COVAXIN-Peds: COVAXIN in a Pediatric Cohort
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study vaccine SARS-COV2 vaccine |
Biological: COVAXIN
Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)
|
Outcome Measures
Primary Outcome Measures
- Reactogenicity [Within 7 days after each dose of vaccination]
Occurrence of Solicited Adverse events
- Immunogenecity [6 months]
GMTs of SARS-CoV-2 virus neutralizing antibodies by MNT/PRNT assay.
Secondary Outcome Measures
- Immunogenicity [6 months]
The GMT of binding antibodies (bAb's) IgG against spike protein (S1) and Nucleocapsid (N) protein in all three groups.
Other Outcome Measures
- Unsolicited Adverse Events [Within 28 days after each dose of vaccination]
Occurrence of Unsolicited Adverse events
- Adverse Events of Special Interest [Through study completion ,an average of 9 months]
Occurrence of Adverse Events of Special Interest
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Participants of either gender of age between ≥2 to ≤18years (Participant should be ≤18 years at the time of Screening of the study).
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Good general health as determined by the discretion of investigator.
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Expressed interest and availability to fulfill the study requirements.
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Agrees not to participate in another clinical trial at any time during the study period.
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Agrees to remain in the study area for the entire duration of the study.
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Willing to allow storage and future use of biological samples for future research.
Exclusion Criteria:
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History of any other COVID-19 investigational vaccination.
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Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
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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.
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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.
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Receipt of any licensed vaccine within four weeks before enrollment in this study.
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Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
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Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
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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.
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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).
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Any history of hereditary angioedema or idiopathic angioedema.
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Any history of anaphylaxis in relation to vaccination.
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History of congenital diseases.
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Any history of albumin-intolerance.
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History of any cancer.
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History of psychiatric severe conditions likely to affect participation in the study.
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A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
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Any other serious chronic illness requiring hospital specialist supervision.
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Respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
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Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
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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.
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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
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Anaphylactic reaction following administration of the investigational vaccine.
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Virologically confirmed cases of COVID-19
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Jawahar Lal Nehru Medical college | Ajmer | Rajasthan | India | 305001 |
| 6 | Pranam Hospitals Hyderabad | Hyderabad | Telangana | India | 500050 |
| 7 | Prakhar Hospital | Kanpur | Uttar Pradesh | India | 208002 |
Sponsors and Collaborators
- Bharat Biotech International Limited
Investigators
- Principal Investigator: Dr.Vasant Khalatkar, MBBS,MD, Meditrina Institute of Medical Sciences,Nagpur
- Principal Investigator: Dr.V.N Tripathi, MBBS,MD, Prakhar Hospital Pvt Ltd.,Kanpur
- Principal Investigator: Dr Padmavathi I V, MBBS,MD, Victoria Government Hospital
- Principal Investigator: Dr.Lokesh Kumar Tiwari, MBBS,DNB, All India Institute of Medical Scienes,Patna
- Principal Investigator: Dr.Jai Prakash Narayan, MBBS,MD, JLN Medical college,Ajmer
- Principal Investigator: Dr Mirza Nizam Baig, MBBS,MD, Pranam Hospitals Hyderabad
- Principal Investigator: Dr Prashanth Siddiah, MBBS,MD, Cheluvambha Hospital,Mysore
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BBIL/BBV152/2021