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Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m

NCT00136604 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2020-02-20

Study results available
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Summary

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.

Conditions

  • Whole Cell Pertussis
  • Haemophilus Influenzae Type b
  • Hepatitis B
  • Diphtheria
  • Tetanus
  • Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin

Interventions

BIOLOGICAL

Tritanrix-HepB/Hib-MenAC

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine

BIOLOGICAL

Mencevax ACWY

GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine

BIOLOGICAL

Tritanrix-HepB/Hiberix

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine

BIOLOGICAL

Meningitec

Wyeth's MenC CRM197 conjugated vaccine, Meningitec

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
427 Days
Max Age
730 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-22
Primary Completion
2006-04-23
Completion
2006-04-23

Countries

  • Thailand

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 NCT00136604 on ClinicalTrials.gov