Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults

• DOI: 10.1371/journal.pone.0281566
• Publication Date: 2023-08-24T17:31:13Z
• Authors: Eddy Fadlyana; Meita Dhamayanti; Rodman Tarigan; Susantina Prodjos...; Andri Reza Rahmadi; Rini Mulia Sari; Kusnandi Rusmil; Cissy B. Kartasas...
• Keywords: Seroconversion; Trivalent influenza vaccine; Hemagglutination assay

One of the newest strategies developed by Global Influenza Strategy has been to broaden composition current influenza vaccine formulations from trivalent products quadrivalent products. This study aimed assess immunogenicity and safety Quadrivalent HA (QIV) compared with Trivalent (TIV) evaluate three consecutive batches QIV equivalence in Indonesian children adults. was an experimental, randomized, double blind, four arm parallel group bridging involving unprimed healthy adults aged 9-40 years. A total 540 subjects were enrolled this randomized into groups. Each subject received one dose TIV or different batch codes. Serology tests performed at baseline 28 days after vaccination. Hemagglutination inhibition (HI) antibody titers analyzed for Geometric Mean Titer (GMT), seroprotection, seroconversion rates. Solicited, unsolicited, serious adverse events observed up 537 completed per protocol criteria. All The percentage anti-HI titer ≥1:40 vaccination 99.5% A/H1N1; A/H3N2; 93.1% B/Texas, 99.0% B/Phuket. GMT, rates not significantly those common strains (p > 0.01) added B/Phuket < 0.01). Most solicited injection-site systemic reactions either mild moderate resolved within a few days. Antibody response among comparable between age groups each 4 strains. immunogenic well-tolerated had profiles all equivalent Trial registration. Clinical registration: NCT03336593.