title: Safety and immunogenicity of an adjuvanted whole virion, inactivated A (H1N1) 2009 influenza vaccine in young and elderly adults, and children.
abstract: An alum adjuvanted whole virion inactivated vaccine against the A (H1N1) 2009 pandemic virus was developed in India. Two double-blind, randomized studies were conducted. Fifty adults (18-50 years) were enrolled in the Phase I study, whereas the Phase II/III study consisted of 330 adults (≥18 years) and children ≥3 years. Safety (both studies) and immunogenicity (Phase II/III study) by hemagglutination inhibition (HI) antibody titers, of 10 μg or 15 μg of hemagglutinin (HA) antigen were compared. In the Phase I study, mostly mild and transient injection site and systemic reactions were reported. Similar events were seen in the Phase II/III study. The overall seroprotection was 96% and 89% with 10 and 15 μg doses, respectively, while the seroconversion was 92% and 88%. The new Indian-made pandemic H1N1 vaccine is safe and immunogenic in adults and children above 3 years of age.
authors.affiliation: Serum Institute of India Ltd., Pune, India. drpsk@seruminstitute.com
authors.forename: Prasad S
authors.initials: PS
authors.lastname: Kulkarni
authors.forename: K
authors.initials: K
authors.lastname: Manjunath
authors.forename: Sharad
authors.initials: S
authors.lastname: Agarkhedkar
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology / Q000472:pathogenicity*; D007252:Influenza Vaccines / Q000627:therapeutic use*; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D014771:Virion / Q000276:immunology*; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines