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Trial record 90 of 187 for:    "Haemophilus influenzae"

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 : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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 Biological: Tritanrix-HepB Biological: Mencevax™ ACWY Biological: Hiberix™ Biological: Meningitec™ Biological: Hib-MenAC-TT 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.

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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 1, 2006
Actual Study Completion Date : April 23, 2006


Arm Intervention/treatment
Experimental: Trianrix-Hepb/Hib-MenAC-TT GROUP
Subjects vaccinated with 3 doses of Trianrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Biological: Tritanrix-HepB
GlaxoSmithKline (GSK) Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine

Biological: Hib-MenAC-TT
GSK Biologicals' combined Haemophilus influenzae type b-Neisseria meningitidis serogroup A and C-tetanus toxoid conjugate vaccine

Experimental: Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were 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
GlaxoSmithKline (GSK) Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine

Biological: Mencevax™ ACWY
GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine

Biological: Hiberix™
GSK Biologicals' Haemophilus influenzae type b vaccine

Experimental: TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP
Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were 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
GlaxoSmithKline (GSK) Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine

Biological: Mencevax™ ACWY
GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine

Biological: Hiberix™
GSK Biologicals' Haemophilus influenzae type b vaccine

Biological: Hib-MenAC-TT
GSK Biologicals' combined Haemophilus influenzae type b-Neisseria meningitidis serogroup A and C-tetanus toxoid conjugate vaccine

Experimental: TRITANRIX-HEPB+Mencevax GROUP
Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were 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
GlaxoSmithKline (GSK) Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine

Biological: Mencevax™ ACWY
GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine

Biological: Hiberix™
GSK Biologicals' Haemophilus influenzae type b vaccine

Experimental: TRITANRIX-HEPB+Mencevax + Meningitec GROUP
Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ + Meningitec vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were 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
GlaxoSmithKline (GSK) Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine

Biological: Mencevax™ ACWY
GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine

Biological: Hiberix™
GSK Biologicals' Haemophilus influenzae type b vaccine

Biological: Meningitec™
Wyeth's MenC CRM197 conjugated vaccine, Meningitec




Primary Outcome Measures :
  1. 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.

  2. 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).


  3. 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 :
  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. 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).


  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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 ().

  11. 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.

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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.

  20. 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.

  21. 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.

  22. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

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

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104727 (Booster - 15-24 mths)
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104727 (Booster - 15-24 mths)
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104727 (Booster - 15-24 mths)
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104727 (Booster - 15-24 mths)
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104727 (Booster - 15-24 mths)
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104727 (Booster - 15-24 mths)
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00136604     History of Changes
Other Study ID Numbers: 104727 (Booster - 15-24 mths)
104730
First Posted: August 29, 2005    Key Record Dates
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Prophylaxis diphtheria
Hib & meningococcal serogroup A & C disease

Additional relevant MeSH terms:
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Hepatitis B
Diphtheria
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs