COVAXIN in a Pediatric Cohort

NCT04918797 | Completed Phase 2 DMC

• 1 other identifier: BBIL/BBV152/2021
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 7

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.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Immunogenicity

  6 months

Other Outcomes (2)

• Unsolicited Adverse Events

  Within 28 days after each dose of vaccination

• Adverse Events of Special Interest

  Through study completion ,an average of 9 months

Study Arms (1)

Study vaccine

EXPERIMENTAL

SARS-COV2 vaccine

Biological: COVAXIN

Interventions

COVAXIN BIOLOGICAL

Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)

Study vaccine

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (7)

Victoria Government Hospital

Visakhapatnam, Andhra Pradesh, 530001, India

Location

All India Institute of Medical Sciences

Patna, Bihar, 801507, India

Location

Cheluvambha Hospital

Mysore, Karnataka, 570001, India

Location

Meditrina Institute of Medical Sciences

Nagpur, Maharashtra, 440010, India

Location

Jawahar Lal Nehru Medical college

Ajmer, Rajasthan, 305001, India

Location

Pranam Hospitals Hyderabad

Hyderabad, Telangana, 500050, India

Location

Prakhar Hospital

Kanpur, Uttar Pradesh, 208002, India

Location

Related Publications (1)

• 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.

  PMID: 35717995 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BBV152 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 9, 2021
• Study Start: May 26, 2021
• Primary Completion: August 15, 2021
• Study Completion: January 25, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (7)