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Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

NCT00316147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2016-09-28

No results posted yet for this study

Summary

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:

* one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
* the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

Conditions

  • Diphtheria
  • Acellular Pertussis
  • Tetanus
  • Haemophilus Influenzae Type b
  • Hepatitis B
  • Poliomyelitis

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-12-31
Completion
2006-08-31

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 NCT00316147 on ClinicalTrials.gov