Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose

Summary

A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.

Group 1: (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.

Group 2: (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.

Group 3: (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.

Group 4: (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.

Group 5: (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.

Conditions

• COVID-19 Respiratory Infection

Interventions

BIOLOGICAL

BBV154 Intranasal Vaccine

Administered BBV154 vaccine in form of drops (0.5 mL) via intranasal route

BIOLOGICAL

Intramuscular vaccine COVAXIN

Administered BBV152 vaccine via intramuscular route

BIOLOGICAL

Covishield

Administered vaccine via intramuscular route

Sponsors & Collaborators

• Bharat Biotech International Limited

  lead INDUSTRY

Principal Investigators

• Dr. Sanjay Rai, MBBS,MD · AIIMS, New Delhi

• Dr Chandramani Singh, MBBS,MD · All India Institute of Medical Sciences

• Dr Anil Kumar Pandey, MBBS,MD · ESIC Medical College and Hospital Faridabad

• Dr Chandrashekhar S Gillurkar, MBBS,MD · Gillurkar Multispeciality Hopistal

• Dr Amit Suresh Bhate, MBBS,MD · Jeevan Rekha Hospital

• Dr Jitendra Singh Kushwaha, MBBS,MD · Prakhar Hospital Pvt Ltd

• Dr Shivaraj K K, MBBS,MD · Vagus Super Specilaity Hospitals

• Dr A Venkateshwar Rao, MBBS,MD · St. Theresa Hospital

• Dr Ajeet Pratap Singh, MBBS,MD · Rana Hospital Pvt Ltd

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-26

Primary Completion

2022-05-03

Completion

2022-09-28

Countries

• India

Study Locations