Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults
Public ClinicalTrials.gov record NCT05258669. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Observer-Blind, Immuno-bridging, and Broadening Study of a Whole, Inactivated Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Vaccine (BBV152) in Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study to demonstrate the equivalence of the immune response between participants enrolled in Phase 3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J\&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint.
Study identification
- NCT ID
- NCT05258669
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 19, 2022
- Primary completion
- Aug 31, 2023
- Completion
- Oct 30, 2023
- Last update posted
- Mar 26, 2023
2022 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Voyage Medical | Tempe | Arizona | 85282 | Recruiting |
| Angels Clinical Institute | Miami | Florida | 33122 | Recruiting |
| Suncoast Research Group LLC | Miami | Florida | 33135 | Recruiting |
| Palm Springs Community Health Center | Miami Lakes | Florida | 33016 | Recruiting |
| Clinical Site Partners | Winter Park | Florida | 332789 | Recruiting |
| IACT Health | Columbus | Georgia | 31904 | Recruiting |
| Jay Meyer Meridian Research | Lincoln | Nebraska | 68510 | Recruiting |
| PRX Research | Dallas | Texas | 75149 | Recruiting |
| Wellness Clinical Research | McKinney | Texas | 75071 | Recruiting |
| Meridian Research 3235 Academy Ave | Portsmouth | Virginia | 237803 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05258669, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2023 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05258669 live on ClinicalTrials.gov.