PUNE: Enrolment of children in the age group of 12 to 17 years from Pune district for the second and third phase paediatric trials of Covovax would start from Monday at KEM Hospital’s Vadu branch.
Dr Ashish Bavdekar, the principal trial investigator at KEM Hospital Research Centre, told TOI, “The enrolment has started at the Delhi trial site and we would start on Monday... Vadu is the same area where adults have taken part in Covovax trials for the adult cohort. So, people are aware of the paediatric trials. They are happy to have their children volunteer.”
Bharati Hospital in Dhankawdi and KEM Hospital’s Vadu branch are among the 10 sites across the country, where 920 minors fitting the criterion would undergo the advanced trials.
Dr Jitendra Oswal, the deputy medical director at Bharati Hospital, said, “Nearly 100 participants would be enrolled per centre.”
Dr Bavdekar said the trial would be held in phases -- beginning with the 12-17 age group, followed by 7-11, and then two to 6 age groups. “The safety data for the first age group would be submitted to the DSMB (Data and Safety Monitoring Board) and DCGI (Drugs Controller General of India) for assessment and approval. Once they give their nod, the next phase for the other age groups would begin,” he said.
He said though 10 sites in India would conduct the trails, initially only 100 children would be enrolled for data assessment. “Then, there may be a two-week gap, after which more children would be enrolled,” said Dr Bavdekar.
The study objective in this cohort is to evaluate the safety of Covovax in comparison with placebo and immunogenicity of the vaccine in children in the age group of 12 to 17 years of age and those between two and 11 years of age in comparison with the adult participants. Two doses of the vaccine would be given to the study participants 21 days apart.
