COVAXIN in a Pediatric Cohort

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.

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