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Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

NCT02584816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2018-09-11

No results posted yet for this study

Summary

This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).

Conditions

  • Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

BRV-PV Lot A + DPT-HepB-Hib + OPV

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week

BIOLOGICAL

BRV-PV Lot B + DPT-HepB-Hib + OPV

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week

BIOLOGICAL

BRV-PV Lot C + DPT-HepB-Hib + OPV

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week

BIOLOGICAL

ROTARIX + DPT-HepB-Hib + OPV

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr Prasad Kulkarni, M.D. · Serum Institute of India Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-30
Completion
2017-06-30

Countries

  • India

Study Locations

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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 NCT02584816 on ClinicalTrials.gov