Status:
COMPLETED
COVAXIN in a Pediatric Cohort
Lead Sponsor:
Bharat Biotech International Limited
Conditions:
SARS-CoV2 Infection
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
PHASE3
Brief Summary
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 viri...
Detailed Description
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 Voluntee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT04918797
Start Date
May 26 2021
End Date
January 25 2022
Last Update
August 18 2022
Active Locations (7)
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1
Victoria Government Hospital
Visakhapatnam, Andhra Pradesh, India, 530001
2
All India Institute of Medical Sciences
Patna, Bihar, India, 801507
3
Cheluvambha Hospital
Mysore, Karnataka, India, 570001
4
Meditrina Institute of Medical Sciences
Nagpur, Maharashtra, India, 440010