Table 1.
Population | All age groups from the general population (> 6 months). |
Intervention | Quadrivalent inactivated influenza vaccine (inactivated fragmented without adjuvant) via intramuscular application. |
Comparator | Trivalent inactivated influenza vaccine (inactivated fragmented without adjuvant) via intramuscular application. |
Outcomes |
Primary outcomes: 1) Immunogenicity of Influenza B lineages: measured by the seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean titer ratio (GMTR). 2) Safety: measured by the number of Adverse Events (AEs) and Serious Adverse Events (SAEs) following vaccination. Secondary outcomes: • Number of cases of laboratory-confirmed Influenza Like Illness. • Number of laboratory-confirmed cases of SARI (Severe acute respiratory infection). • Number of hospitalizations due to influenza. • Number of laboratory-confirmed cases of pneumonia. • Number of laboratory-confirmed cases of acute otitis media. • Number of cases of mortality due to influenza. Exploratory outcomes: • Quality-Adjusted Live Years (QALY). • Work days lost. |