A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E (ROTAVAC)
A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
Sponsor: Bharat Biotech International Limited
A PHASE3 clinical study on Viral Gastroenteritis Due to Rotavirus, this trial is ongoing. The trial is conducted by Bharat Biotech International Limited and has accumulated 5 data snapshots since 2011. Infectious disease trials contribute critical data for public health response and treatment development.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Unknown PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE3
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE3
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE3
First recorded
Mar 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bharat Biotech International Limited
- Ministry of Science and Technology, India
- PATH
For direct contact, visit the study record on ClinicalTrials.gov .