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Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013–2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu®
- Source :
- Human Vaccines & Immunotherapeutics. 12:1229-1234
- Publication Year :
- 2016
- Publisher :
- Informa UK Limited, 2016.
-
Abstract
- Anflu® is a seasonal trivalent inactivated split-virion influenza vaccine manufactured by Sinovac Biotech Co., Ltd. The objectives of this study were to evaluate the safety of Anflu® (2013–14 formulation: H1N1, H3N2 and BYAM) in infants and adults and its immunogenicity and cross-reactivity against mismatched influenza B lineage and avian influenza A(H7N9) viruses (hereafter BVIC and H7N9, respectively) in adults. In this phase IV open label trial, infants 6–35 months old (n=61) each received two injections with 28 days apart; adults 18–60 yrs old (n=60) and elderly >60 yrs old (n=61) each received one injection. Information of adverse events was collected through safety observation and follow-up visits. Pre- and post-immune blood samples (day 0 and 21) were collected from subjects ≥18 yrs old to detect hemagglutination inhibition antibody titers and calculate seroprotection rates (SPRs) and seroconversion rates (SCRs). The overall adverse reaction incidence was 1.6% (3/182), and no serious adverse event was reported during the study period. For subjects ≥18 yrs old, the SCRs, SPRs, and the geometric mean titers (GMTs) met the European criteria for all three strains. In addition, the point estimations of SCR, SPR and GMT for BVIC also met the European criteria. Six subjects were seroconverted against H7N9; however the serological results did not meet the European criteria. In conclusion, the results showed a satisfactory safety and immunogenicity profile of Anflu® and cross-reactivity against BVIC, but did not demonstrate cross-reactivity against H7N9 (Clinicaltrials.gov ID: NCT02269852).
- Subjects :
- Adult
Male
0301 basic medicine
Adolescent
Influenza vaccine
Immunology
Cross Reactions
Antibodies, Viral
Influenza A Virus, H7N9 Subtype
medicine.disease_cause
Cross-reactivity
Young Adult
03 medical and health sciences
Immunogenicity, Vaccine
Influenza A Virus, H1N1 Subtype
0302 clinical medicine
Influenza, Human
Humans
Immunology and Allergy
Medicine
030212 general & internal medicine
Pharmacology
business.industry
Incidence
Influenza A Virus, H3N2 Subtype
Immunogenicity
Infant
Cross reactions
Hemagglutination Inhibition Tests
Middle Aged
Research Papers
Virology
Influenza B virus
030104 developmental biology
Vaccines, Inactivated
Influenza Vaccines
Child, Preschool
Female
Seasons
Influenza virus vaccine
business
Subjects
Details
- ISSN :
- 2164554X and 21645515
- Volume :
- 12
- Database :
- OpenAIRE
- Journal :
- Human Vaccines & Immunotherapeutics
- Accession number :
- edsair.doi.dedup.....db2075d83da3c7ceccf23d929be62431