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

NCT ID: NCT00136604

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 617 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-22
• Study Completion Date: 2006-04-23

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ACAC GROUP

Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.

Group Type: EXPERIMENTAL

Tritanrix-HepB/Hib-MenAC

Intervention Type: BIOLOGICAL

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

ACHibPS GROUP

Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm

Group Type: EXPERIMENTAL

Mencevax ACWY

Intervention Type: BIOLOGICAL

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

Tritanrix-HepB/Hiberix

Intervention Type: BIOLOGICAL

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

HibACPS GROUP

Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm

Group Type: EXPERIMENTAL

Tritanrix-HepB/Hib-MenAC

Intervention Type: BIOLOGICAL

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

Mencevax ACWY

Intervention Type: BIOLOGICAL

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

HibHibPS GROUP

Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.

Group Type: EXPERIMENTAL

Mencevax ACWY

Intervention Type: BIOLOGICAL

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

Tritanrix-HepB/Hiberix

Intervention Type: BIOLOGICAL

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

CC GROUP

Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.

Group Type: EXPERIMENTAL

Tritanrix-HepB/Hiberix

Intervention Type: BIOLOGICAL

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

Meningitec

Intervention Type: BIOLOGICAL

Wyeth's MenC CRM197 conjugated vaccine, Meningitec

Interventions

Tritanrix-HepB/Hib-MenAC

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

Intervention Type: BIOLOGICAL

Mencevax ACWY

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

Intervention Type: BIOLOGICAL

Tritanrix-HepB/Hiberix

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

Intervention Type: BIOLOGICAL

Meningitec

Wyeth's MenC CRM197 conjugated vaccine, Meningitec

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy male or female between and including 15 and 24 months of age
• Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)

Exclusion Criteria

• Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
• History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.

• Minimum Eligible Age: 427 Days
• Maximum Eligible Age: 730 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Khon Kaen, , Thailand

GSK Investigational Site

Songkhla, , Thailand

Countries

Thailand

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

http://www.clinicaltrials.gov/ct/show/NCT00317161

Primary Study

Other Identifiers

104730

Identifier Type: -

Identifier Source: secondary_id

104727 (Booster - 15-24 mths)

Identifier Type: -

Identifier Source: org_study_id