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Vaccine. 2012 Dec 17;31(1):20-2. doi: 10.1016/j.vaccine.2012.10.081. Epub 2012 Nov 4.

Safety and immunogenicity of an adjuvanted whole virion, inactivated A (H1N1) 2009 influenza vaccine in young and elderly adults, and children.

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1
Serum Institute of India Ltd., Pune, India. drpsk@seruminstitute.com

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.

PMID:
23131207
DOI:
10.1016/j.vaccine.2012.10.081
[Indexed for MEDLINE]

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