Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    covaxin
Previous Study | Return to List | Next Study

COVAXIN in a Pediatric Cohort (COVAXIN-Peds)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04918797
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Bharat Biotech International Limited

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
SARS-CoV2 Infection Biological: COVAXIN 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : January 25, 2022

Arm Intervention/treatment
Experimental: Study vaccine
SARS-COV2 vaccine
Biological: COVAXIN
Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)




Primary Outcome Measures :
  1. Reactogenicity [ Time Frame: Within 7 days after each dose of vaccination ]
    Occurrence of Solicited Adverse events

  2. Immunogenecity [ Time Frame: 6 months ]
    GMTs of SARS-CoV-2 virus neutralizing antibodies by MNT/PRNT assay.


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 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:
  1. Unsolicited Adverse Events [ Time Frame: Within 28 days after each dose of vaccination ]
    Occurrence of Unsolicited Adverse events

  2. Adverse Events of Special Interest [ Time Frame: Through study completion ,an average of 9 months ]
    Occurrence of Adverse Events of Special Interest



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ≤18years (Participant should be ≤18 years at the time of Screening of the study).
  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:

  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 enrollment 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04918797


Contacts
Layout table for location contacts
Contact: Dr. V Krishna Mohan, PhD 04023480567 kmohan@bharatbiotech.com

Locations
Layout table for location information
India
Victoria Government Hospital Not yet recruiting
Visakhapatnam, Andhra Pradesh, India, 530001
Contact: Dr I V Padmavathi, MBBS,MD    9666140568    padmavathi.vgh@gmail.com   
All India Institute of Medical Sciences Not yet recruiting
Patna, Bihar, India, 801507
Contact: Dr Lokesh Tiwari, MBBS,MD    9555989176    lokeshkumartiwari789@gmail.com   
Cheluvambha Hospital Not yet recruiting
Mysore, Karnataka, India, 570001
Contact: Dr Prashanth, MBBS,MD    9606352062    drsp2013@rediffmail.com   
Meditrina Institute of Medical Sciences Not yet recruiting
Nagpur, Maharashtra, India, 440010
Contact: Dr.Vasant Khalatkar, MBBS,MD    9823044438    vasant.khalatkar@gmail.com   
Jawahar Lal Nehru Medical college Not yet recruiting
Ajmer, Rajasthan, India, 305001
Contact: Dr Jai Prakash Narayan, MBBS,MD    9314294402    narayan_jaiprakash@yahoo.co.in   
Pranam Hospitals Hyderabad Recruiting
Hyderabad, Telangana, India, 500050
Contact: Dr Mirza Nizam Baig Baig, MBBS,MD    9949389002    drmnb007@yahoo.co.in   
Prakhar Hospital Not yet recruiting
Kanpur, Uttar Pradesh, India, 208002
Contact: Dr Virendra Nath Tripathy, MBBS,MD    9415050777    dr.vntripathicr@gmail.com   
Sponsors and Collaborators
Bharat Biotech International Limited
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Bharat Biotech International Limited
ClinicalTrials.gov Identifier: NCT04918797    
Other Study ID Numbers: BBIL/BBV152/2021
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No