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Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old

NCT00439660 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2021-02-23

No results posted yet for this study

Summary

This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10\^4.0, 10\^5.0 and 10\^6.0 FFU and for three administrations of each of these dosages given to infants at 4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the three dosage levels. The progression from the lower to the next higher dosage will be based on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of Biotechnology, New Delhi.

Conditions

Interventions

BIOLOGICAL

Oral Rotavirus Vaccine 116E Live Attenuated

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • Centers for Disease Control and Prevention

    collaborator FED

  • National Institutes of Health (NIH)

    collaborator NIH

  • Stanford University

    collaborator OTHER

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • PATH

    collaborator OTHER

  • Bharat Biotech International Limited

    lead INDUSTRY

Principal Investigators

  • Nita Bhandari, MBBS, PhD · Society for Applied Studies

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00439660 on ClinicalTrials.gov