Repeated exposure to an MF-59 adjuvanted quadrivalent subunit influenza vaccine (aQIV) in children: Results of two revaccination studies
| Autor: | Punee Pitisuttithum, Rosario Z. Capeding, Keith P. Ramsey, Daphne C. Sawlwin, Timo Vesikari, Janine Oberye, Esther Heijnen, Bin Zhang, Igor Smolenov |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Randomization Influenza vaccine Immunization Secondary Antibodies Viral Seasonal influenza 03 medical and health sciences Influenza A Virus H1N1 Subtype 0302 clinical medicine Adjuvants Immunologic 030225 pediatrics Internal medicine Influenza Human Humans Medicine 030212 general & internal medicine Child Hemagglutination assay Reactogenicity General Veterinary General Immunology and Microbiology business.industry Immunogenicity Public Health Environmental and Occupational Health Hemagglutination Inhibition Tests Vaccination Influenza B virus Titer Infectious Diseases Vaccines Inactivated Influenza Vaccines Molecular Medicine business |
| Zdroj: | Vaccine. 38:8224-8231 |
| ISSN: | 0264-410X |
| DOI: | 10.1016/j.vaccine.2020.10.036 |
| Popis: | Background Pediatric adjuvanted seasonal influenza vaccines induce higher immune responses and have the potential to confer better protection against influenza among young vaccine-naive children. Limited data describe benefits and risks of repeated administration of adjuvanted influenza vaccines in children. Two revaccination studies assess the safety and immunogenicity of repeated exposure to an MF59-adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®) compared to routine non-adjuvanted quadrivalent influenza vaccine (QIV). Methods Children previously enrolled in the parent study, who received vaccination with aQIV or nonadjuvanted influenza vaccine (TIV or QIV), were recruited in Season 1 (n = 607) or Season 2 (n = 1601) of the extension trials. Season 1 participants remained in their original randomization groups (aQIV-aQIV or TIV-QIV); Season 2 subjects were re-randomized to either vaccine, resulting in four groups (aQIV-aQIV, aQIV-QIV, QIV-aQIV, or QIV-QIV). All subjects received a single-dose vaccination. Blood samples were taken for immunogenicity assessment prior to vaccination and 21 and 180 days after vaccination. Reactogenicity (Days 1–7) and safety were assessed in all subjects. Results Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2. Higher HI titers against heterologous influenza strains were observed after aQIV vaccination during both seasons. Mild to moderate severity and short duration reactogenicity was more common in the aQIV than QIV groups, but the overall safety profiles were similar to the parent study. Conclusion The safety and immunogenicity results from this study demonstrate benefit of aQIV for both priming and revaccination of children aged 12 months to 7 years. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect