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Safety and immunogenicity of unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine in children and adolescents.
- Source :
-
Vaccine [Vaccine] 2019 Aug 23; Vol. 37 (36), pp. 5161-5170. Date of Electronic Publication: 2019 Jul 30. - Publication Year :
- 2019
-
Abstract
- Objective: In response to the emergence of influenza viruses with pandemic potential, we evaluated a swine-origin influenza A/H3N2 variant (H3N2v) vaccine in children.<br />Study Design: This multicenter phase II open-label study assessed the safety and immunogenicity of two doses, 21 days apart, of investigational unadjuvanted subvirion monovalent inactivated H3N2v vaccine administered via intramuscular injection. Children 6-35 months of age received 7.5mcg or 15mcg of hemagglutinin (HA)/dose; children 3-17 years of age received 15mcg HA/dose. Safety and reactogenicity were assessed by measuring the occurrence of solicited injection site and systemic reactions in the 7 days after each vaccination; adverse events were assessed for 42 days and serious adverse events for 7 months after the first vaccination. Immunogenicity was evaluated by measuring hemagglutination inhibition (HAI) and neutralizing (Neut) antibodies to H3N2v prior to and 21 days after each vaccination. Cross-reactivity against seasonal H3N2 strains was evaluated.<br />Results: The H3N2v vaccine was well tolerated. Transient mild to moderate injection site tenderness, pain and erythema was observed, with the most commonly reported systemic reactogenicity being irritability in children 6-35 months, and headache and fatigue in children 9-17 years old. Children 6-35 months old, whether they received 7.5mcg or 15mcg/dose, had low HAI and Neut antibody responses after two doses compared to older children. Children under 9 years of age required two doses of vaccine to demonstrate a response, while 9-17 year olds responded well after one dose. Previous influenza vaccination and older age were associated with higher immune responses to H3N2v vaccine. Children 9-17 years of age also developed cross-reactive antibodies against recent seasonal H3N2 influenza viruses.<br />Conclusion: The H3N2v vaccine was safe and immunogenic in children and adolescents. Age-related increases in immunogenicity against H3N2v and seasonal H3N2 viruses were observed, suggesting prior priming via infection and/or immunization. Clinical trial registry: The trial is registered with clinicaltrial.gov: NCT02100436.<br /> (Copyright © 2019 Elsevier Ltd. All rights reserved.)
- Subjects :
- Adolescent
Adult
Antibodies, Viral immunology
Antibodies, Viral metabolism
Child
Child, Preschool
Female
Hemagglutination Inhibition Tests
Humans
Influenza Vaccines adverse effects
Male
Vaccines, Inactivated adverse effects
Young Adult
Influenza A Virus, H3N2 Subtype immunology
Influenza A Virus, H3N2 Subtype pathogenicity
Influenza Vaccines immunology
Influenza Vaccines therapeutic use
Influenza, Human immunology
Influenza, Human prevention & control
Vaccines, Inactivated immunology
Vaccines, Inactivated therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2518
- Volume :
- 37
- Issue :
- 36
- Database :
- MEDLINE
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 31375440
- Full Text :
- https://doi.org/10.1016/j.vaccine.2019.07.085