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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
617
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
Wyeth's MenC CRM197 conjugated vaccine, Meningitec
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Khon Kaen, Thailand
GSK Investigational Site
Songkhla, Thailand
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Time frame: One month Post-Booster vaccination at 15-24 months of age
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value
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).
Time frame: One Month Post-Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value
Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).
Time frame: One Month Post-Booster vaccination at 15-24 months of age
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-SBA-MenC Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
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
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).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-rSBA-MenA Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PSC Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PSA Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values
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.
Time frame: One month after (POST) the Booster vaccination at 15-24 months of age
Anti-D Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-TT Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value
Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).
Time frame: One month Post-Booster vaccination
Anti-BPT Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value
Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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.
Time frame: During the 4-day (Day 0 to Day 3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: Up to one month Post-Booster vaccination
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