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Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

NCT00325156 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2590

Last updated 2020-01-02

Study results available
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Summary

To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Diphtheria
  • Tetanus
  • Poliomyelitis
  • Acellular Pertussis
  • Haemophilus Influenzae Type b
  • Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines

Interventions

BIOLOGICAL

GSK Biologicals' combined DTPa-IPV/Hib vaccine

4 intramuscular injections

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Weeks
Max Age
17 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-02
Primary Completion
2007-08-23
Completion
2007-08-23

Countries

  • Singapore

Study Locations

More Related Trials

Entities

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 NCT00325156 on ClinicalTrials.gov