Immunogenicity and safety of two quadrivalent influenza vaccines in healthy adult and elderly participants in India - A phase III, active-controlled, randomized clinical study
| Autor: | Shishir Joshi, Manish Agarwal, Kanakapura Vrushabaiah Giriraja, Pradeep Kumar Mishra, Sunil Naik, Vijay K. Shukla, Indraneel Basu, Pravin Dinkar Supe, Serge van de Witte, Ranjit Vijayakumar, Peersab M Pinjar, Manoj K. Srivastava, Viral Shah |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty Influenza vaccine 030231 tropical medicine Immunology India Antibodies Viral 03 medical and health sciences 0302 clinical medicine Immunogenicity Vaccine Double-Blind Method Internal medicine Influenza Human Immunology and Allergy Medicine Humans 030212 general & internal medicine Vaccines Combined Seroconversion Adverse effect Aged Pharmacology Hemagglutination assay Reactogenicity business.industry Immunogenicity Hemagglutination Inhibition Tests Clinical trial Vaccination Vaccines Inactivated Influenza Vaccines business |
| Zdroj: | Human vaccinesimmunotherapeutics. 18(1) |
| ISSN: | 2164-554X |
| Popis: | Background: This 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.Method: This 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.Results: The 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|