Safety & Immunogenicity of Fractional Doses of Vaccines Among Nigerian Adults- A Randomised Non-Inferiority Triple Blind Trial
Phase 3
- Conditions
- COVID -19
- Registration Number
- PACTR202206754734018
- Lead Sponsor
- igeria Federal Ministry of health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1812
Inclusion Criteria
Healthy based on medical examination/history at the inclusion
Age 18-65 years
Signed informed consent
Prepared to grant authorized persons access to the medical records
The volunteer is likely to comply with instructions
Non pregnant female above 18 years
Exclusion Criteria
On current treatment with investigational agents for prophylaxis of COVID-19.
Plan to travel outside Nigeria from enrolment through 28 days after the last vaccination
Participation in other clinical trials
Known hypersensitivity to any of the vaccine components
History of hypersensitivity or severe allergic reaction
Laboratory parameters outside of normal range considered clinically relevant
Pregnant woman
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method