COVAXIN in a Pediatric Cohort

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Biological: COVAXIN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent (by the parents or legally acceptable/authorized representative (LAR) and assent by the children (verbal/oral assent for the children of age between 7-12 years, and written assent for the children of age between >12 to 18 years), and Audio video consent for all participants. Participants of either gender of age between ≥2 to ≤18years (Participant should be ≤18 years at the time of Screening of the study). Good general health as determined by the discretion of investigator. Expressed interest and availability to fulfill the study requirements. Agrees not to participate in another clinical trial at any time during the study period. Agrees to remain in the study area for the entire duration of the study. Willing to allow storage and future use of biological samples for future research. Exclusion Criteria: History of any other COVID-19 investigational vaccination. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. Receipt of any licensed vaccine within four weeks before enrollment in this study. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. Long-term use (>2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). Any history of hereditary angioedema or idiopathic angioedema. Any history of anaphylaxis in relation to vaccination. History of congenital diseases. Any history of albumin-intolerance. History of any cancer. History of psychiatric severe conditions likely to affect participation in the study. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. Any other serious chronic illness requiring hospital specialist supervision. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. Re-Vaccination Exclusion Criteria Anaphylactic reaction following administration of the investigational vaccine. Virologically confirmed cases of COVID-19

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study vaccine<br>SARS-COV2 vaccine | Biological: COVAXIN<br>* Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactogenicity | Occurrence of Solicited Adverse events | Within 7 days after each dose of vaccination | 
| Immunogenecity | GMTs of SARS-CoV-2 virus neutralizing antibodies by MNT/PRNT assay. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | The GMT of binding antibodies (bAb's) IgG against spike protein (S1) and Nucleocapsid (N) protein in all three groups. | 6 months |