This was an extensive, double-blind, randomized, placebo-controlled phase 3 study that aimed to evaluate the safety and immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) in children from 6 months to under 18 years old and the elderly over 60 years old in Vietnam. The main target: Evaluating the safety of the single or double dose of seasonal influenza vaccine (IVACFLU-S) in Vietnamese children aged 6 months to 17 years and adults over 60 years old. Evaluating the immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) after 1st injection on day 22 (+7) for groups ≥ 9 years old or day 49 (+7) for groups of 6 months to 8 years for each antigenic component of the vaccine.
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Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Timeframe: Within 30 minutes of vaccination
Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Timeframe: within 7 days (day 1 to 7) of each vaccination
Number of Subjects Experiencing Unsolicited Adverse Events (AE)
Timeframe: within 21 days (age group 9-17 and older than 60 years) or 49 days (group 6 months to 8 years) after each vaccination
Number of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
Timeframe: Day 1 to Day 91
Number of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Timeframe: Day 22 (+7) for groups 9 years and above or 49 (+7) for groups of 6 months to under 9 years