Trial Outcomes & Findings for A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (NCT NCT05415462)

Last Updated: 2024-09-24

Results Overview

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

6102 participants

Primary outcome timeframe

Up to 28 days post-vaccination

Results posted on

2024-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Fluarix Tetra Participants received a single dose of Fluarix Tetra by intramuscular (IM) injection on Day 1.	mRNA-1010 Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Overall Study STARTED	3057	3045
Overall Study Received Injection	3048	3035
Overall Study COMPLETED	2824	2857
Overall Study NOT COMPLETED	233	188

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluarix Tetra Participants received a single dose of Fluarix Tetra by intramuscular (IM) injection on Day 1.	mRNA-1010 Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Overall Study Death	18	10
Overall Study Lost to Follow-up	72	64
Overall Study Physician Decision	5	5
Overall Study Protocol Deviation	1	0
Overall Study Withdrawal by Subject	129	101
Overall Study Other Than Specified	8	8

Baseline Characteristics

A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluarix Tetra n=3057 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=3045 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.	Total n=6102 Participants Total of all reporting groups
Age, Continuous	48.0 years STANDARD_DEVIATION 16.49 • n=5 Participants	48.0 years STANDARD_DEVIATION 16.41 • n=7 Participants	48.0 years STANDARD_DEVIATION 16.45 • n=5 Participants
Sex: Female, Male Female	1742 Participants n=5 Participants	1787 Participants n=7 Participants	3529 Participants n=5 Participants
Sex: Female, Male Male	1315 Participants n=5 Participants	1258 Participants n=7 Participants	2573 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2222 Participants n=5 Participants	2209 Participants n=7 Participants	4431 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	812 Participants n=5 Participants	819 Participants n=7 Participants	1631 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	1745 Participants n=5 Participants	1733 Participants n=7 Participants	3478 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	706 Participants n=5 Participants	708 Participants n=7 Participants	1414 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	320 Participants n=5 Participants	305 Participants n=7 Participants	625 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiple	216 Participants n=5 Participants	220 Participants n=7 Participants	436 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized Race · Missing	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Population: The Per Protocol Immunogenicity Set (PPIS) included all randomized participants who received any study vaccination, who had baseline and Day 29 antibody assessment via HAI assay, complied with the immunogenicity testing schedule, and had no significant protocol deviations that impacted key or critical data. Number Analyzed = participants evaluable for specified categories.

Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=2823 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=2850 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza A H1N1 Antibody	266.52 titer Interval 256.16 to 277.29	268.94 titer Interval 259.28 to 278.95
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza A H3N2 Antibody	175.06 titer Interval 167.61 to 182.85	290.19 titer Interval 277.9 to 303.02
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Victoria Lineage	127.50 titer Interval 122.13 to 133.11	84.16 titer Interval 80.66 to 87.8
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Yamagata Lineage	254.38 titer Interval 245.52 to 263.57	169.98 titer Interval 164.41 to 175.74

PRIMARY outcome

Timeframe: Day 29

Population: The PPIS included all randomized participants who received any study vaccination, who had baseline and Day 29 antibody assessment via HAI assay, complied with the immunogenicity testing schedule, and had no significant protocol deviations that impacted key or critical data. Number Analyzed = participants evaluable for specified categories.

Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as either a Baseline HAI titer \<1:10 and a post-Baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-Baseline HAI Ab titer.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=2823 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=2850 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H3N2 Antibody	63.2 percentage of participants Interval 61.35 to 64.94	80.1 percentage of participants Interval 78.56 to 81.52
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H1N1 Antibody	70.6 percentage of participants Interval 68.89 to 72.3	76.4 percentage of participants Interval 74.76 to 77.92
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Victoria Lineage	49.7 percentage of participants Interval 47.83 to 51.57	32.4 percentage of participants Interval 30.63 to 34.11
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Yamagata Lineage	65.2 percentage of participants Interval 63.36 to 66.91	49.5 percentage of participants Interval 47.62 to 51.33

PRIMARY outcome

Timeframe: 7 days post-vaccination

Population: The Solicited Safety Set included all randomized participants who received any study vaccination and contributed any solicited AR data, that is, had at least 1 post-baseline solicited safety assessment.

Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=3046 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=3035 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Any	1463 Participants	2137 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 1	1051 Participants	1160 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 2	309 Participants	659 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 3	93 Participants	312 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 4	10 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to 28 days post-vaccination

Population: The Safety Set included all participants who were randomized and received any study vaccination.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=3048 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=3035 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With Unsolicited AEs	749 Participants	800 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 361 (Month 12)

Population: The Safety Set included all participants who were randomized and received any study vaccination.

An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 \[COVID-19\] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 361) are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=3048 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=3035 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation SAEs	131 Participants	132 Participants
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation AESIs	13 Participants	9 Participants
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation MAAEs	1481 Participants	1422 Participants
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation AEs Leading to Discontinuation	17 Participants	10 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: The Modified Intent-to-Treat (mITT) Set included all participants who were randomized and received any study vaccination and who provided any follow-up for ILI beginning at least 14 days following administration of study intervention.

A protocol-defined ILI was 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 included sore throat, cough/rhinorrhea/nasal congestion (≥1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature \>37.2 degrees Celsius (°C) (\>99 degrees Fahrenheit \[°F\]), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=2979 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=2980 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Strain of Influenza Virus	54 Participants	64 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

A CDC-defined ILI was defined as body temperature ≥37.8°C (100°F) accompanied by cough and/or sore throat.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=2979 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=2980 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Strain of Influenza Virus	22 Participants	24 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: The mITT Set included all participants who were randomized and received any study vaccination and who provided any follow-up for ILI beginning at least 14 days following administration of study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified categories.

A protocol-defined ILI was 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 included sore throat, cough/rhinorrhea/nasal congestion (≥1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature \>37.2°C (\>99°F), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=1534 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=1512 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Any Strain of Influenza Virus in Participants Aged 50 Years and Older or 65 Years and Older 50 Years and Older	15 Participants	21 Participants
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Any Strain of Influenza Virus in Participants Aged 50 Years and Older or 65 Years and Older 65 Years and Older	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 29

Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=2823 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=2850 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza A H3N2 Antibody	92.1 percentage of participants Interval 91.04 to 93.07	96.9 percentage of participants Interval 96.21 to 97.52
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza A H1N1 Antibody	97.0 percentage of participants Interval 96.3 to 97.6	97.6 percentage of participants Interval 97.0 to 98.16
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza B/Victoria Lineage	88.0 percentage of participants Interval 86.78 to 89.22	80.7 percentage of participants Interval 79.25 to 82.19
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza B/Yamagata Lineage	98.5 percentage of participants Interval 97.99 to 98.92	96.7 percentage of participants Interval 95.94 to 97.29

SECONDARY outcome

Timeframe: Baseline, Day 29

The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.

Outcome measures

Outcome measures
Measure	Fluarix Tetra n=2823 Participants Participants received a single dose of Fluarix Tetra by IM injection on Day 1.	mRNA-1010 n=2850 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H1N1 Antibody	7.27 ratio Interval 6.93 to 7.62	7.42 ratio Interval 7.13 to 7.73
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H3N2 Antibody	4.92 ratio Interval 4.73 to 5.12	8.15 ratio Interval 7.83 to 8.48
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/Victoria Lineage	3.59 ratio Interval 3.44 to 3.73	2.38 ratio Interval 2.3 to 2.46
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/Yamagata Lineage	5.27 ratio Interval 5.07 to 5.48	3.46 ratio Interval 3.35 to 3.56

Adverse Events

Fluarix Quadrivalent 60 ug

Serious events: 131 serious events

Other events: 809 other events

Deaths: 18 deaths

mRNA-1010 50 ug

Serious events: 132 serious events

Other events: 803 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Fluarix Quadrivalent 60 ug n=3048 participants at risk Participants received a single intramuscular (IM) injection of Fluarix Quadrivalent 60 ug on Day 1	mRNA-1010 50 ug n=3035 participants at risk Participants received a single intramuscular (IM) injection of mRNA-1010 50 ug on Day 1
Infections and infestations COVID-19	13.9% 424/3048 • Number of events 445 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	14.6% 442/3035 • Number of events 461 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Rhinovirus infection	4.9% 150/3048 • Number of events 167 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	5.5% 167/3035 • Number of events 185 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Upper respiratory tract infection	6.7% 205/3048 • Number of events 243 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	6.6% 200/3035 • Number of events 251 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
General disorders Influenza like illness	5.5% 168/3048 • Number of events 207 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	5.4% 165/3035 • Number of events 206 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 361]). Other (not including serious) adverse events were collected for 28 days after the vaccination. As pre-specified, All-cause mortality data were collected and reported for all randomized participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.

Additional Information

Moderna Clinical Trials Support Center

ModernaTX, Inc.

Phone: 1-877-777-7187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place