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Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children
- Source :
- Human Vaccines & Immunotherapeutics. 11:358-376
- Publication Year :
- 2015
- Publisher :
- Informa UK Limited, 2015.
-
Abstract
- Mass immunization of children has the potential to decrease infection rates and prevent the transmission of influenza. We evaluated the immunogenicity, safety, and tolerability of different formulations of cell-derived MF59-adjuvanted and nonadjuvanted A/H1N1 influenza vaccine in children and adolescents. This was a randomized, single-blind, multicenter study with a total of 666 healthy subjects aged 6 months–17 y in one of 3 vaccination groups, each receiving formulations containing different amounts of influenza A/H1N1 antigen with or without MF59. A booster trivalent seasonal MF59 vaccine was administered one year after primary vaccinations. Antibody titers were assessed by hemagglutination inhibition (HI) and microneutralization assays obtained on days 1, 22, 43, 366, and 387 (3 weeks post booster). Safety was monitored throughout the study. One vaccination with 3.75 μg of A/H1N1 antigen formulated with 50% MF59 (3.75_halfMF59) or 7.5 μg of A/H1N1 antigen formulated with 100% MF59 (7.5_fullMF59) induced an HI titer ≥1:40 in >70% of children in the 1–70% while 2 doses of 3.75_halfMF59 were required to achieve this result. All vaccines were well tolerated. Our findings support the immunogenicity and safety of the 3.75_halfMF59 (2 doses for children
- Subjects :
- Male
Squalene
Adolescent
medicine.medical_treatment
INFLUENZA/Research Papers
Immunology
MF59
Polysorbates
Antibodies, Viral
Influenza A Virus, H1N1 Subtype
Adjuvants, Immunologic
Antigen
Neutralization Tests
Humans
Immunology and Allergy
Medicine
Single-Blind Method
Child
Pharmacology
Hemagglutination assay
business.industry
Immunogenicity
Vaccination
Antibody titer
Infant
Hemagglutination Inhibition Tests
Healthy Volunteers
Tolerability
Influenza Vaccines
Child, Preschool
Female
business
Adjuvant
Subjects
Details
- ISSN :
- 2164554X and 21645515
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- Human Vaccines & Immunotherapeutics
- Accession number :
- edsair.doi.dedup.....865d41776e0ee66cfa18b0b434594027