Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6–35 months in China
- 29 April 2020
- journal article
- research article
- Published by Taylor & Francis Ltd in Human Vaccines & Immunotherapeutics
- Vol. 16 (7), 1691-1698
- https://doi.org/10.1080/21645515.2020.1721994
Abstract
Mismatch between circulating influenza B viruses and vaccine strains occurs frequently. In a randomized, double-blind, controlled phase III clinical study, healthy children aged 6–35 months were randomized into three groups at a ratio of 2:1:1, received two doses of quadrivalent influenza vaccines (QIVs) or licensed trivalent influenza vaccines (TIVs). The primary objective was to evaluate the non-inferiority immunogenicity of QIV compared with the two TIVs, containing B/Victoria or B/Yamagata strain. Safety information was collected for 28 days after each vaccination. Serious adverse events (SAEs) were monitored for 6 months after the second vaccination. A total of 2146 subjects (QIV: 1069, TIV–Vic: 540, TIV-Yam: 537) were enrolled in this study. QIV was found non-inferior to TIVs for shared strains (A/H1N1 and A/H3N2) and corresponding BY strain based on hemagglutination inhibition (HI) antibodies 28 days after the second dose of vaccination. The resulted geometric mean titer (GMT) ratios (QIV/TIV) were 0.98 (0.89, 1.07) for H1N1, 0.95 (0.85, 1.05) for H3N2 and 0.89 (0.81, 0.98) for BY. And the seroconversion rate differences (QIV-TIV) were −0.46% (−3.24%, 2.31%) for H1N1, −1.95% (−5.54%, 1.65%) for H3N2 and −3.58% (−8.11%, 0.95%) for BY. The BV strain in QIV did not reach the non-inferiority criteria, with GMT of 1:52.25 (vs. 1:61.02 of TIV–Vic) and seroconversion rate of 59.49% (vs. 66.85% of TIV–Vic). No increased safety concerns occurred in QIV group. Candidate QIV can provide good protection for children aged 6 to 35 months, and its immunogenicity and safety were proved. Clinical Trials Registration: ClinicalTrials.gov number: NCT03859141.Keywords
Funding Information
- Sinovac Biotech Co., LTD
This publication has 22 references indexed in Scilit:
- Epidemiological and virological characteristics of influenza B: results of the Global Influenza B StudyInfluenza and Other Respiratory Viruses, 2015
- Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6–35 Months of Age During 2013–2014: Results From A Phase II Randomized TrialJournal of the Pediatric Infectious Diseases Society, 2015
- Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adultsVaccine, 2015
- Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.Journal of the Pediatric Infectious Diseases Society, 2014
- Impact of Influenza B Lineage-Level Mismatch Between Trivalent Seasonal Influenza Vaccines and Circulating Viruses, 1999–2012Clinical Infectious Diseases, 2014
- Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of AgeThe Pediatric Infectious Disease Journal, 2014
- The substantial hospitalization burden of influenza in central China: surveillance for severe, acute respiratory infection, and influenza viruses, 2010–2012Influenza and Other Respiratory Viruses, 2013
- Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: A Phase III Randomized Controlled Trial in ChildrenThe Journal of Infectious Diseases, 2013
- Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adultsVaccine, 2013
- Efficacy of live attenuated influenza vaccine in children against influenza B viruses by lineage and antigenic similarityVaccine, 2010