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Vaccine
Available online 4 November 2012
In Press, Uncorrected Proof ? Note to users
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Brief report
Safety and immunogenicity of an adjuvanted whole virion, inactivated A (H1N1) 2009 influenza vaccine in young and elderly adults, and children
Prasad S. Kulkarnia, Corresponding author contact information, E-mail the corresponding author,
K. Manjunathb,
Sharad Agarkhedkarc,
Group of SII IIV Studies1
a Serum Institute of India Ltd., Pune, India
b Lambda Therapeutics Pvt. Ltd., Ahmedabad, India
c D.Y. Patil Medical College, Pimpri, India
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.
Highlights
► An alum adjuvanted whole virion inactivated (H1N1) 2009 vaccine was assessed in India. ► Mostly mild and transient injection site and systemic reactions reported in few subjects. ► The overall seroprotection and seroconversion were ≥88%. ► The vaccine was highly safe and immunogenic.
Available online 4 November 2012
In Press, Uncorrected Proof ? Note to users
Cover image
Brief report
Safety and immunogenicity of an adjuvanted whole virion, inactivated A (H1N1) 2009 influenza vaccine in young and elderly adults, and children
Prasad S. Kulkarnia, Corresponding author contact information, E-mail the corresponding author,
K. Manjunathb,
Sharad Agarkhedkarc,
Group of SII IIV Studies1
a Serum Institute of India Ltd., Pune, India
b Lambda Therapeutics Pvt. Ltd., Ahmedabad, India
c D.Y. Patil Medical College, Pimpri, India
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.
Highlights
► An alum adjuvanted whole virion inactivated (H1N1) 2009 vaccine was assessed in India. ► Mostly mild and transient injection site and systemic reactions reported in few subjects. ► The overall seroprotection and seroconversion were ≥88%. ► The vaccine was highly safe and immunogenic.