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Phase III Study of Liquid Formulation of ROTAVIN

NCT03703336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2021-01-25

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

ROTAVIN (liquid formulation)

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

BIOLOGICAL

ROTAVIN-M1 (frozen formulation)

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

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Center for Research and Production of Vaccines and Biologicals, Vietnam

    lead OTHER_GOV

Principal Investigators

  • Niraj Rathi, MD · PATH India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
91 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-16
Primary Completion
2020-01-08
Completion
2020-01-08

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703336 on ClinicalTrials.gov