Skip to main content
OpenTrials
Completed

NCT Number: NCT00136604

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Whole Cell Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pasteurellaceae Infections Tetanus Virus Diseases

Age range

427 day–730 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bangkok, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tritanrix-HepB/Hib-MenAC

Biological

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

Mencevax ACWY

Biological

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

Tritanrix-HepB/Hiberix

Biological

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

Meningitec

Biological

Wyeth's MenC CRM197 conjugated vaccine, Meningitec

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Aug 29, 2005
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.