drugset / Trial / NCT05029245
IntraDermal Versus Intramuscular Comirnaty® Efficacy Study
Phase 3
Withdrawn
Department of Medical Services Ministry of Public Health of Thailand
Department of Medical services · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
The 8-week, Prospective, Randomized controlled of IntraDermal administration of Comirnaty® 6 microgram compare to Intramuscular Comirnaty® 30 microgram by 28 days interval Efficacy Study in 4 groups of healthy volunteer ( 1 people who complete sinovac vaccination 2 people who received 1 dosage of AstraZeneca vaccine 3 naive vaccination 4 any other vaccination not in 1-3 with anti Spike antibody less than 650 AU/ ml) . Comparison of antibody level and T cell response to SAR-CoV-2 antigen in vitro after 28 day post vaccination is primary outcome and the side effect as well as infection rate in 8 weeks is secondary outcomes.
Timeline
- Start
- 2021-08-31
- Primary completion
- 2022-08-31
- Completion
- 2022-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT162b2 | Messenger RNA (mRNA) | 6 ug | Other |
| Subject | BNT162b2 | Messenger RNA (mRNA) | 30 ug | Other |