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Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

NCT00696423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2018-06-06

Study results available
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Summary

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.

Conditions

  • Acellular Pertussis
  • Diphtheria
  • Tetanus

Interventions

BIOLOGICAL

Infanrix™

Intramuscular injection, one dose

BIOLOGICAL

Hiberix™

Intramuscular injection, one dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-07
Primary Completion
2008-07-26
Completion
2008-07-26

Countries

  • China

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 NCT00696423 on ClinicalTrials.gov