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SARS-CoV2 InfectionPhase 2/3COVAXIN-PedsNCT04918797

COVAXIN in a Pediatric Cohort

A Phase 2/3 study testing COVAXIN in people with SARS-CoV2 Infection, run by Bharat Biotech International Limited at 7 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 18 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV2 Infection
What is being tested?
COVAXIN
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
525 participants
Where
7 sitesIndia
Study dates
26 May 2021to 25 Jan 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.
  • A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Any other serious chronic illness requiring hospital specialist supervision.
  • Respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
  • Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
  • 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.
  • 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
  • Anaphylactic reaction following administration of the investigational vaccine.
  • Virologically confirmed cases of COVID-19

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

India7 sites

  • Jawahar Lal Nehru Medical college

    Ajmer, Rajasthan, 305001

  • Pranam Hospitals Hyderabad

    Hyderabad, Telangana, 500050

  • Prakhar Hospital

    Kanpur, Uttar Pradesh, 208002

  • Cheluvambha Hospital

    Mysore, Karnataka, 570001

  • Meditrina Institute of Medical Sciences

    Nagpur, Maharashtra, 440010

  • All India Institute of Medical Sciences

    Patna, Bihar, 801507

  • Victoria Government Hospital

    Visakhapatnam, Andhra Pradesh, 530001

Other trials in India

About this study

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.

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.

Read the 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.

Being tested
COVAXIN
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVAXINBiological

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

Study groups in NCT04918797
Study groupRoleWhat they receive
Study vaccineExperimentalSARS-COV2 vaccine
Receives: Biological: COVAXIN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reactogenicity

    Occurrence of Solicited Adverse events

    Measured: Within 7 days after each dose of vaccination

  2. Immunogenecity

    GMTs of SARS-CoV-2 virus neutralizing antibodies by MNT/PRNT assay.

    Measured: 6 months

Secondary outcomes (1)

  1. Immunogenicity

    The GMT of binding antibodies (bAb's) IgG against spike protein (S1) and Nucleocapsid (N) protein in all three groups.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start26 May 2021
  3. Primary completion15 Aug 2021
  4. Study completion25 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Open label
Masking
None (open label)
Enrolment
525 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918797
Sponsor's protocol ID
BBIL/BBV152/2021
Acronym
COVAXIN-Peds
Status last verified
Aug 2022
First submitted
18 May 2021
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35717995

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing COVAXIN in people with SARS-CoV2 Infection, run by Bharat Biotech International Limited at 7 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reactogenicity (time frame: Within 7 days after each dose of vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04918797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.

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