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Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

NCT00753649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2019-11-27

Study results available
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Summary

This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.

Conditions

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

Interventions

BIOLOGICAL

Infanrix™ hexa

Intramuscular, three doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-23
Primary Completion
2013-03-12
Completion
2013-03-12

Countries

  • Canada

Study Locations

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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 NCT00753649 on ClinicalTrials.gov