The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and in adults 18 to \< 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age. Primary Observational Objectives * To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. * To submit available sera from approximately 90 participants (30 participants 3 to \< 9 years of age and 30 participants 18 to \< 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
All participants received a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1. For participants 3 to \< 9 years of age for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume) was administered during Visit 2. Solicited adverse reaction (AR) information was collected for 7 days after vaccination. Unsolicited non-serious adverse event (AE) and serious adverse event (SAE) information was collected from Visit 1 to Visit 2 or from Visit 1 to Visit 3 for those participants receiving 2 doses of study vaccine. Immunogenicity was evaluated in all participants prior to vaccination on Day 0 (Visit 1) and after the final vaccination on Day 28 for 3 to \< 9 year olds and Day 21 days for adults 18 years and older.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
180
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Bardstown, Kentucky, United States
Unnamed facility
Metairie, Louisiana, United States
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)
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.
Time frame: Within 7 days after any vaccination
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)
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.
Time frame: Within 7 days after any vaccination
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years)
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years)
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage.
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years)
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.
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years)
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.
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years)
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.
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
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