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Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

NCT00627458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2018-06-06

Study results available
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Summary

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

Conditions

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

Interventions

BIOLOGICAL

Infanrix Hexa

Vaccine administered as a booster dose at 16-20 months of age

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Months
Max Age
20 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-01
Primary Completion
2008-08-18
Completion
2008-08-18

Countries

  • Finland

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 NCT00627458 on ClinicalTrials.gov