PACTR202306533302513
Not yet recruiting
Phase 3
A randomised, controlled clinical trial to assess and compare the immunogenicity, safety and reactogenicity of the bivalent-Omicron BA.4/BA.5-adapted, and the original-Wuhan-Hu-1-strain-monovalent, BNT162b2 COVID-19 vaccine formulations in healthy unvaccinated East African adults.
OXFORD0 sites580 target enrollmentApril 8, 2023
ConditionsCOVID-19
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- OXFORD
- Enrollment
- 580
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adult (?18 years of age) males, or non\-pregnant females.
- •2\) Able and willing to comply with trial requirements.
- •3\) For females only, a negative pregnancy test within 24 hours prior to administration of each of the two vaccine doses and willing to take contraception till 28 days after the second vaccine dose.
- •4\) Provide written informed consent.
Exclusion Criteria
- •1\)Documented history of any COVID\-19 vaccination.
- •2\)Prior receipt of an investigational, or licensed vaccine within the last 30 days.
- •3\)Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the first vaccine dose.
- •4\)Any confirmed, or suspected immunosuppressive, or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short\-term oral steroids (course lasting \<14 days).
- •5\)History of allergic disease, or reactions that could be exacerbated by any component of study vaccine.
- •6\)Any history of angioedema or anaphylaxis.
- •7\) Any history of myocarditis and pericarditis.
- •8\)Pregnancy or lactation at the time of screening.
- •9\)Bleeding disorders, or other conditions that in the opinion of the investigator contraindicate intramuscular injection.
- •10\)Any other conditions that in the opinion of the investigator may jeopardise participant safety and / or interfere with study outcomes
Outcomes
Primary Outcomes
Not specified
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