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Immunogenicity of a COVID-19 Booster Vaccine in Older Adults
- BDCTR ID
- BDCTR-2026-000039
- Sponsor
- Bangladesh Medical University
- Information provided by
- Bangladesh Medical University (Responsible Party)
- Last Update Posted
- 2026-04-18
Terminated
No longer looking for participants
Study Overview
Brief Summary
This study assessed the immunogenicity and safety of a COVID-19 booster vaccine in older adults. The study was terminated early due to low enrolment.
Detailed Description
Older adults were randomised to the booster vaccine or placebo. Antibody responses were measured at 28 days. Enrolment was stopped early and the study was terminated.
Official Title
Conditions
- COVID-19
- Immunisation
Intervention/Treatment
- Biological/Vaccine: COVID-19 booster vaccine
- Other: Placebo
Other Study ID Numbers
BMU-MED-2026-001
Study Start
Primary Completion
Study Completion
Enrollment (Estimated)
Study Type
Resource links provided by the National Library of Medicine
- MedlinePlus related topics: COVID-19, Immunisation
- Genetic and Rare Diseases Information Center resources: COVID-19, Immunisation
- Drug Information available for: COVID-19 booster vaccine
- FDA Drug and Device Resources
Contacts and Locations
This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.
To learn more, please see the Contacts and Locations section in How to Read a Study Record.
This study has 1 location
Bangladesh
Dhaka, Dhaka, Bangladesh, 1000
Terminated
Bangladesh Medical University, Clinical Research Centre
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
<p>Inclusion Criteria:</p><ul><li>Adults aged 60 years and older.</li><li>Completed a primary COVID-19 vaccination series.</li></ul><p>Exclusion Criteria:</p><ul><li>Known allergy to a vaccine component.</li></ul>
Ages Eligible for Study
Sexes Eligible for Study
Accepts Healthy Volunteers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose:
- Prevention
- Allocation:
- Randomized
- Interventional Model:
- Parallel Assignment
- Masking:
- Double blind
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental: Booster vaccine | Biological/Vaccine: COVID-19 booster vaccine |
Placebo Comparator: Placebo | Other: Placebo |
What is the study measuring?
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
| Geometric mean antibody titre | 28 days post-vaccination |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
| Rate of solicited adverse events | 7 days post-vaccination |
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
icddr,b
Study Record Dates
These dates track the progress of study record and summary results submissions to the registry. Study records and reported results are reviewed by the Registry Office to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted that Met QC Criteria
First Posted
Study Record Updates
Last Update Submitted that Met QC Criteria
Last Update Posted
Last Verified
More Information
Terms related to this study
Keywords Provided by Bangladesh Medical University
- COVID-19
- vaccine
- booster
- immunogenicity
Plan for Individual Participant Data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents, and helpful links
Data Monitoring Committee