Ronan Kelly
Retired 2020
Phase-I human trials of H1N1 vaccine a success: SII
Umesh Isalkar , TNN, 13 February 2010, 02:43am ISTText Size:|Topics:vaccine
H1N1
PUNE: The Pune-based vaccine major Serum Institute of India (SII) on Friday announced the success of phase-I human clinical trials of its indigenous intra-nasal swine flu vaccine.
?As per the safety data analysis, the vaccine has been found to be safe for humans,? Rajeev Dhere, senior director of the SII told TOI on Friday.
The next phase will begin after obtaining the necessary permission from the Drug Controller General of India. The trial will be aimed at evaluating immunogenicity, that is antibody-producing capacity of the vaccine in humans, he said.
?The phase-I trial was a randomised, double-blind, placebo-controlled, single-dose safety study in which 100 volunteers, males as well as females, aged 18-49 years participated.? Dhere said.
Conducted by a designated clinical research organisation (CRO) in Ahemadabad, the phase-I trials started from January 16 and concluded on February 8, he said. ?The safety data was decoded by the CRO between February 9 and 12 and it was found to be safe.?
The next phase of human clinical trials will be multi-centric and last for 40-45 days. It will be conducted in Pune, Delhi and Ahmedabad.
Volunteers from age groups 3-17, 18-49 and 49 onwards will participate in this phase. It is aimed at evaluating resistance-producing capacity of the vaccine, Dhere said.
http://timesofindia.indiatimes.com/...vaccine-a-success-SII/articleshow/5566728.cms
Umesh Isalkar , TNN, 13 February 2010, 02:43am ISTText Size:|Topics:vaccine
H1N1
PUNE: The Pune-based vaccine major Serum Institute of India (SII) on Friday announced the success of phase-I human clinical trials of its indigenous intra-nasal swine flu vaccine.
?As per the safety data analysis, the vaccine has been found to be safe for humans,? Rajeev Dhere, senior director of the SII told TOI on Friday.
The next phase will begin after obtaining the necessary permission from the Drug Controller General of India. The trial will be aimed at evaluating immunogenicity, that is antibody-producing capacity of the vaccine in humans, he said.
?The phase-I trial was a randomised, double-blind, placebo-controlled, single-dose safety study in which 100 volunteers, males as well as females, aged 18-49 years participated.? Dhere said.
Conducted by a designated clinical research organisation (CRO) in Ahemadabad, the phase-I trials started from January 16 and concluded on February 8, he said. ?The safety data was decoded by the CRO between February 9 and 12 and it was found to be safe.?
The next phase of human clinical trials will be multi-centric and last for 40-45 days. It will be conducted in Pune, Delhi and Ahmedabad.
Volunteers from age groups 3-17, 18-49 and 49 onwards will participate in this phase. It is aimed at evaluating resistance-producing capacity of the vaccine, Dhere said.
http://timesofindia.indiatimes.com/...vaccine-a-success-SII/articleshow/5566728.cms