Trial reportHuman vaccines & immunotherapeutics2022
Immunogenicity and safety of two quadrivalent influenza vaccines in healthy adult and elderly participants in India - A phase III, active-controlled, randomized clinical study.
Trial report in Human vaccines & immunotherapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 19 citations in OpenAlex.
- A prospective, randomized, parallel, active controlled, phase III Indian study of immunogenicity and safety of two inactivated influenza vaccines - Vaxiflu-4 and Fluarix tetra in children aged 6 months to 35 months.Human vaccines & immunotherapeutics · 2024Trial
- Safety and immunogenicity of a quadrivalent, inactivated, split-virion influenza vaccine (IIV4-W) in healthy people aged 3-60 years: a phase III randomized clinical noninferiority trial.Human vaccines & immunotherapeutics · 2022Trial
- Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine in children and adolescents 6 months through 17 years of age in India.Human vaccines & immunotherapeutics · 2022Trial
- Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system.Drug delivery · 2021Trial
- Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China: A Phase IV Study.Infectious diseases and therapy · 2026Article
- Influenza vaccination post-COVID-19 expands vaccine-specific effector CD4 T-cells and Tregs under positive influence of host trained innate immunity.NPJ vaccines · 2025Article
- Seasonality of Influenza and Optimizing Timing of Vaccination: Systematic Review and Meta-Analysis.Cureus · 2025Review
- Article
- IAPSM's Position Paper on Influenza Vaccines for Adult Immunization in India.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2024Article
- Review
- Anti-SARS-CoV-2 antibodies among vaccinated healthcare workers: Repeated cross-sectional study.Journal of family medicine and primary care · 2022Article
Corrections and comments
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Authors and funding
13 authors at 13 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study was conducted to compare the immunogenicity and safety profile of two quadrivalent influenza vaccines (QIVs) in healthy adults (18-60 years) and elderly (>61 years) participants.
methodThis phase III study was conducted from March 2018 to April 2018 across 12 sites in India. In this randomized, observer-blind, active-controlled study, 480 participants were randomized to receive a single dose of test vaccine (subunit, inactivated influenza vaccine; Influvac® Tetra, Abbott) (n = 240) or reference vaccine (split virion, inactivated influenza vaccine; VaxiFlu-4, Zydus Cadilla Healthcare) (n = 240). The primary objective was to describe and compare the immunogenicity of each vaccination group based on hemagglutination inhibition (HI) assay seroprotection and seroconversion rates, and geometric mean fold increase (GMFI) against four vaccine strains in two age groups. Safety and reactogenicity were also compared for the vaccines in both the age groups.
resultsThe pre- and post-vaccination HI titers for both the vaccines were comparable. The GMFI varied from 4.3 - 22.7 in the test and 3.7-21.6 in the reference vaccine group. The seroprotection rates were >90% for the A-strains and ranged between >43% and <60% for B-strains for both the vaccines. Seroconversion rates varied between 41.4% and 78.8%. Overall, the reported adverse events (AEs) for both the vaccines were <1% and comparable. Reported local and systemic reactions were comparable.
conclusionInfluvac® Tetra elicited an adequate immune response with a favorable safety profile which was comparable with the reference vaccine. (Clinical trial registry number: CTRI/2018/02/012222).
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