Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
- Conditions
- Infections, Meningococcal
- Interventions
- Biological: Tritanrix™- HepBBiological: Hiberix™Biological: Mencevax™ ACWY
- Registration Number
- NCT00291343
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Detailed Description
Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.
Blood samples will be drawn from subjects as follows:
* prior to and one month after the full dose of the Mencevax™ ACWY vaccine.
* prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 296
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP Tritanrix™- HepB Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP Hiberix™ Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP Tritanrix™- HepB Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP Hiberix™ Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP Mencevax™ ACWY Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP Mencevax™ ACWY Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
- Primary Outcome Measures
Name Time Method Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). Antibody cut-offs were higher than or equal to (≥) 1:128
- Secondary Outcome Measures
Name Time Method Number of Subjects With Solicited General Symptoms During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever \[≥ 38 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade.
Number of Subjects With Unsolicited Adverse Events (AEs) From Day 0 at months 15-24 of age to study end at Months 25-31 of age 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 is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128
Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).
Anti-HBs Concentrations Prior to the Mencevax ACWY vaccination at 24-30 Months of age Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).
Anti-rSBA-MenA, C Antibody Titers Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. Antibody titers were expressed as Geometric Mean Titers (GMTs)
Anti-PSA, Anti-PSC Antibody Concentrations Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs Prior to the Mencevax ACWY vaccination at 24-30 Months of age The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).
Number of Subjects With Vaccine Response for rSBA-Men A, C 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer \< 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA \> 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.
Number of Subjects With Solicited Local Symptoms During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.
Number of Subjects With Serious Adverse Events (SAEs) From 15-24 Months of age up to Months 25-31 of age SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇭Sampaloc, Manila, Philippines