drugset / Trial / NCT04344054
Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine
Phase 2
Completed
850 enrolled
PATH
Bill and Melinda Gates Foundation · collabChildren's Hospital Medical Center, Cincinnati · collabMurdoch Childrens Research Institute · collabSK Bioscience Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study will evaluate safety and immunogenicity of LORV (Rotarix and RV3-BB) when TV P2-VP8, a parentally administered rotavirus vaccine is administered either concomitantly or as a prime/boost model. Participants would be newborn babies or infants approximately at 6 weeks of age ta the time of enrollment. The vaccines will be administered at birth (only for one cohort) and at 6, 10 and 14 weeks. Immune response will be assessed prior to first vaccination, 14 weeks and at 18 weeks of age. The study will also evaluate the shedding of Rotarix virus after a challenge dose administered 28 days after last investigational product administration. Safety assessments will be conducted throughout the study duration.
Timeline
- Start
- 2021-02-22
- Primary completion
- 2022-09-06
- Completion
- 2022-09-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RV3-BB | Vaccine | 1 ml | Oral |
| Subject | Rotarix | Vaccine | 1.5 ml | Oral |
| Subject | Trivalent P2-VP8 | Vaccine | 90 ug | — |