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. 2023 Aug 29;23:563. doi: 10.1186/s12879-023-08541-0

Table 1.

Study characteristics used as eligibility criteria

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.