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Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

NCT00325143 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2018-06-06

Study results available
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Summary

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This 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

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

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib

1 intramuscular injection (3rd study vaccine dose)

BIOLOGICAL

DTPa-IPV/Hib vaccine

3 intramuscular injections (1st, 2nd and 4th vaccine dose)

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
2003-12-01
Primary Completion
2007-02-01
Completion
2007-02-01

Countries

  • Singapore

Study Locations

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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 NCT00325143 on ClinicalTrials.gov