COVAXIN in a Pediatric Cohort (COVAXIN-Peds)

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.

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Biological: COVAXIN

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 Type: Interventional
• Enrollment (Actual): 525
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530001
      • Victoria Government Hospital
  • Bihar
    • Patna, Bihar, India, 801507
      • All India Institute of Medical Sciences
  • Karnataka
    • Mysore, Karnataka, India, 570001
      • Cheluvambha Hospital
  • Maharashtra
    • Nagpur, Maharashtra, India, 440010
      • Meditrina Institute Of Medical Sciences
  • Rajasthan
    • Ajmer, Rajasthan, India, 305001
      • Jawahar Lal Nehru Medical College
  • Telangana
    • Hyderabad, Telangana, India, 500050
      • Pranam Hospitals Hyderabad
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208002
      • Prakhar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactogenicity	Occurrence of Solicited Adverse events	Within 7 days after each dose of vaccination
Immunogenecity	GMTs of SARS-CoV-2 virus neutralizing antibodies by MNT/PRNT assay.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	The GMT of binding antibodies (bAb's) IgG against spike protein (S1) and Nucleocapsid (N) protein in all three groups.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unsolicited Adverse Events	Occurrence of Unsolicited Adverse events	Within 28 days after each dose of vaccination
Adverse Events of Special Interest	Occurrence of Adverse Events of Special Interest	Through study completion ,an average of 9 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Vadrevu KM, Reddy S, Jogdand H, Ganneru B, Mirza N, Tripathy VN, Singh C, Khalatkar V, Prasanth S, Rai S, Ella R, Blackwelder W, Prasad S, Ella K. Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2-18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study. Lancet Infect Dis. 2022 Sep;22(9):1303-1312. doi: 10.1016/S1473-3099(22)00307-3. Epub 2022 Jun 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BBIL/BBV152/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No