GMFR = geometric mean fold rise; GMT = geometric mean titer; 
HA = hemagglutinin; HAI = hemagglutination inhibition; LLOQ = lower limit of quantification; MAAE = 
medically attended adverse event; nAb = neutralizing antibody; PsVNA = pseudovirus neutralization assay; SAE = 
serious adverse event; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. 

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4. 
STUDY DESIGN 
4.1. 
General Design 
This is a Phase 1/2, randomized, stratified, observer-blind study to evaluate the safety, 
reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 
and mRNA-1273 vaccines and to the individual vaccines alone in healthy adults 18 to 75 years 
of age. 
Participants in the study will participate in a Screening period (up to 28 days before Day 1), 
treatment period (single dose of vaccine on Day 1), and a follow-up period (up to 6 months after 
vaccination). The study schema is presented in Figure 1. 
On Day 1, each participant will receive 2 injections administered IM, one in each arm, in the 
deltoid muscle. The vaccines to be tested include: 1) mRNA-1273 vaccine encoding for the 
full-length S protein of SARS-CoV-2, modified to introduce S-2P in a prefusion conformation; 
2) mRNA-1010 vaccine encoding for the HA surface glycoproteins of the 4 strains by the WHO 
for the 2022 SH influenza season cell- or recombinant-based vaccines; and 3) mRNA-1073 
vaccine encoding for the respective antigens also encoded for by mRNA-1010 and mRNA-1273. 
The placebo and the diluent for mRNA-1073 vaccine will be 0.9% sodium chloride (normal 
commercial saline) injection, which meets the criteria of the US Pharmacopeia (USP). 
The study will enroll approximately 550 generally healthy adults 18 to 75 years of age who were 
previously fully vaccinated for COVID-19 primary series with a locally authorized and approved 
SARS-CoV-2 vaccine, and their last COVID-19 vaccine (primary series or booster) must be 
≥ 120 days prior (or less per local guidance) to the randomization visit. Participants must not 
have received a licensed influenza vaccine within ≤ 180 days of randomization and have no 
known history of confirmed influenza infection within ≤ 180 days or SARS-CoV-2 infection 
within ≤ 90 days of Screening. Randomization will be stratified by age (18 to 49 years old and 
50 to 75 years old, balanced across the 2 age groups within each vaccination group). A complete 
listing of inclusion and exclusion criteria is provided in Section 5. The numbers of participants 
and groups are shown in Table 3.  

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Table 3 
Study Arms 
# 
Group Name 
Sample Size (N=550) 
1 
mRNA-1273
+ placebo 
50 
2 
mRNA-1010
+ placebo 
100 
3 
mRNA-1010
 + mRNA-1273
co-administration 
100 
4 
mRNA-1073
 + placebo  
100 
5 
mRNA-1073
 placebo  
100 
6 
mRNA-1073
 placebo 
100 
The Schedule of Events (SoE) is provided in Table 1. 
Participants will have 6 visits and 4 safety phone calls. Vaccines (mRNA-1073, mRNA-1010, or 
mRNA-1273) and placebo (as indicated) will be administered as IM injections, one in each arm, 
in the deltoid muscle. Safety and/or immunogenicity and/or biomarkers study visits will occur on 
Days 4, 8, 29, and 181 (end of study [EoS]). Study visits will include scheduled safety phone 
calls at Days 57, 91, 121, and 151 to collect adverse events (AEs), medically attended AEs 
(MAAEs), AEs of special interest (AESIs), AEs leading to withdrawal, serious adverse events 
(SAEs), and information about concomitant medications and receipt of non-study vaccinations. 
At the dosing visit on Day 1, participants will be instructed how to record solicited ARs within 
the provided electronic diary (eDiary). Solicited ARs will be collected for 7 days (the day of 
injection and the following 6 days), and local solicited ARs will be collected separately for each 
injection site. Unsolicited AEs will be collected for 28 days (the day of injection and the 
following 27 days) after injection; SAEs, MAAEs, AEs leading to withdrawal, and AESIs will 
be collected throughout the study. All participants will be tested for the presence of 
SARS-CoV-2 and influenza antigens at baseline via nasopharyngeal (NP) swabs (Day 1) and at 
any unscheduled visits. Blood draws will be collected on Days 1, 8, 29, and 181/EoS. There will 
be an additional visit on Day 4 at which blood will be drawn for future biomarker assessment. 
Optionally, blood draws for genomic analysis will be collected at Day 1 and for transcriptomic 
analysis at Days 1, 8, and 29. The collected samples will be processed and analyzed per the 
Laboratory Manual. Active surveillance for intercurrent or breakthrough SARS-CoV-2 infection 
will occur throughout the study and reported as AEs (confirmed symptomatic infections will be 
reported as MAAEs if not SAEs). Participants with signs and symptoms meeting the CDC case 
definition for COVID-19 (21 February 2021 or most recent; CDC 2021b) will be asked to 
contact the site and undergo prompt assessment, which will include reverse transcriptase 
polymerase chain reaction (RT-PCR) testing (of a respiratory sample) to assess symptomatic 
COVID-19. Participants with any clinical or radiographic evidence of pneumonia will also 
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undergo RT-PCR testing. Suspected COVID-19 cases will also be tested using a multiplex assay 
to assess for non-SARS-CoV-2 causes of upper or lower respiratory tract infection. Participants 
will have blood samples collected at scheduled study site visits during the study for 
immunogenicity assessments or other medical concerns according to the investigator’s judgment.  
Participants may experience AEs (including symptoms of COVID-19) that necessitate an 
unscheduled visit. There may also be situations in which the investigator asks a participant to 
report for 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. 
The IST will conduct ad hoc reviews throughout the study, as requested by the study medical 
monitor and the 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. Safety data will be reviewed as needed when study stopping or pausing criteria 
are met, or as otherwise requested by the study team and/or IST as described in the DSMB 
charter. See Section 8.5 for details on the IST and DSMB constituted in this study.  
An interim analysis (IA) will be performed after all 550 participants randomized into Group 1 
through Group 6 have completed their Day 29 visit assessments and will include the safety and 
immunogenicity data collected up to Day 29. The final study analysis will be completed for all 
participants after Day 181/EoS. 
This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), and 
all applicable regulatory requirements. 
4.2. 
Scientific Rationale for Study Design 
This study is designed as a randomized, stratified, observer-blind study to evaluate the safety, 
reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 
and mRNA-1273 and to mRNA-1010 vaccine and mRNA-1273 vaccine administered alone in 
healthy adults 18 to 75 years of age. The purpose of this Phase 1/2 study (mRNA-1073-P101) is 
to generate sufficient safety and immunogenicity data to enable the initiation of a Phase 2/3 
study. 
All participants will provide NP swab samples before the injection on Day 1 for assessment of 
infection with respiratory pathogens, including influenza virus and SARS-CoV-2, as influenza or 
COVID-19 symptoms may confound reactogenicity assessments. Furthermore, NP swab samples 
for assessment of infection with respiratory pathogens, including influenza virus and 
SARS-CoV-2, will be collected anytime from Day 1 through Day 181/EoS if the participants 
have protocol-defined ILI or symptoms suggestive of COVID-19 or other upper or lower 

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respiratory infection at the investigator’s discretion. Additionally, clinical information may be 
collected to evaluate the severity of the clinical case.  
4.3. 
Choice of Vaccine Doses 
The Sponsor is currently conducting mRNA-1010-P101, the FIH Phase 1/2 study of mRNA-
1010 to establish preliminary safety, reactogenicity, and immunogenicity data at 3 dose levels of 
vaccine (
) against a placebo control (NCT04956575). The IA1 of safety data 
at Day 29 of 180 healthy adults (45 participants per group) in the United States showed no 
significant safety concerns for the doses tested, with the 
 dose of mRNA-1010 having the 
most favorable reactogenicity profile. The immunogenicity data at Day 29 showed that 
mRNA-1010 elicited immune responses as measured by HAI for all 4 strains included in the 
vaccine, across all dose levels and age groups. Encouragingly, all 3 dose levels elicited similar 
levels of immune responses. Additional information is available in the IB. 
The mRNA-1010-P101 study has enrolled 498 adults in a Phase 2 NH cohort in 4 groups: 
 
mRNA-1010 (n=151), 
 mRNA-1010 (n=147), 
 mRNA-1010 (n=147), and Afluria 
(n=53). The IA2 of safety data through Day 29 demonstrated no significant safety concerns. The 
frequency and severity of the reports of solicited ARs in the mRNA-1010 groups were 
acceptable across all dose levels. 
IA1 and IA2 data through Day 29 for both the Phase 1/2 and the Phase 2 NH portions 
demonstrated local and systemic solicited ARs to be mostly mild to moderate in severity, without 
any Grade 4 ARs. There were no AESIs or AEs leading to study pauses. There were no SAEs or 
AEs leading to study discontinuation that were assessed as related to the study vaccine. 
Additional information is available in the IB. 
The Sponsor developed mRNA-1273, an mRNA-based vaccine against SARS-CoV-2. Having 
achieved the primary endpoint in a pivotal Phase 3 study for SARS-CoV-2 infection, mRNA-
1273 was granted EUA in December 2020 and BLA in January 2022 for the prevention of 
COVID-19 for individuals 18 years of age and older (Baden et al 2021). Given the potential for 
waning immunity, the emergence of highly transmissible SARS-CoV-2 variants, and the ability 
of some variants to partially escape immunity, the Sponsor assessed the immunogenicity and 
safety of a 
 booster immunization. The FDA has authorized for emergency use the 
administration of a single booster dose (
) of mRNA-1273 vaccine after completing the 
primary series of this vaccine in individuals 18 years of age and older. Additionally, the FDA 
recently amended the EUA to authorize a second booster dose for people 50 years of age and 
older and for certain immunocompromised individuals. Additional information is available in the 
IB.  
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Based on the Sponsor’s prior studies as described above, mRNA-1073 at dose levels of 
 
 are being assessed and are anticipated to be immunogenic and well 
tolerated.  
4.4. 
End of Study 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 the study vaccination on Day 1), as shown in 
the SoE (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 SoE (Table 1), for the last participant in the study. 
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5. 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria 
Each participant must meet all of the following criteria to be enrolled in this study: 
1. Adults 18 to 75 years of age at the time of consent (Screening Visit). 
2. Investigator assessment that participant understands and is willing and physically able to 
comply with protocol-mandated follow-up, including all procedures. 
3. Participant has provided written informed consent for participation in this study, 
including all evaluations and procedures as specified in this protocol. 
4. Body mass index (BMI) of 18 kg/m2 to 35 kg/m2 (inclusive) at the Screening Visit.  
5. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as postmenopausal or permanently sterilized. A 
follicle-stimulating hormone (FSH) level may be measured at the discretion of the 
investigator to confirm postmenopausal status (please see Section 11.2 for details). 
6. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all the following criteria: 
• Has a negative pregnancy test at the Screening Visit and on the day of vaccination 
(Day 1). 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to Day 1. 
• Has agreed to continue adequate contraception through 3 months following vaccine 
administration. Adequate female contraception is defined as consistent and correct 
use of a local health authority approved contraceptive method in accordance with the 
product label (Appendix 11.2). 
• Is not currently breastfeeding. 
7. Participants must have been fully vaccinated for COVID-19 primary series according to 
the locally authorized or approved regimen, and their last COVID-19 vaccine (primary 
series or booster) was ≥ 120 days prior to the randomization visit (or less per local 
guidance). 

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5.2. 
Exclusion Criteria 
Participants meeting any of the following criteria at the Screening Visit, unless noted otherwise, 
will be excluded from the study: 
1. Participant is acutely ill or febrile (temperature ≥ 38.0℃ [100.4°F]) 72 hours prior to or 
at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled 
within the 28-day Screening window and will retain their initially assigned participant 
number. 
2. Participant has a 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, provided that 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, due to therapies used to treat them (eg, immune-modifying 
treatments), at the discretion of the investigator. 
3. Participant has a reported history of congenital or acquired immunodeficiency, 
immunosuppressive condition, or immune-mediated disease. 
4. Participant has dermatologic conditions that could affect local solicited adverse reaction 
(AR) assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid areas). 
5. Participant has a reported history of anaphylaxis or severe hypersensitivity reaction after 
receipt of any mRNA vaccine(s) or any components of the mRNA vaccines. 
6. Participant has a reported history of bleeding disorder that is considered a 
contraindication to IM injection or phlebotomy. 
7. Participant has a diagnosis of malignancy within previous 10 years (excluding 
nonmelanoma skin cancer). 
8. Participant has 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. 

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9. Participant has received systemic immunosuppressants or immune-modifying drugs for 
> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of 
prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at 
any time during participation in the study. Inhaled, nasal, and topical steroids are not 
exclusionary. 
10. 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 before or after the study 
injections. 
11. Participant has received a seasonal influenza vaccine or any other investigational 
influenza vaccine ≤ 180 days prior to the randomization visit. 
12. Participant has tested positive for influenza by local health authority approved testing 
methods ≤ 180 days prior to the Screening Visit. 
13. Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 
as defined by the US CDC in the past 10 days prior to the Screening Visit. 
14. Participant has known history of SARS-CoV-2 infection within ≤ 90 days. 
15. Participant has received systemic immunoglobulins or blood products ≤ 90 days prior to 
the Screening Visit or plans to receive systemic immunoglobulins or blood products 
during the study. 
16. Participant has a history of myocarditis, pericarditis, or myopericarditis.  
17. 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. 
18. 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. 
19. Participant is an immediate family member or household member of study personnel, 
study site staff, or Sponsor personnel. 
20. Participant has clinical screening laboratory values (total white blood cell count, 
hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase 
(AST), creatinine, alkaline phosphatase, and total bilirubin) > Grade 1 (DHHS 2007). 
5.3. 
Lifestyle Restrictions 
Participants must not eat or drink anything hot or cold within 10 minutes before oral temperature 
is taken. Participants in the study should defer vaccination with an approved COVID-19 vaccine 

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or seasonal influenza vaccine until after completion of their Day 29 visit, and ideally until 
Day 181 visit, if such vaccines are available, and they have discussed with the investigators and 
have chosen to receive it. 
5.4. 
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. 
Minimum information includes date of informed consent, demography, reason(s) for screen 
failure, eligibility criteria, and information on any SAE that may have occurred from the time 
informed consent was obtained to the time of withdrawal. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened one time within the 28-day Screening window if they will be eligible upon 
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6. 
STUDY TREATMENT 
6.1. 
Investigational Products Administered 
The term investigational product (IP) refers to mRNA-1073, mRNA-1010, or mRNA-1273 
vaccine administered in this study.  
mRNA-1073 
mRNA-1073 is administered as a single dose and aims to elicit protection from influenza and 
SARS-CoV-2. mRNA-1073 contains mRNA coding for 4 HA antigens of the influenza virus 
strains recommended for the 2022 SH seasonal vaccines by the WHO and the mRNA for the 
S protein of SARS-CoV-2 virus formulated in a mixture of 4 lipids common to the Sponsor’s 
mRNA vaccine platform: SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine 
(DSPC), and 1-monomethoxypolyethyleneglycol-2,3-dimyristylglycerol with polyethylene 
glycol of average molecular weight 2000 (PEG-2000-DMG). mRNA-1073 is based on the 
antigens encoded for by mRNA-1010 and mRNA-1273 and is intended as a single annual dose 
for protection from seasonal influenza and SARS-CoV-2. Commercially available 0.9% sodium 
chloride, USP will be used as appropriate for dose preparation. 
mRNA-1010 
mRNA-1010 is administered as a single dose and aims to elicit protection from influenza A and 
B viruses. mRNA-1010 is a quadrivalent vaccine containing mRNAs encoding for the HAs of 
the 4 strains recommended by the WHO for 2022 SH cell- or recombinant-based vaccines 
formulated in a mixture of 4 lipids common to the Sponsor’s mRNA vaccine platform: SM-102, 
cholesterol, DSPC, and PEG-2000-DMG. Equal amounts of mRNAs encoding for each of the 
4 different strains are used for the HA components. mRNA-1010 is administered as a single dose 
and aims to elicit protection from all seasonal influenza viruses covered by the vaccine. 
mRNA-1273 
mRNA-1273 is administered as a single dose and aims to elicit protection from SARS-CoV-2. 
mRNA-1273 contains mRNA CX-024414 encoding for the S-2P of Wuhan-Hu-1. mRNA-1273 
consists of the mRNA formulated in a mixture of 4 lipids common to the Sponsor’s mRNA 
vaccine platform: SM-102, cholesterol, DSPC, and PEG-2000-DMG. 
6.2. 
Randomization and Blinding 
The Sponsor’s Biostatistics Department or designee will generate the randomized allocation 
schedule(s) for vaccination group assignment. Participants will be randomized in a 
 
 to receive mRNA-1273 (
 + placebo (50 participants), mRNA-1010 
 + placebo 
(100 participants), mRNA-1010 (
 + mRNA-1273 
 co-administration 
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(100 participants), mRNA-1073 (
) + placebo (100 participants), mRNA-1073 (
) + 
placebo (100 participants), or mRNA-1073 (
) + placebo (100 participants). Randomization 
will be stratified by age (18 to 49 years old and 50 to 75 years old, balanced across the 2 age 
groups within each vaccination group). 
6.3. 
Preparation/Handling/Storage/Accountability 
6.3.1. 
Preparation of Study Vaccine 
The IP (mRNA-1073, mRNA-1010, and mRNA-1273) and placebo preparation instructions are 
detailed in the Pharmacy Manual. 
6.3.2. 
Study Vaccine Administration 
mRNA-1073, mRNA-1010, or mRNA-1273 and placebo (if indicated) 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 60 minutes after vaccination. 
Assessments will include vital sign measurements and monitoring for local or systemic ARs as 
shown in the SoE (Table 1). 
The study site will be appropriately staffed with individuals with basic cardiopulmonary 
resuscitation training/certification. Either onsite resuscitation equipment and personnel or 
appropriate protocols for the rapid transport of a participant to a resuscitation area or facility are 
required. 
Please see details provided in the Pharmacy Manual. 
6.3.3. 
Study Vaccine Delivery and Receipt 
The Sponsor or designee is responsible for the following: 
• Supplying the IP (mRNA-1073, mRNA-1010, and mRNA-1273) and placebo 
(0.9% sodium chloride) 
• Confirming the appropriate labeling of the IP, so it complies with the legal requirements 
of the United States 
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 
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• 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 IP is properly prepared using aseptic technique 
Further description of the IP and instructions for the receipt, storage, preparation, administration, 
accountability, and destruction of IP are described in the Pharmacy Manual. 
6.3.4. 
Study Vaccine Packaging and Labeling 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of the IP. Sterile mRNA-1073, mRNA-1010, and mRNA-1273 are packaged in 2R glass vials. 
The IP will have all required labeling per regulations. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, Code of Federal Regulations (CFR) Title 21 Good Manufacturing 
Practice guidelines, International Council for Harmonisation (ICH) GCP guidelines, guidelines 
for Quality System Regulations, and applicable regulations. 
6.3.5. 
Study Vaccine Storage 
mRNA-1073 and mRNA-1010 must be stored at -25°C to -15°C (-13°F to 5°F) in a secure area 
with limited access and must be protected from moisture and light until they are prepared for 
administration (Section 6.3.1). mRNA-1273 must be stored at -90°C to -60°C in a secure area 
with limited access and must be protected from moisture and light until it is prepared for 
administration (Section 6.3.1). The freezer should have automated temperature recording and a 
24-hour alert system in place that allows for rapid response in case of freezer malfunction. It is 
recommended that there should be an available backup freezer. It is also recommended that the 
freezer should be connected to a backup generator. In addition, for IP accountability, staff are 
required to keep a temperature log to establish a record of compliance with these storage 
conditions. The study site is responsible for reporting any IP that was not temperature controlled 
during shipment or storage. Such IP will be retained for inspection by the monitor and disposed 
of according to approved methods. The 0.9% sodium chloride injection (USP) should be stored 
at 20°C to 25°C (68°F to 77°F) in a restricted access area. 
6.3.6. 
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, site IP inventory, IP dispensing, IP injections, and 
return to the Sponsor or alternative disposition of used and unused IP vials. 

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A site monitor will review the inventory and accountability log during site visits and at the 
completion of the study. Additional details are found in the Pharmacy Manual. 
6.3.7. 
Study Vaccine Handling and Disposal 
A site monitor will reconcile the IP inventory during the conduct and at the EoS for compliance. 
Once reconciled at the site at the EoS, the IP should be destroyed on site, if site procedures 
allow, or returned to a destruction depot per instruction of the Sponsor. Additional details are 
found in the Pharmacy Manual. 
6.4. 
Study Intervention Compliance 
All IPs will be administered at the study site under direct observation of medically qualified 
unblinded study staff and appropriately recorded (date and time) in the eCRF. The qualified 
unblinded staff will confirm that the participant has received the entire dose of IP and will record 
the injection site (left or right deltoid) and the corresponding vaccine or placebo administered 
and will keep the information confidential from other study documents/personnel until 
unblinding is authorized. If a participant does not receive IP or does not receive all of the 
planned dose, the reason for the missed dose will be recorded. Data will be reconciled with site 
accountability records to assess compliance. 
The study site staff are responsible for ensuring that 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 a visit within the defined visit window specified in the SoE (Table 1). If 
a participant does not complete a visit within the time window, that visit may be classified as a 
missed visit and the participant will continue with subsequent scheduled study visits. All safety 
requirements of the missed visit will be captured and included in the subsequent visit. 
6.5. 
Prior and Concomitant Medications 
6.5.1. 
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. 
6.5.2. 
Concomitant Medications and Therapies 
At study site, study staff must question the participant regarding any medications taken and 
non-study vaccinations received by the participant and record the following information in the 
eCRF: 

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• All non-study vaccinations administered within the period starting 28 days before the 
study injection and through Day 181/EoS. 
• Any seasonal influenza vaccine administered since April 2021. 
• Any authorized or investigational COVID-19 vaccine at any time before the IP injection.  
• 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. 
• Systemic steroids (≥ 10 mg/day of prednisone or equivalent), immunosuppressants, 
immune-modifying drugs, immunoglobulins, and/or blood products administered at any 
time during the study period after the IP injection. 
• Any concomitant medications used to prevent or treat COVID-19 or its 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 post-injection study visits or via other 
participant interactions (eg, telephone calls). 
• Historical 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.  
If a participant takes a prohibited drug therapy, the investigator and the contract research 
organization’s (CRO’s) medical monitor will make a joint decision about continuing or 
withholding further injection of the participant based on the time the medication was 
administered, the drug’s pharmacology and pharmacokinetics, and whether use of the medication 
will compromise the participant’s safety or interpretation of the data. It is the investigator’s 
responsibility to ensure that details regarding the concomitant medications are adequately 
recorded in the eCRF. 
6.5.3. 
Concomitant Medications and Vaccines That May Lead to the Elimination of a 
Participant From 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 9.4): 

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• Any investigational or nonregistered product (drug or vaccine) other than the IPs used 
during the study period. 
• Immunosuppressants or other immune-modifying drugs administered chronically (ie, 
more than 14 days in total) during the study period. For corticosteroids, this will mean 
that prednisone ≥ 10 mg/day or the equivalent is not permitted. Inhaled, nasal, and topical 
steroids are allowed. 
• Long-acting immune-modifying drugs administered at any time during the study period 
(eg, infliximab). 
• An authorized or licensed vaccine administered during the period from 28 days before 
through 28 days after vaccination. 
• Immunoglobulins and/or any blood products administered during the study period. 
• Antiviral and antiretroviral medications. 
6.6. 
Intervention After the End of the Study 
Investigational product will not be available to the participants following the end of the study. 

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7. 
DELAY OR DISCONTINUATION OF STUDY INTERVENTION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Pause Rules 
Study pause rules will be continuously monitored during all periods of the study by the 
investigators, IST, and DSMB (as warranted). If the investigator, IST, or DSMB request that the 
study be paused due to a safety concern, further study vaccination will be suspended, but all 
other planned procedures relating to safety, reactogenicity, and immunogenicity assessments will 
continue as described in the study protocol. An unblinded statistician will support the 
determination if study pause rules have been met. The IST will be composed of the Sponsor’s 
physicians. The Sponsor will notify the Center for Biologics Evaluation and Research within 
48 hours in the event of a study pause. 
7.1.1. 
Pause Rules Based on the Occurrence of a Single Event and Adjudicated by the 
Data and Safety Monitoring Board  
The occurrence of any of the events listed in Table 4, regardless of vaccination group, will result 
in immediate suspension of dosing and enrollment. An unscheduled DSMB will be convened to 
assess specific data concerns and to make recommendations.  
Table 4 
Pause Rule Criteria, Events, and Thresholds – Single Event  
Pause Rule 
Event 
Number of 
Participants 
1 
Any SAE that cannot be reasonably attributed to a cause other 
than study vaccination  
≥ 1 
2 
Any Grade 4 AE1 that cannot be reasonably attributed to a cause 
other than study vaccination  
≥ 1 
3 
A systemic immediate hypersensitivity reaction within 
60 minutes after the study vaccination2  
≥ 1 
4 
Suspected or confirmed myocarditis and/or pericarditis 
≥ 1 
Abbreviations: AE = adverse event; AR = adverse reaction; FDA = Food and Drug Administration; SAE = serious 
adverse event; US = United States.  
1  Grade 4 AE includes any Grade 4 solicited local or systemic AR and any Grade 4 laboratory abnormality. Grading 
of laboratory parameters will be based on the US FDA Guidance for Industry “Toxicity Grading Scale for Healthy 
Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials” (DHHS 2007).  
2  Systemic immediate hypersensitivity reaction refers to anaphylaxis as defined in Section 8.4.7.1. 

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7.1.2. 
Pause Rules Based on the Occurrence of Events in a Proportion of Participants  
The occurrence of safety events that will pause study dosing based on defined threshold levels, 
which are aggregate incidences relative to the number of exposed participants within a 
vaccination group, are summarized in Table 5.  
Table 5 
Pause Rule Criteria, Events, and Thresholds – Proportion of Participants  
Pause Rule Event 
Number or Percentage of Participants1 
5 
Any Grade 3 solicited local AR lasting more 
than 48 hours, within the 7-day, 
post-vaccination period  
≥ 22 participants per group or ≥ 20% of 
participants 
6 
Any Grade 3 solicited systemic AR lasting 
more than 48 hours (24 hours for fever) that 
cannot be reasonably attributed to a cause 
other than vaccination, within the 7-day, post-
vaccination period  
≥ 22 participants per group or ≥ 20% of 
participants 
7 
Any severe unsolicited AE in a vaccination 
group that cannot be reasonably attributed to a 
cause other than vaccination  
OR  
Any Grade 3 laboratory abnormality3 in a 
vaccination group that cannot be reasonably 
attributed to a cause other than vaccination  
≥ 22 participants per group or ≥ 20% of 
participants 
Abbreviations: AE = adverse event; AR = adverse reaction; FDA = Food and Drug Administration; MedDRA = 
Medical Dictionary for Regulatory Activities; US = United States.  
1  The rate of AEs and laboratory abnormalities will be computed based on the number of exposed participants who 
have provided safety data (ie, have completed a postdosing visit for assessment of safety).  
2  For the first 9 participants in each vaccination group, the pause rule will be considered to be met if 2 of the first 
9 participants experience the same solicited AR or the same MedDRA preferred term unsolicited AE or laboratory 
abnormality. The calculation for ≥ 20% of participants in the expansion stage includes exposed participants in the 
initial stage and the expansion stage as the total number of participants in the denominator.  
3  Grading of laboratory parameters (specified in Section 8.1.5) will be based on the US FDA Guidance for Industry 
“Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials” (DHHS 2007).  
If a pause is triggered in the study, each participant’s study site visits will continue until EoS. If a 
pause affects a participant’s Vaccination Visit, the window for that participant’s Vaccination 
Visit will be suspended until the pause is lifted and vaccination can resume. Once the pause is 
lifted, vaccination should be reinstated as soon as possible.  
If a participant is in the Screening period for more than 28 days as the result of a pause, the 
participant may be rescreened for study eligibility (and will receive a new screening number) as 
long as the participant continues to provide consent to participate in the study.  

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7.2. 
Criteria for Delay of Vaccine Administration 
7.2.1. 
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 SoE (Table 1), 
or the participant may be discontinued from dosing at the discretion of the investigator 
(Section 7.3): 
• 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: 
1. Becomes pregnant. 
2. Develops symptoms or conditions listed in the exclusion criteria. 
3. 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. 
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 CRO’s medical monitor 
(Section 6.5.3). 
7.3. 
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) 
• AESI (specify) 
• SAE (specify) 
• Solicited AR or reactogenicity event (specify) 
• Death 
• Lost to follow-up (LTFU) 
• Physician decision (specify) 
• Pregnancy 
• Protocol deviation 
• Study terminated by Sponsor 
• Withdrawal of consent by participant (specify) 
• Other (specify) 
Participants who are withdrawn from the study because of AEs (including SAEs, AESIs, 
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, SAE, AESI, 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 11.1.6). 
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 

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biological samples that have already been collected may be retained and analyzed at a later date 
(or as permitted by local regulations). 
7.4. 
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 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 subject but no other contact is established, 
the subject 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. 

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8. 
STUDY ASSESSMENTS AND PROCEDURES 
Before performing any study procedures, all potential participants will sign an informed consent 
form (ICF) (as detailed in Section 11.1.6). Participants will undergo study procedures at the time 
points specified in the SoE (Table 1). A participant can also be seen for an unscheduled visit at 
any time during the study. Reasons for an unscheduled visit may include, but are not limited to, 
reactogenicity issues, symptoms of potential ILI and/or COVID-19, or new or ongoing AEs. The 
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 “FDA Guidance on Conduct of Clinical Trials of Medical Products during 
COVID-19 Public Health Emergency,” 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 SoE (Table 1). 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 will not be performed on the same day. Additionally, 
the Screening Visit assessments may be performed over multiple visits if within the 
28-day Screening window. 
8.1. 
Safety Assessments and Procedures 
Safety assessments will include monitoring and recording of the following for each participant, 
according to the SoE (Table 1): 
• Solicited local and systemic ARs (Section 8.4.3) that occur during the 7 days following 
vaccine administration (ie, the day of study injections [Day 1] and 6 subsequent days). 

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Solicited ARs will be recorded daily using electronic diaries (Section 8.1.1). Local 
solicited ARs will be recorded separately for each injection site. 
• Unsolicited AEs observed or reported during the 28 days following vaccination (ie, the 
day of injection [Day 1] and 27 subsequent days). Unsolicited AEs are defined in 
Section 8.4.1.  
• SAEs, AESIs, MAAEs, and AEs leading to discontinuation from study participation from 
vaccination on Day 1 through Day 181/EoS or withdrawal from the study. 
• Results of safety laboratory tests (Section 8.1.5). 
• Vital sign measurements (Section 8.1.4). 
• Physical examination findings (Section 8.1.6). 
• Symptom Reporting eDiary for ILI and COVID-19 from Day 1 through Day 181/EoS as 
described below in Section 8.1.8. 
• Details of all pregnancies in female participants will be collected after the start of study 
treatment and until the end of their participation in the study (Section 8.4.8). 
The incidence and severity of the above events will be monitored by an IST as per the charter.  
8.1.1. 
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). The local and system ARs that will be solicited by the eDiary are 
described in Table 6. Participants will also use the Symptom Reporting eDiary to record any ILI 
and/or COVID-19 symptoms that they experience after vaccination from Day 1 through 
Day 181/EoS. 
On Day 1 (dosing 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 Day 1 (dosing day), participants will record data into the eDiary starting approximately 
60 minutes after the injection under supervision of the study site staff to ensure successful entry 
of assessments. 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, preferably in the evening and 
at the same time each day, on the day of injection and for 6 days following injection. 
Participants will record the following data in the eDiary: 
• Solicited local and systemic reactogenicity ARs, as defined in Section 8.4.3. 

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• For symptom reporting for ILI and SARS-CoV-2 (Section 8.4.5 and Section 8.4.6), 
participants will be instructed to report whether these symptoms have been experienced, 
once weekly from Day 1 through Day 181/EoS, via eDiary or telephone calls. If there is 
no response to an eDiary prompt for 2 consecutive entries, the study site staff will contact 
the participant by telephone. The results of the safety call should be recorded in the 
appropriate source documentation. 
• Daily oral body temperature measurement should be performed at approximately the 
same time each day 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) will be performed using the ruler provided by the study site. 
• Record whether any medications were taken to treat or prevent pain or fever on Day 1 or 
for the next 6 days. 
Study site staff will review eDiary data with participants during the Day 8 visit (Visit 3) after 
vaccination. 
8.1.1.1. 
Ancillary Supplies for Participant Use 
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. 
8.1.2. 
Safety Telephone Call 
A safety telephone call is a telephone call made to the participant by a trained site personnel. 
This call will follow a Sponsor-approved script, which will facilitate the collection of relevant 
safety information. Safety calls by the site to each participant will occur at the time points 
indicated in the SoE (Table 1). 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 non-study vaccinations (Section 8.4.9). In 
addition, study personnel will collect information on known participant exposure to someone 
with COVID-19 or SARS-CoV-2 infection and on the participant’s experience of COVID-19 
symptoms. 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 contact. As noted in Section 8.1.1, an unscheduled follow-up safety call may be 
triggered if an eDiary record results in identification of a relevant safety event. 

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8.1.3. 
Pregnancy Testing  
Pregnancy testing includes the following:  
• A point-of-care urine pregnancy test will be performed at the Screening Visit and before 
the IM injections on Day 1. At any time, a pregnancy test either via blood or point-of-
care urine can be performed, at the discretion of the investigator.  
• If not documented in a female participant’s medical records, FSH test may be performed 
at the Screening Visit, as necessary and at the discretion of the investigator, to confirm 
menopausal status (please see Section 11.2 for details).  
8.1.4. 
Vital Sign Measurements 
Vital sign measurements will 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 SoE (Table 1). On the day of IP administration, vital sign measurements will be 
collected once before and at least 60 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 
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 on Day 1 may 
be rescheduled within the relevant 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 time point, the order of 
procedures should be vital sign measurements and then blood collection. 
8.1.5. 
Safety Laboratory Assessments 
Blood samples for safety testing will be taken at Screening and Day 8. Safety laboratory tests 
will include total white blood cell count, hemoglobin, platelets, ALT, AST, total bilirubin, 
alkaline phosphatase, and creatinine. Any clinically significant finding (DHHS 2007) identified 
on the safety laboratory testing should be reported as an AE. 

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Additional blood samples for safety laboratory tests may be taken at the discretion of the 
investigator if warranted to ensure participant’s safety.  
8.1.6. 
Physical Examinations 
A full physical examination, including height and weight, will be performed at the Screening 
Visit as indicated in the SoE (Table 1). The full examination will include assessment of skin, 
head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular system, abdomen, lymph 
nodes, and musculoskeletal system and extremities. At Screening, the BMI will be calculated 
using the formula weight (kg) / (height [m])2. Any clinically significant finding identified during 
a study visit 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, prior to injection, both arms and associated lymph 
nodes should be examined, and any abnormalities should be documented. 
8.1.7. 
Electrocardiogram (ECG) 
A 12-lead electrocardiogram (ECG) will be obtained, after 10 minutes of supine rest, at Visit 
1/Day 1 prior to vaccination. Skin preparation should be thorough and electrode placement 
should be according to standard 12-lead ECG procedure. The purpose of the ECG is to serve as a 
baseline comparison, should it be necessary, for subsequent clinical evaluation of suspected 
myocarditis/pericarditis. The ECG output should be filed in the participant’s binder. No 
additional action (including review/interpretation) is required. 
8.1.8. 
Assessment for Respiratory Viral Infection 
During the study, participants might experience symptoms consistent with ILI or SARS-CoV-2 
infection. 
All participants will provide NP swab samples before the injection on Day 1 for assessment of 
infection with respiratory pathogens, including influenza viruses and SARS-CoV-2, as influenza 
or COVID-19 symptoms may confound reactogenicity assessments (CDC 2021b). 
A study illness visit or a consultation will be arranged within 24 hours or as soon as possible to 
collect an NP swab (Table 1) to test for presence of respiratory pathogens (including influenza 
viruses and SARS-CoV-2) via RT-PCR if a participant experiences: 
• Symptoms of ILI or SARS-CoV-2 infection (for definitions, see Section 8.4.5 and 
Section 8.4.6). 
Additionally, clinical information will be carefully collected to evaluate the severity of the 
clinical case. All findings will be recorded in the eCRF. 

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• Participants will be instructed to report via Symptom Reporting eDiary or telephone calls 
whether ILI/COVID-19 symptoms have been experienced (see Section 8.4.5 and 
Section 8.4.6 for symptoms), once weekly from Day 1 through Day 181/EoS. If 
symptoms occur, participants will be directed to return to the study site as soon as 
possible, but no later than 72 hours after the onset of symptoms, for medical evaluation 
and an NP swab. Participants will be contacted by the study site if they have missed 
reporting in the eDiary. If there is no response to an eDiary prompt for 2 consecutive 
entries, the study site staff will contact the study participant by telephone. 
It is important to note that some of the symptoms of ILI and COVID-19 overlap with solicited 
systemic ARs that are expected after vaccination with mRNA-1073, mRNA-1010, and 
mRNA-1273 (eg, myalgia, headache, fever, and chills). During the first 7 days after vaccination, 
when these solicited ARs are common, investigators should use their clinical judgment to decide 
whether an NP swab should be collected. The collection of an NP swab prior to the Day 1 
vaccination can help ensure that cases of influenza or COVID-19 are not overlooked. Any study 
participant reporting symptoms consistent with protocol-defined ILI (Section 8.4.5) or COVID-
19 (Section 8.4.6) during the 7-day period after vaccination should be evaluated for COVID-19 
and influenza. 
If scheduled, a study site illness visit may include additional assessments such as medical history 
and physical examination. The NP swab sample may be tested by multiplex RT-PCR for 
respiratory viruses besides SARS-CoV-2 and influenza to evaluate the severity of the clinical 
case. 
All cases that meet the CDC definition of ILI and/or COVID-19 will be captured as MAAEs, 
along with relevant concomitant medications and details about severity, seriousness, and 
outcome. 
8.2. 
Immunogenicity Assessments 
Blood samples for immunogenicity assessments will be collected at the time points indicated in 
the SoE (Table 1). Immunogenicity assessments will be performed for all participants. Immune 
response to influenza vaccine antigens will be using HAI assay, with potential utilization on 
microneutralization assay for influenza strains that do not perform favorably in the HAI assay. 
Immune responses to SARS-CoV-2 vaccine antigens will utilize either pseudovirus 
neutralization (PsVNA) nAb assay or multiplex bAb assay, depending on the timing of data 
delivery. The following analytes will be measured: 
• Influenza: Serum antibody level as measured by HAI assay 

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• Influenza: Serum nAb level as measured by microneutralization assay as potential 
substitution to the HAI assay  
• SARS-CoV-2: Serum nAb titers as measured by PsVNA and potentially serum binding 
antibody titers by ELISA or multiplex assay specific to the SARS-CoV-2 proteins 
• Cellular immunogenicity in a subset of participants 
Sample aliquots will be designed to ensure that backup samples are available and that vial 
volumes are likely to be adequate for future testing needs. The actual date and time of each 
sample will be collected. Unique sample identification will be utilized to maintain the blind at 
the laboratory at all times and 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 antibody levels will be performed in a laboratory designated by the Sponsor. 
According to the ICF (Section 11.1.6), excess serum from 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 influenza and SARS-CoV-2 viruses, additional assay 
development, and the immune response across influenza viruses. 
8.3. 
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.  
8.4. 
Safety Definitions and Related Procedures 
8.4.1. 
Adverse Event 
An AE is defined as any untoward medical occurrence associated with the use of a drug/vaccine 
in humans, whether or not considered related to the drug/vaccine. 
Events Meeting the Adverse Event Definition 
• Exacerbation of a chronic or intermittent pre-existing condition including an increase in 
frequency and/or intensity of the condition, after the IP injection. 
• New conditions detected or diagnosed after the IP injection even though they may have 
been present before the start of the study. 
Events NOT Meeting the Adverse Event Definition 
• Procedures planned before study entry (eg, hospitalization for preplanned surgical 
procedure). 

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• Medical or surgical procedure (eg, endoscopy, 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 8.4.3). For the purposes of IND safety reporting, “reasonable possibility” means that 
there is evidence to suggest a causal relationship between the vaccine and the AE. 
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AR in 
the protocol or is specified as a solicited AR but starts outside the protocol-defined period for 
reporting solicited ARs (ie, 7 days after vaccination).  
An incidental, asymptomatic RT-PCR confirmed COVID-19 case (ie, workplace screening) 
should be reported as an unsolicited AE of “asymptomatic COVID-19” if occurring during the 
first 28 days post study vaccination unless the RT-PCR test was performed on the NP swab 
collected prior to study vaccination (Day 1). 
8.4.2. 
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. 
• 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 

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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. 
8.4.3. 
Solicited Adverse Reactions 
The term “reactogenicity” refers to the occurrence and intensity of selected signs and symptoms 
(ARs) occurring after IP injection. The eDiary will solicit daily participant reporting of ARs 
using a structured checklist (Section 8.1.1). Participants will record such occurrences in an 
eDiary during the 7 days after vaccination (ie, the day of injection [Day 1] 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 into the 
eDiary according to the grading scales presented in Table 6 modified 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 AR 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 site should collect 
an end date from the participant to close out the event on the Reactogenicity page of the eCRF. If 
the participant reported an event after the solicited period (ie, after Day 7), it should be recorded 
as an AE on the AE page of the eCRF. 

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All solicited ARs (local and systemic) will be considered causally related to dosing.  
Table 6 
Solicited Adverse Reactions and Grades 
Reaction 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Injection site pain 
No interference 
with activity 
Some interference 
with activity 
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 
Some interference 
with activity 
Prevents daily 
activity 
Emergency room 
visit or 
hospitalization 
Headache 
No interference 
with activity 
Some interference 
with activity 
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 above but starting > 7 days post 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: Modified from 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 reactogenicity 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 8.4.4). 
• 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. 
8.4.4. 
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, abnormal laboratory 
follow-up, COVID-19 [Section 8.1.8]) and visits to HCPs external to the study site (eg, urgent 
care, primary care physician). Investigators will review unsolicited AEs for the occurrence of 
any MAAEs. Unsolicited AEs will be captured on the AE page of the eCRF. 
All cases of RT-PCR-confirmed ILI and/or confirmed COVID-19 will be recorded as MAAEs. 

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8.4.5. 
Influenza-like Illness 
A protocol-defined ILI is determined by the occurrence of at least 1 respiratory illness symptom 
concurrently with at least 1 systemic symptom or the occurrence of any 2 or more respiratory 
symptoms. 
Respiratory Symptoms 
Systemic Symptoms 
1. Sore throat 
2. Cough/rhinorrhea/nasal congestion 
(≥ 1 of the 3 symptoms count as 
1 respiratory symptom) 
3. Sputum production 
4. Wheezing 
5. Difficulty breathing 
1. Body temperature > 37.2°C (> 99°F) 
2. Chills 
3. Tiredness 
4. Headache 
5. Myalgia 
6. Nausea/Vomiting 
7. Diarrhea  
A CDC-defined ILI is defined as body temperature ≥ 37.8°C (100°F) accompanied by a cough 
and/or sore throat. 
An RT-PCR-confirmed influenza infection is defined as a positive influenza result on a 
respiratory sample by RT-PCR done within 7 days of onset of protocol-defined ILI at any setting 
during the study period. 
8.4.6. 
Suspicion of SARS-CoV-2 Infection 
SARS-CoV-2 should be suspected if the participant experiences the acute onset or worsening of 
any one of the symptoms listed below (CDC 2021c): 
• Fever (temperature ≥ 38.0°C [100.4°F]) or chills (of any duration) 
• Cough (of any duration) 
• Shortness of breath and/or difficulty breathing (of any duration) 
• Nausea, vomiting or diarrhea (of any duration) 
• Fatigue (lasting ≥ 48 hours) 
• Muscle or body aches (lasting ≥ 48 hours) 
• Headache (lasting ≥ 48 hours) 
• New loss of taste and/or smell (lasting ≥ 48 hours) 
• Sore throat, congestion, or runny nose (lasting ≥ 48 hours) 
Symptomatic COVID-19 is defined by the presence of one of the above CDC-listed symptoms 
(CDC 2021c) and a positive RT-PCR test on a respiratory sample. Asymptomatic SARS-CoV-2 

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infection is defined as a positive RT-PCR test on a respiratory sample in the absence of 
symptoms or a positive serologic test for anti-nucleocapsid antibody after a negative test result at 
the time of enrollment, with the serologic assay detecting previously resolved SARS-CoV-2 
infections that may have occurred between visits, and the RT-PCR to detect active viral infection 
at the time of a visit. If participants are confirmed to have SARS-CoV-2 infection and are 
symptomatic or asymptomatic, the investigator will notify the participants’ primary care 
physicians of the diagnosis and the local public health authorities as required per local 
regulations. 
8.4.7. 
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.  
Section 11.3 (Appendix 3) provides a list of AESIs pertinent to this study.  
All AESIs will be collected through the entire study period 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 8.4.13). 
8.4.7.1. 
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 8.4.13. 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 (as 
described below) should be reported as a potential case of anaphylaxis. This is provided as 
general guidance for investigators and is based on the Brighton Collaboration case definition 
(Rüggeberg et al 2007). 
Anaphylaxis is an acute hypersensitivity reaction with multi-organ 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: 

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• 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. 
8.4.7.2. 
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 criteria per the CDC case definition. The event 
should also be reported as an SAE if it meets seriousness criteria (Section 8.4.2). The CDC case 
definition is provided in Section 11.4 (Appendix 4) as guidance.  
8.4.8. 
Recording and Follow-up of Pregnancy 
Female participants who have a positive pregnancy test at Screening should not be enrolled; 
participants who have a positive pregnancy test at any time during the study should receive no 
further dosing with IP but should remain in the study and be monitored for safety. 
Details of all pregnancies in female participants will be collected after the start of study 
treatment and until the end of their participation in the study. If a pregnancy is reported, the 
investigator should inform the Sponsor within 24 hours of learning of the pregnancy and should 
follow the procedures outlined in this section. Abnormal pregnancy outcomes (eg, spontaneous 
abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) will be considered as 
SAEs. 
Pregnancies occurring in participants after enrollment must be reported to Sponsor or designee 
within 24 hours of the site learning of its occurrence, using the paper Pregnancy Reporting Form 
provided by the Sponsor. 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 

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and/or newborn complications. This follow-up should occur even if 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. 
8.4.9. 
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 Day 1 through 7 days after vaccination. Other (unsolicited) 
AEs will be collected from Day 1 through 28 days after vaccination. 
The MAAEs, AESIs, AE leading to withdrawal, and SAEs will be collected from participants as 
specified in the SoE (Table 1) until the end of their participation in the study. Any AEs occurring 
before receipt of IP will be analyzed separately from AEs occurring after receipt of the study 
vaccine(s). 
At every study site visit or telephone contact, participants will be asked a standard question to 
elicit any medically related changes in their well-being (including respiratory viral infection and 
COVID-19 symptoms) 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 non-study 
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 visits/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 7.4). All contacts, or contact attempts, concerning follow-up of 
AEs/SAEs should be recorded in the participant’s source documentation. 
8.4.10. 
Assessment of Intensity 
An event is defined as “serious” when it meets at least one of the predefined outcomes as 
described in the definition of an SAE (Section 8.4.2), 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 

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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 8.4.3. 
The determination of severity for all unsolicited AEs should be made by the investigator based 
upon 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. 
Study staff should elicit from the participant the impact of AEs on the participant’s activities of 
daily living to assess severity and document 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 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. 
8.4.11. 
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 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. 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. 
8.4.12. 
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. 

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All unsolicited AEs reported or observed during the study will be recorded on the AE page of the 
eCRF. Information to be collected includes type of event, time of onset, investigator-specified 
assessment of 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 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 of screening 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. 
8.4.13. 
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 that meets SAE criteria (Section 8.4.2) 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 as described in 
Section 8.4.11.  
If the eCRF is unavailable at the time of the SAE, the paper SAE/AESI reporting form provided 
by the Sponsor is to be used for SAE reporting. 
The Sponsor will be responsible for notifying the relevant regulatory authorities of any SAE as 
outlined in 21 US CFR Parts 312 and 320. The investigator is responsible for notifying the 
institutional review board (IRB) directly. Regulatory reporting requirements for SAEs are 
described in Section 8.4.18. 
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 IP or study procedures, or caused the 
participant to discontinue the study until they are considered resolved or clinically stable, per the 
investigator’s judgement. 
8.4.14. 
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 

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designee is responsible for reporting the AESI to the Sponsor, regardless of relationship 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. 
8.4.15. 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse 
Event Information 
Medical occurrences that begin before IP dosing but after obtaining informed consent will be 
recorded in the Medical History/Current Medical Conditions section of the eCRF and not in the 
AE section; however, if the condition worsens at any time after IP administration, it will be 
recorded and reported as an AE. 
Adverse events may be collected as follows: 
• 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 the paper SAE/AESI report form provided by the Sponsor. 
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. 

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Participants who develop ILI will be followed through 30 days from the onset of ILI, even if 
Day 30 is beyond Day 181/EoS. 
8.4.16. 
Method of Detecting AEs and SAEs 
Electronic diaries have specifically been designed for this study by the Sponsor. The diaries 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. 
8.4.17. 
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 7.4. 
8.4.18. 
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. 

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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. 
8.5. 
Safety Monitoring Committees 
8.5.1. 
Internal Safety Team 
An internal safety team, 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 DSMB. The IST 
will conduct a scheduled review of safety data after at least 55 participants (approximately 5 
participants in Group 1 and approximately 10 participants in Groups 2 to 6) (see Table 3) have 
completed the Day 8 visit. Enrollment will be ongoing while this review is conducted if no pause 
rules (Section 7.1) have been met and the study team has not identified any safety concerns. The 
IST will also conduct ad hoc reviews as requested by the study medical monitor and the study 
team. 
8.5.2. 
Data and Safety Monitoring Board 
The DSMB, composed of external/independent subject matter experts, will conduct both, a 
scheduled unblinded review of safety data and as needed reviews of safety data if any pause rule 
is met or as otherwise requested by the study team and/or IST as described in the DSMB charter. 
8.5.3. 
Cardiac Event Adjudication Committee 
An independent Cardiac Event Adjudication Committee (CEAC) that includes pediatric and 
adult cardiologists will review suspected cases of myocarditis and pericarditis 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 or pericarditis 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. 
8.6. 
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 11.1.8). 

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8.7. 
Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 
8.8. 
Pharmacodynamics 
Pharmacodynamic parameters are not evaluated in this study. 
8.9. 
Biomarkers 
Immunogenicity assessments are described in Section 8.2. Samples for potential biomarker 
analysis will be collected from all participants. Transcriptomic and genomic samples will be part 
of the optional biomarker assessment once consented by the study participant. Exploratory 
assessments may include assessment of biomarkers for safety, reactogenicity, and inflammation. 
Serologic markers of disease severity, immune response to SARS-CoV-2 or influenza, RT-PCR 
of NP swab or saliva samples, genetic sequences of SARS-CoV-2 or influenza strains isolated 
from participants’ samples, and genomic and transcriptomic samples may also be evaluated. 
8.10. 
Health Economics 
Health economics are not evaluated in this study. 

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9. 
STATISTICAL ANALYSIS PLAN 
This section summarizes the planned statistical analysis strategy and procedures for the study. 
The details of statistical analysis will be provided in the statistical analysis plan (SAP), which 
will be finalized before the clinical database lock for the study. If changes are made to primary 
and/or secondary objectives or the 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 clinical study report (CSR) for the 
study. Ad hoc exploratory analyses, if any, will be clearly identified in the CSR. 
9.1. 
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 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 9.6). 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 unblinded safety data provided by the independent unblinded 
statistician to safeguard the interests of clinical study participants and to help ensure the 
integrity of the study. The DSMB will review unblinded statistical outputs for ad hoc 
safety reviews triggered by pause rules, should this occur. Section 11.1.11 provides 
additional information on DSMB and safety review. 

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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. 
9.1.1. 
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 CRO’s medical monitor, preferably via electronic protocol inquiry platform, to 
explain the need for unblinding within 24 hours of opening the 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 
interactive response technology (IRT). All unblinding instances will be tracked via an audit trail 
in IRT and documented in the final study report. 
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 time point(s) for analysis as outlined in Section 9.1. 
9.2. 
Statistical Hypotheses 
No formal hypotheses will be tested. All analyses will be descriptive and presented by vaccine 
group. 
9.3. 
Sample Size Determination 
The sample size for this study is not driven by statistical assumptions for formal hypothesis 
testing. The number of proposed participants is considered sufficient to provide a descriptive 
summary of the safety and immunogenicity of different study groups. 

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The study will enroll approximately 550 generally healthy adults 18 to 75 years of age who were 
previously fully vaccinated for COVID-19 primary series with a locally authorized and approved 
SARS-CoV-2 vaccine, and their last COVID-19 vaccine must be ≥ 120 days prior to the 
randomization visit (or less per local guidance). Participants must not have received a licensed 
influenza vaccine within ≤ 180 days of randomization and have not had known history of 
confirmed influenza infection within ≤ 180 days or SARS-CoV-2 infection within ≤ 90 days of 
Screening. The number of participants and groups are shown in Table 3. 
Approximately 550 participants will be enrolled at a 
 A sample size of 
100 participants in one group has at least an 85% (or 95%) probability to observe at least 
1 participant with an AE at a true 2% (or 3%) AE rate (Table 7). 
Table 7 
Randomized Sample Size Calculations  
Sample Size 
True AE Rate 
Probability to Observe 
0 AEs 
Power to Detect at 
Least 1 AE 
50 
0.05 
7.7% 
92.3% 
50 
0.03 
21.8% 
78.2% 
100 
0.03 
4.8% 
95.2% 
100 
0.02 
13.3% 
86.7% 
Abbreviation: AE = adverse event. 
9.4. 
Analysis Sets 
The analysis sets are described in Table 8. 
Table 8 
Analysis Sets 
Set 
Description 
Randomization Set 
The randomization set consists of all participants who are randomly 
assigned. 
FAS1 
The FAS consists of all randomly assigned participants who receive 
the IP. 
PP Set2 
The PP set consists of all participants in the FAS who comply with 
the injection schedule, comply with the timings of immunogenicity 
blood sampling to have a baseline and at least 1 post-injection 
assessment, do not have influenza or SARS-CoV-2 infection at 
baseline and post-baseline up to Day 29 (as documented by positive 
RT-PCR testing result), and have no major protocol deviations and/or 
prohibited concomitant medication use (documented in the 
Section 6.5.3) that are prespecified with impacts on the immune 
response and should be excluded from the PP set. 
Safety Set3 
The safety set consists of all randomly assigned participants who 
receive the IP. 
CCI

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Set 
Description 
Solicited Safety Set4 
The solicited safety set consists of all participants in the safety set 
who contribute any solicited AR data. 
Abbreviations: AR = adverse reaction; FAS = full analysis set; IP = investigational product; PP = per-protocol. 
1  For the FAS, participants will be analyzed according to the group to which they were randomized. 
2  The PP set will be used as the primary analysis set for analyses of immunogenicity unless otherwise specified. 
Participants will be analyzed according to the group to which they were randomized. 
3 The safety set will be used for all analyses of safety, except for the solicited ARs. Participants will be included in 
the vaccination group corresponding to what they actually received. 
4 The solicited safety set will be used for the analyses of solicited ARs and participants will be included in the 
vaccination group corresponding to what they actually received. 
9.5. 
Statistical Methods 
9.5.1. 
Baseline Characteristics and Demographics 
Demographic variables (eg, age, gender, race, ethnicity, height, and weight) and baseline 
characteristics will be summarized by descriptive statistics for participants in the FAS.  
9.5.2. 
Safety Analyses 
All safety analyses are descriptive in nature and 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 study arm. Participants will be included in the vaccination group 
corresponding to what they actually received. Local solicited reactogenicity analysis will be 
presented by study group and for each injection content, respectively. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters, including 
solicited ARs (local and systemic ARs); unsolicited AEs (including any clinical safety laboratory 
abnormalities); treatment-related AEs; severe AEs, SAEs, MAAEs, AESIs, and AEs leading to 
withdrawal from study participation; vital sign measurements; and physical examination 
findings.  
The number and percentage of participants with any solicited local AR, with any solicited 
systemic AR, with any solicited AR during the 7-day follow-up period after each vaccination, 
and with any Grade 3 or higher solicited AR will be summarized. A 2-sided 95% exact 
confidence interval (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, treatment-related AEs, severe 
AEs, SAEs, MAAEs, AESIs, and AEs leading to withdrawal will be summarized. Unsolicited 
AEs will be presented by MedDRA system organ class and preferred term. Unsolicited AEs will 
be coded according to the MedDRA Dictionary for AR Terminology. 

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The number of events of solicited ARs, unsolicited AEs/SAEs, MAAEs, AEs leading to 
withdrawal, and AESIs will be reported in summary tables accordingly. Pregnancy outcomes 
will also be summarized. 
Table 9 summarizes the analysis strategy for safety parameters. For all other safety parameters, 
descriptive summary statistics will be provided. Further details will be described in the SAP. 
Table 9 
Analysis Strategy for Safety Parameters 
Safety Endpoint 
Number and Percentage of 
Participants, Number of 
Events 
Any Solicited AR (overall and by local, systemic) 
X 
Any Unsolicited AE 
X 
Any SAE 
X 
Any Unsolicited MAAE 
X 
Any Unsolicited AESI 
X 
Any Unsolicited Treatment-Related AE 
X 
Any Treatment-Related SAE 
X 
Any Unsolicited AE Leading to Withdrawal From 
Study Participation 
X 
Any Severe Unsolicited AE 
X 
Any Treatment-Related Severe Unsolicited AE 
X 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; CI = 
confidence interval; MAAE = medically attended adverse event; SAE = serious adverse event. 
Notes: 95% CI using the Clopper-Pearson method; X = results will be provided. 
9.5.3. 
Immunogenicity Analysis 
The analyses of immunogenicity will be based on the PP set. 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. 
For the immunogenicity endpoints, the geometric mean of specific antibody titers with 
corresponding 95% CI at each time point and the geometric mean fold rise (GMFR) of specific 
antibody titers with the corresponding 95% CI at each post-baseline time point over pre-injection 
baseline at Day 1 will be provided by treatment arm, with adjustment for baseline antibody titer 
and other potential covariates, including age group and primary vaccine type. Descriptive 
summary statistics, including median, minimum, and maximum, will also be provided. 

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For summarizations of geometric mean titer, antibody titers reported as below the lower limit of 
quantification (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. 
For mRNA-1010, seroconversion rate from baseline will be provided with a 2-sided 95% CI 
using the Clopper-Pearson method at each post-baseline time point. Rate of seroconversion is 
defined as the proportion of participants with either a pre-vaccination HAI titer < 1:10 and a 
post-vaccination HAI titer ≥ 1:40 or a pre-vaccination HAI titer ≥ 1:10 and a minimum 4-fold 
rise in post-vaccination HAI antibody titer. 
For mRNA-1273, seroresponse is defined as either: participants with GMFR in nAb or bAb titers 
of ≥ 4-fold at Day 29 compared to Day 1 in those with baseline titer ≥ LLOQ, or Day 29 titer 
≥ 4 × LLOQ if baseline titer is < LLOQ. 
The immunogenicity of mRNA-1073 will follow the same rules as mRNA-1010 and 
mRNA-1273. 
Between-group comparisons will be evaluated in terms of immunogenicity endpoints (GMR and 
SCR/SRR difference) in the PP set and will be specified in the SAP in greater detail. 
9.5.4. 
Exploratory Analyses 
Exploratory analyses not addressed in Section 9.5.3 will be described in the SAP before database 
lock. 
9.5.5. 
Subgroup Analyses 
The protocol does not define any formal subgroup analyses; however, age specific analyses 
might be performed and will be detailed in the SAP.  
9.6. 
Planned Analyses 
One IA and final analysis will be conducted in the study. Further details can be found in the 
SAP.   
9.6.1. 
Interim Analysis 
An IA will be performed after all the 550 participants randomized into Group 1 through Group 6 
have completed their Day 29 visit assessments and will include the safety and immunogenicity 
data collected up to Day 29. Either nAb or bAb assay will be used for assessment of 
immunogenicity. The IA will be performed by a separate team of unblinded programmers and 
statisticians. The analysis will be presented by vaccination groups. Except for a limited number 
of Sponsor and CRO personnel who will be unblinded to perform the IA, the study site staff, 

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investigators, study monitors, and participants will remain blinded until after the final database 
lock for final analysis. 
9.6.2. 
Final Analyses 
The final analysis of all endpoints will be performed after all participants complete Day 
181/EoS. Results of this analysis will be presented in a final CSR, including individual listings. 
The final CSR will include full analyses of all safety and immunogenicity data through 
Day 181/EoS. For immunogenicity analysis, either nAb or bAb assays will be used in the study. 

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10. 
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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
APPENDIX 1: Study Governance Considerations 
11.1.1. 
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 
11.1.2. 
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 

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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 
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. 
11.1.3. 
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 

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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. 
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. 
11.1.4. 
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. 
11.1.5. 
Recruitment Strategy 
Enrollment targets will be established to ensure the participant population reflects those that are 
most at risk for the condition, or those that are most reflective of the general population, if 
appropriate. 
Participant recruitment and retention initiatives will be incorporated into the trial. These include, 
but are not limited to, services that provide a means to identify potential participants and direct 
them to participating clinical trial sites, participant support services such as concierge, and trial 
information and support collateral for both the participant and the site. 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/IEC. 

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11.1.6. 
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. 
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 participant should also be informed that he/she is authorizing such access by 
signing the ICF. 
A copy of the 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 28 days from the previous ICF signature date (within the initial Screening period). 
The ICF will also explain that excess serum from 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 SARS-CoV-2, additional assay development, and the immune response 
across CoV. 

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11.1.7. 
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). 
11.1.8. 
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. 
11.1.9. 
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 which would make the participant identifiable will not be transferred. 

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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 health care provider 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. 
• The contract between the Sponsor or designee and the study sites may specify 
responsibilities of the parties related to data protection, including handling of data 
security breaches and respective communication and cooperation of the parties. 
• Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access. 
11.1.10. 
Sample Retention and Future Biomedical Research 
The Sponsor may store samples for the time frame specified in the ICF to achieve 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 measures of adaptive 
immunity and include humoral and cellular immune assay methodologies to measure responses 

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to influenza and/or SARS-CoV-2 on any remaining blood or serum samples, including samples 
from participants who are screened but are not subsequently enrolled. These analyses will extend 
the search for other potentially relevant biomarkers to investigate the effect of mRNA-1073 as 
well as to determine how changes in biomarkers may relate to exposure to mRNA vaccines 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. 
11.1.11. 
Safety Oversight 
Safety monitoring for the study is described in Section 8.5. 
11.1.12. 
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, EU clinical trial register (eu.ctr), as well as some national registries. 
11.1.13. 
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 onsite 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. 

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• 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 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 onsite inspections/audits and source data checks. Direct access to source documents is 
required for the purpose of these periodic inspections/audits. 
11.1.14. 
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. 

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Adverse events will be coded with MedDRA. Concomitant medications will be coded using 
WHO – Drug Reference List. 
11.1.15. 
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. 
11.1.16. 
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 
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. 
11.1.17. 
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. 

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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, the requirements of the IRB or 
local health authorities, the Sponsor's procedures, or GCP guidelines 
• Inadequate recruitment of participants by the investigator 
• Discontinuation of further mRNA-1073 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. 
11.1.18. 
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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11.2. 
APPENDIX 2: Contraceptive Guidance  
Definitions: Woman of Childbearing Potential 
Women in the following categories are considered WOCBP (fertile): 
1. Following menarche 
2. From the time of menarche until becoming postmenopausal unless permanently sterile 
(see below) 
3. A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
o A high follicle-stimulating hormone (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 one FSH measurement is required.  
o 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. 
4. Permanent sterilization methods (for the purpose of this study) include: 
o Documented hysterectomy 
o Documented bilateral salpingectomy 
o Documented bilateral oophorectomy 
o Documented bilateral tubal ligation 
o For individuals with permanent infertility due to an alternate medical cause other than 
the above, (eg, Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), 
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. 
• If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle 
cannot be confirmed before first dose of study intervention, additional evaluation should 
be considered. 
Contraception Guidance: 
Adequate female contraception is defined as consistent and correct use of an FDA-approved 
contraceptive method in accordance with the product label. For example: 
• Barrier method (such as condoms, diaphragm, or cervical cap) with spermicide 
• Intrauterine device 

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• Prescription hormonal contraceptive taken or administered via oral (pill), transdermal 
(patch), subdermal, or IM route 
• Sterilization of a female participant’s monogamous male partner prior to entry into the 
study 
Note that periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) 
and withdrawal are not acceptable methods of contraception. 
 
 

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11.3. 
APPENDIX 3: Adverse Events of Special Interest Terms 
The Investigator’s medical judgement must be applied to assess an event as an AESI, as 
most AESIs are based on medical concepts. The table below does not provide a 
comprehensive list of terms. 
The following table (Table 10) describes events/medical concepts that are of interest in COVID-
19 vaccine safety surveillance. Some are specific to vaccines; however, some are of interest due 
to 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. 
Please note: COVID-19 itself is not an AESI. 
Table 10 
Adverse Events of Special Interest 
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 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 non-specific 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 (ex. stroke, DVT, pulmonary 
embolism, disseminated intravascular coagulation (DIC), etc.) 
Acute cardiovascular 
injury 
• 
New onset of clinically confirmed, acute cardiovascular injury, such 
as myocarditis, pericarditis, arrhythmia confirmed by ECG (ex. atrial 
fibrillation, atrial flutter, supraventricular tachycardia), stress 
cardiomyopathy, heart failure, acute coronary syndrome, myocardial 
infarction, etc. 

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Medical Concept 
Medical Concept Descriptions/Guidance 
• 
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 times baseline, known or 
presumed to have occurred within prior 7 days 
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 (DRESS), fixed drug eruptions, and necrotic 
or exfoliative reactions. 
Multisystem 
inflammatory disorders 
• 
Multisystem inflammatory syndrome in adults (MIS-A) or children 
(MIS-C) 
• 
Kawasaki’s disease 
• 
Hemophagocytic lymphohistiocytosis (HLH) 
Thrombocytopenia 
• 
Platelet counts < 150 × 109/L (thrombocytopenia) 
• 
New clinical diagnosis, or worsening, of thrombocytopenic condition, 
such as immune thrombocytopenia, thrombocytopenic purpura, or 
HELLP 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 PCR 
• 
DOES NOT INCLUDE new onset of chronic arthritic conditions 

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Medical Concept 
Medical Concept Descriptions/Guidance 
New onset of or 
worsening of neurologic 
disease 
• 
Immune-mediated neurological disorders 
• 
Guillain-Barre syndrome 
• 
Acute disseminated encephalomyelitis (ADEM) 
• 
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 
Other syndromes 
• 
Fibromyalgia 
• 
Postural orthostatic tachycardia syndrome 
• 
Chronic fatigue syndrome 
• 
Myalgic encephalomyelitis 
• 
Postviral fatigue syndrome 
• 
Myasthenia gravis 
Abbreviations: ALT = alanine aminotransferase; ARDS = acute respiratory distress syndrome; AST = aspartate 
aminotransferase; COVID-19 = coronavirus disease 2019, HELLP = hemolysis, elevated liver enzymes, and low 
platelet count. 
 
 

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11.4. 
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 11. 
Table 11 
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 symptoms:1 
Presence of ≥ 1 new or worsening of 
the following clinical symptoms:1 
• 
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 
• 
tachypnea 
• 
tachypnea 
• 
lethargy 
• 
lethargy 
AND 
AND 
≥ 1 new finding of 
≥ 1 new finding of 
• 
troponin level above upper limit 
of normal (any type of troponin) 
• 
Histopathologic confirmation 
of myocarditis2 
• 
abnormal electrocardiogram 
(ECG or EKG) or rhythm 
monitoring findings consistent 
with myocarditis3 
• 
abnormal cardiac function or 
wall motion abnormalities on 
echocardiogram 
• 
cMRI findings consistent 
with myocarditis in the 
presence of troponin level 

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Condition 
Definition 
• 
cMRI findings consistent with 
myocarditis 
above upper 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 
pericarditis4 
Presence of ≥ 2 new or worsening of the following clinical features: 
• 
acute chest pain5 
• 
pericardial rub on exam 
• 
new ST-elevation or PR-depression on EKG 
• 
new or worsening pericardial effusion on echocardiogram or MRI 
Myopericarditis 
This term may be used for patients who meet criteria for both myocarditis and 
pericarditis. 
Abbreviations: AV = atrioventricular; CDC = Centers for Disease Control and Prevention; cMRI = cardiac magnetic 
resonance imaging; COVID-19 = coronavirus disease 2019; ECG or EKG = electrocardiogram; MRI = magnetic 
resonance imaging; mRNA = messenger RNA. 
Note: An independent Cardiac Event Adjudication Committee (CEAC) comprised of medically qualified personnel, 
including cardiologists, will review suspected cases of myocarditis, pericarditis, and myopericarditis to determine 
if they meet CDC 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. 
Persons who lack the listed symptoms but who meet other criteria may be classified as subclinical myocarditis 
(probable or confirmed). 
Using the Dallas criteria (Aretz 1987). Autopsy cases may be classified as confirmed clinical myocarditis on the 
basis of meeting histopathologic criteria if no other identifiable cause. 
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. 
https://academic.oup.com/eurheartj/article/36/42/2921/2293375external icon. 
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. 
Reference: (Gargano et al 2021). 

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11.5. 
APPENDIX 5: Protocol Amendment History 
11.5.1. 
Amendment 1 (25 Feb 2022) 
Main Rationale for the Amendment: 
The purpose of this amendment is to allow people who have received a coronavirus disease 2019 
(COVID-19) booster to participate in this study. The booster is now widely available in the 
United States, and inclusion of individuals who received immunizations beyond the primary 
series is a protocol change for updated vaccination recommendations. mRNA-1073 is envisioned 
as an annual vaccine, with the intent to provide continued protection from infections from 
seasonal influenza viruses and severe acute respiratory syndrome coronavirus 2. Including 
individuals who have received immunizations beyond the primary series is consistent with the 
long-term vision for the use of mRNA-1073 as an annual vaccine. 
The summary of changes table provided below describes the major changes made in 
Amendment 1 compared to the original protocol, including the sections modified and the 
corresponding rationales. As applicable, the synopsis of Amendment 1 has been modified to 
correspond to changes in the body of the protocol. 
Summary of Major Changes From the Original Protocol to Protocol Amendment 1 
Section # and Name 
Description of Change 
Brief Rationale 
Global 
• Removed passive surveillance 
from the protocol. Participants 
will be instructed to contact study 
sites if they have ILI/COVID-19 
symptoms outside the Symptom 
Reporting eDiary period. 
• Reduced the frequency during the 
first month to 1 time per week 
from 3 to 4 times per week. 
• To improve compliance 
with eDiary reporting: 
Passive surveillance will be 
replaced by Symptom 
Reporting eDiary prompts. 
• The reduction in frequency 
is intended to reduce 
participant fatigue and 
increase compliance. 
Global 
• Added 6th arm to study design for 
Phase 1 to include 
100 participants at a 
 
of mRNA-1073. 
• Increased the number of subjects 
in Arms 2 and 5 from 50 to 100. 
• Based on the interim 
analysis of mRNA-1010 
Phase 1/2 showing no 
immunogenicity dose 
response, a lower dose is 
being assessed to support 
dose selection of 
mRNA-1073. Arms 2 and 5 
increased in size improve 
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Section # and Name 
Description of Change 
Brief Rationale 
comparability across 
treatments. 
Sections 1.1 
(Synopsis), 
2.1.2 (mRNA-1273), 
and 4.3 (Choice of 
Vaccine Dose) 
• Updated mRNA-1273 booster 
guidance to individuals 18 years 
of age and older. 
• The FDA has authorized 
for emergency use the 
administration of a single 
booster dose (
) of 
mRNA-1273 vaccine in 
individuals 18 years of age 
and older. 
Sections 1.1 
(Synopsis), 2.1.2 
(mRNA-1273), and 4.3 
(Choice of Vaccine 
Dose) 
• Added: In January 2022, the US 
FDA approved the Biologics 
License Application (BLA) for 
SPIKEVAX (mRNA-1273) to 
prevent COVID-19 in individuals 
18 years of age and older. 
• This updated BLA 
approval was added to the 
protocol. 
Sections 1.1 
(Synopsis), 
4.1 (General Design), 
5.1 (Inclusion Criteria), 
and 9.3 (Sample Size 
Determination) 
• Updated inclusion criteria 
(inclusion criterion 7) to allow for 
a COVID-19 booster vaccine and 
clarify that the last COVID-19 
vaccine received (from the 
primary series or booster) must be 
≥ 120 days prior to the 
randomization visit (or less per 
local guidance). 
• Because this amendment is 
allowing participants who 
have received a COVID-19 
booster, this updated 
verbiage specifies that the 
last vaccine (primary series 
or booster) must be 
≥ 120 days prior to the 
randomization visit (or less 
per local guidance). 
Sections 1.1 (Synopsis) 
and 5.2 (Exclusion 
Criteria) 
• Deleted exclusion criterion 15 
(participant has received a booster 
dose of a COVID-19 vaccine) and 
renumbered the criteria. 
• Per the main rationale of 
the amendment, this 
exclusion criterion was 
removed to allow study 
participants who have 
received a booster dose of a 
COVID-19 vaccine to 
participate in this study. 
Sections 1.1 
(Synopsis), 4.1 
(General Design), 5.2 
(Exclusion Criteria), 
• Exclusion criteria 14 was 
changed to the following: 
Participant has known 
history of SARS-CoV-2 
infection within ≤ 90 days. 
• The time from known 
history of SARS-CoV-
2 infection was 
reduced from ≤ 180 
days to ≤ 90 days to 
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Section # and Name 
Description of Change 
Brief Rationale 
and 9.3 (Sample Size 
Determination) 
allow study 
participants who may 
have been infected 
during the Omicron 
wave. 
Sections 1.1 
(Synopsis), 
4.1 (General Design), 
and 
6.2 (Randomization 
and Blinding) 
• Added: Randomization for 
Phase 2 will be stratified by 
receipt of a COVID-19 booster 
(yes or no) instead of receipt of 
prior SARS-CoV-2 vaccine that is 
mRNA based. 
• Per the main rationale of 
the amendment to allow 
study participants who 
have received a booster 
dose of a COVID-19 
vaccine, this change in 
randomization scheme for 
Phase 2 is more 
appropriate. 
Sections 1.1 (Synopsis) 
and 2.2.2 (Clinical 
Studies) 
• Deleted reference to a substudy to 
mRNA-1010-P101 in the 
background sections. 
• This substudy was 
cancelled and is no longer 
applicable. 
Sections 1.1 (Synopsis) 
and 5.2 (Exclusion 
Criteria) 
• Exclusion criterion 13 was 
updated to the following: 
Participant has had close contact 
to someone with SARS-CoV-2 
infection or COVID-19 as defined 
by the US CDC in the past 
10 days prior to the Screening 
Visit. 
• This change was made for 
clarity and to harmonize 
across Sponsor programs. 
Section 2.2.2 (Clinical 
Studies) 
• Background information was 
added highlighting that an 
amendment is planned (for a 
separate study, mRNA-1010-
P101) to assess 6.25 µg and 
12.5 µg dose levels of mRNA-
1010 as well as 25 µg mRNA-
1010 and an active comparator in 
the Phase 2 Extension portion of 
the study 
• This detail was added to 
update the background of 
the clinical program 
pertaining to doses of 
mRNA-1010 under 
investigation. 
Section 2.2.1 
(Nonclinical Studies) 
• Additional nonclinical study 
background information provided 
regarding test article related 
• Test article related clinical 
pathology and cytokine 
changes were generally 

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Section # and Name 
Description of Change 
Brief Rationale 
clinical pathology and cytokine 
changes. 
reversed or reversing by the 
end of the 2-week recovery 
period.  
Sections 2.3.3 (Overall 
Benefit/Risk 
Conclusion) and 4.3 
(Choice of Vaccine 
Dose) 
• Added mRNA-1010 immune 
response data to support 
benefit/risk discussion. 
• IA data from the mRNA-
1010-P101 study showing 
tolerability profile and 
similar levels of anti- 
hemagglutination antibody 
responses across doses 
support the selection of 
mRNA-1073 at 
 
dose levels in 
Phase 1. 
Section 8.4.3 (Solicited 
Adverse Reactions) 
• Modified Grade 2 and Grade 3 
solicited adverse reaction 
descriptions for injection site 
pain, axillary swelling or 
tenderness ipsilateral to the side 
of injection, and headache 
(Table 8). All of these Grade 2 
solicited adverse reactions are 
now described as “some 
interference with activity” and all 
of these Grade 3 solicited adverse 
reactions are now described as 
“prevents daily activity.” 
• These grade definitions 
were modified to more 
clearly differentiate 
between Grade 2 and Grade 
3 injection site pain, 
axillary swelling or 
tenderness ipsilateral to the 
side of injection, and 
headache solicited adverse 
reactions. 
Global 
• Editorial changes. 
• Minor editorial changes 
throughout based on 
amendment updates. 
Abbreviations: CDC = Centers for Disease Control and Prevention; COVID-19 = coronavirus disease 2019; 
eDiary = electronic diary; FDA = Food and Drug Administration; HAI = hemagglutination inhibition; IA = interim 
analysis; ILI = influenza-like illness; mRNA = messenger RNA; SARS-CoV-2 = severe acute respiratory 
syndrome coronavirus 2; US = = United States. 
 
CCI

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