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This is an archive article published on March 5, 2010

First phase of H1N1 vaccine trial over

Zydus Cadila announced completion of the first phase of the H1N1 vaccine trial on Thursday. The Ahmedabad-based drug maker will now commence the phase II and phase III clinical trials in Ahmedabad,Bangalore,Jaipur and Pune.

Zydus Cadila announced completion of the first phase of the H1N1 vaccine trial on Thursday. The Ahmedabad-based drug maker will now commence the phase II and phase III clinical trials in Ahmedabad,Bangalore,Jaipur and Pune.

It will take another six months for the completion of the next two trials,the company said in a press release.

The statement added: “Multi-centric trials extending for a period of six weeks are currently underway. On successful completion of the trials,the group will submit the results to the Drug Controller General of India (DGCI) for marketing approval.”

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The company expects to make the vaccine available in the market by April this year. It had earlier projected to manufacture six million doses initially. The demand for H1N1 vaccine in India is expected around 50 to 60 million dosages initially.

The vaccine has been developed by a team of experts using conventional technology at the company’s Vaccine Technology Centre here,the statement said.

Vaccinations against the deadly H1N1 (swine flu) virus are likely to begin in India next week.

The 1.5 million doses of vaccines imported by the government from Sanofi Pasteur recently,have passed the safety test. The French vaccine manufacturers submitted the results of their clinical bridge study – conducted in New Delhi and Pune on 100 adult subjects. The trials were completed on February 21.

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