Biological E Gets CDSCO Panel Nod To Study Inactivated Poliomyelitis Vaccine
New Delhi: Vaccine major Biological E has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of Biological E's inactivated poliomyelitis vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.
This came after the firm presented a Phase II study report along with a Phase III clinical trial Protocol,titled, “A single blind, randomized, active-controlled, Phase Ill study to valuate immunogenicity and safety of Biological E's inactivated poliomyelitis vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.”
The committee noted the results from the Phase II clinical trial report. The inactivated poliovirus vaccine (IPV) is a vaccine that protects against poliovirus types 1, 2, and 3.
Polio is an illness caused by a virus that mainly affects nerves in the spinal cord or brain stem. In its most severe form, polio can lead to a person being unable to move certain limbs, also called paralysis. It can also lead to trouble breathing and sometimes death. The disease is also called poliomyelitis.
The inactivated poliovirus vaccine (IPV) contains a killed (inactivated) virus, so it can’t cause polio. It is given as a series of shots.
At the recent SEC meeting, the expert panel reviewed the Phase II study report along with the Phase III clinical trial Protocol,titled, “A single blind, randomized, active-controlled, Phase Ill study to evaluate immunogenicity and safety of Biological E's inactivated poliomyelitis vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.”
After detailed deliberation, the committee recommended the conduct of the Phase III clinical trial as per the presented protocol.
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