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Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine

NCT00877357 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2009-05-06

No results posted yet for this study

Summary

A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Haemophilus Influenzae Type B

Interventions

BIOLOGICAL

Shan 5

Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Sponsors & Collaborators

  • Shantha Biotechnics Limited

    lead INDUSTRY

Principal Investigators

  • Raman Rao, MD · Shantha Biotechnics Limited

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
2009-01-31
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • India

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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 NCT00877357 on ClinicalTrials.gov