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Immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months: A systematic review and meta-analysis.

ABSTRACT: Evidence of the immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months has been emerging. To evaluate the immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months in a systematic review and meta-analysis. This meta-analysis included 12 studies with 6722 participants receiving QIV, 3575 participants receiving TIV, 4249 participants receiving full-dose QIV (F-QIV), and 3722 participants receiving half-dose QIV (H-QIV). Among children aged 6 to 35 months, QIV produces a better Immunogenicity against influenza B vaccine strains not contained in TIV. However, injection site reaction was more common for QIV, F-QIV showed superior efficacy for the B lineage, but fever and injection site pain was more frequently reported for F-QIV than H-QIV. These data support the immunogenicity and safety of quadrivalent inactivated influenza vaccine among children aged 6 to 35 months.

SUBMITTER: Wei X

PROVIDER: S-EPMC10557567 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months: A systematic review and meta-analysis.

Wei Xia X Tan Xue X Guan Qinghu Q Zhang Ruizhi R Lei Shiguang S Wei Shaofeng S

Human vaccines & immunotherapeutics 20230801 2

Evidence of the immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months has been emerging. To evaluate the immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months in a systematic review and meta-analysis. This meta-analysis included 12 studies with 6722 participants receiving QIV, 3575 participants receiving TIV, 4249 participants receiving full-dose QIV (F-QIV), and 3722 participants receiving half-d ...[more]

PMID: 37794647

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Project description:BackgroundTwo antigenically distinct influenza B lineages have co-circulated since the 1980s, yet inactivated trivalent influenza vaccines (TIVs) include strains of influenza A/H1N1, A/H3N2, and only one influenza B from either the Victoria or Yamagata lineage. This means that exposure to B-lineage viruses mismatched to the TIV is frequent, reducing vaccine protection. Formulations including both influenza B lineages could improve protection against circulating influenza B viruses. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in adults in stable health.MethodsA total of 4659 adults were randomized 5:5:5:5:3 to receive one dose of QIV (one of three lots) or a TIV containing either a B/Victoria or B/Yamagata strain. Hemagglutination-inhibition assays were performed pre-vaccination and 21-days after vaccination. Lot-to-lot consistency of QIV was assessed based on geometric mean titers (GMT). For QIV versus TIV, non-inferiority against the three shared strains was demonstrated if the 95% confidence interval (CI) upper limit for the GMT ratio was ≤1.5 and for the seroconversion difference was ≤10.0%; superiority of QIV versus TIV for the alternate B lineage was demonstrated if the 95% CI lower limit for the GMT ratio was > 1.0 and for the seroconversion difference was > 0%. Reactogenicity and safety profile of each vaccine were assessed. Clinicaltrials.gov: NCT01204671.ResultsConsistent immunogenicity was demonstrated for the three QIV lots. QIV was non-inferior to TIV for the shared vaccine strains, and was superior for the added alternate-lineage B strains. QIV elicited robust immune responses against all four vaccine strains; the seroconversion rates were 77.5% (A/H1N1), 71.5% (A/H3N2), 58.1% (B/Victoria), and 61.7% (B/Yamagata). The reactogenicity and safety profile of QIV was consistent with TIV.ConclusionsQIV provided superior immunogenicity for the additional B strain compared with TIV, without interfering with antibody responses to the three shared antigens. The additional antigen did not appear to alter the safety profile of QIV compared with TIV. This suggests that the candidate QIV is a viable alternative to TIV for use in adults, and could potentially improve protection against influenza B.Trial registrationClinical Trials.gov: NCT01204671/114269.

Dataset Information

Immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months: A systematic review and meta-analysis.

Publications

Immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months: A systematic review and meta-analysis.

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