The study to check the safety and immune response of (Covid-19 vaccine) COVOVAX in adults (more than 18 years of age) and pediatric population (more than 2 years and less than 17 years of age) in India.
- Registration Number
- CTRI/2021/02/031554
- Lead Sponsor
- Serum Institute of India Private Limited Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2520
Adult Cohort:
1. Adults aged more than or equal to 18 years of either sex
2. Written informed consent by participants
3. The participant is resident of the study area and is willing to comply with study protocol requirements
4. Healthy, as determined by medical history and physical examination
5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit
6. Female participants of childbearing potential must have a negative
urine pregnancy test within 24 hours prior to study vaccine
Pediatric Cohort:
1. Children aged = 2 to 17 years of either sex
2. The participant is a resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study
3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator.
4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children
5. Participants assent (verbal assent for 7- to 11-year old children and written assent for 12- to 17-year old children), as required, prior to study enrolment and to comply with study procedures.
6. Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test within 24 hours prior to study vaccine administration
Adult Cohort:
1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
2. History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease.
3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
4. Prior receipt of an investigational or licensed vaccine likely to
impact interpretation of the trial data
5. Current or planned participation in prophylactic drug trials for the
duration of the study
Pediatric Cohort
1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
2. History of laboratory confirmed (by PCR or serology to SARS-CoV-2) COVID-19 disease
3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of causally related serious <br/ ><br>adverse events (SAEs) throughout the study duration following vaccination <br/ ><br> <br/ ><br>Immunogenicity Outcomes: <br/ ><br>a. Ratio of GMEUs of anti-Spike (S) protein IgG and Ratio of GMTs of NAb against SARS CoV-2 <br/ ><br> <br/ ><br>Safety Outcomes: <br/ ><br> <br/ ><br>a. Occurrence of solicited local and systemic AEsTimepoint: Throughout the study follow up period <br/ ><br> <br/ ><br>14 days after second vaccination (35 days post first dose vaccination) <br/ ><br> <br/ ><br>For 7 days following each dose <br/ ><br> <br/ ><br>35 days post first dose vaccination <br/ ><br> <br/ ><br>Throughout the study period following vaccination
- Secondary Outcome Measures
Name Time Method