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Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

NCT00879827 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

Conditions

  • Diphtheria
  • Poliomyelitis
  • Hepatitis B
  • Tetanus
  • Acellular Pertussis

Interventions

BIOLOGICAL

Pediarix TM, Infanrix penta TM

The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

BIOLOGICAL

Hiberix TM

The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2001-05-31
Completion
2001-05-31

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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 NCT00879827 on ClinicalTrials.gov