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A Study of Comparing Safety and Reactogenicity, of Lyophilized BCG Vaccine IP of Green Signal Bio Pharma Private Limited, India With BCG Vaccine of Serum Institute of India Limited in 120 Healthy Children.

NCT01250249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2010-11-30

No results posted yet for this study

Summary

To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy children.

Conditions

  • Healthy

Interventions

BIOLOGICAL

BCG Vaccine IP - Serum Institute of India

0.1 ml for adults and children aged 1 month and over 0.05 ml for infants under 1 month of age

Sponsors & Collaborators

  • Green Signal Biopharma Private Limited

    lead INDUSTRY

Principal Investigators

  • SR Lakshimipathy, MBBS, DCH · KC General Hospital, Malleswaram, Bangalore

  • Mohamed Kizhar Irshat, MBBS, DCH · Arya vysya maternity home & child welfare centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-06-30
Completion
2009-06-30

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 NCT01250249 on ClinicalTrials.gov