Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia (ROTAVAC)
An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants
Sponsor: Bharat Biotech International Limited
A PHASE2/PHASE3 clinical study on Diarrhea and Diarrhea Rotavirus, this trial is completed. The trial is conducted by Bharat Biotech International Limited and has accumulated 7 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
7 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2/PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2_PHASE3
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Mar 2020 — Jan 2021 [monthly]
Completed PHASE2_PHASE3
Status: Recruiting → Completed
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Dec 2019 — Mar 2020 [monthly]
Recruiting PHASE2_PHASE3
▶ Show 2 earlier versions
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Mar 2019 — Dec 2019 [monthly]
Recruiting PHASE2_PHASE3
Status: Not Yet Recruiting → Recruiting
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Aug 2018 — Mar 2019 [monthly]
Not Yet Recruiting PHASE2_PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Bharat Biotech International Limited
- Centre for Infectious Disease Research in Zambia
- Children's Hospital Medical Center, Cincinnati
- Christian Medical College, Vellore, India
- PATH
For direct contact, visit the study record on ClinicalTrials.gov .