Trial Outcomes & Findings for Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. (NCT NCT05513053)

Last Updated: 2025-09-09

Results Overview

GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1308 participants

Primary outcome timeframe

Day 29

Results posted on

2025-09-09

Participant Flow

This study was conducted at 36 investigational sites in 4 countries between 27 Oct 2022 to 27 Oct 2023.

A total of 1308 participants were enrolled in this study.

Participant milestones

Participant milestones
Measure	Cohort 1: Participants Aged 9 to 17 Years Participants received a single intramuscular (IM) injection of RIV4 0.5 milliliter (mL) on Day 1.	Cohort 2: Participants Aged 18 to 49 Years Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Overall Study STARTED	648	660
Overall Study COMPLETED	629	635
Overall Study NOT COMPLETED	19	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Participants Aged 9 to 17 Years Participants received a single intramuscular (IM) injection of RIV4 0.5 milliliter (mL) on Day 1.	Cohort 2: Participants Aged 18 to 49 Years Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Overall Study Lost to Follow-up	9	11
Overall Study Withdrawal by parent/guardian	2	0
Overall Study Withdrawal by Subject	2	9
Overall Study Protocol Violation	6	3
Overall Study Adverse Event	0	2

Baseline Characteristics

Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Participants Aged 9 to 17 Years n=648 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=660 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Total n=1308 Participants Total of all reporting groups
Age, Continuous	13.0 years STANDARD_DEVIATION 2.49 • n=5 Participants	34.3 years STANDARD_DEVIATION 9.21 • n=7 Participants	23.7 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	312 Participants n=5 Participants	395 Participants n=7 Participants	707 Participants n=5 Participants
Sex: Female, Male Male	336 Participants n=5 Participants	265 Participants n=7 Participants	601 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	157 Participants n=5 Participants	98 Participants n=7 Participants	255 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	467 Participants n=5 Participants	536 Participants n=7 Participants	1003 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Population: Analysis was performed on the Per-protocol analysis set (PPAS)-subset of full analysis set (FAS) which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample.

GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=609 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=606 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 A/H1N1	1946 titer Interval 1795.0 to 2109.0	982 titer Interval 881.0 to 1094.0
Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 A/H3N2	1975 titer Interval 1771.0 to 2202.0	604 titer Interval 531.0 to 687.0
Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 B/Victoria	405 titer Interval 362.0 to 452.0	258 titer Interval 233.0 to 285.0
Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 B/Yamagata	1941 titer Interval 1779.0 to 2118.0	1593 titer Interval 1477.0 to 1717.0

PRIMARY outcome

Timeframe: Day 29

Population: Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 29 are reported.

Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (\>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer \>= 1:10 at Day 1 and a \>= 4-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=609 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=606 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 A/H1N1	78.3 percentage of participants Interval 74.8 to 81.5	76.4 percentage of participants Interval 72.8 to 79.7
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 A/H3N2	86.5 percentage of participants Interval 83.6 to 89.1	87.1 percentage of participants Interval 84.2 to 89.7
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 B/Victoria	76.8 percentage of participants Interval 73.3 to 80.1	73.6 percentage of participants Interval 69.8 to 77.0
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 B/Yamagata	77.2 percentage of participants Interval 73.6 to 80.5	62.9 percentage of participants Interval 58.9 to 66.7

SECONDARY outcome

Timeframe: Pre-vaccination on Day 1

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=609 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=606 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
GMTs Against Influenza Vaccine Antibodies at Day 1 A/H1N1	154 titer Interval 137.0 to 173.0	74.9 titer Interval 65.8 to 85.1
GMTs Against Influenza Vaccine Antibodies at Day 1 A/H3N2	111 titer Interval 95.4 to 128.0	29.0 titer Interval 25.7 to 32.8
GMTs Against Influenza Vaccine Antibodies at Day 1 B/Victoria	48.1 titer Interval 43.0 to 53.8	37.3 titer Interval 34.0 to 40.9
GMTs Against Influenza Vaccine Antibodies at Day 1 B/Yamagata	272 titer Interval 243.0 to 305.0	300 titer Interval 269.0 to 335.0

SECONDARY outcome

Timeframe: On Days 1 and 29

Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 and \>=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=609 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=606 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: A/H1N1: Day 1	97.0 percentage of participants Interval 95.4 to 98.2	89.8 percentage of participants Interval 87.1 to 92.1
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: A/H1N1: Day 29	100 percentage of participants Interval 99.4 to 100.0	99.3 percentage of participants Interval 98.3 to 99.8
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: A/H1N1: Day 1	87.2 percentage of participants Interval 84.3 to 89.7	71.8 percentage of participants Interval 68.0 to 75.3
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: A/H1N1: Day 29	99.7 percentage of participants Interval 98.8 to 100.0	97.5 percentage of participants Interval 96.0 to 98.6
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: A/H3N2: Day 1	89.2 percentage of participants Interval 86.4 to 91.5	77.7 percentage of participants Interval 74.2 to 81.0
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: A/H3N2: Day 29	100 percentage of participants Interval 99.4 to 100.0	99.7 percentage of participants Interval 98.8 to 100.0
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: A/H3N2: Day 1	74.7 percentage of participants Interval 71.1 to 78.1	45.0 percentage of participants Interval 41.0 to 49.1
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: A/H3N2: Day 29	99.0 percentage of participants Interval 97.9 to 99.6	95.0 percentage of participants Interval 93.0 to 96.6
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: B/Victoria: Day 1	92.1 percentage of participants Interval 89.7 to 94.1	91.7 percentage of participants Interval 89.2 to 93.8
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: B/Victoria: Day 29	99.5 percentage of participants Interval 98.6 to 99.9	99.8 percentage of participants Interval 99.1 to 100.0
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: B/Victoria: Day 1	61.4 percentage of participants Interval 57.4 to 65.3	59.8 percentage of participants Interval 55.8 to 63.8
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: B/Victoria: Day 29	95.6 percentage of participants Interval 93.6 to 97.1	97.0 percentage of participants Interval 95.3 to 98.2
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: B/Yamagata: Day 1	97.9 percentage of participants Interval 96.4 to 98.9	99.5 percentage of participants Interval 98.6 to 99.9
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=10: B/Yamagata: Day 29	100 percentage of participants Interval 99.4 to 100.0	100 percentage of participants Interval 99.4 to 100.0
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: B/Yamagata: Day 1	93.1 percentage of participants Interval 90.8 to 95.0	95.2 percentage of participants Interval 93.2 to 96.8
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 Titer >=40: B/Yamagata: Day 29	99.5 percentage of participants Interval 98.6 to 99.9	100 percentage of participants Interval 99.4 to 100.0

SECONDARY outcome

Timeframe: On Days 1 and 29

GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=609 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=606 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies A/H3N2	17.9 ratio Interval 15.7 to 20.3	20.8 ratio Interval 18.4 to 23.6
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies A/H1N1	12.7 ratio Interval 11.1 to 14.5	13.1 ratio Interval 11.4 to 15.0
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies B/Victoria	8.41 ratio Interval 7.55 to 9.37	6.91 ratio Interval 6.25 to 7.64
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies B/Yamagata	7.13 ratio Interval 6.46 to 7.87	5.31 ratio Interval 4.79 to 5.88

SECONDARY outcome

Timeframe: Within 30 minutes post-vaccination on Day 1

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=641 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=658 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Number of Participants With Immediate Unsolicited Adverse Events (AEs)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 7 days post-vaccination (up to Day 8)

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. Number of participants analyzed signifies those participants with data collected for this outcome measure and number analyzed signifies those participants with data collected for specified category.

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=618 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=635 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions Solicited injection site reaction	220 Participants	259 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions Solicited systemic reaction	182 Participants	230 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days post-vaccination (up to Day 29)

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=641 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=658 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Number of Participants With Unsolicited AEs	93 Participants	119 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days post-vaccination (up to Day 29)

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=641 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=658 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Number of Participants With Medically Attended Adverse Events (MAAEs)	27 Participants	35 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 6 months post-vaccination, 181 days

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Aged 9 to 17 Years n=641 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=658 Participants Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) SAE	3 Participants	7 Participants
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) AESI	0 Participants	0 Participants

Adverse Events

Cohort 1: Participants Aged 9 to 17 Years

Serious events: 3 serious events

Other events: 263 other events

Deaths: 0 deaths

Cohort 2: Participants Aged 18 to 49 Years

Serious events: 7 serious events

Other events: 336 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Participants Aged 9 to 17 Years n=641 participants at risk Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=658 participants at risk Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Injury, poisoning and procedural complications Intentional Overdose	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Injury, poisoning and procedural complications Overdose	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Injury, poisoning and procedural complications Spinal Fracture	0.16% 1/641 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.00% 0/658 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Nervous system disorders Seizure	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Gastrointestinal disorders Obstructive Pancreatitis	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Infections and infestations Kidney Infection	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer Recurrent	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Psychiatric disorders Major Depression	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Psychiatric disorders Suicidal Ideation	0.31% 2/641 • Number of events 3 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/641 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	0.15% 1/658 • Number of events 1 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.

Other adverse events

Other adverse events
Measure	Cohort 1: Participants Aged 9 to 17 Years n=641 participants at risk Participants received a single IM injection of RIV4 0.5 mL on Day 1.	Cohort 2: Participants Aged 18 to 49 Years n=658 participants at risk Participants received a single IM injection of RIV4 0.5 mL on Day 1.
Nervous system disorders Headache	17.8% 114/641 • Number of events 121 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	23.1% 152/658 • Number of events 153 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
Musculoskeletal and connective tissue disorders Myalgia	18.6% 119/641 • Number of events 119 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	19.6% 129/658 • Number of events 129 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
General disorders Chills	7.0% 45/641 • Number of events 45 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	6.1% 40/658 • Number of events 40 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
General disorders Injection Site Pain	33.1% 212/641 • Number of events 212 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	38.8% 255/658 • Number of events 256 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.
General disorders Malaise	15.6% 100/641 • Number of events 100 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.	16.1% 106/658 • Number of events 106 • From Day 1 up to 6 months post-vaccination, 181 days Analysis was performed on the Safety analysis set.

Additional Information

Trial Transparency Team

Sanofi Pasteur

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER