CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 825 enrolled
Drug / intervention
ROTAVIN (liquid formulation) +1 morebiological
Likely dose
ROTAVIN (liquid formulation) 2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03703336
NCT03703336Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Partially Double- Blind, Active Control Study to Compare the Immunogenicity and Safety of a Liquid Formulation of ROTAVIN With the Currently Licensed Frozen Formulation of the Vaccine (ROTAVIN-M1), in Healthy Vietnamese Infants

Center for Research and Production of Vaccines and Biologicals, Vietnam·interventional·Posted Oct 11, 2018·Updated Jan 25, 2021

In Brief

A Phase 3 clinical trial evaluating ROTAVIN (liquid formulation) and ROTAVIN-M1 (frozen formulation) for Diarrhea and Diarrhea Rotavirus. Completed, enrolled 825 participants across 2 sites.

Detailed Summary

This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, Diarrhea Rotavirus
CountriesVietnam
CollaboratorsPATH, National Institute of Hygiene and Epidemiology, Vietnam, Children's Hospital Medical Center, Cincinnati

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 11, 2018
Enrollment StartMar 16, 2019
Primary CompletionJan 8, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.7 years ago

Interventions

ROTAVIN (liquid formulation)biological

Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 plaque forming units (PFU) of strain G1P\[8\] per dose of 2 mL.

ROTAVIN-M1 (frozen formulation)biological

Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 PFU of strain G1P\[8\] per dose of 2 mL.