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

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ClinicalTrials.gov Identifier: NCT00136604

Recruitment Status : Completed

First Posted : August 29, 2005

Results First Posted : September 17, 2018

Last Update Posted : February 20, 2020

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Whole Cell Pertussis Haemophilus Influenzae Type b Hepatitis B Diphtheria Tetanus Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin	Biological: Tritanrix-HepB/Hib-MenAC Biological: Mencevax ACWY Biological: Tritanrix-HepB/Hiberix Biological: Meningitec	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	617 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Care Provider)
Primary Purpose:	Prevention
Official Title:	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
Actual Study Start Date :	January 22, 2006
Actual Primary Completion Date :	April 23, 2006
Actual Study Completion Date :	April 23, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Haemophilus Infections

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Diphtheria Haemophilus Influenzae

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Biological: Tritanrix-HepB/Hib-MenAC Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
Experimental: 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	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
Experimental: 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	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
Experimental: 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.	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
Experimental: 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.	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

Outcome Measures

Primary Outcome Measures :

Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value [ Time Frame: One month Post-Booster vaccination at 15-24 months of age ]
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value [ Time Frame: One Month Post-Booster vaccination at 15-24 months of age ]
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value [ Time Frame: One Month Post-Booster vaccination at 15-24 months of age ]
Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).

Secondary Outcome Measures :

Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).
Anti-PRP Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Anti-SBA-MenC Antibody Titers [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody titers were presented as geometric mean titers (GMTs).
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Anti-rSBA-MenA Antibody Titers [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody titers were presented as geometric mean titers (GMTs).
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Anti-PSC Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Anti-PSA Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().
Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values [ Time Frame: One month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were < 0.1 IU/ml when assessed by ELISA.
Anti-D Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).
Anti-TT Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value [ Time Frame: One month Post-Booster vaccination ]
Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).
Anti-BPT Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).
Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).
Anti-HBs Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age ]
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0 to Day 3) post-vaccination period ]
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Up to one month Post-Booster vaccination ]
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

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Ages Eligible for Study:	427 Days to 730 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136604

Locations

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Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Khon Kaen, Thailand, 40002
GSK Investigational Site
Songkla, Thailand, 90110

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Primary Study This link exits the ClinicalTrials.gov site