None listed
Conditions
Interventions
Intervention1: BBV152: 0.5 ml administered intramuscular at day 0 and day 28
Control Intervention1: NA: NA
Sponsors
Bharat Biotech International Limited
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 2. Participants of either gender of age between >=2 to 3. Good general health as determined by the discretion of investigator. 4. Expressed interest and availability to fulfill the study requirements. 5. Agrees not to participate in another clinical trial at any time during the study period. 6. Agrees to remain in the study area for the entire duration of the study. 7. Willing to allow storage and future use of biological samples for future research
Exclusion criteria
Exclusion criteria: 1. History of any other COVID-19 investigational vaccination. 2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. 3. 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. 4. 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. 5. Receipt of any licensed vaccine within four weeks before enrolment in this study. 6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. 7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. 8. 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. 9. 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). 10. Any history of hereditary angioedema or idiopathic angioedema. 11. Any history of anaphylaxis in relation to vaccination. 12. History of congenital diseases. 13. Any history of albumin-intolerance. 14. History of any cancer. 15. History of psychiatric severe conditions likely to affect participation in the study. 16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. 17. Any other serious chronic illness requiring hospital specialist supervision. 18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma. 19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness. 20. 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. 21. 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 22. Anaphylactic reaction following administration of the investigational vaccine. 23. Virologically confirmed cases of COVID-19 through nucleic acid tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Occurrence of immediate adverse events within two hours of vaccination 2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination. 3 Occurrence of Serious Adverse Events throughout the study duration. 4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration 5 To evaluate the GMTs and seroconversion of COVAXIN®Timepoint: Day 28±2, 56±7, 118±7 and 208±7 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the GMT and four-fold seroconversion rate of binding antibodies (bAbâ??s) IgG against spike protein (S1 and RBD) and Nucleocapsid (N) protein in all three groups from baseline to day 28, 56, 118 and 208. [Time Frame: Baseline to Day 28±2, 56±7, 118±7 and 208±7].Timepoint: Day 28±2, 56±7, 118±7 and 208±7 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech International Limited
Outcome results
None listed