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ROTAVAC 5C vs ROTAVAC in Infants
NCT04819412Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2015
- Primary completion
- Oct 2015
- Sponsor
- Bharat Biotech
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- rotavirus gastroenteritis
01
Overview
Phase 3, randomised, single-blind trial of rotavirus vaccine 116E in rotavirus gastroenteritis (3 arms), sponsored by Bharat Biotech. Primary endpoint: Immunogenicity in terms of Geometric Mean Titer (GMT) and four-fold seroconversion at Day 84. Started Mar 2015; status: completed.
02
Design
3 arms- Study design
- RandomizedSingle-blind
ROTAVAC 5C -F1
ROTAVAC 5C formulation BBIL-R2014-1 (3 doses)
ROTAVAC 5C -F2
ROTAVAC 5C formulation BBIL-R2014-2 (3 doses)
ROTAVAC®
Active Comparator: ROTAVAC® with buffer (3 doses)
03
Who it enrols
Healthy infants 6-8 weeks of age. Excludes those with fever, diarrhea, vomiting, significant malnutrition, or prior rotavirus vaccination.
04
Endpoints
Primary
Immunogenicity in terms of Geometric Mean Titer (GMT) and four-fold seroconversion
Secondary
Occurrence of adverse events and Serious Adverse events
Evaluation of shedding of rotavirus
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