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To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus

NCT04819412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1975

Last updated 2021-03-29

No results posted yet for this study

Summary

Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.

* The advantages of the liquid vaccines are: Liquid vaccines take lesser time to administer compared to the current practice of giving antacid buffer prior to vaccine which takes 40% more time to administer.
* Easier to transport as it is stable at 2-80C compared to the frozen formulation that needs to be stored at -200C and transported in dry ice.
* Chances of human error during administration are lesser than the sequential administration of antacid and vaccine.

Conditions

  • Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

ROTAVAC 5C -F2

ROTAVAC 5C formulation BBIL-R2014-2

BIOLOGICAL

ROTAVAC®

ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer

BIOLOGICAL

ROTAVAC 5C -F1

ROTAVAC 5C formulation BBIL-R2014-1

Sponsors & Collaborators

  • Georgia Institute for Clinical Research, LLC

    collaborator OTHER

  • Bharat Biotech International Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-20
Primary Completion
2015-10-30
Completion
2016-12-30

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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 NCT04819412 on ClinicalTrials.gov