Serum Institute gets CDSCO panel nod to conduct clinical trial of Reduced Inactivated Salk Polio Vaccine
New Delhi: Vaccine maker Serum Institute of India (SII) has recently got approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct Phase II/III clinical trial of Reduced Inactivated Salk Polio Vaccine (Adsorbed).
However, the proposal is approved on the condition that the clinical trial locations for both IPV vaccination trials be kept separate and that intermediate findings from phase II be reported before moving on to phase III.
Poliomyelitis is a contagious disease caused by the poliomyelitis virus, an enterovirus belonging to the Picornaviridae viral family with three serotypes: 1, 2, and 3. Poliomyelitis is prevented with the use of polio vaccinations (polio). In general, two kinds of poliovirus are used: an inactivated poliovirus administered by injection (IPV) and a weakened poliovirus administered by mouth (OPV).
Serum Institute of India supplies Poliomyelitis vaccine (Inactivated) under the brand name POLIOVAC (PFS/SD), which is indicated for active immunization of infants, children and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2 and 3.
Serum Institute of India presented its proposal for conduct of Phase II/III clinical trial of Reduced Inactivated Salk Polio Vaccine (Adsorbed), at recent Subject Expert Committee (SEC) meeting for Vaccine and the matters related to Biologicals & PAC proposals. At the meeting, The committee evaluated the vaccine maker's proposal.
After detailed deliberation, the committee recommended for grant of permission to conduct clinical trial subject to the condition that the clinical trial sites for both IPV vaccines studies should be separate and the interim results of phase II should be presented before proceeding to Phase III study.