Clinical Trials Directory

Trials / Completed

CompletedNCT00136604

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

Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
617 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
427 Days – 730 Days
Healthy volunteers
Accepted

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.

Detailed description

This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.

Conditions

Interventions

TypeNameDescription
BIOLOGICALTritanrix-HepB/Hib-MenACCombined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
BIOLOGICALMencevax ACWYGSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
BIOLOGICALTritanrix-HepB/HiberixCombined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
BIOLOGICALMeningitecWyeth's MenC CRM197 conjugated vaccine, Meningitec

Timeline

Start date
2006-01-22
Primary completion
2006-04-23
Completion
2006-04-23
First posted
2005-08-29
Last updated
2020-02-20
Results posted
2018-09-17

Locations

3 sites across 1 country: Thailand

Source: ClinicalTrials.gov record NCT00136604. Inclusion in this directory is not an endorsement.