Page 22 - JCTR-11-3

Journal of Clinical and
Translational Research Immunogenicity and safety of flu vaccines

Figure 1. Flow chart of studies displaying the inclusion and exclusion of studies at every review step and reasons for exclusion

2.3. Study selection and data extraction and extraneous confounding factors. Bias susceptibility of
individual investigations was classified as “low,” “unclear,”
The methods of research article screening, assessment or “high.” Study quality was independently assessed by
of methodological validity, data extraction, and cross- two investigators, and any differences were settled through
verification were performed through a double-blind discussion.
review mechanism. An independent arbiter assisted in
disambiguating any discrepancies and consulting the 2.5. Statistical analysis
corresponding authors for additional evidence when
necessary. The following details were extracted from the This study conducted a statistical analysis of the
studies included in the analysis: first authorodological immunogenicity data of subjects who received influenza
validity, data extraction, and cross-verification were vaccination. The primary outcome measures include
performed through a double-blind review mechanism. seroprotection (defined as hemagglutination inhibition
12
An independent arbiter assisted in disambiguating [HI] titer ≥40), GMTs, and seroconversion. For subjects
any discreculture, use of adjuvant, safety data, and who were baseline negative (<1:10), seroconversion is
immunogenicity data. defined as a HI titer of ≥1:40. For subjects who were
13
baseline positive (HI ≥1:10), seroconversion is defined
2.4. Quality assessment as four times or greater increase in HI titer. Subgroup
analyses were performed based on the common influenza
To gauge the quality of the studies that were included, virus strains.
the methodological reliability of the selected randomized
controlled trials (RCTs) was assessed using the standards This study conducted a statistical analysis on the safety
for quality evaluation outlined in the Cochrane Handbook data of subjects who received influenza vaccination,
for Systematic Reviews of Interventions 5.1.0. The risk and the most prevalent local side effects (including
of bias tool consists of seven domains: randomization injection site aches and swelling) and systemic side effects
protocol integrity (computer-generated sequences), (including fever and muscle aches) associated with the
allocation opacity, participant-personnel blinding integrity, vaccine were noted. Adverse events were classified by type,
masking fidelity of outcome assessment, missing data and the incidence rates and corresponding confidence
management, selective outcome reporting verification, intervals for each type were calculated. We performed a

Volume 11 Issue 3 (2025) 16 doi: 10.36922/JCTR025060006