The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - \>12, ≤12 -\>6, ≤ 6 - \>2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart. Data will be un-blinded to the third party bio-statistician and an interim analysis will be performed on day 56 for Immunogenicity, Safety and submitted to CDSCO.
Study design: A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity, of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers ages ≤18 to ≥2 Years. A total sample size of 525 healthy volunteers. The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - \>12, ≤12 -\>6, ≤ 6 - \>2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart. Group1: A total of 175 healthy volunteers ages ≤18-\>12, years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2. Group 2: A total of 175 healthy volunteers ages ≤12-\>6, years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2. Group 3: A total of 175 healthy volunteers ages ≤6-\> 2 years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2. Data will be un-blinded to the third party bio-statistician and an interim analysis will be performed on day 56 for Immunogenicity, Safety and submitted to CDSCO. Immunogenicity analysis: A total of 5 ml of blood is collected at days 0, 28+2, 56±7, 118±7 and 208±7. SARS-CoV-2 test will be conducted at the time of screening using RT-PCR and ELISA method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
525
Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)
Victoria Government Hospital
Visakhapatnam, Andhra Pradesh, India
All India Institute of Medical Sciences
Patna, Bihar, India
Cheluvambha Hospital
Mysore, Karnataka, India
Meditrina Institute of Medical Sciences
Nagpur, Maharashtra, India
Reactogenicity
Occurrence of Solicited Adverse events
Time frame: Within 7 days after each dose of vaccination
Immunogenecity
GMTs of SARS-CoV-2 virus neutralizing antibodies by MNT/PRNT assay.
Time frame: 6 months
Immunogenicity
The GMT of binding antibodies (bAb's) IgG against spike protein (S1) and Nucleocapsid (N) protein in all three groups.
Time frame: 6 months
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Jawahar Lal Nehru Medical college
Ajmer, Rajasthan, India
Pranam Hospitals Hyderabad
Hyderabad, Telangana, India
Prakhar Hospital
Kanpur, Uttar Pradesh, India