Trial Outcomes & Findings for Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations (NCT NCT02908269)

NCT ID: NCT02908269

Last Updated: 2022-03-29

Results Overview

Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema \& swelling (Grade 1: \>0 to \<25 mm;Grade 2: ≥ 25 to \< 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise \& myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site \& systemic reactions are reported; number of participants with Grade 3 solicited injection-site \& systemic reactions are also reported.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: Within 7 days after any vaccination
• Results posted on: 2022-03-29

Participant Flow

Study participants were enrolled in 2 centers in the United States from 15 September 2016 to 28 September 2016.

A total of 180 participants (60 for each group) were enrolled and vaccinated in the study.

Participant milestones

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Participants aged 18 to \< 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Study STARTED	60	60	60
Overall Study COMPLETED	60	60	60
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

Baseline characteristics by cohort

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years n=60 Participants Participants aged 18 to \< 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years n=60 Participants Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.	Total n=180 Participants Total of all reporting groups
Age, Continuous	6.03 years STANDARD_DEVIATION 1.61 • n=5 Participants	42.2 years STANDARD_DEVIATION 12.9 • n=7 Participants	72.6 years STANDARD_DEVIATION 6.19 • n=5 Participants	40.3 years STANDARD_DEVIATION 28.5 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	42 Participants n=7 Participants	45 Participants n=5 Participants	113 Participants n=4 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	67 Participants n=4 Participants
Region of Enrollment United States	60 participants n=5 Participants	60 participants n=7 Participants	60 participants n=5 Participants	180 participants n=4 Participants

PRIMARY outcome

Timeframe: Within 7 days after any vaccination

Population: Analysis was performed using the Safety Analysis Set, which included all participants who received the study vaccine. Number of participants analyzed corresponds to participants with available data for the listed solicited reaction.

Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema & swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Any Injection site pain	18 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Grade 3 Injection site pain	1 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Any Injection site erythema	6 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Grade3 Injection site erythema	0 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Any Injection site swelling	7 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Grade3 Injection site swelling	0 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Any Fever	3 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Grade 3 Fever	1 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Any Headache	9 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Grade 3 Headache	0 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Any Malaise	15 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Grade 3 Malaise	1 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Any Myalgia	12 Participants	—
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) Grade 3 Myalgia	0 Participants	—

PRIMARY outcome

Timeframe: Within 7 days after any vaccination

Population: Analysis was performed on safety analysis set.

Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema & swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years n=60 Participants Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Any Injection site pain	28 Participants	12 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Grade 3 Injection site pain	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Any Injection site erythema	0 Participants	3 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Grade3 Injection site erythema	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Any Injection site swelling	0 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Grade3 Injection site swelling	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Any Fever	0 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Grade 3 Fever	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Any Headache	11 Participants	8 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Grade 3 Headache	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Any Malaise	10 Participants	4 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Grade 3 Malaise	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Any Myalgia	15 Participants	11 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) Grade 3 Myalgia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)

Population: Analysis was performed using the Per-protocol Analysis Set (PPAS), which included all participants who received study vaccine and had a valid post-vaccination serology result for at least 1 strain.

Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=54 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Post-Vaccination: B Yamagata	1731 Titers (1/dilutions) Interval 1230.0 to 2435.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Pre-Vaccination: A/H1N1	273 Titers (1/dilutions) Interval 177.0 to 419.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Pre-Vaccination: A/H3N2	167 Titers (1/dilutions) Interval 106.0 to 265.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Pre-Vaccination: B Victoria	111 Titers (1/dilutions) Interval 63.1 to 195.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Pre-Vaccination: B Yamagata	170 Titers (1/dilutions) Interval 103.0 to 279.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Post-Vaccination: A/H1N1	1232 Titers (1/dilutions) Interval 961.0 to 1579.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Post-Vaccination: A/H3N2	2495 Titers (1/dilutions) Interval 1893.0 to 3289.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) Post-Vaccination: B Victoria	1208 Titers (1/dilutions) Interval 807.0 to 1809.0	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)

Population: Analysis was performed on PPAS.

Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Pre-Vaccination: A/H1N1	225 Titers (1/dilutions) Interval 151.0 to 335.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Pre-Vaccination: A/H3N2	66.1 Titers (1/dilutions) Interval 45.7 to 95.6	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Pre-Vaccination: B Victoria	195 Titers (1/dilutions) Interval 136.0 to 278.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Pre-Vaccination: B Yamagata	264 Titers (1/dilutions) Interval 181.0 to 386.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Post-Vaccination: A/H1N1	779 Titers (1/dilutions) Interval 584.0 to 1039.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Post-Vaccination: A/H3N2	752 Titers (1/dilutions) Interval 562.0 to 1006.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Post-Vaccination: B Victoria	998 Titers (1/dilutions) Interval 787.0 to 1267.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) Post-Vaccination: B Yamagata	1470 Titers (1/dilutions) Interval 1114.0 to 1941.0	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)

Population: Analysis was performed on PPAS.

Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) Pre-Vaccination: A/H1N1	77.3 Titers (1/dilutions) Interval 51.8 to 115.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) Pre-Vaccination: A/H3N2	59.6 Titers (1/dilutions) Interval 39.6 to 89.6	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) Pre-Vaccination: B Victoria	106 Titers (1/dilutions) Interval 77.4 to 146.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) Post-Vaccination: A/H1N1	347 Titers (1/dilutions) Interval 249.0 to 484.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) Post-Vaccination: A/H3N2	590 Titers (1/dilutions) Interval 406.0 to 858.0	—
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) Post-Vaccination: B Victoria	816 Titers (1/dilutions) Interval 607.0 to 1097.0	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)

Population: Analysis was performed on PPAS.

Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=54 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Pre-Vaccination: A/H1N1	46 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Pre-Vaccination: A/H3N2	47 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Pre-Vaccination: B Victoria	35 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Pre-Vaccination: B Yamagata	41 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Post-Vaccination: A/H1N1	54 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Post-Vaccination: A/H3N2	54 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Post-Vaccination: B Victoria	52 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) Post-Vaccination: B Yamagata	53 Participants	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)

Population: Analysis was performed on PPAS.

Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Pre-Vaccination: A/H1N1	53 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Pre-Vaccination: A/H3N2	40 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Pre-Vaccination: B Victoria	52 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Pre-Vaccination: B Yamagata	56 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Post-Vaccination: A/H1N1	60 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Post-Vaccination: A/H3N2	60 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Post-Vaccination: B Victoria	60 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) Post-Vaccination: B Yamagata	60 Participants	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)

Population: Analysis was performed on PPAS.

Anti-influenza antibodies were measured using HAI assay for 3 strains: H1N1, H3N2, Victoria lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.

Outcome measures

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 Participants Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) Pre-Vaccination: A/H1N1	41 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) Pre-Vaccination: A/H3N2	39 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) Pre-Vaccination: B Victoria	51 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) Post-Vaccination: A/H1N1	56 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) Post-Vaccination: A/H3N2	58 Participants	—
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) Post-Vaccination: B Victoria	60 Participants	—

Adverse Events

Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Fluzone High-Dose Vaccine Group 3: ≥ 65 Years

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 participants at risk Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years n=60 participants at risk Participants aged 18 to \< 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years n=60 participants at risk Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Cardiac disorders Atrial fibrillation	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Pneumonia	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Sepsis	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Renal and urinary disorders Acute kidney injury	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.

Other adverse events

Measure	Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years n=60 participants at risk Participants aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.	Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years n=60 participants at risk Participants aged 18 to \< 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.	Fluzone High-Dose Vaccine Group 3: ≥ 65 Years n=60 participants at risk Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
General disorders Injection site erythema	10.0% 6/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	5.0% 3/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Injection site pain	30.0% 18/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	46.7% 28/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	20.0% 12/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Injection site swelling	11.7% 7/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Malaise	25.0% 15/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	16.7% 10/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	6.7% 4/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Pyrexia	8.3% 5/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	1.7% 1/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Bronchiolitis	5.0% 3/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Pharyngitis streptococcal	6.7% 4/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 12/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	25.0% 15/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	20.0% 12/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Nervous system disorders Headache	15.0% 9/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	18.3% 11/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	13.3% 8/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 6/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 3/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

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