A non-adjuvanted whole-virus H1N1 pandemic vaccine is well tolerated and highly immunogenic in children and adolescents and induces substantial immunological memory

• Published in: Vaccine 2012-09, Vol.30 (41), p.5956-5966
• Main Authors: Loew-Baselli, Alexandra, Pavlova, Borislava G, Fritsch, Sandor, Poellabauer, Eva Maria, Draxler, Wolfgang, Kistner, Otfried, Behre, Ulrich, Angermayr, Rudolf, Neugebauer, Johannes, Kirsten, Karola, Förster-Waldl, Elisabeth, Koellges, Ralph, Ehrlich, Hartmut J, Barrett, P. Noel
• Format: Article
• Language: English
• Subjects: Adolescence; Adolescent; Adolescents; adverse effects; Age; Allergy and Immunology; Animals; Antibodies; Antibodies, Viral - blood; Antigens; Avian flu; Body temperature; Cercopithecus aethiops; Child; Child, Preschool; Children; Data processing; Diaries; Dose-Response Relationship, Immunologic; Fever; Humans; immune response; Immunization; Immunization Schedule; Immunization, Secondary; Immunogenicity; Immunologic Memory; Immunological memory; Infant; Influenza; Influenza A Virus, H1N1 Subtype - pathogenicity; Influenza Vaccines - administration & dosage; Influenza Vaccines - immunology; Influenza, Human - immunology; Influenza, Human - prevention & control; Injections, Intramuscular; Laboratories; Non-adjuvanted; Pain; pandemic; Pandemics; Pediatric; Pediatrics; randomized clinical trials; secondary immunization; Side effects; Swine flu; Teenagers; Vaccination; Vaccination - methods; Vaccines; Vero cell-derived; Vero Cells; viruses; Whole-virus H1N1 pandemic vaccine
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2012.07.039

Highlights ► Vero cell-derived whole-virus H1N1 vaccine was well tolerated, inducing low adverse reaction rates (overall fever rate: 6% after the first vaccination; 7% after the second vaccination) in children and adolescents. ► Two vaccinations with the 7.5 μg dose induced high seroprotection rates in all subjects ranging from 84.2% to 100%. ► Persistence of antibodies against the vaccine strain was demonstrated at 6 months (GMTs ranging from 65.6 to 212.8) and at 12 months (GMTs ranging from 33.6 to 124.1) after primary vaccination. ► Vaccination with a seasonal influenza vaccine induced a strong booster response to the A/California/07/2009 strain reaching 100% seroprotection in all age groups, with GMTs ranging from 640.0 to 886.3.