Pune: Enrollment of children in the age group 12 to 17 years of Regency Pune for testing pediatric Covovax second and third phase will start on Monday at the Branch Vadu KEM Hospital.
Dr Ashish Bavdekar, the main trial investigator at KEM Hospital Research Center, told TOI, “Enrollment has begun in the pilot areas of Delhi and we’ll start on Monday …
Vadu is the same area where adults have taken part in the trial Covovax for the cohort of adults.
So, people aware of the trial pediatric use.
They are happy to have a child volunteers.
“Hospital Bharati in Branch Vadu Hospital Dhankawdi and KEM is one of 10 sites across the country, where 920 children underage fit the criteria will undergo further testing.
Dr Jitendra Oswal, Deputy Medical Director at the Hospital Bharati, said, “Nearly 100 participants will be enrolled per center.” Dr Bavdekar said the trial will be held in phases – starting with the 12-17 age group, followed by 7-11, and then two to six age groups.
“Data safety for the first age group will be submitted to the DSMB (Data and Safety Monitoring Board) and DCGI (Drug Controller General of India) for assessment and approval.
Once they give their nod, the next phase for the other age groups will begin,” he said.
He said that although 10 sites in India will do the trail, initially only 100 children who will be enrolled for the assessment data.
“Then, there may be a gap of two weeks, after which more children would be enrolled,” said Dr.
Bavdekar.
Interest in this cohort study was to evaluate the safety Covovax compared to placebo and immunogenicity of the vaccine in children in the age group 12 to 17 years and those aged between two and 11 years compared with adult participants.
Two doses of the vaccine will be given to research participants 21 days apart.