A Phase 3, Randomized, Stratified, Observer-blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older
Phase: PHASE3
Conditions: Seasonal Influenza
Sponsor: ModernaTX, Inc.

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 1 
CLINICAL STUDY PROTOCOL 
Protocol Title: 
A Phase 3, randomized, stratified, observer-blind, active-
controlled study to evaluate the immunogenicity and safety of 
mRNA-1010 seasonal influenza vaccine in adults 18 years and 
older 
Protocol Number: 
mRNA-1010-P301 
Sponsor Name: 
ModernaTX, Inc. 
Legal Registered Address: 
200 Technology Square 
Cambridge, MA 02139 
Sponsor Contact and 
Medical Monitor: 
 
 
ModernaTX, Inc. 
Telephone: 
 
e-mail: 
Regulatory Agency 
Identifier Number(s): 
IND 27460 
EudraCT: Not applicable 
Amendment Number 
2 
Date of Protocol 
Amendment 2 
19 Jul 2022 
Date of Protocol 
Amendment 1 
10 Feb 2022 
Date of Original Protocol: 
05 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. 
NCT #: NCT05415462
PPD
PPD
PPD

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 2 
PROTOCOL APPROVAL – SPONSOR SIGNATORY 
Study Title: 
A Phase 3, randomized, stratified, observer-blind, active-controlled 
study to evaluate the immunogenicity and safety of mRNA-1010 
seasonal influenza vaccine in adults 18 years and older 
Protocol Number: 
mRNA-1010-P301 
Date of Protocol 
Amendment 2 
19 Jul 2022 
Date of Protocol 
Amendment 1 
10 Feb 2022 
Date of Original 
Protocol: 
05 Nov 2021 
 
Protocol accepted and approved by: 
 
See eSignature and date signed on 
last page of the document 
 
 
 
 
 
ModernaTX, Inc. 
200 Technology Square 
Cambridge, MA 02139 
Telephone: 
 
 
 
Date 
 
 
 
 
 
 
PPD
PPD

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 3 
DECLARATION OF INVESTIGATOR 
I have read and understood all sections of the protocol entitled A Phase 3, randomized, stratified, 
observer-blind, active-controlled study to evaluate the immunogenicity and safety of 
mRNA-1010 seasonal influenza vaccine in adults 18 years dated 19 Jul 2022 and older 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)/independent ethics committee (IEC) approval except to 
eliminate an immediate risk to participants. 
I agree to administer study vaccine only to participants under my personal supervision or the 
supervision of a subinvestigator. I will not supply study vaccine 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/IEC. 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. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 4 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
DOCUMENT HISTORY 
Document 
Date 
Amendment 2 
19 Jul 2022 
Amendment 1 
10 Feb 2022 
Original Protocol 
05 Nov 2021 
 
Amendment 2, 19 Jul 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 main rationale for this amendment is to enhance clarity, implement additional protocol 
administrative changes, and to address feedback received from regulatory agencies. 
The summary of changes table provided below describes the major changes made in 
Amendment 2 relative to Amendment 1, including the sections modified and the corresponding 
rationales. The synopsis of Amendment 2 has been modified to correspond to changes in the 
body of the protocol. Minor grammar and formatting corrections were made throughout the 
document to enhance clarity and readability (which did not affect the conduct of the study). 
Summary of Major Changes in Protocol Amendment 2: 
Section # and Name 
Description of Change 
Brief Rationale 
Synopsis 
• 
Updated the estimated dates of first 
participant enrolled and last participant 
completed. 
• 
To better reflect current 
projections. 
1.2 Schedule of 
Events (Table 1) 
• 
Removed footnote 24, the specification that 
participants who develop influenza-like 
illness (ILI) will be followed up for 30 days 
even if this is after the end of the study.  
• 
To remove incorrect 
information. 
 
 
 
• 
Footnote 8, referring to blood draws for 
genomic, transcriptomic, and 
immunogenicity analyses was made 
applicable only to Day 1 visit as it is only 
applicable to the day of vaccination. 
• 
To correct an error. 
1.2 Schedule of 
Events (Table 1); 4.1 
General Design 
• 
Clarified that approximately the first 
1000 participants will have additional 
humoral immunogenicity blood samples 
taken, and that immunogenicity analysis 
will be performed on a subset of these 
participants. 
• 
To clarify how the 
participants for the 
immune response 
biomarker subset will 
be selected. 
Schedule of Events 
(Table 1); 4.1 
General Design; 8.9.4 
• 
Clarified that participants can report 
symptoms of ILI from Day 1 to Day 361 
• 
To clarify the 
participants’ and 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 5 
Section # and Name 
Description of Change 
Brief Rationale 
Use of Electronic 
Diaries 
(Month 12)/EoS via the electronic diary 
(eDiary) or by contacting the site. 
• 
Specified that if symptoms are reported, the 
Investigator must contact the participant to 
assess symptoms and collect 
nasopharyngeal (NP) swabs within 
72 hours of symptom onset, preferably 
prior to initiation of antiviral therapy. 
Investigators’ 
responsibilities. 
2.2.3 Clinical Studies 
• 
Updated results from study mRNA-1010-
P101. 
• 
To provide the most 
recent interim analysis 
results. 
3 Objectives and 
Endpoints (Table 2) 
• 
Added adverse events (AEs) leading to 
discontinuation to coprimary endpoint. 
• 
Removed influenza B strain from the 
secondary endpoint of superiority. 
• 
Added proportion of participants reaching 
seroconversion at Day 29 as measured by 
HAI assay to secondary endpoint. 
• 
Specified that analyses of the secondary 
endpoint will involve only the first episode 
of RT–PCR confirmed ILI. 
• 
Changed Day 361 (Month 12)/EoS to 
Day 181 (Month 6)/end of influenza season 
for the secondary endpoint. 
• 
Clarified that only a proportion of 
participants will be analyzed in the 
secondary endpoint. 
• 
Added further analyses at Day 181 and Day 
361 in the exploratory endpoints for 
vaccine-matched and -mismatched strains. 
• 
Added the proportion of participants with 
seroconversion and with a titer ≥ 1:40 at 
Day 181 and Day 361 to exploratory 
endpoints. 
• 
Added number of cases of RT-PCR–
confirmed protocol-defined ILI cases that 
begin at least 14 days postvaccination 
through Day 361/EoS to exploratory 
endpoints. 
• 
Administrative changes 
for consistency 
throughout the protocol. 
These items were 
previously part of the 
statistical section. 
3 Objectives and 
Endpoints 
• 
Updated other exploratory objectives to 
specify that number and percentage of 
participants aged ≥ 65 years will be 
analyzed for protocol-defined ILI. 
• 
Administrative change 
for consistency with the 
statistical section. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 6 
Section # and Name 
Description of Change 
Brief Rationale 
 
• 
Updated all other exploratory objectives to 
specify protocol-defined ILI will be 
considered. 
• 
To clarify how ILI will 
be defined. 
4.1 General Design; 
6.2 Randomization 
and Blinding 
• 
Added that it is anticipated that 
approximately 300 participants will be 
≥ 75 years old. 
• 
To clarify the 
expectations for 
enrollment of 
participants ≥ 75 years 
old. 
4.1 General Design; 
Table 3; 4.3 
Justification for 
Dose, Control 
Product, and Choice 
of Study Population; 
5 Study Population; 
6.1 Investigational 
Product and Active 
Comparator 
Administered; Table 
4  
• 
Amended the name of the comparator from 
Fluarix to Fluarix Tetra.  
• 
To use the full name of 
the comparator product. 
4.1 General Design 
(Table 3) 
• 
Added “of mRNA” to the amount of 
mRNA-1010 and “of protein” to the 
amount of comparator. 
• 
To be more precise and 
specify that the study 
vaccine contains HA 
mRNA, and the 
comparator contains HA 
protein. 
4.3 Justification for 
Dose, Control 
Product, and Choice 
of Study Population 
• 
Changed the status of the Phase 2 
Extension of study mRNA-1010-P101 from 
“planned” to “ongoing”. 
• 
To reflect the progress 
of the study. 
5.2 Exclusion 
Criteria 
• 
Added to Exclusion Criterion #4 that 
participants with stable immune-mediated 
disease who do not require 
immunosuppressants are eligible to enroll 
into the study. 
• 
Added to Exclusion Criterion #9 that 
inhaled, nasal and topical steroids are 
allowed.  
• 
Added to Exclusion Criterion #15 that 
participants who have received long-acting 
biological therapies that affect immune 
responses within 90 days, or plan to receive 
them, will be excluded. 
• 
To enhance clarity. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 7 
Section # and Name 
Description of Change 
Brief Rationale 
6.2 Randomization 
and Blinding; 9.1 
Blinding and 
Responsibility for 
Analyses 
• 
“Efficacy analysis” was changed to 
“6-month analysis.” 
• 
To clarify that analyses 
other than efficacy may 
be performed at the 
6-month time point. 
6.5.1 Recording of 
Concomitant 
Medications, 
Concomitant 
Vaccinations, and 
Concomitant 
Procedures 
• 
“Concomitant Procedures” was added to 
section title. 
• 
To better reflect the 
content of the section. 
• 
Specified that all concomitant 
procedures/surgeries must be recorded in 
the electronic case report form (eCRF). 
• 
To correct an omission. 
• 
Specified that biological therapies that 
affect immune responses should be 
recorded as concomitant medications. 
• 
To enhance clarity. 
6.5.2 Concomitant 
Medications and 
Vaccines That May 
Lead to the 
Elimination of a 
Participant From 
Per-protocol 
Analyses 
• 
Specified that the use of biological 
therapies may lead to exclusion from the 
per protocol analysis. 
• 
To enhance clarity. 
8.5 Randomization 
• 
Changed “Exposure page” to “Injection 
page”.  
• 
To correct an error. 
8.9 Safety 
Assessments 
• 
Removed that pregnancy data received 
after the end of the study may not be 
collected in the clinical database. 
• 
To remove unnecessary 
text (pregnancies are 
not collected in the 
clinical database). 
8.9.2 Assessments for 
Respiratory Viral 
Infections  
• 
Clarified reporting requirement of ILI and 
COVID-19 to: All cases that meet the 
protocol definition of RT-PCR–confirmed 
influenza infection and RT-PCR–
confirmed symptomatic COVID-19 will be 
captured as MAAEs 
• 
To clarify that RT-
PCR–confirmed 
protocol-defined 
influenza infection 
should be reported as an 
MAAE. 
 
• 
Specified that asymptomatic SARS-CoV-2 
infections will not be recorded as MAAEs. 
• 
To clarify that only RT-
PCR confirmed 
symptomatic COVID-
19 infection should be 
reported as an MAAE. 
8.9.4 Use of 
Electronic Diaries 
• 
Specified that participants should report 
medications taken to prevent or treat pain 
or fever on the day of injection and for the 
next 6 days, instead of “or for the next 6 
days.” 
• 
To clarify requirements 
for concomitant 
medication reporting in 
the eDiary. 
8.10 Clinical 
Assessments 
• 
Removed “and will be assessed as MAAEs 
unless the definition of SAE is met.” 
• 
To correct an error. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 8 
Section # and Name 
Description of Change 
Brief Rationale 
8.10 Clinical 
Assessments 
• 
Added a link to Section 8.11.5 (Influenza-
like Illness Case Definitions). 
• 
To enhance clarity. 
8.11.3 Solicited 
Adverse Reactions 
• 
Changed “AE eCRF page” to 
“Reactogenicity eCRF page.”  
• 
To correct an error. 
8.11.4 Medically 
Attended Adverse 
Events 
• 
Added to the definition of MAAEs that 
these are events that require unplanned 
visits to HCPs for assessments and/or 
treatment not required per study protocol 
and that the Investigators will review all 
AEs for occurrences of MAAEs.  
• 
To enhance clarity. 
8.11.5 Influenza-like 
Illness Case 
Definitions 
• 
Added that through Day 28 any illness 
assessed for protocol- defined 
ILI/suspected COVID-19 infection will be 
captured as an AE on the AE eCRF and 
that starting on Day 29, only RT-PCR–
confirmed influenza infection and RT-
PCR–confirmed symptomatic COVID-19 
infection will be recoded as an MAAE. 
• 
To clarify that after 
Day 28 only RT-PCR–
confirmed influenza 
infection and RT-PCR–
confirmed symptomatic 
COVID-19 infection 
should be reported as 
MAAEs. 
8.11.5 Influenza-like 
Illness Case 
Definitions 
• 
Specified that an RT-PCR–confirmed 
protocol-defined influenza infection is 
defined as a positive influenza result on a 
respiratory sample by RT-PCR performed 
at the Global Central Laboratory and/or a 
local certified laboratory within 7 days of 
onset of protocol-defined ILI symptoms at 
any time during the study period. 
• 
Added definition for RT-PCR–confirmed 
CDC defined ILI. 
• 
To enhance clarity. 
8.11.6 Adverse Event 
of Special Interest 
• 
Added “SAE” to the name of the form for 
reporting SAEs/AESIs. 
• 
To update internal 
process for AE 
reporting. 
8.11.8 Recording and 
Follow-up of an AE 
and/or SAE 
• 
Deleted “Any AEs occurring before receipt 
of IP will be analyzed separately from 
TEAEs.” 
• 
To update internal 
process for AE 
reporting.  
8.11.12 Reporting 
Serious Adverse 
Events 
• 
Replaced “outlined in the 21 US CFR Parts 
312 and 320” with “required per applicable 
regulations.” 
• 
To make the 
requirement more 
broadly applicable.  
 
• 
Deleted contact information for SAE 
mailbox, hotline, and fax line and instead 
added that if eCRF is unavailable, SAEs 
should be recorded on the SAE/AESI paper 
form. 
• 
To update internal 
process for AE 
reporting. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 9 
Section # and Name 
Description of Change 
Brief Rationale 
9.2 Statistical 
Hypotheses 
• 
Updated statistical hypotheses based on 
regulatory agencies’ comments. 
• 
To incorporate 
regulatory agencies’ 
comments on 
superiority of 
immunogenicity 
endpoints for mRNA-
1010 vs. active 
comparator. 
9.3 Sample Size 
Determination 
• 
Updated sample size for the PP 
Immunogenicity Set. 
 
• 
To accommodate for 
higher percentage of 
participants excluded 
from PP 
immunogenicity 
analysis and to 
streamline testing. 
 
• 
Replaced “2-sided alpha of 0.05” with “2-
sided 0.025 level.”  
• 
To follow the new 
multiplicity testing 
procedure. 
9.4 Analysis 
Populations 
• 
Updated the analysis sets for efficacy and 
immunogenicity analyses.  
• 
To clarify efficacy 
analysis sets and to 
update the 
immunogenicity 
analyses sets based on 
sample size change. 
9.5.1 Immunogenicity 
Analyses 
• 
Changed the confidence interval for GMT 
ratio and seroconversion rate difference 
between mRNA-1010 vs. active 
comparator from 95% to 97.5%. 
• 
To follow the new 
multiplicity testing 
sequence for pre-
specified statistical 
hypotheses. 
9.5.2 Efficacy 
Analyses 
• 
Changed the primary analysis population 
for efficacy from Per-Protocol set to mITT 
set. 
• 
Changed the efficacy analysis method from 
using Cox proportional hazard model to 
estimate hazard ration to using Exact 
method estimating the incidence rate for 
the efficacy endpoint. 
• 
To fit the objective of 
analyzing efficacy 
endpoints. 
9.5.4 Exploratory 
Analyses 
• 
Specified that ILI cases will need to be 
protocol defined and/or CDC defined for 
analysis by vaccination group. 
• 
To specify that cases of 
ILI need to be either 
protocol defined or 
CDC defined. 
 
• 
Added that number and percentage of 
participants aged ≥ 65 years with first 
episode of protocol-defined ILI will be 
presented by baseline frailty status for each 
vaccination group. 
• 
To correct an omission. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 10 
Section # and Name 
Description of Change 
Brief Rationale 
9.6.2 Multiplicity 
• 
Multiple testing sequence was updated 
based on study hypotheses change. 
• 
To incorporate 
regulatory agencies’ 
comments on 
superiority testing of 
immunogenicity 
endpoints. 
11.1.5 Recruitment 
Strategy 
• 
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.” 
• 
To align with EU-CTR. 
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.” 
• 
To align with EU-CTR. 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 11 
1. PROTOCOL SUMMARY 
1.1 Protocol Synopsis 
Name of Sponsor/Company: ModernaTX, Inc. 
Name of Investigational Product: mRNA-1010 
Protocol Title: A Phase 3, randomized, stratified, observer-blind, active-controlled study to 
evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults 
18 years and older 
Protocol Number: mRNA-1010-P301 Amendment 2 
Study Period: Approximately 13 months per participant 
Phase of Development: Phase 3 
Estimated date first participant enrolled: June 2022 
Estimated date last participant completed: August 2023 
Total Number of Sites: 
Site Locations: approximately 50 sites across approximately 5 countries in Latin America and 
Asia-Pacific 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
 
• 
To evaluate the humoral 
immunogenicity of mRNA-1010 
relative to that of an active 
comparator against vaccine-
matched influenza A and B 
strains at Day 29 
• 
Geometric mean titer (GMT) at Day 29 as 
measured by hemagglutination 
inhibition (HAI) assay 
• 
Proportion of participants reaching 
seroconversion at Day 29 as measured by 
HAI assay 
• 
To evaluate the safety and 
reactogenicity of mRNA-1010 
• 
Frequency and grade of each solicited local 
and 
systemic 
reactogenicity 
adverse 
reaction (AR) during a 7-day follow-up period 
post vaccination 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 12 
• 
Frequency and severity of any unsolicited 
adverse events (AEs) during the 28-day 
follow-up period post vaccination 
• 
Frequency of any serious AEs (SAEs), AEs 
of special interest (AESIs), medically 
attended AEs (MAAEs), and AEs leading to 
discontinuation from Day 1 through Day 361 
(Month 12)/end of study (EoS)  
Secondary 
 
• To further evaluate the 
immunological response of 
mRNA-1010 (for superiority) 
relative to an active comparator 
against vaccine-matched 
influenza A virus strains at 
Day 29 
• 
GMT at Day 29 as measured by HAI assay 
• 
Proportion of participants reaching 
seroconversion at Day 29 as measured by 
HAI assay 
• To evaluate relative vaccine 
efficacy to prevent influenza 
caused by any strain of influenza 
virus  
• 
First 
episode 
of 
reverse 
transcription 
polymerase 
chain 
reaction 
(RT-PCR)-
confirmed 
protocol-defined 
influenza-like 
illness (ILI) that begins at least 14 days post 
vaccination through Day 181 (Month 6)/end of 
influenza season caused by any strain of 
influenza virus regardless of antigenic match 
to the strains selected for the seasonal vaccine 
• 
First episode of RT-PCR confirmed Centers 
for Disease Control and Prevention (CDC)-
defined ILI that begins at least 14 days 
postvaccination through Day 181 (Month 
6)/end of influenza season caused by any 
strain of influenza virus regardless of 
antigenic match to the strains selected for the 
seasonal vaccine 
• 
First episode of RT-PCR-confirmed protocol-
defined ILI cases that begin at least 14 days 
post-vaccination through Day 181 
(Month 6)/end of influenza season caused by 
any strain of influenza virus regardless of 
antigenic match to the strains selected for the 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 13 
seasonal vaccine, in participants aged 50 
years and older or 65 years and older 
• To evaluate the humoral 
immunogenicity of each study 
arm against vaccine-matched 
influenza A and B strains at 
Day 29 
• 
The proportion of participants with a titer 
≥ 1:40 at Day 29 as measured by HAI assay 
• 
Geometric mean fold rise (GMFR) comparing 
Day 29 to Day 1 (Baseline) as measured by 
HAI assay 
Other exploratory objectives are as follows: 
• To explore the number and percentage of participants aged 65 years and older with 
first episode of protocol-defined ILI by baseline frailty status. 
• To describe EuroQoL 5-dimension 5-levels (EQ-5D-5L) health questionnaire utility 
score at regular intervals as well as for participants with protocol-defined ILI. 
• To describe Work Productivity and Activity Impairment Questionnaire: Influenza-like 
Illness (WPAI:ILI) v2.0 impairment percentages for absenteeism, presenteeism, work 
productivity loss, and activity impairment for participants with protocol-defined ILI. 
Overall Study Design 
This is a Phase 3, randomized, stratified, observer-blind, active-controlled study to evaluate 
the immunogenicity and safety of mRNA-1010 vaccine in preventing seasonal influenza in 
adults aged 18 years and older. 
The mRNA-1010 vaccine to be tested includes messenger ribonucleic acids (mRNAs) 
encoding for the surface HAs of the influenza strains recommended by the World Health 
Organization (WHO) for 2022 Southern Hemisphere (SH) cell or recombinant-based vaccines: 
• A/Wisconsin/588/2019 (A/H1N1)-like virus; 
• A/Darwin/6/2021 (A/H3N2)-like virus; 
• B/Michigan/01/2021 (B/Victoria lineage)-like virus; and 
• B/Phuket/3073/2013 (B/Yamagata lineage)-like virus. 
Study vaccine administration is planned prior to or during the typical SH influenza vaccination 
campaign period. Medically stable adults, aged 18 years and older, will be screened and 
enrolled. 
The Sponsor’s Phase 1/2 mRNA-1010-P101 study is currently ongoing to provide first-in-
human safety and immunogenicity data on 3 dose levels of mRNA-1010 encoding strains (50, 
100, or 200 µg total mRNA) recommended by the WHO for the 2021 SH. An amendment to 
mRNA-1010-P101 includes a Phase 2 Northern Hemisphere (NH) portion to the study to 
increase the size of the safety database for the 50 µg and 100 µg dose levels and to test an 
additional 25 µg dose level of mRNA-1010, as well as a licensed seasonal influenza vaccine 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 14 
as an active comparator. mRNA-1010 encoding strains recommended for the 2021/22 NH 
influenza season will be used in the Phase 2 NH portion. A Phase 2 Extension portion is 
ongoing to study additional dose levels of 6.25 µg and 12.5 µg mRNA-1010 as well as 25 µg 
mRNA-1010 and an active comparator. The interim analysis of safety data through Day 29 of 
180 healthy adults in the Phase 1/2 portion of mRNA-1010-P101 showed a preferable 
reactogenicity profile for the 50 µg dose of mRNA-1010. The Phase 2 NH interim analysis of 
safety data through Day 29 demonstrated no significant safety concerns of the dose levels 
tested (25, 50, and 100 µg). 
Approximately 6000 participants will be randomly assigned to treatment in this study in a 
1:1 ratio to 1 of 2 vaccination groups to receive either a single dose of mRNA-1010 or a single 
dose of a licensed seasonal influenza vaccine as an active comparator (Fluarix Tetra, see table 
below). Randomization will be stratified by age categories (18 to < 50 years old, ≥ 50 to 
< 65 years old, or ≥ 65 years old) and influenza vaccine status in the prior 12 months (received 
or not received) at Screening. At least 50% of enrollees will be ≥ 50 years old, including 
approximately 20% who will be ≥ 65 years old. The Sponsor anticipates approximately 
300 participants will be ≥ 75 years old. 
Vaccination Groups and Dose Levels 
Vaccination 
Group 
Vaccination 
Received 
mRNA/Antigen 
Total Dose (µg) 
Number of 
Participants 
HA (each) (µg) 
1 
mRNA-1010 
12.5 (of mRNA) 
50 (of mRNA) 
3000 
2 
Active 
Comparator 
(Fluarix Tetra) 
15 (of protein) 
60 (of protein) 
3000 
Abbreviations: HA = hemagglutinin; mRNA = messenger ribonucleic acid. 
Clinic visits will consist of a Screening Visit (up to 28 days before the Day 1 visit), a 
Vaccination Visit on Day 1 (may be on the same day as the Screening Visit), a clinic visit on 
Day 29, and subsequent clinic visits in a subset of participants on Day 181 and Day 361 
(Month 12)/EoS, with up to 13 months of study participation for each participant. There will 
also be 1 optional visit on Day 4. Contact by electronic means or telephone calls will proceed 
as specified in the Schedule of Events (SoE). Unscheduled clinic visits for potential ILI 
symptoms and viral respiratory panel testing will also be conducted. 
All participants will provide blood samples at baseline and on Day 29 (28 days post 
vaccination) for assessment of geometric mean titer (GMT), geometric mean fold rise 
(GMFR), and seroconversion, as measured by HAI assay. In addition, approximately the first 
1000 randomized participants will also provide blood samples at Day 181 and Day 361, a 
subset of which will be used for immunogenicity analysis. These participants will require a 
clinic visit on Day 181 and Day 361 (Month 12)/EoS. There will be an optional visit on Day 4 
at which blood will be drawn for future biomarker assessment.  

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 15 
Participants who manifest protocol-defined ILI, will be evaluated by real-time reverse 
transcription polymerase chain reaction (RT-PCR) testing of nasopharyngeal (NP) swab 
specimen(s) for influenza (and other respiratory pathogens).  
Participants will be instructed to report via Symptom Reporting electronic diary (eDiary) or by 
contacting the site if ILI symptoms have been experienced from Day 1 to Day 361 
(Month 12)/EoS. If symptoms are reported, the investigator must contact the participant to 
assess symptoms and ensure an NP swab is collected within 72 hours of symptom onset. If 
possible, NP swabs should be collected prior to initiation of antiviral therapy. If there is no 
response to an eDiary prompt for 2 consecutive entries, the clinic staff will attempt to contact 
the study participant by telephone. All participants who report symptoms of ILI will receive 
eDiary prompts to complete PRO questionnaires for EuroQoL 5-dimension 5-levels (EQ-5D-
5L) and Work Productivity and Activity Impairment Questionnaire: Influenza-like Illness 
(WPAI:ILI). 
For participants aged 65 years and older, the frailty status will be assessed by clinic staff at 
baseline using the Edmonton Frail Scale (EFS). 
There may 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 should be completed for each unscheduled visit. 
All personnel involved in the conduct of the study will remain blinded to individual treatment 
assignment until planned study unblinding, except for appropriately delegated unblinded 
pharmacists, vaccine administrators, and monitors. Neither the participant nor the investigator 
nor clinical staff responsible for study assessments/safety will have access to the treatment 
assignment during the conduct of the study. The investigator may unblind in the event of an 
emergency. 
Safety Oversight: 
Safety monitoring for this study will include the blinded study team members, inclusive of at a 
minimum, the Sponsor medical monitor and contract research organization medical monitor, 
as well as safety reviews by an unblinded Data and Safety Monitoring Board (DSMB). The 
study team will conduct ongoing blinded safety reviews during the study and will be 
responsible for notifying the DSMB of potential safety signal events. The DSMB, composed 
of external, independent subject matter experts, including an unblinded statistician, will 
conduct unblinded reviews of safety data on a periodic basis, as defined in a DSMB charter, or 
as otherwise requested by the study team. 
Study Duration: Approximately 13 months for each participant. 
Study participants may be screened up to 28 days prior to randomization and vaccination and 
will be followed for 12 months after a single intramuscular (IM) administration of 
investigational product (IP). 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 16 
Number of Participants: Approximately 6000 participants will be enrolled in a 1:1 ratio to 
receive either a single dose of mRNA-1010 or a single dose of a licensed seasonal influenza 
vaccine as an active comparator (approximately 3000 participants in each vaccination group). 
Study Eligibility Criteria: 
Inclusion Criteria: 
Participants are eligible to be included in the study only if all the following criteria apply: 
1. Individual is at least 18 years of age at the time of consent (Screening Visit). 
2. Investigator has assessed that the 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 by this protocol. 
4. Female participants of nonchildbearing potential may be enrolled in the study. Non-
childbearing potential is defined as post-menopausal or permanently sterilized. Follicle-
stimulating hormone may be measured at the discretion of the investigator to confirm 
postmenopausal status (see additional information in Section 11.2). 
5. 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 prior to vaccine dose being administered on Day 1. 
• Has practiced adequate contraception or has abstained from all activities that 
could result in pregnancy for at least 28 days prior to the first dose (Day 1). 
Adequate female contraception is defined as consistent and correct use of a local 
health authority-approved contraceptive method in accordance with the product 
label. 
• Has agreed to continue adequate contraception through 90 days following 
vaccine administration. 
Exclusion Criteria: 
Participants are excluded from the study if any of the following criteria apply: 
1. Participant has had close contact to someone with severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) as 
defined by the US CDC or has had a positive SARS-CoV-2 test in the past 10 days prior 
to the Screening Visit. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 17 
2. 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. 
3. 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 within the 60 days prior to the Screening Visit and 
includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis 
or condition. 
4. Reported 
history 
of 
congenital 
or 
acquired 
immunodeficiency, 
immunocompromising/immunosuppressive condition, asplenia, or recurrent severe 
infections. The following conditions are permitted at the discretion of the Investigator: 
a) Participants who have HIV and on antiretroviral therapy with cluster of 
differentiation 4 count ≥ 350 cells/mm3 and HIV RNA ≤ 500 copies/mL within the 
past 12 months. 
b) Participants with immune-mediated diseases which are stable, (eg, Hashimoto’s 
thyroiditis and type 1 diabetes) or conditions such as asthma, psoriasis, vitiligo, 
gout, alopecia areata, or autoimmune ovarian failure which do not require systemic 
immunosuppressants per Exclusion Criterion 9. 
5. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, 
psoriasis patches affecting skin over the deltoid areas). 
6. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any 
mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, 
including egg protein. 
7. Reported history of coagulopathy or bleeding disorder that is considered a 
contraindication to IM injection or phlebotomy. 
8. Any medical, psychiatric, or occupational condition, including reported history of 
substance abuse, that, in the opinion of the investigator, may pose additional risk due to 
participation in the study or that could interfere with the interpretation of study results. 
9. Participant has received systemic immunosuppressants or immune-modifying drugs for 
> 14 days in total within 180 days prior to the Screening Visit (for corticosteroids, 
≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for systemic 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 18 
immunosuppressive treatment at any time during participation in the study. Inhaled, 
nasal, and topical steroids are allowed. 
10. Participant has received any vaccine authorized or approved by local health agency 
≤ 28 days prior to study injection (Day 1) or plans to receive a vaccine authorized or 
approved by local health agency within 28 days before or after the study injection. 
11. Participant is not aware whether they have received an influenza vaccine in the past 
12 months. 
12. Participant has received a seasonal influenza vaccine or any other investigational 
influenza vaccine within 180 days prior to Day 1. 
13. Participant has tested positive for influenza by local health authority-approved testing 
methods within 180 days prior to the Screening Visit. 
14. Participant has a history of myocarditis, pericarditis, or myopericarditis within 60 days 
prior to the Screening Visit. Participants who have not returned to baseline after their 
convalescent period will also be excluded. 
15. Participant has received systemic immunoglobulins or blood products within 90 days 
prior to the Screening Visit or plans to receive systemic immunoglobulins or blood 
products during the study. In addition, participants who have received long-acting 
biological therapies that affect immune responses (eg, infliximab) within 90 days prior 
to the Screening Visit, or plan to receive them, during the study are also excluded. 
16. 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. 
17. Participant has 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. 
18. Participant is an immediate family member or household member of study personnel, 
clinic staff, or Sponsor personnel. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 19 
Study Vaccines: 
Investigational Product, Dosage, and Mode of Administration: 
mRNA-1010 IP contains lipid nanoparticle (LNP) dispersions encoding the seasonal influenza 
vaccine antigens, HA, from influenza strains A/Wisconsin/588/2019 (A/H1N1)pdm09-like 
virus; A/Darwin/6/2021 (A/H3N2)-like virus; B/Michigan/01/2021 (B/Victoria lineage)-like 
virus; and B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.  
All mRNAs are formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially 
available) and provided as a sterile liquid for injection, white-to-off-white dispersion in 
appearance, at a concentration of 0.1 mg/mL in 
 Tris buffer containing 
 
sucrose and 
 sodium acetate at pH 7.0-8.0. 
mRNA-1010 IP will be administered as a single IM injection dose at mRNA total dose level of 
50 µg. 
Active Comparator, Dosage, and Mode of Administration: 
Quadrivalent, inactivated influenza vaccine, Fluarix Tetra, administered as single 0.5 mL IM 
injection. 
Procedures and Assessments: 
Immunogenicity Assessments: 
Blood samples for immunogenicity assessments will be collected at the time points indicated 
in the SoE. The following analytes will be measured: 
• Serum antibody level as measured by HAI assay. 
• Serum nAb level as measured by MN assay or similar methods may also be performed. 
Safety Assessments: 
Safety assessments will include monitoring and recording of the following for each 
participant: 
• Solicited local and systemic ARs that occur during the 7 days following the study 
injection (ie, the day of injection and 6 subsequent days). Solicited ARs will be 
recorded daily using eDiaries. 
• Unsolicited AEs observed or reported during the 28 days following the study injection 
(ie, the day of injection and 27 subsequent days). 
CCI
CCI
CCI

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 20 
• AEs leading to discontinuation from study participation from Day 1 through Day 361 
(Month 12)/EoS or withdrawal from the study. 
• MAAEs from Day 1 through Day 361 (Month 12)/EoS or withdrawal from the study. 
• SAEs and AESIs from Day 1 through Day 361 (Month 12)/EoS or withdrawal from the 
study. 
• Details of all pregnancies in female participants will be collected after the start of study 
vaccine and until the end of their participation in the study. All pregnancies must be 
followed to determine the outcome. 
Clinical Assessments: 
Participants who develop symptoms consistent with protocol-defined ILI and/or COVID-19 
will have NP swabs collected for testing. The initial test will be a real-time, RT-PCR-based 
assay, to determine if either influenza A and/or B strains, as well as other respiratory viruses 
such as SARS-CoV-2, are present in the clinical sample. For samples that test positive for 
influenza in the RT-PCR assay, further testing by PCR-based genetic sequencing of the HA 
segments and/or other influenza virus genes may be performed to identify the specific subtype 
of the influenza strain. The RT-PCR-positive samples may be cultured. Cultured viruses may 
be used to evaluate similarity (match) to the current year’s vaccine strains using ferret antisera 
to determine antigenic similarity to vaccine strains.  
ILI Case Definitions: 
Protocol-defined ILI: 
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  

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 21 
CDC-defined ILI: 
A CDC-defined ILI is defined as body temperature ≥ 37.8°C (100°F) accompanied by cough 
and/or sore throat. 
RT-PCR-confirmed Protocol-defined Influenza Infection: 
An RT-PCR-confirmed protocol-defined influenza infection is defined as a positive influenza 
result on a respiratory sample by RT-PCR performed at the Global Central Laboratory and/or 
a local certified laboratory within 7 days of onset of protocol-defined ILI symptoms, at any 
time during the study period. 
RT-PCR-confirmed CDC-defined Influenza Infection: 
An RT-PCR-confirmed CDC-defined influenza infection is defined as a positive influenza 
result on a respiratory sample by RT-PCR performed at the Global Central Laboratory and/or 
a local certified laboratory within 7 days of onset of CDC-defined ILI symptoms at any time 
during the study period. 
Statistical Methods: 
Statistical Hypotheses:  
The null hypothesis H10: immunogenicity response to mRNA-1010, as measured by GMT or 
by seroconversion rate at Day 29 using HAI assay, is inferior compared to that in participants 
who received the active comparator for A strains (ie, H1N1, H3N2). Four coprimary 
immunogenicity endpoints will be tested for noninferiority of mRNA-1010 vs. active 
comparator for A strains at two-sided 0.025 level. 
The null hypothesis H20: immunogenicity response to mRNA-1010, as measured by GMT or 
by seroconversion rate at Day 29 using HAI assay, is inferior compared to that in participants 
who received the active comparator for B strains (ie, B/Victoria, B/Yamagata). Four 
coprimary immunogenicity endpoints will be tested for non-inferiority of mRNA-1010 vs. 
active comparator for B strains at two-sided 0.025 level. 
At Day 29, for each individual influenza virus strain, 
• The noninferiority in GMT in participants who received mRNA-1010 compared to that 
of participants who received the active comparator will be demonstrated by the lower 
bound of the 97.5% confidence interval (CI) of the GMT ratio (geometric mean ratio 
[GMR]) ruling out 0.667 (lower bound > 0.667) using a noninferiority margin of 1.5. 
The GMR is the ratio of the GMT of HAI titer in those receiving mRNA-1010 
compared with the GMT of those receiving the active comparator. 
• The noninferiority in seroconversion rate in the mRNA-1010 group compared to that 
of the active comparator group will be demonstrated by the lower bound of the 97.5% 
CI of the seroconversion rate difference (mRNA-1010 vs. active comparator) ruling 
out -10% (lower bound > -10%) using a noninferiority margin of 10%. 
The success criteria of non-inferiority for A strains are met if H10 is rejected at a two-sided 
0.025 level on all four co-primary endpoints. Similarly, the success criteria of non-inferiority 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 22 
for B strains are met if H20 is rejected at a two-sided 0.025 level on all four co-primary 
endpoints.  
Additional details about the hypothesis testing can be found in the statistical section of the 
protocol.  
Sample Size Justification: 
With approximately 3000 participants exposed to IP in the mRNA-1010 group, the study has 
an approximately 95% probability to observe at least 1 participant with an AE at a true 0.1% 
AE rate. 
Assuming approximately 15% of randomized participants will be excluded from Per-
Protocol (PP) Immunogenicity Set, with approximately 5100 participants in the PP 
Immunogenicity Set (1:1 ratio, approximately 2550 in each vaccine group), the study has at 
least 95% power to demonstrate noninferiority of the immune response in all 4 strains, as 
measured by the GMT in participants receiving mRNA-1010 compared with that in the active 
comparator group, at a 2-sided alpha of 0.025, assuming an underlying GMR of 0.9 in all 4 
strains and a non-inferiority margin of 1.5. The standard deviation of the natural log-
transformed levels is assumed to be 1.5.  
The study has at least 95% power to demonstrate noninferiority of the immune response in all 
4 strains, as measured by seroconversion rate in the mRNA-1010 group compared with that in 
the active comparator group, at a 2-sided alpha of 0.025, assuming a seroconversion rate of 
70% in influenza A strains and 60% in influenza B strains, respectively, in the mRNA-1010 
group (a true rate difference is 0 compared to the active comparator group), and a non-
inferiority margin of 10%. 
Analysis Populations: The analysis sets are defined in the following table: 
Population 
Description 
Randomization Set 
All participants who are randomly assigned to treatment, regardless 
of the participants’ treatment status in the study. 
Full Analysis Set (FAS) 
All participants randomly assigned to treatment who received any 
study vaccination. Participants will be analyzed according to the 
group to which they were randomized. 
Modified Intent-to-Treat 
(mITT) Set 
All participants in the FAS who provide any follow-up for ILI 
beginning at least 14 days following administration of study 
intervention. 
Participants will be analyzed according to the group to which they 
were randomized. 
PP Set for Efficacy 
A subset of participants in the mITT Set who do not have 
significant protocol deviations that could adversely impact efficacy, 
eg, disease or therapeutic intervention that might cause suboptimal 
response to the study intervention.  
Participants will be analyzed according to the group to which they 
were randomized. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 23 
Immunogenicity Set 
All participants in the FAS who have baseline and Day 29 antibody 
assessment via HAI assay. 
Participants will be analyzed according to the group to which they 
were randomized. 
PP Immunogenicity Set 
The PP Immunogenicity Set includes all participants in the 
Immunogenicity Set who received planned dose of IP, complied 
with the immunogenicity testing schedule, and had no major 
protocol deviations that impact key or critical data. Participants 
with RT-PCR-confirmed influenza between Days 1 to 29 will be 
removed from the PP Immunogenicity Set. 
The PP Immunogenicity Set will be used for all analyses of 
immunogenicity unless specified otherwise. 
Participants will be analyzed according to the group to which they 
were randomized. 
Solicited Safety Set 
All randomized participants who received any study vaccination 
and contributed any solicited AR data. 
The Solicited Safety Set will be used for the analyses of solicited 
ARs, and participants will be included in the vaccination group 
corresponding to the vaccination that they actually received. 
Safety Set 
All participants randomly assigned to treatment who received any 
study vaccination. 
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 the IP that they actually received. 
Abbreviations: AR = adverse reaction; IP = investigational product; PP = Per-protocol; RT-PCR = reverse 
transcription polymerase chain reaction. 
Immunogenicity Analyses: 
The primary analysis population for immunogenicity will be the PP Immunogenicity Set, 
unless specified otherwise. The primary objective of this study is to use the immunogenicity 
response to infer efficacy in participants receiving mRNA-1010. 
Immune responses, as measured by GMT and seroconversion rate in the mRNA-1010 group 
based on Day 29 HAI titers, will be compared to that in participants receiving the active 
comparator for all 4 strains. 
An analysis of covariance model will be carried out. The model will include the log-
transformed HAI titers at Day 29 as the dependent variable, vaccination group as the fixed 
variable, log-transformed baseline HAI titers as a fixed covariate, adjusting for the 
stratification factors. The geometric least square mean (GLSM), and its corresponding 95% CI 
results in log-transformed scale estimated from the model will be back-transformed to obtain 
these estimates in the original scale, as an estimate of the GMT. GMR, estimated by the ratio 
of GLSM and the corresponding 2-sided 97.5% CI will be provided to assess the treatment 
difference. The corresponding 2-sided 97.5% CI of GMR will be provided to assess the 
difference in immune response between the mRNA-1010 compared to the active comparator 
group at Day 29. For each strain, the non-inferiority of GMT will be considered demonstrated 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 24 
if the lower bound of the 97.5% CI of the GMR is > 0.667 based on the non-inferiority margin 
of 1.5. 
The number and percentage of participants with seroconversion due to vaccination will be 
provided with 2-sided 95% CI using the Clopper-Pearson method at Day 29. To compare the 
seroconversion rates between the vaccination groups, the Miettinen-Nurminen’s method will 
be used to calculate the 97.5% CI for the difference in seroconversion rates. The 
seroconversion rate difference with the corresponding 97.5% CI at Day 29 will be provided. 
For each strain, the non-inferiority of seroconversion rate will be considered demonstrated if 
the lower bound of the 97.5% CI of the seroconversion rate difference is > -10% based on the 
non-inferiority margin of 10%. 
The primary analyses will be repeated using the Immunogenicity Set as a sensitivity analysis. 
Subgroup analysis for the coprimary immunogenicity endpoints will be conducted as 
appropriate. 
Once the noninferiority criteria are met for A strains, superiority of mRNA-1010 relative to 
the active comparator for A strains may be further evaluated. More details about the testing 
sequence can be found in Section 9.6.2 and the statistical analysis plan (SAP). 
In addition, the GMT of HAI titers with corresponding 95% CI will be provided at each time 
point. The 95% CIs will be calculated based on the t-distribution of the log-transformed values 
then back-transformed to the original scale. The GMFR of HAI titers with corresponding 95% 
CI at each post-baseline time point over baseline will be provided. Descriptive summary 
statistics including median, minimum, and maximum will also be provided. 
For summarizations of GMTs, antibody titers reported as below the lower limit of 
quantification (LLOQ) will be replaced by 0.5 x LLOQ. Values that are greater than the upper 
limit of quantification (ULOQ) will be converted to the ULOQ. 
Rate of seroconversion is defined as the proportion of participants with either a pre-
vaccination HAI titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre vaccination HAI titer 
≥ 1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer. 
Efficacy analyses: 
The analysis population of efficacy is the mITT Set.  
To evaluate the incidence of the first episode of RT-PCR-confirmed protocol-defined ILI after 
vaccination with mRNA-1010 or the active comparator, the incidence rate will be calculated 
as the number of participants with a case (ie, first occurrence of ILI at least 14 days after the 
study injection through Day 181/end of influenza season) divided by the number of 
participants at risk adjusted by person-time (years). The person-time is calculated as the time 
from randomization to the date of the first episode for participants with a case, or the time 
from randomization to the date of discontinuation or death, or Day 181/end of influenza 
season, whichever occurs first, for participants without a case. Person-time, incidence rate, and 
95% CI for incidence rate will be provided by vaccination group. Relative vaccine efficacy 
will be estimated by 1- ratio of incidence rate (mRNA-1010 vs. active comparator) adjusting 
for person-time, and the 95% CI will be computed using the exact method conditional upon 
the total number of cases adjusting for person-time. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 25 
Sensitivity analyses may be performed on the PP Set for Efficacy. 
RT-PCR-confirmed protocol-defined ILI and RT-PCR-confirmed CDC-defined ILI in 
participants aged 50 years and older or 65 years and older will be analyzed similarly. 
Safety Analyses: 
All safety analyses will be based on the Safety Set, except summaries for solicited ARs, which 
will be based on the Solicited Safety Set. All safety analyses will be provided by vaccination 
group. Participants will be included in the vaccination group corresponding to what they 
actually received. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters, 
including solicited ARs (local and systemic events), unsolicited AEs, SAEs, AESIs, MAAEs, 
and AEs leading to discontinuation. 
The number and percentage of participants with any solicited local AR, solicited systemic AR, 
and solicited AR during the 7-day follow-up period after the injection will be summarized. 
A 2-sided 95% exact CI using the Clopper-Pearson method will also 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 from study participation 
will be summarized. Unsolicited AEs will be coded according to the Medical Dictionary for 
Regulatory Activities (MedDRA) and presented by MedDRA system organ class and 
preferred term. 
Solicited ARs will be coded by system organ class and preferred term according to the 
MedDRA for AR terminology. The Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventive Vaccine Clinical Trials will be used in this study with 
modification for rash, solicited ARs, and vital signs. 
The number of events of unsolicited AEs, SAEs, AESIs, and MAAEs will be reported in 
summarization tables accordingly. 
For all other safety parameters, descriptive summary statistics will be provided. 
Planned Analyses: 
The primary analysis of safety and immunogenicity will be performed after all participants 
have completed the Day 29 Visit. All data relevant to the primary study analysis through the 
Day 29 visit will be cleaned and locked for primary analysis (ie, data that are as clean as 
possible) and a report may be generated. 
A 6-month analysis may be performed once all participants complete the Day 181 Visit or the 
influenza season ends, whichever occurs later. All of safety, immunogenicity, and efficacy 
data will be cleaned and locked for the analysis. Additional safety analyses at other time points 
may be performed. 
The above 2 analyses will be performed by a separate team of unblinded programmers and 
statisticians. More details can be found in the study data blinding plan. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 26 
Final analysis of all safety, immunogenicity, and efficacy data will be performed once all 
participants complete the Day 361 (Month 12)/EoS Visit. 
The SAP will describe the planned analyses in greater detail. 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 27 
1.2 Schedule of Events 
Table 1: Schedule of Events 
Visit Number 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
USV 
Type of Visit/Contact 
C 
C 
C 
SC 
SC 
C 
SC 
SC/C 
SC 
SC/C 
C 
Month Timepoint 
 
 
 
 
 
M1 
M3 
M6 
M9 
M12 
Up to M12 
Study Visit  
Screening1 D1 (Baseline) D4 
D8 
D15 
D29 
D91 
D181 
D271 
D361/EoS 
USV 
Window Allowance (Days) 
-28 
N/A 
-2 
±3 
±3 
-7 to +3 
±5 
±14 
±14 
±14 
N/A 
Informed consent form, demographics, concomitant 
medications, medical history2  
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
Physical examination3 
X 
 
 
 
 
 
 
 
 
 
 
Vital signs4 
X 
X 
 
 
 
 
 
 
 
 
 
Pregnancy testing5 
X 
X 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
Study vaccination (including 30-minute post-dosing 
observation period)6 
 
X 
 
 
 
 
 
 
 
 
 
Collection of Edmonton Frail Scale7  
 
X 
 
 
 
 
 
 
 
 
 
Blood collection for humoral immunogenicity 
 
X8 
 
 
 
X 
 
X9 
 
X9 
 
Genomic sample (optional) 
 
X8 
 
 
 
 
 
 
 
 
 
Transcriptomic sample (optional) 
 
X8 
 
 
 
X 
 
 
 
 
 
Optional blood sample for potential biomarker 
analysis10 
 
 
X 
 
 
 
 
 
 
 
 
NP swab for virus detection11 
 
 
 
 
 
 
 
 
 
 
X 
eDiary activation for recording solicited ARs 
(7 days)12 
 
X 
 
 
 
 
 
 
 
 
 
Review of eDiary for solicited ARs 
 
 
 
X 
 
 
 
 
 
 
 
Symptom Reporting eDiary activation13 
 
X 
 
 
 
 
 
 
 
 
 
Symptom Reporting eDiary for collection of 
symptoms of ILI14 
 
 
Once weekly 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 28 
Visit Number 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
USV 
Type of Visit/Contact 
C 
C 
C 
SC 
SC 
C 
SC 
SC/C 
SC 
SC/C 
C 
Month Timepoint 
 
 
 
 
 
M1 
M3 
M6 
M9 
M12 
Up to M12 
Study Visit  
Screening1 D1 (Baseline) D4 
D8 
D15 
D29 
D91 
D181 
D271 
D361/EoS 
USV 
Window Allowance (Days) 
-28 
N/A 
-2 
±3 
±3 
-7 to +3 
±5 
±14 
±14 
±14 
N/A 
Review of Symptom Reporting eDiary15 
 
Review participant-recorded ILI starting on Day 1 through Day 361 (Month 12)/EoS  
Follow-up safety call 
 
 
 
X 
X 
 
X 
X16 
X 
X16 
 
eDiary collection of EQ-5D-5L17 
 
X 
eDiary prompts18 
eDiary collection of WPAI:ILI19 
 
 
eDiary prompts20 
Recording of unsolicited AEs 
 
X 
 
X 
X 
X 
 
 
 
 
 
Recording of SAEs, AESIs, and MAAEs, as well as 
AEs that led to discontinuation and relevant 
concomitant medications/procedures21 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant medications and non-
study vaccinations22 
 
X 
 
X 
X 
X 
 
 
 
 
 
Recording of hospitalizations and outpatient 
treatment-related to or for the treatment of the 
MAAE or SAE23 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Study completion 
 
 
 
 
 
 
 
 
 
X 
 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; C = clinic; COVID-19 = coronavirus disease 2019; 
D = day; eDiary = electronic diary; EFS = Edmonton Frail Scale; EoS = end of study; EQ-5D-5L = EuroQoL 5-dimension 5-levels; FDA = Food and Drug 
Administration; HRQoL = health-related quality of life; 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 call (or 
contact by electronic means); USV = unscheduled visit; WPAI:ILI = Work Productivity and Activity Impairment Questionnaire: Influenza-like Illness. 
Note: In accordance with FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency (FDA 2020), 
investigators may convert clinic visits to telemedicine visits with the approval of the Sponsor. 
1. 
The Screening Visit and Day 1 may be performed on the same day or a different day. Additionally, the Screening Visit may be performed over multiple 
visits if within the 28-day screening window. 
2. 
Verbal medical history is acceptable. 
3. 
Physical examination: A full physical examination, including height and weight, will be performed at the Screening Visit; symptom-directed physical 
examinations may be performed at other clinic visits. Interim physical examinations will be performed at the discretion of the investigator. Any clinically 
significant finding identified by a healthcare professional during clinic visits should be reported as an MAAE. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 29 
4. 
Vital signs measurements: Systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. The preferred route of temperature 
assessment is oral. On the day of vaccination, vital signs will be collected once before vaccination and once 30 minutes after vaccination. Vital signs may be 
collected at other clinic visits in conjunction with a symptom-directed physical examination. 
5. 
A pregnancy test either via blood or point-of-care urine test will be performed at the Screening Visit and before the vaccine dose on Day 1, if Day 1 is not on 
the same day as the Screening Visit. At the discretion of the investigator, a pregnancy test either via blood or point-of-care urine can be performed at any 
time. The participant’s follicle stimulating- hormone level may be measured at the Screening Visit, as necessary, and at the discretion of the investigator, to 
confirm postmenopausal status. 
6. 
See Table 3 for dose levels and vaccination groups. All participants will be randomized to receive a single IM injection. 
7. 
Assessment of EFS will only be performed for participants aged 65 years and older. EFS is a brief, valid and reliable tool for the assessment of frailty across 
9 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional 
performance. 
8. 
Samples for humoral immunogenicity and transcriptomics must be collected prior to receipt of vaccination on Day 1. 
9. 
Samples for humoral immunogenicity on Day 181 and Day 361 (Month 12)/EoS will be collected for approximately the first 1000 participants and analyzed 
in a subset. These participants will require a clinic visit on Day 181 and Day 361 (Month 12)/EoS. 
10. Biomarker plasma and biomarker serum samples will be stored for potential future biomarker assessment 
11. The NP swab specimen(s) for pathogens, including influenza virus and other respiratory pathogens (e.g., SARS-CoV-2) will be collected any time from Day 
1 to Day 361 (Month 12)/EoS if participants have protocol-defined- ILI or symptoms suggestive of COVID-19 or other upper or lower respiratory infection 
as defined in the ILI Case Definitions in Section 8.11.5. If participants experience these signs or symptoms, they will be instructed to contact the clinic to 
have an NP swab collected for testing. Nasopharyngeal (NP) swabs may be collected as part of a home visit in lieu of a clinic visit. In the event that NP 
swabs during ILI cannot be collected, any available influenza and/or SARS CoV-2 testing results performed outside of the study should be captured in the 
eCRF. 
12. The eDiary entries will be recorded at approximately 30 minutes after injection while at the clinic with instruction provided by the clinic staff. Study 
participants will continue to record in the eDiary for solicited ARs each day after they leave the clinic, preferably in the evening and at the same time each 
day, on the day of injection and the subsequent 6 days following injection. If the event starts during the solicited period, but continues beyond 7 days after 
dosing, the participant should notify the site to provide an end date and 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. All solicited ARs (local and 
systemic) will be considered causally related to dosing. 
13. The Symptom Reporting eDiary will be activated for collection of ILI symptoms starting at Day 1 and lasting until Day 361 (Month 12)/EoS. 
14. Symptom Reporting eDiary: Participants will be instructed to report via Symptom Reporting eDiary or by contacting the site if ILI symptoms have been 
experienced from Day 1 to Day 361 (Month 12)/EoS. If symptoms are reported, the investigator must contact the participant to assess symptoms and ensure 
an NP swab is collected within 72 hours of symptom onset. If possible, NP swabs should be collected prior to initiation of antiviral therapy. If there is no 
response to an eDiary prompt for 2 consecutive entries, the clinic staff will attempt to contact the study participant by telephone. 
15. Review of eDiary for recording of symptoms of ILI. 
16. Participants in the subset require a clinic visit on Day 181 and Day 361 (Month 12)/EoS for sample collection. 
17. EQ-5D-5L is a well-validated, reliable, standardized instrument for measuring non-disease-specific HRQoL. EQ-5D-5L consists of a short descriptive 
system questionnaire and a visual analogue scale (EQ-VAS). The short descriptive questions are designed to assess 5 dimensions of health including 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 30 
mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-VAS records the health status on a scale between 0 and 100, with 0 
indicating the worst imaginable health and 100 indicating the best imaginable health. 
18. All participants will receive eDiary prompts to complete the EQ-5D-5L at Day 1 (baseline), Day 91, Day 181, Day 271, and Day 361 (Month 12)/EoS. For 
participants reporting symptoms of ILI, the EQ-5D-5L responses will be collected using the eDiary on the day of the symptoms reporting (+1 day) and 5 
days (+1 day) later. 
19. WPAI consists of 6 questions, which can quantitatively assess the amount of absenteeism, presenteeism, overall work impairment, and activity impairment 
attributable to a patient’s health issues based on a 1-week recall period. The WPAI is available in different versions, such as WPAI: Specific Health Problem 
(WPAI:SHP), which can be adapted to a specific disease. 
20. For participants reporting symptoms of ILI, the WPAI over the previous 7 days will be collected using the eDiary 5 days (+1 day) following the start of ILI 
symptoms reporting. 
21. Trained study personnel will call all participants to collect information relating to any MAAEs, AEs leading to study discontinuation, SAEs, AESIs, 
information on concomitant medications associated with those events, and any non-study vaccinations. All concomitant medications relevant to or for the 
treatment of an SAE, AESI, or MAAE will be recorded from Day 1 through Day 361 (Month 12)/EoS. 
22. All concomitant medications and non-study vaccinations will be recorded through 28 days after IP injection (including receipt of any authorized or 
investigational COVID-19 vaccine). 
23. All hospitalizations, outpatient/physician visits, emergency room/urgent care visits, and telemedicine visits associated with MAAEs or SAEs will be 
recorded from Day 1 through Day 361 (Month 12)/EoS. 
 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 31 
TABLE OF CONTENTS 
CLINICAL STUDY PROTOCOL ..................................................................................................1 
PROTOCOL APPROVAL – SPONSOR SIGNATORY ................................................................2 
DECLARATION OF INVESTIGATOR .........................................................................................3 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................4 
1. 
PROTOCOL SUMMARY ..........................................................................................11 
1.1 
Protocol Synopsis .......................................................................................................11 
1.2 
Schedule of Events .....................................................................................................27 
TABLE OF CONTENTS ...............................................................................................................31 
LIST OF TABLES .........................................................................................................................36 
LIST OF FIGURES .......................................................................................................................36 
LIST OF ABBREVIATIONS ........................................................................................................37 
2. 
INTRODUCTION ......................................................................................................40 
2.1 
Study Rationale ...........................................................................................................40 
2.2 
Background and Overview .........................................................................................40 
2.2.1 
mRNA-1010 ...............................................................................................................40 
2.2.2 
Nonclinical Studies .....................................................................................................41 
2.2.3 
Clinical Studies ...........................................................................................................42 
2.3 
Benefit/Risk Assessment ............................................................................................43 
2.3.1 
Known Potential Benefits ...........................................................................................43 
2.3.2 
Risks From Study Participation and Their Mitigation ................................................43 
2.3.3 
Overall Benefit/Risk Conclusion ................................................................................44 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................45 
4. 
STUDY DESIGN .......................................................................................................48 
4.1 
General Design ...........................................................................................................48 
4.2 
Scientific Rationale for Study Design ........................................................................50 
4.3 
Justification for Dose, Control Product, and Choice of Study Population .................50 
4.4 
End of Study Definition ..............................................................................................51 
5. 
STUDY POPULATION .............................................................................................52 
5.1 
Inclusion Criteria ........................................................................................................52 
5.2 
Exclusion Criteria .......................................................................................................52 
5.3 
Lifestyle Restrictions ..................................................................................................54 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 32 
5.4 
Screen Failures ............................................................................................................54 
6. 
STUDY TREATMENT ..............................................................................................56 
6.1 
Investigational Product and Active Comparator Administered ..................................56 
6.2 
Randomization and Blinding ......................................................................................57 
6.3 
Preparation/Handling/Storage/Accountability ............................................................57 
6.3.1 
Clinical Study Material Preparation ...........................................................................57 
6.3.2 
Clinical Study Material Administration......................................................................58 
6.3.3 
Clinical Study Material Packaging and Labeling .......................................................58 
6.3.4 
Clinical Study Material Storage ..................................................................................58 
6.3.5 
Clinical Study Material Accountability ......................................................................58 
6.3.6 
Clinical Study Material Handling and Disposal .........................................................59 
6.3.7 
Unblinding ..................................................................................................................59 
6.4 
Study Intervention Compliance ..................................................................................59 
6.5 
Concomitant Therapy .................................................................................................59 
6.5.1 
Recording of Concomitant Medications, Concomitant Vaccinations, and 
Concomitant Procedures .............................................................................................59 
6.5.2 
Concomitant Medications and Vaccines That May Lead to the Elimination of 
a Participant From Per-protocol Analyses ...................................................................60 
6.6 
Intervention After the End of the Study .....................................................................61 
7. 
DELAY OR DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL .......................................62 
7.1 
Participant Discontinuation/Withdrawal From the Study ...........................................62 
7.2 
Lost to Follow-up .......................................................................................................63 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................64 
8.1 
Screening ....................................................................................................................64 
8.2 
Confirm Inclusion and Exclusion Criteria ..................................................................64 
8.3 
Demographic and Baseline Data ................................................................................64 
8.4 
Medical History ..........................................................................................................64 
8.5 
Randomization ............................................................................................................64 
8.6 
Physical Examination and Vital Signs ........................................................................64 
8.7 
Study Vaccine Administration ....................................................................................65 
8.8 
Efficacy and Immunogenicity Assessments ...............................................................65 
8.8.1 
Sampling for Efficacy Assessments ...........................................................................65 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 33 
8.8.2 
Sampling for Immunogenicity Assessments ..............................................................65 
8.9 
Safety Assessments .....................................................................................................65 
8.9.1 
Pregnancy Screen and Testing ....................................................................................66 
8.9.2 
Assessments for Respiratory Viral Infections ............................................................66 
8.9.3 
Safety Telephone Calls ...............................................................................................67 
8.9.4 
Use of Electronic Diaries ............................................................................................67 
8.9.5 
Blood Sampling Volumes ...........................................................................................68 
8.9.6 
Ancillary Supplies for Participant Use .......................................................................68 
8.10 
Clinical Assessments ..................................................................................................68 
8.11 
Safety Definitions .......................................................................................................69 
8.11.1 
Adverse Event .............................................................................................................69 
8.11.2 
Serious Adverse Events ..............................................................................................69 
8.11.3 
Solicited Adverse Reactions .......................................................................................70 
8.11.4 
Medically Attended Adverse Events ..........................................................................73 
8.11.5 
Influenza-like Illness Case Definitions .......................................................................73 
8.11.6 
Adverse Event of Special Interest ...............................................................................74 
8.11.7 
Recording and Follow-up of Pregnancy .....................................................................76 
8.11.8 
Recording and Follow-up of an AE and/or SAE ........................................................76 
8.11.9 
Assessment of Intensity ..............................................................................................77 
8.11.10 
Assessment of Causality .............................................................................................77 
8.11.11 
Reporting Adverse Events ..........................................................................................78 
8.11.12 
Reporting Serious Adverse Events .............................................................................78 
8.11.13 
Time Period and Frequency for Collecting AE and SAE Information .......................78 
8.11.14 
Method of Detecting AEs and SAEs ..........................................................................79 
8.11.15 
Follow-up of AEs and SAEs .......................................................................................79 
8.11.16 
Regulatory Reporting Requirements for SAEs ...........................................................80 
8.12 
Safety Oversight .........................................................................................................80 
8.13 
Treatment of Overdose ...............................................................................................80 
8.14 
Pharmacokinetics ........................................................................................................80 
8.15 
Pharmacodynamics .....................................................................................................81 
8.16 
Biomarkers ..................................................................................................................81 
8.17 
Patient -reported Outcomes and Medical Resource Utilization .................................81 
8.17.1 
Patient-reported Outcome Measures ...........................................................................81 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 34 
8.17.2 
Medical Resource Utilization .....................................................................................82 
9. 
STATISTICAL CONSIDERATIONS .......................................................................83 
9.1 
Blinding and Responsibility for Analyses ..................................................................83 
9.2 
Statistical Hypotheses .................................................................................................83 
9.3 
Sample Size Determination ........................................................................................85 
9.4 
Analyses Populations ..................................................................................................85 
9.5 
Statistical Analyses .....................................................................................................86 
9.5.1 
Immunogenicity Analyses ..........................................................................................87 
9.5.2 
Efficacy Analyses .......................................................................................................88 
9.5.3 
Safety Analyses ..........................................................................................................88 
9.5.4 
Exploratory Analyses ..................................................................................................89 
9.6 
Planned Analyses ........................................................................................................89 
9.6.1 
Interim Analyses .........................................................................................................89 
9.6.2 
Multiplicity .................................................................................................................90 
10. 
REFERENCES ...........................................................................................................92 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................95 
11.1 
APPENDIX 1: Study Governance Considerations .....................................................95 
11.1.1 
Regulatory and Ethical Considerations ......................................................................95 
11.1.2 
Study Monitoring ........................................................................................................95 
11.1.3 
Audits and Inspections ................................................................................................96 
11.1.4 
Financial Disclosure ...................................................................................................97 
11.1.5 
Recruitment Strategy ..................................................................................................97 
11.1.6 
Informed Consent Process ..........................................................................................97 
11.1.7 
Protocol Amendments ................................................................................................98 
11.1.8 
Protocol Deviations ....................................................................................................99 
11.1.9 
Data Protection ...........................................................................................................99 
11.1.10 
Sample Retention and Future Biomedical Research ................................................100 
11.1.10.1 Data and Safety Monitoring Board ...........................................................................100 
11.1.10.2 Dissemination of Clinical Study Data ......................................................................100 
11.1.11 
Data Quality Assurance and Quality Control ...........................................................101 
11.1.12 
Data Collection and Management ............................................................................102 
11.1.13 
Source Documents ....................................................................................................102 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 35 
11.1.14 
Retention of Records ................................................................................................102 
11.1.15 
Study and Site Closure..............................................................................................103 
11.1.16 
Publication Policy .....................................................................................................103 
11.2 
APPENDIX 2: Contraceptive Guidance ...................................................................104 
11.3 
APPENDIX 3: Adverse Events of Special Interest ..................................................105 
11.4 
APPENDIX 4: CDC Working Case Definitions of Pericarditis, Myocarditis, 
and Myopericarditis Occurring After Receipt of COVID-19 mRNA 
Vaccines ....................................................................................................................106 
11.5 
APPENDIX 5: Protocol Amendment History ..........................................................108 
11.5.1 
Amendment 1, 10 Feb 2022 ......................................................................................108 
 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 36 
LIST OF TABLES 
Table 1: 
Schedule of Events .....................................................................................................27 
Table 2: 
Study Objectives and Endpoints .................................................................................45 
Table 3: 
Vaccination Groups and Dose Levels .........................................................................49 
Table 4: 
Investigational Product and Active Comparator Administered ..................................56 
Table 5:  
Solicited Adverse Reactions and Grades ....................................................................71 
Table 6:  
Respiratory and Systemic Symptoms for Protocol-defined Influenza-like 
Illness ..........................................................................................................................73 
Table 7: 
Populations for Analyses ............................................................................................85 
Table 8: 
Analysis Strategy for Safety Parameters ....................................................................89 
Table 9: 
Adverse Events of Special Interest ...........................................................................105 
Table 10: Case Definitions of Probable and Confirmed Myocarditis, Pericarditis, and 
Myopericarditis .........................................................................................................106 
 
LIST OF FIGURES 
Figure 1: Testing Sequence of the Primary and Secondary Objectives .........................................90 
 
 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 37 
LIST OF ABBREVIATIONS 
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 
AR 
adverse reaction 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
COVID-19 
coronavirus disease 2019 
CRO 
contract research organization 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
eCRF 
electronic case report form 
eDiary 
electronic diary 
EFS 
Edmonton Frail Scale 
EoS 
end of study 
EQ-5D 
EuroQoL 5-dimension 
EQ-5D-5L 
EuroQoL 5-dimension 5-levels 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GLSM 
geometric least square mean 
GMFR 
geometric mean fold rise 
GMR 
geometric mean ratio 
GMT 
geometric mean titer 
HA 
hemagglutinin 
HAI 
hemagglutination inhibition 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 38 
Abbreviation or Specialist Term 
Definition 
HCP 
healthcare practitioner 
HIV 
human immunodeficiency virus 
IB 
investigator’s brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IgG 
immunoglobulin G 
ILI 
influenza-like illness 
IM 
intramuscular(ly) 
IP 
investigational product 
IRB 
Institutional Review Board 
IRT 
interactive response technology  
LLOQ 
lower limit of quantification 
LNP 
lipid nanoparticle 
MAAE 
medically attended adverse event 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
modified intent-to-treat 
mITT1 
modified intent-to-treat-1 
MN 
Microneutralization 
mRNA 
messenger ribonucleic acid 
nAb 
neutralizing antibody 
NH 
Northern Hemisphere 
NP 
Nasopharyngeal 
PP  
per protocol 
QA 
quality assurance 
RT-PCR 
reverse transcription polymerase chain reaction 
SAE 
serious adverse event 
SAP 
statistical analysis plan 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 39 
Abbreviation or Specialist Term 
Definition 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SH 
Southern Hemisphere 
SoE 
Schedule of Events 
TEAE 
treatment-emergent adverse event 
ULOQ 
upper limit of quantification 
USP 
United States Pharmacopeia 
WHO 
World Health Organization 
WPAI:ILI 
Work Productivity and Activity Impairment Questionnaire: 
Influenza-like Illness 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 40 
2. INTRODUCTION 
2.1 Study Rationale 
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, which is 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), respectively (Riedel et al 2019). Since influenza viruses 
continuously change through a process termed antigenic drift, the circulating viruses are actively 
monitored by a worldwide monitoring network coordinated by the WHO (Monto 2018). Based 
on the observed circulation patterns and antigenic changes, an expert panel recommends 
influenza virus strains to be used for vaccine manufacturing twice a year (once for the NH and 
once for the SH. Influenza A and 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 60% overall effectiveness and 
are poorly effective during the years when circulating viruses do not match the strains elected for 
the vaccine antigens (Centers for Disease Control and Prevention [CDC] 2020a). Influenza 
vaccines based on messenger ribonucleic acid (mRNA) technology could provide several 
benefits compared with 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, and improved protection in older adults 
(Rockman et al 2020). 
2.2 Background and Overview 
ModernaTX, Inc. (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 antigens(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. 
Two mRNA vaccines against the severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) including Pfizer, Inc.’s BNT162b2 (Polack et al 2020) and the Sponsor’s 
mRNA-1273 (NCT04283461, NCT04405076, and NCT04470427) have received full 
authorizations by the US Food and Drug Administration (FDA). 
2.2.1 mRNA-1010 
The Sponsor is using its mRNA-based platform to develop a lipid nanoparticle (LNP)-
encapsulated mRNA-based vaccine against disease caused by influenza virus types A and B. The 
proposed development candidate, mRNA-1010, is a quadrivalent vaccine containing mRNAs 
that encode for the hemagglutinin (HA) of the 4 strains recommended by the WHO for cell- or 
recombinant-based vaccines. Equal amounts of mRNAs encoding for each of the 4 different 
strains will be used for the HA components. The mRNA-1010 development candidate is 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 41 
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 this pivotal Phase 3 trial of its seasonal influenza mRNA vaccine 
(mRNA-1010) to establish immunogenicity and safety in support of licensure. The design of this 
study will include immunogenicity objectives for hemagglutination inhibition (HAI), a surrogate 
endpoint of prevention of influenza illness and its complications. The rationale for this approach 
is based on the established precedent of using HA-based immunologic correlates for clinical 
assessment and licensure of influenza vaccines (Department of Health and Human Services 
[DHHS] 2007a; Dunning et al 2016; European Medicines Agency 2016). 
Summaries of nonclinical and clinical studies of mRNA-1010 can be found in Section 2.2.2 and 
Section 2.2.3, respectively. 
This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), and 
all applicable regulatory requirements. 
2.2.2 Nonclinical Studies 
Using individually formulated HA-encoding mRNAs (preclinical material), 2 mouse 
immunogenicity studies were performed. The HA sequences used for preclinical formulation 
were from wild-type HAs. 
Both studies used a prime/boost regimen with a 3-week interval. Immunized mice were bled on 
Day 21 (3 weeks after the prime dose) and Day 36 (2 weeks after the boost dose), and 
immunoglobulin G (IgG) antibody titers were determined with an enzyme-linked immunosorbent 
assay using recombinant HA proteins. 
The first study compared mice immunized with individual mRNAs or a combination of all 4 HA 
mRNAs at 2 different doses (2 or 0.4 µg of each mRNA), based on the following strains 
recommended for the 2020 to 2021 NH influenza season: 
• A/Hawaii/70/2019(H1N1)pdm09 
• A/Hong Kong/45/2019(H3N2) 
• B/Washington/02/2019 (B/Victoria lineage) 
• B/Phuket/3073/2013 (B/Yamagata lineage) 
High IgG antibody titers were observed against all HAs following immunization, with both 
individual mRNA constructs and mRNA combinations after a single dose. A dose response and 
booster effect were observed for most mRNA constructs (individual and combinations). 
The second mouse immunogenicity study aimed to confirm that the 2021 SH composition is 
similarly immunogenic with the 2020 to 2021 NH composition. The compositions differed only 
for the H1N1 strain; the SH composition included A/Wisconsin/588/2019(H1N1)pdm09 instead 
of the A/Hawaii/70/2019(H1N1)pdm09 strain. 
No difference in immunogenicity (HA IgG antibody titers) based on the strain/mRNA construct 
used for immunization (A/Hawaii/70/2019 in the NH composition versus A/Wisconsin/588/2019 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 42 
in the SH composition) was observed, suggesting that the mRNA platform will support annual 
strain updates. 
Additional studies to assess protection of mice from challenge with mouse-adapted H1N1 and 
H3N2 viruses after a single immunization and a study to assess immunogenicity and protection 
from H1N1 challenge after 2 immunizations in ferrets have been completed. Using non-GMP 
co-formulated material, mice and ferrets were immunized with mRNA-1010 of the SH 2021 
composition (mRNA-1010-SH21) followed by a viral challenge. Control animals were 
immunized with phosphate-buffered saline or a commercially available MF59-adjuvanted 
influenza vaccine (FLUAD®, 2020/21 NH composition). 
Ferrets were administered via IM injection on a prime/boost schedule with a 3-week interval, 
antibody responses were measured at Day 21 and Day 42 followed by H1N1 challenge on Day 
42. Mice received a single dose via IM injection, antibody responses were measured at Day 21, 
and the animals were challenged that day with either an H1N1 or H3N2 virus. 
In both animal models, serological analyses demonstrated that HAI antibody titers were 
detectable against the 4 viral strains after the first immunization with mRNA-1010 and in the 
case of ferrets, titers were further boosted by the second immunization. In addition, the HAI 
antibody titers induced by mRNA-1010 were as robust as the titers induced by the adjuvanted 
influenza vaccine (FLUAD). 
Upon live virus challenge, ferrets that were vaccinated with mRNA-1010 had lower detectable 
viral loads compared to the placebo group across different tissues. Compared to FLUAD, 
mRNA-1010 performed equally well and reduced viral loads to lower levels in the nose, throat, 
and nasal turbinates. No virus was detected in the lung 4 days after challenge. 
Upon H3N2 live virus challenge, mice that were vaccinated with mRNA-1010 lost less weight 
and showed fewer clinical symptoms as compared to animals that received FLUAD or animals in 
the control group. Upon (H1N1)pdm09-like virus challenge, animals that received mRNA-1010 
or FLUAD were fully protected against morbidity and showed no scorable clinical symptoms. 
In conclusion, vaccination with mRNA-1010 induces strong antibody responses in mice and 
ferrets and confers protective efficacy against live virus challenge. 
A detailed review of the nonclinical experience with mRNA-1010 vaccine will be provided in 
the investigator’s brochure (IB). 
2.2.3 Clinical Studies 
The Sponsor’s Phase 1/2 mRNA-1010-P101 study (NCT04956575) is currently ongoing to 
provide initial first-in-human safety and immunogenicity data on 3 dose levels of mRNA-1010 
encoding strains (50, 100, or 200 µg total mRNA) recommended by the WHO for the 2021 SH. 
An amendment to mRNA-1010-P101 includes a Phase 2 NH portion to the study to increase the 
size of the safety database for the 50 µg and 100 µg dose levels and to test an additional 25 µg 
dose level of mRNA-1010 as well as a licensed seasonal influenza vaccine as an active 
comparator. A Phase 2 Extension portion to this trial is ongoing to study additional dose levels of 
mRNA-1010 (6.25 µg and 12.5 µg) as well as 25 µg of mRNA-1010 and an active comparator. 
No significant safety concerns have been observed in the ongoing Phase 1/2 mRNA-1010-P101 
study upon review of safety data up to 29 days by the Data Safety Monitoring Board (DSMB). In 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 43 
that study, 45 participants in each group received 50 µg, 100 µg, or 200 µg doses of mRNA-
1010. The 50-µg dose of mRNA-1010 showed a preferable reactogenicity profile. The local and 
systemic adverse reactions (ARs) were mostly mild to moderate in severity. There were no 
Grade 4 ARs or serious adverse events (SAEs) assessed by the investigator as related to the study 
vaccine. There was a death due to stage 4 kidney cancer that was unrelated to the study vaccine 
and occurred after Day 29 visit. Vaccination with mRNA-1010 elicited HAI antibodies in both 
younger and older adults against all strains at all dose levels. HAI titers elicited at the 50 µg dose 
level were comparable with the titers elicited at higher dose levels. 
The interim analysis from the Phase 2 NH part of mRNA-1010-P101 included data through 
Day 29 from 498 adults who received study injection. The number of participants in the 4 groups 
were 151 (25 µg mRNA-1010), 147 (50 µg mRNA-1010), 147 (100 µg mRNA-1010) and 53 
(Afluria). No significant safety concerns were identified. The frequency and severity of the 
reports of solicited ARs in the mRNA-1010 groups increased in a dose-dependent manner 
particularly in the older age groups but were acceptable across all dose levels. The solicited ARs 
were higher in the mRNA-1010 groups than in the Afluria group. Local and systemic solicited 
ARs were mostly mild to moderate in severity without any Grade 4 ARs, adverse events of 
special interest (AESIs) or SAEs assessed to be related to the study vaccines. There were no 
study discontinuations due to AEs, and no AEs that led to a study pause. There was one death 
due to cardiac arrest in a 67-year-old male participant with a relevant history of diabetes mellitus, 
hypertension, and obesity. The event occurred 15 days after study vaccination and was assessed 
by the investigator to be unrelated to the study intervention. mRNA-1010 elicited high levels of 
HAI antibodies on Day 29 across all dose levels, substantially exceeding the 1:40 threshold 
associated with a 50% reduction in risk of infection. Antibody responses induced by mRNA-
1010 against the influenza A strains H1N1 and H3N2 were higher compared with those against 
Afluria and were similar to the influenza B strains. 
A description of the immunogenicity and safety of mRNA-1010 is provided in the IB. 
2.3 Benefit/Risk Assessment 
2.3.1 Known Potential Benefits 
The mRNA-1010 vaccine may be effective against seasonal influenza strains as defined by the 
WHO for the 2022 SH influenza season. 
Considering the safety data for mRNA-1010 to date, the Sponsor considers the potential benefits 
of participation to exceed the risks. 
Participants will obtain medical advice about their general health status through the medical 
evaluations/assessments associated with this study (ie, physical examination, vital signs 
measurement, nasopharyngeal [NP] swabs testing). 
Participants will be contributing to the process of developing a new potentially prophylactic 
measure in an area of unmet medical need. 
2.3.2 Risks From Study Participation and Their Mitigation 
As with all injectable vaccines, immediate systemic allergic reactions to vaccination, ranging 
from mild allergic reactions (eg, urticaria) to systemic allergic reactions (eg, anaphylaxis) can 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 44 
occur. These reactions are very rare and are estimated to occur once per 450,000 vaccinations for 
vaccines that do not contain allergens such as gelatin or egg protein (Zent et al 2002). Since the 
authorization of the mRNA-1273 vaccine for coronavirus disease 2019 (COVID-19), the US 
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 precautionary measure, all participants will remain under 
observation at the clinic for at least 30 minutes after vaccination. 
Vasovagal syncope (fainting) can occur before or after any vaccination, is usually triggered by 
the pain or anxiety caused by the injection, and is not related to the substance injected. 
Therefore, it is important that standard precautions and procedures be followed to avoid injury 
from fainting. 
Intramuscular injection with other mRNA vaccines manufactured by the Sponsor containing the 
proprietary SM-102 (44eptadecane-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. The clinical significance of these observations is unknown. 
In a recently completed Phase 3 study of the mRNA-1273 vaccine for COVID-19 in 
30,420 healthy adults, the most commonly reported local reactions included pain, swelling, and 
erythema at the injection site. 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 headache, 
myalgia, arthralgia, fatigue, chills, and fever. In most cases, the reactions resolved spontaneously 
within several days (Baden et al 2021). 
Similarly, safety results from Phase 1 studies conducted by the Sponsor on 2 mRNA vaccines 
containing the HA glycoproteins from the H10N8 and H7N9 avian influenza viruses were well 
tolerated, although the Sponsor’s LNP/mRNA platform has since been updated (eg, SM-102 is 
used in mRNA-1010 and mRNA-1273; Feldman et al 2019). 
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 (Gargano et al 2021). 
Further details are provided in the current IB. 
2.3.3 Overall Benefit/Risk Conclusion 
Considering the safety data for mRNA-1010 to date, the Sponsor considers the potential benefits 
of participation exceed the risks. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 45 
3. OBJECTIVES AND ENDPOINTS 
The objectives which will be evaluated in this study and endpoints associated with each objective 
are provided in Table 2. 
Table 2: Study Objectives and Endpoints
Objectives 
Endpoints 
Primary 
 
• 
To evaluate the humoral immunogenicity of 
mRNA-1010 relative to that of an active 
comparator against vaccine-matched 
influenza A and B strains at Day 29 
• 
GMT at Day 29 as measured by HAI assay 
• 
Proportion of participants reaching 
seroconversion at Day 29 as measured by 
HAI assay 
• 
To evaluate the safety and reactogenicity of 
mRNA-1010 
• 
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 through Day 361 (Month 12)/EoS 
Secondary 
 
• 
To further evaluate the immunological 
response of mRNA-1010 (for superiority) 
relative to an active comparator against 
vaccine-matched influenza A virus strains at 
Day 29 
• 
GMT at Day 29 as measured by HAI assay 
• 
Proportion of participants reaching 
seroconversion at Day 29 as measured by 
HAI assay 
• 
To evaluate relative vaccine efficacy to 
prevent influenza caused by any strain of 
influenza virus  
• 
First episode of RT-PCR–confirmed 
protocol-defined ILI that begins at least 
14 days postvaccination through Day 181 
(Month 6)/end of influenza season caused by 
any strain of influenza virus regardless of 
antigenic match to the strains selected for the 
seasonal vaccine 
• 
First episode of RT-PCR–confirmed Centers 
for Disease Control and Prevention (CDC)–
defined ILI that begins at least 14 days 
postvaccination through Day 181 (Month 
6)/end of influenza season caused by any 
strain of influenza virus regardless of 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 46 
Objectives 
Endpoints 
antigenic match to the strains selected for the 
seasonal vaccine 
• 
First episode of RT-PCR–confirmed 
protocol-defined ILI cases that begin at least 
14 days postvaccination through Day 181 
(Month 6)/end of influenza season caused by 
any strain of influenza virus regardless of 
antigenic match to the strains selected for the 
seasonal vaccine, in participants aged 
50 years and older or 65 years and older 
• 
To evaluate the humoral immunogenicity of 
each study arm against vaccine-matched 
influenza A and B strains at Day 29 
• 
The proportion of participants with a titer 
≥ 1:40 at Day 29 as measured by HAI assay 
• 
GMFR comparing Day 29 to Day 1 
(Baseline) as measured by HAI assay 
Exploratory (May Be Performed) 
 
• 
To evaluate the humoral immunogenicity of 
mRNA-1010 to that of an active comparator 
against vaccine-matched or 
vaccine-mismatched influenza A and B 
strains, including the use of alternative 
methods 
• 
GMT and GMFR of nAbs by assays such as 
MN and/or HAI assays or alternative methods 
against vaccinematched or 
vaccinemismatched strains on Day 29 
compared with Day 1 (Baseline) 
• 
GMT and GMFR of anti-HA antibody titers 
against vaccine-matched and mismatched 
strains on Day 181 and Day 361, as measured 
by HAI assay 
• 
The proportion of participants with 
seroconversion and the proportion of 
participants with a titer ≥ 1:40 at Day 181 and 
Day 361, as measured by HAI assay 
• 
To further characterize the immune response 
to mRNA-1010 and active comparator 
• 
Frequency, specificities, or other endpoints to 
be determined, for the further characterization 
of immune responses 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 47 
Objectives 
Endpoints 
• 
To describe the occurrence of clinical 
influenza cases throughout the study period 
• 
Number of cases of RT-PCR–confirmed 
protocol-defined ILI cases that begin at least 
14 days postvaccination through Day 361/EoS 
caused by any strain of influenza virus 
regardless of antigenic match to the strains 
selected for the seasonal vaccine 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; CDC = 
Centers for Disease Control and Prevention; EoS = end of study; GMFR = geometric mean fold rise; GMT = 
geometric mean titer; HA = hemagglutinin; HAI = hemagglutination inhibition; ILI = influenza-like illness; 
MAAE = medically attended adverse event; MN = microneutralization; nAb = neutralizing antibody; RT-
PCR = reverse transcription polymerase chain reaction; SAE = serious adverse event. 
Other exploratory objectives are as follows: 
• To explore the number and percentage of participants aged 65 years and older with first 
episode of protocol-defined ILI by baseline frailty status. 
• To describe EuroQoL 5-dimension 5-levels (EQ-5D-5L) health questionnaire utility score 
at regular intervals as well as for participants with protocol-defined ILI. 
• To describe Work Productivity and Activity Impairment Questionnaire: Influenza-like 
Illness (WPAI:ILI) v2.0 impairment percentages for absenteeism, presenteeism, work 
productivity loss, and activity impairment for participants with protocol-defined ILI. 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 48 
4. STUDY DESIGN 
4.1 General Design 
This is a Phase 3, randomized, stratified, observer -blind, active -controlled study to evaluate the 
immunogenicity and safety of mRNA-1010 vaccine in preventing seasonal influenza in adults 
aged 18 years and older. 
The mRNA-1010 vaccine to be tested includes mRNAs encoding for the surface HAs of the 
influenza strains recommended by the WHO for 2022 SH cell- or recombinant-based vaccines: 
• A/Wisconsin/588/2019 (A/H1N1)like virus; 
• A/Darwin/6/2021 (A/H3N2)like virus; 
• B/Michigan/01/2021 (B/Victoria lineage)like virus; and 
• B/Phuket/3073/2013 (B/Yamagata lineage)like virus. 
Study vaccine administration is planned prior to or during the typical SH influenza vaccination 
campaign period. Medically stable adults, aged 18 years and older, will be screened and enrolled. 
A complete list of inclusion and exclusion criteria is provided in Section 5. 
The Sponsor’s Phase 1/2 mRNA-1010-P101 study is currently ongoing to provide initial first-in-
human safety and immunogenicity data on 3 dose levels of mRNA-1010 encoding strains (50, 
100, or 200 µg total mRNA) recommended by the WHO for the 2021 SH. An amendment to 
mRNA-1010-P101 includes a Phase 2 NH portion to the study to increase the size of the safety 
database for the 50 µg and 100 µg dose levels and to test an additional 25 µg dose level of 
mRNA-1010 as well as a licensed seasonal influenza vaccine as an active comparator. 
mRNA-1010 encoding strains for the 2021 to 2022 NH will be used in the Phase 2 NH portion. 
A Phase 2 Extension portion is assessing additional dose levels of 6.25 µg and 12.5 µg mRNA-
1010 as well as 25 µg mRNA-1010 and an active comparator. The interim analysis of safety data 
through Day 29 of 180 healthy adults in the Phase 1/2 portion of mRNA-1010-P101 showed 
preferable reactogenicity profile for the 50 µg dose of mRNA-1010. The Phase 2 NH interim 
analysis of safety data through Day 29 demonstrated no significant safety concerns of the dose 
levels tested (25, 50, and 100 µg). 
Approximately 6000 participants will be randomly assigned to treatment in this study in a 
1:1 ratio to 1 of 2 vaccination groups to receive either a single dose of mRNA-1010 or a single 
dose of a licensed seasonal influenza vaccine as an active comparator (Fluarix Tetra, Table 3). 
Randomization will be stratified by age categories (18 to < 50 years old, ≥ 50 to < 65 years old, 
or ≥ 65 years old) and influenza vaccine status in the prior 12 months (received or not received) 
at Screening. At least 50% of participants enrolled will be ≥ 50 years old, including 
approximately 20% who will be ≥ 65 years old. The Sponsor anticipates approximately 300 
participants will be ≥ 75 years old. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 49 
Table 3: Vaccination Groups and Dose Levels 
Vaccination 
Group 
Vaccination 
Received 
mRNA/Antigen 
Total Dose (µg) 
Number of 
Participants 
HA (each) (µg) 
1 
mRNA-1010 
12.5 (of mRNA) 
50 (of mRNA) 
3000 
2 
Active 
Comparator 
(Fluarix Tetra) 
15 (of protein) 
60 (of protein) 
3000 
Abbreviations: HA = hemagglutinin; mRNA = messenger ribonucleic acid. 
Table 1 displays the study Schedule of Events (SoE). Clinic visits will consist of a Screening 
Visit (up to 28 days before the Day 1 visit), a Vaccination Visit on Day 1 (may be on the same 
day as the Screening Visit), a clinic visit on Day 29, and subsequent clinic visits in a subset of 
participants (approximately the first 1000 participants) on Day 181 and Day 361 (Month 12)/end 
of study (EoS), with up to 13 months of study participation for each participant. There will also 
be 1 optional visit on Day 4. Contact by electronic means or telephone calls will proceed as 
specified in the SoE (Table 1). Unscheduled clinic visits for potential influenza like- illness (ILI) 
symptoms and viral respiratory panel testing will also be conducted. 
All participants will provide blood samples at baseline and on Day 29 (28 days post vaccination) 
for assessment of geometric mean titer (GMT), geometric mean fold rise (GMFR), and 
seroconversion, as measured by HAI assay. In addition, approximately the first 1000 randomized 
participants will also provide humoral immunogenicity blood samples at Day 181 and Day 361, a 
subset of which will be used for immunogenicity analysis. There will be an optional visit on 
Day 4 at which blood will be drawn for future biomarker assessment.  
Participants who manifest protocol-defined ILI will be evaluated by real-time reverse 
transcription polymerase chain reaction (RT-PCR) testing of NP swab specimen(s) for influenza 
(and other respiratory pathogens).  
Participants will be instructed to report once weekly from Day 1 to Day 361 (Month 12)/EoS via 
Symptom Reporting electronic diary (eDiary) or by contacting the site if ILI symptoms have 
been experienced from Day 1 to Day 361 (Month 12)/EoS. If symptoms occur, the investigator 
must contact the participant to assess symptoms and ensure an NP swab is collected within 72 
hours of symptom onset. If possible, NP swabs should be collected prior to initiation of antiviral 
therapy. If there is no response to an eDiary prompt for 2 consecutive entries, the clinic staff will 
attempt to contact the study participant by telephone. All participants who report symptoms of 
ILI will receive eDiary prompts to complete PRO questionnaires for EQ-5D-5L and WPAI:ILI. 
For participants aged 65 years and older, the frailty status will be assessed by clinic staff at 
baseline using the Edmonton Frail Scale (EFS). 
There may be situations in which the investigator asks a participant to report for an unscheduled 
visit following the report of an adverse event (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. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 50 
All personnel involved in the conduct of the study will remain blinded to individual treatment 
assignment until planned study unblinding, except for appropriately delegated unblinded 
pharmacists, vaccine administrators, and monitors. Neither the participant nor the investigator 
nor clinical staff responsible for study assessments/safety will have access to the treatment 
assignment during the conduct of the study. The investigator may unblind in the event of an 
emergency (refer to Section 6.3.7). 
4.2 Scientific Rationale for Study Design 
This study is designed as an observer-blind study. Participants will receive a single dose of either 
mRNA-1010 vaccine or a licensed quadrivalent seasonal influenza vaccine (an active 
comparator) to assess noninferior immunogenicity. 
In this observer-blind study, participants, clinic staff involved in participant assessment, and 
Sponsor personnel (or its designees) will be blinded to participant vaccine allocation. A limited 
number of Sponsor and/or contract research organization (CRO) personnel will be unblinded to 
conduct safety data analyses for the DSMB safety data reviews (as described in the DSMB 
charter) and perform the primary analysis. Unblinded study personnel, who will not participate in 
any other aspect of the study, will perform investigational product (IP) accountability, dose 
preparation, and IP administration. 
The NP swab specimen(s) for assessment of pathogens, including influenza virus and 
SARS-CoV-2, will be collected any time from Day 1 through Day 361 (Month 12)/EoS if the 
participants have protocol-defined ILI or symptoms suggestive of COVID-19 or other upper or 
lower respiratory infection at the investigator’s discretion (see Section 8.11.5). If participants 
experience these signs or symptoms, they will be instructed to contact the clinic to have an NP 
swab collected for testing. Nasopharyngeal swabs may be collected as part of a home visit in lieu 
of a clinic visit. In the event that NP swabs during ILI cannot be collected by the study staff, any 
available influenza and/or SARS-CoV-2 testing results performed by a certified laboratory 
outside of the study should be captured in the eCRF. 
4.3 Justification for Dose, Control Product, and Choice of Study Population 
The Sponsor’s Phase 1/2 mRNA-1010-P101 study is currently ongoing to provide initial first-
in-human safety and immunogenicity data on 3 dose levels of mRNA-1010 encoding strains (50, 
100, or 200 µg total mRNA) recommended by the WHO for the 2021 SH. An amendment to 
mRNA-1010-P101 includes a Phase 2 NH portion to the study to increase the size of the safety 
database for the 50 µg and 100 µg dose levels and to test an additional 25 µg dose level of 
mRNA-1010 as well as a licensed seasonal influenza vaccine as an active comparator (Fluarix 
Tetra). Fluarix Tetra was selected as an active comparator because it is licensed for the 
prevention of influenza disease caused by vaccine-matched strains in the target population (≥ 18 
years old) in SH countries. A Phase 2 Extension portion is ongoing to study additional dose 
levels of mRNA-1010 (6.25 µg and 12.5 µg) as well as 25 µg of mRNA-1010 and an active 
comparator. 
No significant safety concerns have been observed in the ongoing Phase 1/2 mRNA-1010-P101 
study upon review of safety data up to 29 days by the DSMB. The 50-µg dose of mRNA-
1010 showed a preferable reactogenicity profile. Vaccination with mRNA-1010 elicited HAI 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 51 
antibodies in both younger and older adults against all strains at all dose levels. HAI titers 
elicited at the 50 µg dose level were comparable with the titers elicited at higher dose levels. 
The interim analysis from the Phase 2 NH part of mRNA-1010-P101 through Day 29 
demonstrated no significant safety concerns at any dose level (25, 50, or 100 µg) (further details 
are provided in the current IB).  
4.4 End of Study Definition 
A participant is considered to have completed the study if they complete the final visit on 
Day 361 (Month 12) 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. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 52 
5. STUDY POPULATION 
Approximately 6000 participants will be enrolled in a 1:1 ratio to receive either a single dose of 
mRNA-1010 or a single dose of a licensed seasonal influenza vaccine (Fluarix Tetra) as an 
active comparator (approximately 3000 participants in each vaccination group). 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1 Inclusion Criteria 
Participants are eligible to be included in the study only if all the following criteria apply: 
1. Individual is at least 18 years of age at the time of consent (Screening Visit). 
2. Investigator has assessed that the 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 by this protocol. 
4. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as post-menopausal or permanently sterilized. 
Follicle-stimulating hormone (FSH) may be measured at the discretion of the investigator 
to confirm postmenopausal status (see additional information in Section 11.2). 
5. 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 
prior to vaccine dose being administered on Day 1. 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to the first dose (Day 1). Adequate 
female contraception is defined as consistent and correct use of a local health 
authority-approved contraceptive method in accordance with the product label. 
• Has agreed to continue adequate contraception through 90 days following vaccine 
administration. 
5.2 Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 
as defined by the US CDC or has had a positive SARS-CoV-2 test in the past 10 days prior 
to the Screening Visit. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 53 
2. 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. 
3. 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 within the 60 days prior to the Screening Visit and includes ongoing workup 
of an undiagnosed illness that could lead to a new diagnosis or condition. 
4. Reported 
history 
of 
congenital 
or 
acquired 
immunodeficiency, 
immunocompromising/immunosuppressive condition, asplenia, or recurrent severe 
infections. The following conditions are permitted at the discretion of the Investigator: 
a) Participants who are HIV positive and on antiretroviral therapy with cluster of 
differentiation 4 count ≥ 350 cells/mm3 and HIV RNA ≤ 500 copies/mL within the 
past 12 months. 
b) Participants with immune-mediated diseases which are stable (eg, Hashimoto’s 
thyroiditis and type 1 diabetes) or conditions such as asthma, psoriasis, vitiligo, gout, 
alopecia areata, or autoimmune ovarian failure which do not require systemic 
immunosuppressants per Exclusion Criterion 9. 
5. Dermatologic conditions that could affect local solicited adverse reaction (AR) 
assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid areas). 
6. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any 
mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, 
including egg protein. 
7. Reported history of coagulopathy or bleeding disorder that is considered a contraindication 
to IM injection or phlebotomy. 
8. Any medical, psychiatric, or occupational condition, including reported history of 
substance abuse, that, in the opinion of the investigator, may pose additional risk due to 
participation in the study or that could interfere with the interpretation of study results. 
9. Participant has received systemic immunosuppressants or immune-modifying drugs for 
> 14 days in total within 180 days prior to the Screening Visit (for corticosteroids, 
≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for systemic 
immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, 
and topical steroids are allowed. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 54 
10. Participant has received any vaccine authorized or approved by local health agency 
≤ 28 days prior to study injection (Day 1) or plans to receive a vaccine authorized or 
approved by local health agency within 28 days before or after the study injection.  
11. Participant is not aware whether they have received an influenza vaccine in the past 
12 months. 
12. Participant has received a seasonal influenza vaccine or any other investigational influenza 
vaccine within 180 days prior to Day 1. 
13. Participant has tested positive for influenza by local health authority-approved testing 
methods within 180 days prior to the Screening Visit. 
14. Participant has a history of myocarditis, pericarditis, or myopericarditis within 60 days 
prior to the Screening Visit. Participants who have not returned to baseline after their 
convalescent period will also be excluded. 
15. Participant has received systemic immunoglobulins or blood products within 90 days prior 
to the Screening Visit or plans to receive systemic immunoglobulins or blood products 
during the study. In addition, participants who have received long-acting biological 
therapies that affect immune responses (eg, infliximab) within 90 days prior to the 
Screening Visit, or plan to receive them, are also excluded. 
16. 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. 
17. Participant has 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. 
18. Participant is an immediate family member or household member of study personnel, clinic 
staff, or Sponsor personnel. 
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 licensed seasonal influenza 
vaccine until after completion of their Day 29 visit, and ideally until Day 181 Visit, if seasonal 
influenza vaccine is 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 randomly assigned to treatment. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the Consolidated 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 55 
Standards of Reporting Trials publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes date of informed consent, demography, screen failure 
details, eligibility criteria, and information on any SAE which 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 if they will be eligible upon rescreening. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 56 
6. STUDY TREATMENT 
6.1 Investigational Product and Active Comparator Administered 
The term “IP” refers to the mRNA-1010 vaccine and to the licensed seasonal influenza vaccine 
(the “active comparator”) administered in this study. The vaccines to be administered in this 
study are described in Table 4. 
The mRNA-1010 vaccine to be tested includes mRNAs encoding for the surface Has of the 
influenza strains recommended by the WHO for 2022 SH cell- or recombinant-based vaccines: 
• A/Wisconsin/588/2019 (A/H1N1)-like virus; 
• A/Darwin/6/2021 (A/H3N2)-like virus; 
• B/Michigan/01/2021 (B/Victoria lineage)-like virus; and 
• B/Phuket/3073/2013 (B/Yamagata lineage)-like virus. 
mRNA-1010 is formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially 
available): the proprietary ionizable lipid 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 (PEG2000-DMG). The mRNA-1010 
injection is provided as sterile liquid for injection and is a white-to-off-white dispersion at a 
concentration of 0.1mg/mL in 
 Tris buffer containing 
 sucrose and 
 
sodium acetate at pH 7.0 – 8.0. 
The mRNA-1010 vaccine will be administered as a single 0.5 mL IM injection at an mRNA total 
dose level of 50 µg to participants according to the vaccination group assignment (Table 4). 
The active comparator administered in this study is a licensed quadrivalent inactivated seasonal 
influenza vaccine (Fluarix Tetra) administered as a single 0.5 mL IM injection (Table 4). 
Table 4: Investigational Product and Active Comparator Administered 
Vaccination Group: 
Investigational Product 
Active Comparator 
Intervention Name: 
mRNA-1010 
Fluarix Tetra (S-Hemisphere) 
Type 
Vaccine 
Vaccine 
Dosage Level(s): 
50 µg (mRNA) 
60 µg (protein) 
Route of Administration: 
IM injection 
IM injection 
Physical Description: 
Sterile liquid for injection, 
white-to-off-white dispersion 
Sterile, colorless, and slightly 
opalescent suspension 
Source: 
Provided centrally by the 
Sponsor 
Hybrid – Potentially Centrally 
and Locally 
CCI
CCI
CCI

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 57 
Packaging and Labeling: 
mRNA-1010 will be provided in 
2R glass vials. Each vial will be 
labeled as required per country 
requirement. 
Active comparator will be 
provided in a prefilled syringe in 
a carton. Each carton will be 
labeled as required per country 
requirement. 
Abbreviations: IM = intramuscular; mRNA = messenger ribonucleic acid. 
6.2 Randomization and Blinding 
Randomization will be performed using an interactive response technology (IRT). 
Approximately 6000 participants will be randomly assigned to treatment in this study in a 1:1 
ratio to receive either a single dose of mRNA-1010 or a single dose of a licensed seasonal 
influenza vaccine as an active comparator (Table 3). Randomization will be stratified by age 
categories (18 to < 50 years old, ≥ 50 to < 65 years old, or ≥ 65 years old) and influenza vaccine 
status in the prior 12 months (received or not received) at Screening. At least 50% of enrolled 
participants will be ≥ 50 years old, including approximately 20% who will be ≥ 65 years old. The 
Sponsor anticipates that approximately 300 participants will be ≥ 75 years old.  
As the appearance of the study vaccines differ, enrollment will be observer blinded as to 
treatment assignment. 
Dose preparation, administration, and accountability will be performed by designated unblinded 
site personnel who will not participate in any of the clinical study evaluations. The unblinded site 
personnel will prepare the dose out of view of the participant and the blinded site personnel. 
The laboratory personnel in charge of immunogenicity testing will be blinded to the treatment 
assignment of the samples tested throughout the course of the study. 
Except in the case of medical necessity, a participant’s treatment should not be unblinded 
without the approval of the Sponsor. The treatment code should be broken only if the 
investigator in charge of the participant feels that the case cannot be treated without knowing the 
identity of the study vaccine. Instructions regarding emergency unblinding will be provided to 
the investigator and are discussed in Section 6.3.7. 
The investigator, clinic 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 
for the final analysis. At the primary analysis and the 6-month analysis (see Section 9.6), 
pre-identified Sponsor team members and selected CRO team members will be unblinded to 
conduct the analyses. Clinics will remain blinded. 
6.3 Preparation/Handling/Storage/Accountability 
6.3.1 Clinical Study Material Preparation 
The IP will be prepared for each participant based on their vaccination group assignment. The 
mRNA-1010 vaccine injection will have a volume of 0.5 mL and will contain mRNA-1010 at a 
dose of 50 µg. The active comparator will be administered at a volume of 0.5 mL. The 
mRNA-1010 and active comparator preparation instructions are detailed in the Pharmacy 
Manual. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 58 
6.3.2 Clinical Study Material Administration 
The study vaccine (mRNA-1010 or the active comparator) will be administered as a single IM 
injection into the deltoid muscle on Day 1. Preferably, the IP should be administered into the 
nondominant arm. 
Participants will be monitored for a minimum of 30 minutes after administration of the study 
injection. Assessments will include vital sign measurements and monitoring for local or systemic 
reactions as shown in the SoE (Table 1). 
The clinic 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. 
Further instructions for the preparation and administration of mRNA-1010 and active comparator 
are described in the mRNA-1010 Pharmacy Manual. 
6.3.3 Clinical Study Material Packaging and Labeling 
The Sponsor will provide the investigator (via the clinic pharmacy) with adequate quantities of 
the IP. Sterile mRNA-1010 for this study will be packaged in 2R glass vials with a 0.7 mL fill 
volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner 
All Ips used in this study will be prepared, packaged, and labeled in accordance with the standard 
operating procedures of the Sponsor or those of its designee, Code of Federal Regulations (CFR) 
Title 21, Good Manufacturing Practice guidelines, International Council for Harmonisation 
(ICH) GCP guidelines, guidelines for Quality System Regulations, and applicable regulations. 
6.3.4 Clinical Study Material Storage 
mRNA-1010 must be stored at the clinical site at 2°C to 8°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 refrigerator should have automated temperature recording and a 24-hour 
alert system in place that allows for rapid response in case of refrigerator malfunction. The 
refrigerator 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 clinic 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. Please note that the mRNA-1010 will be stored at -25°C to -
15°C at the depots and during shipments to the clinical sites. 
The active comparator should be stored in its original container and in accordance with the 
instructions in the Pharmacy Manual. 
6.3.5 Clinical Study Material Accountability 
The investigator is responsible for ensuring the IP accountability staff maintain an accurate 
record of the shipment receipt, the inventory at the site, dispensing of study vaccines, and the 
return to the Sponsor or alternative disposition of used/unused product(s) in a drug accountability 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 59 
log. Drug accountability will be noted by the site monitor during site visits and at the completion 
of the study. For further direction, refer to the Pharmacy Manual. 
6.3.6 Clinical Study Material Handling and Disposal 
A site monitor will reconcile the clinical study material during study conduct and at the end of 
the study for compliance. Once fully reconciled at the site, the clinical study material can be 
destroyed at the investigational site or Sponsor-selected third party, as appropriate. 
Study products may be destroyed at the clinic only if permitted by local regulations and 
authorized by the Sponsor. A Certificate of Destruction must be obtained and sent to the Sponsor 
or designee. For further direction, refer to Pharmacy Manual. 
6.3.7 Unblinding 
Except in the case of medical necessity, a participant’s treatment 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 treatment assignment will 
affect that participant’s clinical management. In the event of a medical emergency requiring 
identification of individual treatment assignment, the investigator will make every attempt to 
contact the CRO CRA 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 IRT. All unblinding’s will be tracked via an audit trail in IRT and 
documented in the final study report. 
6.4 Study Intervention Compliance 
All vaccinations will be administered by qualified and trained study personnel to ensure that all 
vaccine doses administered comply with those planned. Study vaccine doses administered will 
be recorded in the eCRF. Administration data will be reconciled with site accountability records 
to determine compliance. 
6.5 Concomitant Therapy 
At each clinic visit, the site personnel should question the participant regarding any medications 
taken and vaccinations received and record the information as specified in Section 6.5.1. 
6.5.1 Recording of Concomitant Medications, Concomitant Vaccinations, and 
Concomitant Procedures 
The following concomitant medication(s) and vaccine(s) must be recorded in the eCRF: 
• Any vaccine (authorized or investigational) administered in the prior 12 months. 
• All concomitant medications and non-study vaccines taken through 28 days after the IP 
injection. Antipyretics and analgesics taken prophylactically (ie, taken in the absence of 
any symptoms in anticipation of an injection reaction) will be recorded as such. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 60 
• Any authorized or investigational COVID-19 vaccine at any time before or during the study 
period after the IP injection. 
• Any authorized influenza vaccine at any time during the study period after the IP injection. 
• All concomitant procedures/surgeries at any time during the study period after the IP 
injection. 
• Immunosuppressants or other immune-modifying drugs administered chronically (ie, more 
than 14 days in total) and systemic steroids (≥ 10 mg/day prednisone or equivalent) , 
administered at any time during the study period after the IP injection. 
• Immunoglobulins and long-acting biological therapies that affect immune responses (eg, 
infliximab) and/or any blood products administered during the study period. 
• Any concomitant medications relevant to or for the treatment of an SAE, AESI, or 
medically attended AE (MAAE) from Day 1 through Day 361 (Month 12)/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 the IP injection, including the day of 
injection. Reported antipyretic or analgesic medications should be recorded in the source 
document by the clinic staff during the clinic visits after vaccination or via other participant 
interactions (eg, telephone calls). 
Concomitant medications (including vaccinations) will be coded using the WHO Drug Global. 
If a participant takes a prohibited drug therapy, the investigator and the CRO’s medical monitor 
will make a joint decision about continuing or withholding the study vaccination 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. 
6.5.2 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): 
• Any investigational or nonregistered product (drug or vaccine) other than the IP 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. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 61 
• An authorized or licensed vaccine administered within 28 days after the study vaccination. 
• Immunoglobulins and long-acting biological therapies that affect immune responses (eg, 
infliximab) and/or any blood products administered during the study period. 
6.6 Intervention After the End of the Study 
Any AE occurring after the end of the study and considered to be caused by the study vaccine 
must be reported to the Sponsor. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 62 
7. DELAY OR DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 Participant Discontinuation/Withdrawal From the Study 
Participants who withdraw or are withdrawn from the study will not be replaced. 
From an analysis perspective, 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. 
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 section of the eCRF. 
All data collected until the date of withdrawal or last contact of the participant will be used for 
the analysis. 
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) 
• 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, 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, solicited AR, or reactogenicity event until resolution of the event. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 63 
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 (see 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 
biological samples that have already been collected may be retained and analyzed at a later date 
(or as permitted by local regulations). 
7.2 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 clinic. The 
following actions must be taken if a participant fails to return to the clinic for a required clinic 
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. 
• Should the participant continue to be unreachable or noncompliant with clinic visits or 
procedures, he or she will be considered to have withdrawn from the study. 
• A participant should not be considered LTFU until due diligence has been completed. 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 64 
8. STUDY ASSESSMENTS AND PROCEDURES 
The study SoE can be found in Table 1. 
8.1 Screening 
Before performing any study procedures, all potential participants will sign an informed consent 
form (ICF; Section 11.1.6). 
At the Screening Visit (up to 28 days for the Day 1 visit), all screening requirements, including 
reason for screen failure if a participant is not randomized, must be completed. The Enrollment 
Page in the eCRF must also be completed. 
The Screening Visit and Day 1 may be performed on the same day or a different day. 
Additionally, the Screening Visit may be performed over multiple visits if within the 28-day 
screening window. 
8.2 Confirm Inclusion and Exclusion Criteria 
All inclusion and exclusion criteria described in Section 5.1 and Section 5.2 must be met before 
randomization (Day 1 visit). 
8.3 Demographic and Baseline Data 
Demographic information relating to the participant’s sex, age, race, ethnicity, height, weight, 
and body mass index will be recorded at the Screening Visit on the appropriate eCRF page. 
8.4 Medical History 
Medical history will be collected and recorded from each participant on the appropriate eCRF 
page. Significant findings that were present prior to the signature of the informed consent must 
be included in the Medical History eCRF page. 
8.5 Randomization 
Vaccination group and vaccine assignment allocation will be performed at the Day 1 visit as 
described in Section 6.2. The confirmation for study vaccine administration must be recorded on 
the Injection page of the eCRF. 
8.6 Physical Examination and Vital Signs 
A full physical examination, including height and weight, will be performed at the Screening 
Visit; symptom-directed physical examinations may be performed at other clinic visits. Interim 
physical examinations will be performed at the discretion of the investigator. Any clinically 
significant finding identified by a healthcare professional during clinic visits should be reported 
as an MAAE (Section 8.11.4). 
Vital sign measurements include the assessment of systolic and diastolic blood pressures, heart 
rate, respiratory rate, and body temperature. The preferred route of temperature assessment is 
oral. On the day of vaccination, vital signs will be collected once prior to vaccination and once 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 65 
30 minutes after vaccination. Vital signs may be collected at other clinic visits in conjunction 
with a symptom-directed physical examination. 
The information collected will be recorded in the eCRF. 
8.7 Study Vaccine Administration 
A single-dose vaccination (mRNA-1010 or active comparator) will be administered to all 
participants. 
After completing all prerequisite procedures prior to vaccination, the study vaccine will be 
administered via IM injection into the deltoid muscle. A detailed description of the vaccine 
administration procedure is provided in Section 6.3.2. 
The participants will be observed closely (via clinical assessment including measurement of vital 
signs) for at least 30 minutes following the administration of the vaccine, with appropriate 
medical treatment readily available in case of anaphylaxis or other hypersensitivity reactions. 
8.8 Efficacy and Immunogenicity Assessments 
8.8.1 Sampling for Efficacy Assessments 
Assessment of clinical efficacy may be performed in this study. 
8.8.2 Sampling for Immunogenicity Assessments 
Blood samples for immunogenicity assessments will be collected at the time points indicated in 
the SoE (Table 1). The following analytes will be measured: 
• Serum antibody level as measured by HAI assay. 
• Serum neutralizing antibody level as measured by microneutralization assay or similar 
methods may also be performed. 
Measurement of antibody levels will be performed in a laboratory designated by the Sponsor. 
According to the ICF (Section 11.1.6), 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 vaccines, additional assay development, and the immune 
response across influenza viruses (Section 11.1.10). 
8.9 Safety Assessments 
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 8.11.3) that occur during the 7 days following 
the study injection (ie, the day of injection and 6 subsequent days). Solicited ARs will be 
recorded daily using eDiaries (Section 8.9.4). 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 66 
• Unsolicited AEs observed or reported during the 28 days following the study injection 
(ie, the day of injection and 27 subsequent days). Unsolicited AEs are defined in 
Section 8.11.1. 
• AEs leading to discontinuation from study participation from Day 1 through Day 361 
(Month 12)/EoS or withdrawal from the study. 
• MAAEs from Day 1 through Day 361(Month 12)/EoS or withdrawal from the study. 
Medically attended AEs are defined in Section 8.11.4. 
• SAEs (Section 8.11.2) and AESIs (Section 8.11.6) from Day 1 through Day 361 
(Month 12)/EoS or withdrawal from the study. 
• Details of all pregnancies in female participants will be collected after the start of study 
vaccine and until the end of their participation in the study (Section 8.11.7). All 
pregnancies must be followed to determine the outcome. 
8.9.1 Pregnancy Screen and Testing 
A pregnancy test via blood or point-of-care urine test will be performed for all female 
participants of childbearing potential at the Screening Visit and before the vaccine dose on 
Day 1, if Day 1 is not on the same day as the Screening Visit. At the discretion of the 
investigator, a pregnancy test either via blood or point-of-care urine can be performed at any 
time. Additional pregnancy testing during the study may also be performed if required by local 
regulatory requirements. The participant’s FSH level may be measured at the Screening Visit, as 
necessary, and at the discretion of the investigator, to confirm postmenopausal status 
(Section 11.2). 
Further details on reporting and follow-up of pregnancy are provided in Section 8.11.7. 
8.9.2 Assessments for Respiratory Viral Infections 
The NP swab specimen(s) for pathogens, including influenza virus and SARS-CoV-2, will be 
collected any time from Day 1 to Day 361 (Month 12)/EoS if participants have protocol-defined 
ILI or symptoms suggestive of COVID-19 or other upper or lower respiratory infection, as 
defined in the ILI Case Definitions (Section 8.11.5). If participants experience these signs or 
symptoms, they will be instructed to contact the clinic to have an NP swab collected for testing. 
Nasopharyngeal swabs may be collected as part of a home visit in lieu of a clinic visit. In the 
event that NP swabs during ILI cannot be collected, any available influenza and/or SARS-CoV-2 
testing results performed outside of the study should be captured. 
Symptoms reporting for ILI will be conducted between Day 1 through Day 361 (Month 12)/EoS 
as described in Section 8.9.4. 
All RT-PCR-confirmed influenza (Section 8.11.5) and RT-PCR-confirmed symptomatic 
COVID-19 infections will be recorded as MAAEs along with relevant concomitant medications, 
hospitalizations, outpatient medical care, and details about severity, seriousness, and outcome. 
Asymptomatic RT-PCR-confirmed COVID-19 infections are not to be recorded as MAAEs. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 67 
8.9.3 Safety Telephone Calls 
A safety telephone call is a telephone call made to the participant by trained site personnel. This 
call will follow a script, which will facilitate the collection of relevant safety information. Safety 
telephone calls will follow a schedule for each participant, as shown in the SoE (Table 1). The 
participant will be interviewed according to the script about occurrence of AEs, MAAEs, SAEs, 
AESIs, AEs leading to withdrawal from study participation, concomitant medications associated 
with those events, and any non-study vaccinations (Section 8.11.14). All safety information 
collected from the telephone contact must be documented in source documents as described by 
the participant and not documented on the script used for the safety telephone contact. An 
unscheduled follow-up safety call may be triggered if an eDiary record results in identification of 
a relevant safety event. 
8.9.4 Use of Electronic Diaries 
At the time of consent, the participants must confirm they will be willing to complete an eDiary 
using either an application downloaded to their own device or using a device that is provided at 
the time of enrollment. Before enrollment on Day 1, the participants will be instructed to 
download the eDiary application or will be provided an eDiary device to record solicited ARs 
(Section 8.11.3). Participants will also use the eDiary to record any ILI symptoms (as part of 
active surveillance) that they experience after vaccination from Day 1 through Day 361 
(Month 12)/EoS. 
Participants will be instructed on Day 1 on thermometer usage to measure body temperature, 
ruler usage to measure injection site erythema and swelling/induration (hardness), and 
self-assessment of localized axillary swelling or tenderness on the same side as the injection arm. 
Participants will record data into the eDiary starting approximately 30 minutes after injection 
under supervision of the clinic staff to ensure successful entry of assessments. The clinic staff 
will perform any retraining as necessary. Participants will continue to record data in the eDiary 
after they leave the clinic, 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 ARs, as defined in Section 8.11.3, that occur on the day of 
vaccination and during the 7 days after vaccination (ie, the day of injection and 
6 subsequent days).  
• Symptom reporting of ILI. Participants will be instructed to report via Symptom 
Reporting eDiary or by contacting the site if ILI symptoms have been experienced from 
Day 1 to Day 361 (Month 12)/EoS. If symptoms are reported, the investigator must 
contact the participant to assess symptoms and ensure an NP swab is collected within 
72 hours of symptom onset. If possible, NP swabs should be collected prior to initiation 
of antiviral therapy. If there is no response to an eDiary prompt for 2 consecutive 
entries, the clinic staff will attempt to contact the participant by telephone call 
(Section 8.9.2). 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 68 
• Daily oral body temperature measurement should be performed at approximately the 
same time each day using the thermometer provided by the clinic. If body temperature 
is taken more than once in a given day, only the highest temperature reading should be 
recorded. 
• Measurements, as applicable, for solicited local ARs (injection site erythema and 
swelling/induration) will be performed using the ruler provided by the clinic. 
• Any medications taken to treat or prevent pain or fever on the day of injection and for 
the next 6 days. 
• Patient-reported outcome questionnaires, as defined in Section 8.17. All participants 
will receive eDiary prompts to complete the EQ-5D-5L questionnaire on Day 1, 
Day 91, Day 181, Day 271, and Day 361 (Month 12)/EoS, and participants who report 
symptoms of ILI will receive eDiary prompts to complete EQ-5D-5L and WPAI:ILI 
questionnaires.  
The eDiary will be the only source document allowed for solicited systemic or local ARs 
(including body temperature measurements). Participants will be instructed to complete eDiary 
entries daily. Quantitative temperature recordings and measurement of any injection site 
erythema or swelling/induration reported on the following day may be excluded from the 
analyses of the solicited ARs. 
Clinic staff will review eDiary data with participants at a visit 7 days after the injection. 
8.9.5 Blood Sampling Volumes 
The maximum planned volumes of blood sampled per participant will not exceed 450 mL for the 
complete study. 
8.9.6 Ancillary Supplies for Participant Use 
Clinics will distribute Sponsor-provided oral thermometers and rulers for use by participants in 
assessing body temperature and injection site reactions, 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. 
8.10 Clinical Assessments 
Participants who develop symptoms consistent with protocol-defined ILI (Section 8.11.5) and/or 
COVID-19 will have NP swabs collected for testing. The initial test will be a real-time, 
RT-PCR-based assay, to determine if either influenza A and/or B strains, as well as other 
respiratory viruses such as SARS-CoV-2, are present in the clinical sample. For samples that test 
positive for influenza in the RT-PCR assay, further testing by PCR-based genetic sequencing of 
the HA segments and/or other influenza virus genes may be performed to identify the specific 
subtype of the influenza strain. The RT-PCR positive samples may be cultured. Cultured viruses 
may be used to evaluate similarity (match) to the current year’s vaccine strains using ferret 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 69 
antisera to determine antigenic similarity to vaccine strains. See Section 8.11.5 for how to 
capture these illnesses. 
8.11 Safety Definitions 
8.11.1 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. 
A treatment-emergent AE (TEAE) is defined as any event not present before exposure to IP or 
any event already present that worsens in intensity or frequency after exposure. 
Events Meeting the Adverse Event Definition 
• Exacerbation of a chronic or intermittent pre-existing condition, including either an 
increase in frequency and/or intensity of the condition, after the IP injection 
• New conditions detected or diagnosed after the first dose of IP 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) 
• 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 IP caused the AE 
(Section 8.11.3). For the purposes of investigational new drug safety reporting, “reasonable 
possibility” means that there is evidence to suggest a causal relationship between the study 
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; is specified as a solicited AR in the protocol; or is specified as a solicited AR in the 
protocol but starts outside the protocol-defined period for reporting solicited ARs (ie, for the 
7 days after each dose of IP). 
8.11.2 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 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 70 
during the protocol-defined follow-up period must be reported to the Sponsor, whether or 
not it is considered related to 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 an AE; however, if a complication/AE 
prolongs hospitalization or otherwise fulfills SAE criteria, the complication/AE will be 
recorded as a separate SAE. 
• 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. 
8.11.3 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 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 71 
using a structured checklist (Section 8.9.4). Participants will record such occurrences in an 
eDiary on the day of each IP injection and for the 6 days after the day of dosing. 
Severity grading of reactogenicity will occur automatically based on participant entries into the 
eDiary according to the grading scales presented in Table 5, which are modified from the 
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive 
Vaccine Clinical Trials (DHHS 2007b). 
If a participant reported a solicited adverse reaction during the solicited period and did not record 
the event in the eDiary, the event should be recorded on the Reactogenicity page of the eCRF. 
If the event starts during the solicited period, but continues beyond 7 days after dosing, the 
participants should notify the site to provide an end date and close out the event on the 
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. All solicited ARs 
(local and systemic) will be considered causally related to dosing. 
Table 5:  Solicited Adverse Reactions and Grades 
Reaction 
Grade 0 
(None) 
Grade 1 
(Mild) 
Grade 2 
(Moderate) 
Grade 3 
(Severe) 
Grade 41 
(Life-threatening) 
Local 
Injection site pain 
None 
Does not interfere 
with activity  
Repeated use of over-
the-counter pain 
reliever > 24 hours or 
interferes with 
activity  
Any use of 
prescription 
pain 
reliever or 
prevents 
daily 
activity 
Requires 
emergency room 
visit or 
hospitalization 
Injection site 
erythema (redness) 
< 25 mm/ 
 < 2.5 cm 
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 mm/ 
< 2.5 cm 
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 
None 
No interference with 
activity 
Repeated use of 
over-the-counter pain 
reliever > 24 hours or 
some interference 
with activity 
Any use of 
prescription 
pain 
reliever or 
prevents 
daily 
activity 
Emergency room 
visit or 
hospitalization 
Systemic 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 72 
Reaction 
Grade 0 
(None) 
Grade 1 
(Mild) 
Grade 2 
(Moderate) 
Grade 3 
(Severe) 
Grade 41 
(Life-threatening) 
Headache 
None 
No interference with 
activity 
Repeated use of 
over-the-counter pain 
reliever > 24 hours or 
some interference 
with activity 
Significant; 
any use of 
prescription 
pain 
reliever or 
prevents 
daily 
activity 
Requires 
emergency room 
visit or 
hospitalization 
Fatigue 
None 
No interference with 
activity  
Some interference 
with activity 
Significant; 
prevents 
daily 
activity  
Requires 
emergency room 
visit or 
hospitalization 
Myalgia (muscle 
aches all over 
body) 
None 
No interference with 
activity  
Some interference 
with activity 
Significant; 
prevents 
daily 
activity  
Requires 
emergency room 
visit or 
hospitalization 
Arthralgia (joint 
aches in several 
joints) 
None 
No interference with 
activity  
Some interference 
with activity 
Significant; 
prevents 
daily 
activity  
Requires 
emergency room 
visit or 
hospitalization 
Nausea/vomiting 
None 
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 
None 
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°C 
< 100.4°F 
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 
Grading of Grade 4 events will be determined per investigator and assessment is recorded on the reactogenicity 
event page in the 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: Guidance for Industry – 
Toxicity Grading Scale for Heathy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials (DHHS 2007b). 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 73 
Any solicited AR that meets any of the following criteria must be entered into the 
participant’s source document and must also be recorded as an AE in the participant’s 
Reactogenicity eCRF page:  
• Solicited local or systemic AR that results in a visit to a healthcare practitioner (HCP; 
MAAE) 
• 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 continuing beyond 7 days post injection 
• Solicited local or systemic AR that leads to participant withdrawal from IP 
• Solicited local or systemic AR that otherwise meets the definition of an SAE 
8.11.4 Medically Attended Adverse Events 
An MAAE is an AE that leads to an unplanned visit to a HCP for medical evaluation 
(examinations/testing) and/or treatment that is not required per study protocol. The visit may be 
with an HCP at the clinical trial site or at another facility (eg, medical office, urgent care, 
emergency room). Investigators will review all AEs for the occurrence of MAAEs. 
In addition, all RT-PCR–confirmed influenza and RT-PCR–confirmed symptomatic COVID-19 
infections will be recorded as MAAEs and reported on the participant’s AE eCRF from Day 1 
through the EoS. 
8.11.5 Influenza-like Illness Case Definitions 
Protocol-defined ILI 
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, as shown in Table 6. 
Table 6:  Respiratory and Systemic Symptoms for Protocol-defined Influenza-like Illness 
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 
1. Body temperature > 37.2°C [> 99°F] 
2. Chills 
3. Tiredness 
4. Headache 
5. Myalgia 
6. Nausea/vomiting 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 74 
Respiratory symptoms 
Systemic symptoms 
5. Difficulty breathing 
7. Diarrhea  
CDC-defined ILI 
A CDC-defined ILI is defined as body temperature ≥ 37.8°C (100°F) accompanied by cough 
and/or sore throat. 
RT-PCR-confirmed Protocol-defined Influenza Infection 
An RT-PCR-confirmed protocol-defined influenza infection is defined as a positive influenza 
result on a respiratory sample by RT-PCR performed at the Global Central Laboratory and/or a 
local certified laboratory within 7 days of onset of protocol-defined ILI symptoms at any time 
during the study period. 
RT-PCR–confirmed CDC-defined Influenza Infection 
An RT-PCR–confirmed CDC-defined influenza infection is defined as a positive influenza result 
on a respiratory sample by RT-PCR performed at Global Central Laboratory and/or a local 
certified laboratory within 7 days of onset of CDC-defined ILI symptoms at any time during the 
study period. 
Through Day 28, any illness assessed for protocol-defined ILI/suspected SARS-CoV-2 and 
reports of asymptomatic RT-PCR–confirmed COVID-19 events should be captured as an AE in 
the AE eCRF. Starting on Day 29, asymptomatic COVID-19 events should no longer be captured 
as AEs, and illnesses assessed for protocol-defined ILI/suspected SARS-CoV-2 should only be 
captured as AEs if they have RT-PCR–confirmed influenza or RT-PCR–confirmed symptomatic 
COVID-19 infections (must be recorded as MAAEs), or if they otherwise meet the criteria for 
reporting as an SAE (Section 8.11.2), MAAE (Section 8.11.4), or event leading to 
discontinuation from the study. An event should not be recorded as an MAAE based on visits to 
the clinical trial site for protocol-required assessment of ILI symptoms and NP swab collection. 
8.11.6 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 are required. Such events may require further investigation to 
characterize and understand them. 
AESI for this protocol are described in Section 11.3. 
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 system. If a site received a report of a new AESI from a 
participant or receives updated information on a previously reported AESI at a time after the 
eCRF has been taken offline, then the site can report this information on the paper SAE/AESI 
form provided using the SAE Mailbox. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 75 
Anaphylaxis 
All suspected cases of anaphylaxis should be recorded as MAAEs and AESIs 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 8.11.12. 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 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 hypersensitive 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: 
• 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, red and itchy eyes 
− Cardiovascular: measured hypotension, clinical diagnosis of uncompensated 
shock, loss of consciousness or decreased level of consciousness, 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, 
rhinorrhea 
− Gastrointestinal: diarrhea, abdominal pain, nausea, vomiting 
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 Working Case Definitions. 
The event should also be reported as an SAE if it meets seriousness criteria (see Section 8.11.2). 
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 vaccine assignment. Details regarding the CEAC composition, 
responsibilities, procedures, and frequency of data review will be defined in the CEAC charter. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 76 
The CDC Working Case Definitions are provided in Section 11.4 as guidance. 
8.11.7 Recording and Follow-up of Pregnancy 
The effects of mRNA-1010 on the unborn child and on the newborn baby are not known. 
Because of this, it is important that research study participants are not pregnant and do not 
become pregnant during the course of the research study. Female individuals who have a positive 
pregnancy test at the Screening Visit should not be enrolled; participants who have a positive 
pregnancy test any time during the study should receive no further dosing with IP but should 
remain in the study and be followed-up for safety. Pregnancy testing is scheduled to occur at the 
Screening Visit and Day 1 (Table 1). Additional pregnancy testing during the study may also be 
performed if required by local regulatory requirements. 
Details of all pregnancies in female participants will be collected after the start of study vaccine 
and until Day 361 (Month 12)/EoS. 
• 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) are considered SAEs. 
Pregnancies occurring in participants after enrollment must be reported to the Sponsor or 
designee within 24 hours of the site learning of its occurrence. If the participant agrees to submit 
this information, the pregnancy must be followed to determine the outcome, including 
spontaneous or voluntary termination, details of the birth, and the presence or absence of any 
birth defects, congenital abnormalities, or maternal and/or newborn complications. This follow-
up should occur even if intended duration of the safety follow-up for the study has ended. 
Pregnancy report forms will be distributed to the clinic 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. 
8.11.8 Recording and Follow-up of an AE and/or SAE 
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 the vaccine dose (ie, the day of 
injection and 6 subsequent days). Other (unsolicited) AEs will be collected from Day 1 through 
28 days after the vaccine dose (ie, the day of injection and 27 subsequent days). 
Medically attended AEs, SAEs, and AESIs will be collected from participants as specified in the 
SoE (Table 1) from Day 1 until the end of their participation in the study.  
At every clinic visit or telephone contact, participants will be asked a standard question to elicit 
any medically related changes in their well-being (including surveillance for respiratory viral 
infection 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. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 77 
In addition to participant observations, physical examination findings and other documents 
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 7.2). 
8.11.9 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 8.11.2), 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 2007b) will be used to categorize local 
and systemic reactogenicity events (solicited ARs), clinical laboratory test results, and vital sign 
measurements observed during this study. Specific criteria for local and systemic reactogenicity 
events are presented in Section 8.11.3. 
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. 
Clinic 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. 
8.11.10Assessment 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. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 78 
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. 
8.11.11Reporting Adverse Events 
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to IP or their clinical significance. If there is any doubt as 
to whether a clinical observation is an AE, the event should be reported. 
All unsolicited AEs reported or observed during the study will be recorded on the AE page of the 
eCRF. Information to be collected includes, 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. 
Medical occurrences that begin before the start of IP administration 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. 
8.11.12Reporting Serious Adverse Events 
Any AE considered serious by the investigator or that meets SAE criteria (Section 8.11.2) must 
be reported to the Sponsor immediately (within 24 hours of becoming aware of the SAE). The 
investigator will assess whether there is a reasonable possibility that the IP caused the SAE. The 
Sponsor will be responsible for notifying the relevant regulatory authorities of any SAE as 
required per applicable regulations. The investigator is responsible for notifying the institutional 
review board (IRB) or independent ethics committee (IEC) directly. 
If the eCRF is unavailable at the time of the SAE, the SAE/AESI paper form provided by the 
Sponsor is to be used for SAE reporting. 
Regulatory reporting requirements for SAEs are described in Section 8.11.16. 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE, including SAEs, and remain responsible for 
following up AEs that are serious, considered related to the IP or study procedures, or that 
caused the participant to discontinue the study. 
8.11.13Time Period and Frequency for Collecting AE and SAE Information 
Medical occurrences that begin before the start of IP administration 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. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 79 
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 
All SAEs 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, as indicated in 
Section 8.11.2. The investigator will submit any updated SAE data to the Sponsor within 
24 hours of it being available. 
Investigators are not obligated to actively seek AEs or SAEs after conclusion of the study 
participation (EoS). However, if an investigator learns of any SAE, including a death, at any time 
after a participant has been discharged from the study and considers the event to be reasonably 
related to the study IP or study participation, the investigator must promptly notify the Sponsor. 
8.11.14Method of Detecting AEs and SAEs 
Electronic diaries have specifically been designed for this study by the Sponsor. At the time of 
consent, the participants must confirm they will be willing to complete the eDiary via an 
application downloaded to their smartphone or via a device that is provided at the time of 
enrollment. Prior to enrollment on Day 1, the participant will be instructed to download the 
eDiary application or will be provided an eDiary device to record solicited ARs. 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 vaccination group or 
suspected causal relationship to the 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 or AESI 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. 
8.11.15Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. 
All AEs, SAEs, and AESIs 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 7.2). 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 80 
8.11.16Regulatory Reporting Requirements for SAEs 
Prompt notification by the investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards 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, IECs, and investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
according to local regulatory requirements and Sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing an SAE or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
8.12 Safety Oversight 
Safety monitoring for this study will include the blinded study team members, inclusive of at a 
minimum, the Sponsor medical monitor and CRO medical monitor, as well as safety reviews by 
an unblinded DSMB. The study team will conduct ongoing blinded safety reviews during the 
study and will be responsible for notifying the DSMB of potential safety signal events. The 
DSMB, composed of external, independent subject matter experts, including an unblinded 
statistician, will conduct unblinded reviews of safety data on a periodic basis, as defined in a 
DSMB charter, or as otherwise requested by the study team. 
8.13 Treatment of Overdose 
As the study vaccine is to be administered by a healthcare professional, it is unlikely that an 
overdose will occur. 
However, in the event of an overdose, the investigator should: 
1. Contact the Medical Monitor SAE Hotline immediately. 
2. Closely monitor the participant for any AE/SAE and laboratory abnormalities until the 
last safety follow-up visit. 
3. Report any signs or symptoms associated with the overdose as an AE and record details 
in the relevant AE/SAE sections in the eCRF. 
4. Document the quantity of the excess dose in the eCRF. 
8.14 Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 81 
8.15 Pharmacodynamics 
Pharmacodynamic parameters are not evaluated in this study. 
8.16 Biomarkers 
Biomarker assessments (to be determined) will be evaluated as part of the study, which may 
include genomic and transcriptomic studies. Optional blood collections for DNA and mRNA 
sequencing will be performed and may be used for potential biomarker research. Samples for 
humoral immunogenicity on Day 181 and 361 (Month 12)/EoS will be collected and assessed in 
a subset, which will require a clinic visit on those days. 
8.17 Patient -reported Outcomes and Medical Resource Utilization 
Exploratory objectives related to patient-reported outcomes (PROs) and medical resource 
utilization are listed in Section 3. 
Patient-reported outcomes and medical resource utilization associated with symptoms of ILI will 
be assessed at time points specified in the SoE (Table 1). 
Concomitant medication use collection is detailed in Section 6.5.1. 
8.17.1 Patient-reported Outcome Measures 
Patient-reported outcome measures will include the following questionnaires: EQ-5D-5L scale, 
WPAI:ILI, and the EFS. 
EQ-5D-5L 
The EQ-5D-5L consists of both the EQ-5D descriptive system questionnaire and the EQ visual 
analogue scale (EQ-VAS). 
For all participants, the EQ-5D-5L will be collected by eDiary at Day 1 (Baseline), Day 91, 
Day 181, Day 271, and Day 361 (Month 12)/EoS. For participants reporting ILI symptoms, the 
EQ-5D and EQ-VAS will be collected using the eDiary on the day of the symptoms reporting 
(+1 day) and 5 days (+1 day) later. 
WPAI:ILI 
The participant will be prompted to report productivity or activity impairment related to their ILI 
symptoms. For participants reporting ILI symptoms, the WPAI over the previous 7 days will be 
collected by eDiary 5 days (+1 day) after the start of ILI symptoms reporting. The list of the ILI 
symptoms that is part of their reporting of symptoms is the specific health problem to be 
considered. 
Edmonton Frail Scale 
The EFS will be collected for participants aged 65 years and older at Day 1 (Baseline) by clinic 
staff. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 82 
8.17.2 Medical Resource Utilization 
Hospitalization 
Where hospital stay information is available (new hospitalization or prolongation of existing 
hospital stay), the following information will be collected for confirmed influenza cases from 
SAE and MAAE reports: 
• Admission date 
• Discharge date 
• Intensive care unit stay (yes or no) 
Outpatient Medical Resource Utilization 
For participants reporting MAAEs, outpatient medical resource utilization will be collected, 
where available. Options provided are: outpatient/physician visit; emergency room/urgent care 
visit; and telemedicine visit. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 83 
9. STATISTICAL CONSIDERATIONS 
9.1 Blinding and Responsibility for Analyses 
This is an observer-blind study. The investigator, clinic 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 clinic personnel involved in 
the conduct of the study unless this information is necessary in the case of an emergency. 
• Unblinded clinic 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 
primary analysis and the 6-month analysis (Section 9.6). Sponsor team members will be 
prespecified to be unblinded to the primary analysis and the 6-month analysis results and 
will not communicate the results to the blinded investigators, clinic staff, clinical 
monitors, or participants. 
• The DSMB may review data, as appropriate, to safeguard the interests of clinical study 
participants and to help ensure the integrity of the study. 
The dosing assignment will be concealed by having the unblinded pharmacy personnel prepare 
the IP in a secure location that is not accessible or visible to other clinic staff. An opaque sleeve 
over the syringe used for injection will maintain the blind at the time of injection, as the doses 
containing mRNA-1010 will look different from those of placebo/active comparator. Only 
delegated unblinded clinic staff will conduct the injection procedure. Once the injection is 
completed, only the blinded clinic staff will perform further assessments and interact with the 
participants. Access to the randomization code will be strictly controlled at the pharmacy. 
Procedures for breaking the blind in the case of a medical emergency are provided in 
Section 6.3.7. 
9.2 Statistical Hypotheses 
The null hypothesis H10: immunogenicity response to mRNA-1010, as measured by GMT or by 
seroconversion rate at Day 29 using HAI assay, is inferior compared to that in participants who 
received the active comparator for A strains (ie, H1N1, H3N2). Four coprimary immunogenicity 
endpoints will be tested for noninferiority of mRNA-1010 vs. active comparator for A strains at a 
two-sided 0.025 level. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 84 
The null hypothesis H20: immunogenicity response to mRNA-1010, as measured by GMT or by 
seroconversion rate at Day 29 using HAI assay, is inferior compared to that in participants who 
received the active comparator for B strains (ie, B/Victoria, B/Yamagata). Four coprimary 
immunogenicity endpoints will be tested for non-inferiority of mRNA-1010 vs. active 
comparator for B strains at a two-sided 0.025 level. 
At Day 29, for each individual influenza virus strain, 
• The noninferiority in GMT in participants who received mRNA-1010 compared to that of 
participants who received the active comparator will be demonstrated by the lower bound 
of the 97.5% confidence interval (CI) of the GMT ratio (geometric mean ratio [GMR]) 
ruling out 0.667 (lower bound > 0.667) using a noninferiority margin of 1.5. The GMR is 
the ratio of the GMT of HAI titer in those receiving mRNA-1010 compared with the 
GMT of those receiving the active comparator. 
• The noninferiority in seroconversion rate in the mRNA-1010 group compared to that of 
the active comparator group will be demonstrated by the lower bound of the 97.5% CI of 
the seroconversion rate difference (mRNA-1010 vs. active comparator) ruling out -10% 
(lower bound > -10%) using a noninferiority margin of 10%. 
The success criteria of non-inferiority for A strains are met if H10 is rejected at two-sided 0.025 
level on all four co-primary endpoints. Similarly, the success criteria of non-inferiority for B 
strains are met if H20 is rejected at two-sided 0.025 level on all four co-primary endpoints.  
Once the noninferiority success criteria of the coprimary endpoints for A strains are met, the 
following endpoints will be tested in a sequential order to support secondary objectives: 
The following endpoints will be tested at a two-sided α1=5% level if noninferiority is 
demonstrated for both A and B strains; and at a α1=2.5% level if non-inferiority is only 
demonstrated for A strains.  
The null hypothesis H30: immunogenicity response to mRNA-1010 compared to that in 
participants who received the active comparator, as measured by GMR at Day 29 using HAI assay, 
is ≤ 1 for each individual A strain (H1N1 and H3N2). The superiority in GMT in participants who 
received mRNA-1010 compared to that of participants who received active comparator will be 
demonstrated by the lower bound of the (100%- α) CI of the GMR ruling out 1 (lower bound > 1) 
for both individual A strains.  
Once the success criteria of hypothesis H30 are met, the next null hypothesis to be tested is H40: 
immunogenicity response to mRNA-1010 compared to that in participants who received the active 
comparator, as measured by GMR at Day 29 using HAI assay, is ≤ 1.5 for each individual A strain 
(H1N1 and H3N2). The super-superiority in GMT in participants who received mRNA-1010 
compared to that of participants who received active comparator will be demonstrated by the lower 
bound of the (100%- α) CI of the GMR ruling out 1.5 (lower bound > 1.5) for both individual A 
strains.  
If the success criteria of hypothesis H40 are met, the last null hypothesis to be tested is H50: 
immunogenicity response to mRNA-1010 compared to that in participants who received the 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 85 
active comparator, as measured by seroconversion rate difference at Day 29 using HAI assay, is 
≤ 10% for each individual A strain (H1N1 and H3N2). The super-superiority of seroconversion 
rate in the mRNA-1010 group compared to that in the active comparator group will be 
demonstrated by the lower bound of the (100%- α) CI of the seroconversion rate difference 
ruling out 10% (lower bound > 10%) for both individual A strains. 
9.3 Sample Size Determination 
With approximately 3000 participants exposed to IP in the mRNA-1010 group, the study has an 
approximately 95% probability to observe at least 1 participant with an AE at a true 0.1% AE 
rate. 
Assuming approximately 15% of randomized participants will be excluded from the PP 
Immunogenicity Set, with approximately 5100 participants in the PP Immunogenicity Set (1:1 
ratio; approximately 2550 in each vaccine group), the study has at least 95% power to 
demonstrate noninferiority of the immune response in all 4 strains, as measured by the GMT in 
participants receiving mRNA-1010 compared with that in the active comparator group, at a 
2-sided 0.025 level, assuming an underlying GMR of 0.9 in all 4 strains and a noninferiority 
margin of 1.5. The standard deviation of the natural log-transformed levels is assumed to be 1.5. 
The study has at least 95% power to demonstrate noninferiority of the immune response in all 
4 strains, as measured by seroconversion rate in the mRNA-1010 group compared with that in 
the active comparator group, at a 2-sided 0.025 level, assuming a seroconversion rate of 70% in 
influenza A strains and 60% in influenza B strains, respectively, in the mRNA-1010 group (a 
true rate difference is 0 compared to the active comparator group), and a noninferiority margin of 
10%. 
9.4 Analyses Populations 
The analysis sets are defined in Table 7. 
Table 7: Populations for Analyses 
Population 
Description 
Randomization Set 
All participants who are randomly assigned to treatment, regardless 
of the participants’ treatment status in the study. 
Full Analysis Set (FAS) 
All participants randomly assigned to treatment who received any 
study vaccination. Participants will be analyzed according to the 
group to which they were randomized. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 86 
Population 
Description 
Modified Intent-to-Treat 
(mITT) Set 
All participants in the FAS who provide any follow-up for ILI 
beginning at least 14 days following administration of study 
intervention. 
Participants will be analyzed according to the group to which they 
were randomized. 
PP Set for Efficacy 
A subset of participants in the mITT Set who do not have significant 
protocol deviations that could adversely impact efficacy, eg, disease 
or therapeutic intervention that might cause suboptimal response to 
the study intervention.  
Participants will be analyzed according to the group to which they 
were randomized. 
Immunogenicity Set 
All participants in the FAS who have baseline and Day 29 antibody 
assessment via HAI assay. 
Participants will be analyzed according to the group to which they 
were randomized. 
PP Immunogenicity Set 
The PP Immunogenicity Set includes all participants in the 
Immunogenicity Set who received planned dose of IP, complied with 
the immunogenicity testing schedule, and had no major protocol 
deviations that impact key or critical data. Participants with 
RT-PCR-confirmed influenza between Days 1 to 29 will be removed 
from the PP Immunogenicity Set. 
The PP Immunogenicity Set will be used for all analyses of 
immunogenicity unless specified otherwise. 
Participants will be analyzed according to the group to which they 
were randomized. 
Solicited Safety Set 
All randomized participants who received any study vaccination and 
contributed any solicited AR data. 
The Solicited Safety Set will be used for the analyses of solicited 
ARs, and participants will be included in the vaccination group 
corresponding to the vaccination that they actually received. 
Safety Set 
All participants randomly assigned to treatment who received any 
study vaccination. 
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 the IP that they actually received. 
Abbreviations: AR = adverse reaction; IP = investigational product; PP = Per-protocol; RT-PCR = reverse 
transcription polymerase chain reaction. 
9.5 Statistical Analyses 
The statistical analysis plan (SAP) will be developed and finalized before database lock and will 
describe the pre-planned statistical analysis details/data derivations, the participant populations 
to be included in the analyses, and procedures for accounting for missing and/or unused data. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 87 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints. 
9.5.1 Immunogenicity Analyses 
The primary analysis population for immunogenicity will be the PP Immunogenicity Set, unless 
specified otherwise. The primary objective of this study is to use the immunogenicity response to 
infer efficacy in participants receiving mRNA-1010. 
Immune responses, as measured by GMT and seroconversion rate in the mRNA-1010 group 
based on Day 29 HAI titers, will be compared to that in participants receiving the active 
comparator for all 4 strains. 
An analysis of covariance model (ANCOVA) will be carried out. The model will include the 
log-transformed HAI titers at Day 29 as the dependent variable, vaccination group as the fixed 
variable, log-transformed baseline HAI titers as a fixed covariate, adjusting for the stratification 
factors. The geometric least square mean (GLSM), and its corresponding 95% CI results in 
log-transformed scale estimated from the model will be back-transformed to obtain these 
estimates in the original scale, as an estimate of the GMT. GMR, estimated by the ratio of GLSM 
and the corresponding 2-sided 97.5% CI will be provided to assess the treatment difference. The 
corresponding 2-sided 97.5% CI of GMR will be provided to assess the difference in immune 
response between the mRNA-1010 compared to the active comparator group at Day 29. For each 
strain, the noninferiority of GMT will be considered demonstrated if the lower bound of the 
97.5% CI of the GMR is > 0.667 based on a noninferiority margin of 1.5. 
The number and percentage of participants with seroconversion due to vaccination will be 
provided with 2-sided 95% CI using the Clopper-Pearson method at Day 29. To compare the 
seroconversion rates between the vaccination groups, the Miettinen-Nurminen’s method will be 
used to calculate the 97.5% CI for the difference in seroconversion rates. The seroconversion rate 
difference with the corresponding 97.5% CI at Day 29 will be provided. For each strain, the 
noninferiority of seroconversion rate will be considered demonstrated if the lower bound of the 
97.5% CI of the seroconversion rate difference is > -10% based on a noninferiority margin of 
10%. 
The primary analyses will be repeated using the Immunogenicity Set as a sensitivity analysis. 
Subgroup analysis for the coprimary immunogenicity endpoints will be conducted as 
appropriate. 
Once the noninferiority success criteria are met for A strains, superiority of mRNA-1010 relative 
to the active comparator for A strains may be further evaluated. More details about the testing 
sequence can be found in Section 9.6.2. 
In addition, the GMT of HAI titers with corresponding 95% CI will be provided at each time 
point. The 95% CIs will be calculated based on the t-distribution of the log-transformed values 
then back-transformed to the original scale. The GMFR of HAI titers with corresponding 95% CI 
at each post-baseline time point over baseline will be provided. Descriptive summary statistics 
including median, minimum, and maximum will also be provided.  
The number and percentage of participants with an HAI titer ≥ 1:40 post-injection due to 
vaccination will be provided with 2-sided 95% CI using the Clopper-Pearson method. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 88 
For summarizations of GMTs, antibody titers reported as below the lower limit of 
quantification (LLOQ) will be replaced by 0.5 x LLOQ. Values that are greater than the upper 
limit of quantification (ULOQ) will be converted to the ULOQ. 
Rate of seroconversion is defined as the proportion of participants with either a pre vaccination 
HAI titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre vaccination HAI titer ≥ 1:10 and a 
minimum 4-fold rise in post vaccination HAI antibody titer. 
9.5.2 Efficacy Analyses 
The primary analysis population of efficacy is the mITT Set.  
To evaluate the incidence of first episode of RT-PCR-confirmed protocol-defined ILI after 
vaccination with mRNA-1010 or the active comparator, the incidence rate will be calculated as 
the number of participants with a case (ie, first occurrence of ILI at least 14 days after the study 
injection through Day 181/end of influenza season) divided by the number of participants at risk 
adjusted by person-time (years). The person-time is calculated as the time from randomization to 
the date of the first episode for participants with a case, or the time from randomization to the 
date of discontinuation or death or Day 181/end of influenza season, whichever occurs first, for 
participants without a case. Person-time, incidence rate, and 95% CI for incidence rate will be 
provided by vaccination group. Relative vaccine efficacy will be estimated by 1- ratio of 
incidence rate (mRNA-1010 vs. active comparator) adjusting for person-time, and the 95% CI 
will be computed using the exact method conditional upon the total number of cases adjusting 
for person-time. 
Sensitivity analyses may be performed on the PP Set for Efficacy. 
RT-PCR-confirmed protocol-defined ILI and RT-PCR-confirmed CDC-defined ILI in 
participants aged 50 years and older or 65 years and older will be analyzed similarly. 
9.5.3 Safety Analyses 
All safety analyses will be based on the Safety Set, except summaries of solicited ARs, which 
will be based on the Solicited Safety Set. All safety analyses will be provided by vaccination 
group. Participants will be included in the vaccination group corresponding to what they actually 
received. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters, including 
solicited ARs (local and systemic events), unsolicited AEs, SAEs, AESIs, MAAEs, and AEs 
leading to discontinuation. 
The number and percentage of participants with any solicited local AR, solicited systemic AR, 
and solicited AR during the 7-day follow-up period after the injection will be summarized. A 
2-sided 95% exact CI using the Clopper-Pearson method will also 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 from study participation will be 
summarized. Unsolicited AEs will be coded according to the MedDRA and presented by 
MedDRA system organ class and preferred term. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 89 
Solicited ARs will be coded by system organ class and preferred term according to the MedDRA 
for AR terminology. The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trials (DHHS 2007b) will be used in this study with 
modification for rash, solicited ARs, and vital signs. 
The number of events of unsolicited AEs, SAEs, AESIs, and MAAEs will be reported in 
summarization tables accordingly. 
Table 8 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 8: Analysis Strategy for Safety Parameters 
Safety Endpoint 
Number and Percentage of 
Participants, Number of Events 
95% CI 
Any solicited AR (overall and by local, systemic) 
X 
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. 
Note: 95% CI using the Clopper-Pearson method. X = results will be provided. 
9.5.4 Exploratory Analyses 
Any protocol-defined and/or CDC-defined ILI cases will be presented by vaccination group.  
The number and percentage of participants aged 65 years and older with first episode of protocol 
defined ILI will be presented by baseline frailty status for each vaccination group. 
Analyses of the other exploratory endpoints will be described in the SAP. 
9.6 Planned Analyses 
9.6.1 Interim Analyses  
The primary analysis of safety and immunogenicity will be performed after all participants have 
completed the Day 29 visit. All data relevant to the primary study analysis through the Day 29 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 90 
visit will be cleaned and locked for the primary analysis (ie, data that are as clean as possible) 
and a report may be generated. 
A 6-month analysis may be performed once all participants complete the Day 181 Visit or the 
influenza season ends, whichever occurs later. All of safety, immunogenicity, and efficacy data 
will be cleaned and locked for the analysis. Additional safety analyses at other time points may 
be performed. 
The above 2 analyses will be performed by a separate team of unblinded programmers and 
statisticians. More details can be found in the study data blinding plan. 
Final analysis of all safety, immunogenicity and efficacy data will be performed once all 
participants complete the Day 361 (Month 12)/EoS Visit. 
The SAP will describe the planned analyses in greater detail. 
9.6.2 Multiplicity  
To control the overall Type I error for the study, a hierarchical testing strategy will be used to 
test the primary and secondary immunogenicity objectives (Figure 1). 
Figure 1: Testing Sequence of the Primary and Secondary Objectives 
 
  
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 91 
At the first step in the testing sequence as demonstrated in Figure 1, the noninferiority of mRNA-
1010 compared with active comparator for A strains and for B strains will be tested at a type I 
error rate of 2.5% (2-sided) respectively.  
If noninferiority is demonstrated for A strains only at the first step, the superiority testing for A 
strains will be tested following the order of testing sequency at a type I error rate of 2.5% (2-
sided).  
If non-inferiority is demonstrated for both A and B strains at the first step, the type I error rate 
for the following test will be 5% (2-sided). 
The testing sequence can only continue to the next level if the tests at the higher level meet the 
success criteria (as specified in Section 9.2). If a test at the higher level fails to meet the success 
criteria for that level, the testing sequence will stop, and all testing thereafter will not be 
conducted.  

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 92 
10. REFERENCES 
Aretz HT, Billingham ME, Edwards WD, Factor SM, Fallon JT, Fenoglio JJ Jr., et al. 
Myocarditis. A histopathologic definition and classification. Am J Cardiovasc Pathol. 
1987;1(1):3-14. 
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al; COVE Study Group. 
Efficacy and safety of mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-16. 
Centers for Disease Control and Prevention (CDC) [internet]. Atlanta, GA: CDC seasonal flu 
vaccine effectiveness studies. 2020a Dec 11 [cited 2021 Mar 17]. Available from: 
https://www.cdc.gov/flu/vaccines-work/effectiveness-studies.htm. 
Centers for Disease Control and Prevention (CDC) [internet]. Atlanta, GA: Influenza virus 
testing methods. 2020b Aug 10 [cited 2021 Aug 18]. Available from: 
https://www.cdc.gov/flu/professionals/diagnosis/table-testing-methods.htm. 
Department of Health and Human Services (DHHS), Food and Drug Administration, Center for 
Biologics Evaluation and Research (US). Guidance for industry: Clinical data needed to support 
the licensure of pandemic influenza vaccines. May 2007a [cited 2021 Aug 19]. Available from: 
https://www.fda.gov/media/73691/download. 
Department of Health and Human Services (DHHS), Food and Drug Administration, Center for 
Biologics Evaluation and Research (US). Guidance for industry: Toxicity grading scale for 
healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. 
September 2007b [cited 2021 Aug 19]. Available from: 
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInfor
mation/Guidances/Vaccines/ucm091977.pdf. 
Dunning AJ, DiazGranados CA, Voloshen T, Hu B, Landolfi VA, Talbot HK. Correlates of 
protection against influenza in the elderly: results from an influenza vaccine efficacy trial. Clin 
Vaccine Immunol. 2016;23(3):228-35. 
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). 
Guidance on Influenza Vaccines: Non-clinical and Clinical Module. London, 21 July 2016. 
EMA/CHMP/VWP/457259/2014 [cited 2021 Aug 19]. Available from: 
https://www.ema.europa.eu/en/documents/scientific-guideline/influenza-vaccines-non-clinical-
clinical-module_en.pdf. 
Feldman RA, Fuhr R, Smolenov I, Ribeiro AM, Panther L, Watson M, et al. mRNA vaccines 
against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well 
tolerated in healthy adults in Phase 1 randomized clinical trials. Vaccine. 2019;37(25):3326-34. 
Food and Drug Administration. Conduct of clinical trials of medical products during the 
COVID-19 public health emergency: guidance for industry, investigators, and institutional 
review boards. 2020 Mar [updated: 2021 Aug 30; cited: 2021 Oct 04]. Available from: 
https://www.fda.gov/media/136238/download. 
Gargano JW, Wallace M, Hadler SC, Langley G, Su JR, Oster ME, et al. Use of mRNA 
COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the 
Advisory Committee on Immunization Practices – United States, June 2021. MMWR Morb 
Mortal Wkly Rep. 2021;70(27):977-82. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 93 
ModernaTX, Inc. Dose-confirmation study to evaluate the safety, reactogenicity, and 
immunogenicity of mRNA-1273 COVID-19 vaccine in adults aged 18 years and older. In: 
ClinicalTrials.gov [internet]. Bethesda (MD): National Library of Medicine (US). 2020 May 28 
[updated 2021 Mar 21; cited 2021 Apr 10]. Available from: 
https://clinicaltrials.gov/ct2/show/NCT04405076. NLM identifier: NCT04405076. 
ModernaTX, Inc. A study to evaluate efficacy, safety, and immunogenicity of mRNA-1273 
vaccine in adults aged 18 years and older to prevent COVID-19. In: ClinicalTrials.gov [internet]. 
Bethesda (MD): National Library of Medicine (US). 2020 Jul 14 [updated 2021 Feb 25; cited 
2021 Apr 10]. Available from: https://clinicaltrials.gov/ct2/show/NCT04470427. NLM 
identifier: NCT04470427. 
ModernaTX, Inc. A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults. In: 
ClinicalTrials.gov [internet]. Bethesda (MD): National Library of Medicine (US). 2021 Jul 09 
[updated 2021 Jul 15; cited 2021 Sep 13]. Available from: 
https://clinicaltrials.gov/ct2/show/NCT04956575. NLM identifier: NCT04956575. 
Monto AS. Reflections on the Global Influenza Surveillance and Response System (GISRS) at 
65 years: an expanding framework for influenza detection, prevention, and control. Influenza 
Other Respir Viruses. 2018;12(1):10-12. 
National Institute of Allergy and Infectious Diseases (NIAID). Safety and immunogenicity study 
of 2019-nCov vaccine (mRNA-1273) for prophylaxis of SARS-CoV-2 infection (COVID-19). 
In: ClinicalTrials.gov [internet]. Bethesda (MD): National Library of Medicine (US). 
2020 Feb 21 [updated 2021 Apr 09; cited 2021 Apr 10]. Available from: 
https://clinicaltrials.gov/ct2/show/NCT04283461. NLM identifier NCT04283461. 
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al; C4591001 Clinical 
Trial Group. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med. 
2020;383(27);2603-15. 
Riedel S, Hobden JA, Miller S, Morse SA, Mietzner TA, Detrick B, et al. Orthomyxoviruses 
(Influenza Viruses). In: Riedel S, Morse SA, Mietzner TA, Miller S, eds. Jawetz, Melnick & 
Adelberg’s Medical Microbiology. 28th ed. New York, New York: McGraw-Hill Education; 
2019. p. 565-78. 
Rockman S, Laurie KL, Parkes S, Wheatley A, Barr IG. New technologies for influenza 
vaccines. Microorganisms. 2020;8(11):1745. 
Rüggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, et al; Brighton 
Collaboration Anaphylaxis Working Group. Anaphylaxis: case definition and guidelines for data 
collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675-
84. 
Shimabukuro TT, Cole M, Su JR. Reports of anaphylaxis after receipt of mRNA COVID-19 
vaccines in the US – December 14, 2020-January 18, 2021. JAMA. 2021;325(11):1101-2. 
World Health Organization (WHO) [internet]. Geneva, Switzerland: Influenza (seasonal): Ask 
the expert: influenza Q&A. 2018 Nov 6 [cited 2021 Mar 17]. Available from: 
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal). 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 94 
Zent O, Arras-Reiter C, Broeker M, Hennig R. Immediate allergic reactions after vaccinations – 
a post-marketing surveillance review. Eur J Pediatr. 2002;161(1):21-5. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 95 
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/IEC by the investigator and reviewed 
and approved by the IRB/IEC before the study is initiated. 
• Any amendments to the protocol will require IRB/IEC 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/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC 
− 
Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
− 
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, 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 Moderna 
or its representatives will visit the investigational clinic to: 
• Determine the adequacy of the facilities. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 96 
• Discuss with the investigator(s) and other personnel their responsibilities with regard to 
protocol adherence, and the responsibilities of Moderna or its representatives. This will 
be documented in a Clinical Study Agreement between Moderna, 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 Moderna 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/IEC 
review, and inspection by providing direct access to the source data/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 Moderna 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 AEs and SAEs have been properly documented on eCRFs and confirm any 
SAEs have been forwarded to the SAE Hotline, and those SAEs that met criteria for 
reporting have been forwarded to the IRB/IEC. 
The monitor will be available between visits if the investigator(s) or other staff needs 
information or advice. 
11.1.3 Audits and Inspections 
Moderna, their designee(s), the IRB/IEC, or regulatory authorities will be allowed to conduct site 
visits to the investigational facilities for the purpose of monitoring or inspecting any aspect of the 
study. The investigator agrees to allow Moderna, their designee(s), the IRB/IEC, or regulatory 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 97 
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 Moderna, a regulatory authority, and any IRB/IEC 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 Moderna immediately if 
contacted by a regulatory agency about an inspection. 
The Principal Investigator must obtain IRB/IEC approval for the investigation. Initial IRB/IEC 
approval and all materials approved by the IRB/IEC 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 clinic 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 clinic 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. 
11.1.6 Informed Consent 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/IEC or study center. All consent documents will be approved by the 
appropriate IRB/IEC. The actual ICF used at each center may differ, depending on local 
regulations and IRB/IEC requirements. However, all versions must contain the standard 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 98 
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/IEC 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 him or her in a timely manner. 
Such information will be provided via a revised ICF or an addendum to the original ICF. 
The investigator or his or 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 or her source 
medical records by study monitors, auditors, the IRB/IEC, 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 or 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 contain a separate consent form(s) that addresses the use of remaining optional 
samples for optional exploratory research. The investigator or authorized designee will explain to 
each participant the objectives of the exploratory research. A participant will be told that they are 
free to refuse participation and may withdraw their consent at any time and for any reason during 
the storage period. A separate signature will be required to document agreement to allow any 
remaining specimens to be used for exploratory research. A participant who declines to 
participate in this optional research will not provide this separate signature. 
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)/IEC(s) will be promptly notified. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 99 
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 to by the investigator(s), and approved by the relevant 
IRB(s)/IEC(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)/IEC(s) must be provided to the Sponsor before the study is initiated. 
Administrative changes of 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 investigator(s), and notified to the IRB(s)/IEC(s). 
11.1.8 Protocol Deviations 
The noncompliance may be either on the part of the participant, the investigator, or the clinic 
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 within in a timely manner of the scheduled protocol-required activity. All deviations 
must be addressed in study source documents and reported to the Sponsor and the study medical 
monitor. Protocol deviations must be sent to the reviewing IRB/IEC per their policies. The site 
investigator is responsible for knowing and adhering to the reviewing IRB/IEC 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. 
The participant must be informed that his or 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 or her medical records may be examined by Clinical 
Quality Assurance (QA) auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB/IEC 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 or 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, relevant regulatory authority, or the IRB/IEC. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 100 
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 
Samples may be used for purposes related to this research. The samples may be stored until the 
study team has determined that specimens are no longer needed, and the decision has been made 
that there are no samples to be re-assayed. In addition, identifiable samples can be destroyed at 
any time at the request of the participant. 
These samples could be used to address further scientific questions related to mRNA-1010 or 
anti-respiratory virus immune response, to research the complications associated with influenza 
and other conditions for which individuals with influenza are at increased risk, and to improve 
treatment. 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 to seasonal influenza to include humoral and cellular immune assay methodologies on 
any remaining blood or serum samples, including samples from participants who are screened 
but are not subsequently enrolled. A decision to perform such exploratory research may arise 
from new scientific findings related to the drug/vaccine class or disease, as well as reagent and 
assay availability. 
11.1.10.1 
Data and Safety Monitoring Board 
A DSMB will be used throughout the conduct of this study. The DSMB will be composed of 
independent members with relevant therapeutic and/or biostatistical expertise to allow for the 
ongoing review of safety data from this study population. The data to be reviewed will be 
unblinded. Safety data will be reviewed according to intervals defined in the DSMB charter and 
as needed if potential safety concerns are identified. 
11.1.10.2 
Dissemination of Clinical Study Data 
Moderna 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 clinicaltrialregister (eu.ctr), etc., as well as some national registries. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 101 
11.1.11 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 an 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/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
• Monitoring details describing strategy (eg, risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical 
Risk-Based Monitoring), methods, responsibilities and requirements, including 
handling of noncompliance issues and monitoring techniques (central, remote, or 
on-site monitoring) are provided in the Clinical Monitoring Plan. 
• The Sponsor or designee is responsible for the data management of this study 
including quality checking of the data. 
• The Sponsor assumes accountability for actions delegated to other individuals 
(eg, CROs). 
• Study monitors will perform ongoing source data verification to confirm that data 
entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the investigator for 2 years after study completion unless 
local regulations or institutional policies require a longer retention period. 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. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 102 
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 QA representative from the Sponsor or qualified designee, who is independent of and 
separated from routine monitoring, may periodically arrange inspections/audits of the clinical 
study by reviewing the data obtained and procedural aspects. These inspections may include 
on-site inspections/audits and source data checks. Direct access to source documents is required 
for the purpose of these periodic inspections/audits. 
11.1.12 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 investigational 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. 
Adverse events will be coded with MedDRA. Concomitant medications will be coded using the 
WHO-drug reference list. 
11.1.13 Source Documents 
Source documents are original documents or certified copies and include, but are not limited to, 
diary cards, medical and hospital records, screening logs, informed consent/assent forms, 
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. 
Moderna 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. 
11.1.14 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 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 103 
any local regulations, the local regulations will take precedence unless the local retention policy 
is less than 2 years. 
If it becomes necessary for Moderna 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. 
11.1.15 Study and Site Closure 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of the 
reason for termination or suspension, as specified by the applicable regulatory requirements. The 
investigator shall promptly inform the participant and should assure appropriate participant 
therapy and/or follow-up. 
The Sponsor or designee reserves the right to close the clinic or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. 
The investigator may initiate clinic 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 clinic 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/IEC or local health authorities, the Sponsor's procedures, or GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further mRNA-1010 development. 
Clinics will be closed upon study completion. A clinic is considered closed when all required 
documents and study supplies have been collected and a clinic closure visit has been performed. 
11.1.16 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 Moderna. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 104 
11.2 APPENDIX 2: Contraceptive Guidance 
Definitions: Woman of Childbearing Potential (WOCBP) 
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) 
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. 
Permanent sterilization methods (for the purpose of this study) include: 
o Documented hysterectomy 
o Documented bilateral salpingectomy 
o Documented bilateral oophorectomy 
o Documented 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 a regulatory 
agency-approved contraceptive method in accordance with the product label. For example: 
• Barrier method (such as condoms, diaphragm, or cervical cap)  
• Intrauterine device 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 105 
• 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: Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and 
withdrawal are not acceptable methods of contraception. 
11.3 APPENDIX 3: Adverse Events of Special Interest 
Investigators should report all events which fall into the categories presented in Table 9 as an 
AESI per the reporting processes specified in Section 8.11.6. These AESIs are medical concepts 
that are generally of interest in vaccine safety surveillance as per the Brighton Collaboration and 
Safety Platform for Emergency Vaccines. 
Table 9: Adverse Events of Special Interest 
Medical Concept 
Additional Notes 
Thrombocytopenia 
• 
Platelet counts < 150 x 109 
• 
Including but not limited to immune 
thrombocytopenia, platelet production 
decreased, thrombocytopenia, 
thrombocytopenic purpura, thrombotic 
thrombocytopenic purpura, or HELLP 
syndrome 
New onset of or worsening of the following 
neurologic diseases 
• 
Guillain-Barre syndrome 
• 
Acute disseminated encephalomyelitis 
• 
Idiopathic peripheral facial nerve palsy (Bell’s 
palsy) 
• 
Seizures including but not limited to febrile 
seizures and/or generalized 
seizures/convulsions 
Anaphylaxis 
• 
Anaphylaxis as defined per protocol 
(Section 0) 
• 
Following reporting procedures in 
Section 8.11.6 
Myocarditis/pericarditis 
• 
Myocarditis 
• 
Pericarditis 
• 
Myopericarditis 
Abbreviation: HELLP = hemolysis, elevated liver enzymes, and low platelet count. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 106 
 
11.4 APPENDIX 4: CDC Working Case Definitions of Pericarditis, 
Myocarditis, and Myopericarditis Occurring After Receipt of COVID-19 
mRNA Vaccines 
The CDC Working Case Definitions of probable and confirmed myocarditis, pericarditis, and 
myopericarditis (Gargano et al 2021) are provided in Table 10 as guidance. 
Table 10: Case Definitions of Probable and Confirmed Myocarditis, Pericarditis, and 
Myopericarditis 
Condition 
Definition 
Probable Case 
Confirmed Case 
Acute myocarditis 
Presence of ≥ 1 new or worsening of the 
following clinical symptoms:* 
• 
Chest pain, pressure, or 
discomfort 
• 
Dyspnea, shortness of breath, 
or pain with breathing 
• 
Palpitations 
• 
Syncope 
Presence of ≥ 1 new or worsening of the 
following clinical symptoms:* 
• 
Chest pain, pressure, or 
discomfort 
• 
Dyspnea, shortness of breath, 
or pain with breathing 
• 
Palpitations 
• 
Syncope 
OR infants and children aged < 12 years 
might instead have ≥ 2 of the following 
symptoms: 
• 
Irritability 
• 
Vomiting 
• 
Poor feeding 
• 
Tachycardia 
• 
Lethargy 
OR infants and children aged 
< 12 years might instead have ≥ 2 of the 
following symptoms: 
• 
Irritability 
• 
Vomiting 
• 
Poor feeding 
• 
Tachycardia 
• 
Lethargy 
AND ≥ 1 new finding of: 
• 
Troponin level above upper 
limit of normal (any type of 
troponin) 
• 
Abnormal electrocardiogram 
(ECG or EKG) or rhythm 
monitoring findings consistent 
with myocarditis§ 
• 
Abnormal cardiac function or 
wall motion abnormalities on 
echocardiogram 
• 
cMRI findings consistent with 
myocarditis 
AND ≥ 1 new finding of: 
• 
Histopathologic confirmation 
of myocarditis† 
• 
cMRI findings consistent with 
myocarditis in the presence of 
troponin level 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 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 107 
Condition 
Definition 
Probable Case 
Confirmed Case 
Acute pericarditis** 
Presence of ≥ 2 new or worsening of the following clinical features: 
• 
Acute chest pain†† 
• 
Pericardial rub on examination 
• 
New ST-elevation or PR-depression on 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: CDC = Centers for Disease Control and Prevention; CEAC = Cardiac Event Adjudication 
Committee; cMRI = cardiac magnetic resonance imaging; ECG or EKG = electrocardiogram; MRI = magnetic 
resonance imaging. 
Note: An independent CEAC comprised of medically qualified personnel, including cardiologists, will review 
suspected cases of myocarditis, pericarditis, and myopericarditis to determine if they meet 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 vaccine assignment. 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 et al 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) 
atrioventricular 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. 
 
 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 108 
11.5 APPENDIX 5: Protocol Amendment History 
11.5.1 Amendment 1, 10 Feb 2022 
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 main rationale for this amendment is to enhance clarity and implement additional protocol 
administrative corrections. 
The summary of changes table provided below describes the major changes made in 
Amendment 1 relative to the original protocol, including the sections modified and the 
corresponding rationales. The synopsis of Amendment 1 has been modified to correspond to 
changes in the body of the protocol. Minor grammar and formatting corrections were made 
throughout the document to enhance clarity and readability (which did not affect the conduct of 
the study). 
Summary of Major Changes in Protocol Amendment 1: 
Section # and Name 
Description of Change 
Brief Rationale 
Global 
Changed “active surveillance” 
to “Symptom Reporting 
eDiary”. 
To enhance clarity. 
1.1 Protocol Synopsis 
Changed “April 2022” to “May 
2022” for first participant in and 
“June 2022” to “July 2023” for 
the estimated date last 
participant completed. 
To correct an administrative 
error. 
1.1 Protocol Synopsis 
Changed “ruling out 10% (lower 
bound > 10%)” to “ruling out -
10% (lower bound > -10%)” for 
the noninferiority in 
seroconversion rate. 
Note: The negative sign was 
also added to > 10% in the 
Immunogenicity Analyses 
section of the synopsis. 
To correct an administrative 
error in statistical analysis. 
1.1 Protocol Synopsis, 4.1 
General Design, and 6.1 
Investigational Product and 
Active Comparator 
Administered 
Updated the 2022 Southern 
Hemisphere strains. 
To reflect the actual formulation 
of mRNA-1010. 
1.1 Protocol Synopsis, 4.1 
General Design, and 6.2 
Randomization and Blinding 
Added “at the time of 
screening” to the stratification 
factors. 
To enhance clarity. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 109 
1.1 Protocol Synopsis, 4.1 
General Design, and 6.2 
Randomization and Blinding 
Changed “and” to “including”. 
To enhance clarity. 
1.1 Protocol Synopsis, 4.1 
General Design, 8.9.2 
Assessments for Respiratory 
Viral Infections, and 8.9.4 Use 
of Electronic Diaries 
Removed passive surveillance 
from the protocol. 
Participants will be instructed to 
contact study sites if they have 
ILI symptoms outside the 
Symptom Reporting eDiary 
period. 
To improve compliance in 
eDiary reporting. By removing 
passive surveillance, prompts 
for the participants to complete 
the Symptom Reporting eDiary 
can be programmed.  
1.1 Protocol Synopsis, 1.2 
Schedule of Events (SoE), 4.1 
General Design, and 8.9.4 Use 
of Electronic Diaries 
Changed active 
surveillance/Symptom 
Reporting eDiary from: 
• 3 to 4 times weekly from 
Day 1 to Day 29 and twice 
weekly from Day 91 to Day 
361/EoS to once weekly 
from Day 1 to Day 361 
To reduce participant fatigue 
and improve compliance in 
eDiary reporting. 
1.1 Protocol Synopsis and 5.2 
Exclusion Criteria 
For exclusion criterion 1:  
• 
Changed requirement for 
no close contact with 
someone with SARS-CoV-
2 infection from 14 to 10 
days and removed the 
stipulation about being 
fully vaccinated. 
• 
Removed the requirement 
for absence of confirmed 
SARS-CoV-2 infection 30-
180 days prior to 
enrollment. 
To reflect the changing COVID-
19 landscape and 
transmissibility of new variants 
as well as new Center for 
Disease Control and Prevention 
guidance on SARS-CoV-2. 
1.1 Protocol Synopsis and 5.2 
Exclusion Criteria 
Added exclusion of participants 
who is not aware if they have 
received an influenza vaccine in 
the past 12 months. 
To allow stratification at 
randomization by influenza 
vaccine status. 
1.1 Protocol Synopsis and 
8.11.5 Influenza-like Illness 
Case Definitions 
• Changed “Influenza-like 
Illness” to “Influenza-like 
Infection” for the definition 
of RT-PCR confirmed. 
• Added “respiratory sample” 
and “within 7 days of onset 
of protocol-defined ILI”. 
• To correct an error. 
 
 
 
• To enhance clarity. 
1.1 Protocol Synopsis and 9.4 
Analyses Populations 
• Added a statement that the 
selection for the 
Immunogenicity Subset can 
• To enhance clarity. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 110 
be found in a detailed 
sampling plan. 
• Deleted the statement that 
the selection for the PP 
Immunogenicity Subset can 
be found in a detailed 
sampling plan. 
1.1 Protocol Synopsis and 9.5.1 
Immunogenicity Analyses 
Deleted redundant text on the 
noninferiority criteria in the 
Immunogenicity Analyses 
section of the synopsis. 
To enhance clarity. 
1.1 Protocol Synopsis and 9.3 
Sample Size Determination 
Reduced the sample size for 
immunogenicity analyses from 
4,000 to 3,000 (2,000:1,000 
mRNA-1010:active 
comparator). 
Due to a revisit of the secondary 
endpoints. 
9.5.1 Immunogenicity Analyses 
Added that HAI titer ≥ 1:40 
post-injection due to vaccination 
will be provided with 2 sided 
95% CI using the Clopper 
Pearson method 
To correct an omission. 
1.2 SoE 
Deleted Screening from the SoE 
for: 1) Recording of 
SAEs/AESIs and concomitant 
medications relevant to or for 
the treatment of SAEs/AESIs; 2) 
Recording of concomitant 
medications and nonstudy 
vaccinations; and 3) Recording 
of hospitalizations and 
outpatient treatment-related to 
or for the treatment of the 
MAAE or SAE to reflect these 
will be captured beginning with 
Day 1.  
To correct an error. 
1.2 SoE, 4.2 Scientific Rationale 
for Study Design, and 8.9.2 
Assessments for Respiratory 
Viral Infections 
Added that in the event that NP 
swabs during ILI cannot be 
collected, any available 
influenza and/or SARS-CoV-2 
testing results performed outside 
of the study should be captured 
in the eCRF. 
To capture all instances of 
influenza/SARS-CoV-2 
infections. 
1.2 SoE and 8.9.4 Use of 
Electronic Diaries 
Changed the time frame for 
reporting eDiary entries from 
“1 hour” to “30 minutes” after 
injection. 
To be consistent with other 
Phase 3 studies. 

ModernaTX, Inc. 
Protocol mRNA-1010-P301 Amendment 2 
mRNA-1010 
Confidential 
Page 111 
1.2 SoE and 8.17.1 Patient-
reported Outcome Measures 
Adapted the timing of eDiary 
prompts for participants 
reporting the symptoms of ILI: 
• 
For EQ-5D-5L from 
prompting on the day of 
the report and 7 and 14 
days after (±1 day window 
for all time points) to on 
the day of report (+1 day) 
and 5 days (+1 day) after. 
• 
For WPAI from prompting 
on day 7 and 14 (±1 day 
window for both time 
points) after the report to 
only 5 days (+1 day) after. 
To get QOL data with 
immediacy for any ILI event but 
to avoid generation of multiple 
QOLs appearing on a given 
calendar day. 
1.2 SoE, 8.9.1 Pregnancy Screen 
and Testing, and 8.11.7 
Recording and Follow-up of 
Pregnancy 
Added that a point-of-care blood 
or urine pregnancy test will be 
performed at the Screening Visit 
and that additional pregnancy 
testing may be performed if 
required by local regulatory 
requirements. 
To specify that local regulatory 
requirements regarding 
pregnancy testing should be 
followed. 
2.2.3 Clinical Studies, 4.1 
General Design, and 4.3 
Justification for Dose, Control 
Product, and Choice of Study 
Population 
• 
Added text on vaccination 
with mRNA-1010 on 
antibodies. 
• 
Added text on the planned 
Phase 2 extension study. 
• 
Added text on the interim 
data in the Northern 
Hemisphere from a Phase 2 
study.  
To add supportive data. 
6.3.3 Clinical Study Material 
Packaging and Labeling 
Changed the fill volume from 
0.8 mL to 0.7 mL. 
To correct an error. 
6.3.4 Clinical Study Material 
Storage 
Added a statement on storage 
conditions at the depots and 
during shipping. 
To provide additional details. 
11.2 Appendix 2: Contraception 
Guidance 
Updated the definition of 
“women of childbearing 
potential” and the definition of 
“nonchildbearing potential”. 
To align with the updated 
protocol template text. 
11.2 Appendix 2: Contraception 
Guidance 
Deleted “used in conjunction 
with spermicide”. 
To clarify what constitutes 
adequate contraception, that is 
consistent with contraceptive 
methods used in participating 
Southern Hemisphere countries. 
 

Signature Page for VV-CLIN-004506 v4.0
Signature Page for VV-CLIN-004506 v4.0
2nd Approval
25-Jul-2022 19:32:57 GMT+0000
PPD