Clinical trial NCT00136604: Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Whole Cell Pertussis
Haemophilus Influenzae Type b
Hepatitis B
Diphtheria
Tetanus
Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
Keywords: Prophylaxis diphtheria
Hib & meningococcal serogroup A & C disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 617
Sex: ALL
Minimum age (years): 427
Maximum age (years): 730
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
timeFrame: One month Post-Booster vaccination at 15-24 months of age
measure: Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value
timeFrame: One Month Post-Booster vaccination at 15-24 months of age
measure: Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value
timeFrame: One Month Post-Booster vaccination at 15-24 months of age
Secondary outcomes:
measure: Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-PRP Antibody Concentrations
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-SBA-MenC Antibody Titers
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: 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
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-rSBA-MenA Antibody Titers
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-PSC Antibody Concentrations
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-PSA Antibody Concentrations
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values
timeFrame: One month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-D Antibody Concentrations
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-TT Antibody Concentrations
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value
timeFrame: One month Post-Booster vaccination
measure: Anti-BPT Antibody Concentrations
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Anti-HBs Antibody Concentrations
timeFrame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Day 0 to Day 3) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Up to one month Post-Booster vaccination
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Khon Kaen
country: Thailand
facility: GSK Investigational Site
city: Songkla
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: