The 14-week clinical trial of swine flu vaccine on healthy children will begin in the second week of February

Testing time for children

The 14-week clinical trial of swine flu vaccine on healthy children will begin in the second week of February

One hundred and twenty healthy children between the ages of six months and nine years will create history next month, when they become the first ones from the city to take part in a H1N1 vaccine clinical trial.u00a0

The Sant Dnyaneshwar Medical Education and Research Centre (SDMERC) will begin the 14-week clinical trial of Panacea Biotech's H1N1 vaccine on healthy children at Shaishav Children's Hospital on Laxmi Road in the second week of February. The trial is the first one to be conducted on children in Pune.

Dr Ramchandra Dhongade, president, SDMERC, said the hospital has already developed infrastructure and appointed staff for this trial.

"The trial protocol will be three-armed, so three formulae of the drug will be administered to healthy children in two age groups u00c3u00a2u00c2u0080u00c2u0094 six months to 35 months and three years to nine years," he said. It is a randomised double-blinded control trial in which Phase II and III studies will evaluate the immunogenicity and safety based on three formulae. "We are waiting for the formal nod from the Drug Control Government of India (DCGI)," he added.

No risk
"We can ensure that our trials are safe. Trials of the vaccine conducted on children in several Western countries were completed without any side effects. Now, this is being followed by India," he added.

Panacea Biotech has nearly finished Phase I trials of the vaccine on adults in New Delhi and will soon begin Phase II at D Y Patil Medical College in Pimpri.