Wyeth claims no GCP lapse as India suspends vaccine trial

Wednesday 19 November 2008
Anju Ghangurde - Reporter

Wyeth says that there were no GCP (good clinical practice) lapses in its now-suspended Indian pneumococcal conjugate vaccine trial. The Drugs Controller General of India (DCGI) halted the trial following the death of an infant, alleging that the company had flouted the inclusion-exclusion criteria for the study.

The Wyeth study aimed to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared with Prevenar (PCV7), when given concomitantly with routine paediatric vaccinations in India. Wyeth's Prevenar is available in more than 90 countries and is part of the national immunisation programme in 29 of these.

The trial, which was being conducted across India in Chandigarh, Maharashtra, New Delhi, Punjab, Tamil Nadu and Karnataka, has been suspended pending the DCGI's review of the case. The study involved a total of 354 infants in each of two cohorts, the first of which was completed earlier. The second cohort is subject to the suspension.

Wyeth said it had reviewed the case with GVK Biosciences, the Indian contract research organisation involved and the local investigator. "Based on this review, we believe the study criteria and good clinical practice were followed," Wyeth told Scrip...


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