The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older. The objectives were: * To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96 * To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation * To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine at the first visit. Immunogenicity and safety were assessed in all participants. Adverse events (AE) defined in EMA NfG CPMP/BWP/214/96 were collected for 3 days after vaccination, solicited AE pre-listed in the diary card were collected for 7 days after vaccination, unsolicited AEs were collected for 21 days after vaccination, and serious adverse event (SAE) information was collected throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
0.5-mL, Intramuscular, SH 2015 formulation
Sanofi Pasteur Investigational Site 002
Manila, Philippines
Sanofi Pasteur Investigational Site 003
Manila, Philippines
Sanofi Pasteur Investigational Site 001
Quezon City, Philippines
Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer \>=40 (1/dilution \[dil\]) at pre-vaccination and post-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.
Time frame: Day 0 (pre-vaccination), Day 21 (Post-vaccination)
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and a post-vaccination titer \>= 40 (1/dil). Significant increase was defined as a pre-vaccination titer \>= 10 (1/dil) and \>= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.
Time frame: 21 days post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: \>=25 mm to \<= 50 mm, Grade 2: \>=51 to \<=100 mm, Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius (°C) to \<=38.4°C, Grade 2: \>=38.5°C to \<=38.9 °C, Grade 3: \>= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.
Time frame: Within 7 days after vaccination
Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance
Solicited reactions listed in the CHMP note for guidance included: injection site induration \>= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature \> 38.0°C for at least one day, malaise, and shivering.
Time frame: Within 3 days after vaccination
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