Clinical trial NCT00317109: Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
Official title: Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: meningococcal serogroups A and C diseases
tetanus
hepatitis B
pertussis
Haemophilus influenzae type b
meningococcal vaccine
Prophylaxis diphtheria
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 168
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.

Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* A male or female between, and including, 15 and 18 months of age at the time of vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Having participated in the primary vaccination study (CPMS N° 759346/007).

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
* Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
* History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
* Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures including febrile seizures in infancy.
* Acute disease at the time of enrolment.
* Axillary temperature ≥ 37.5°C at the time of vaccination.
* Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
* Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
* Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.

Primary outcomes:
measure: Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
timeFrame: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Secondary outcomes:
measure: Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
timeFrame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
measure: Anti-rSBA-MenA, C, W-135 Antibody Titers
timeFrame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
measure: Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
timeFrame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
measure: Anti-PSA and Anti-PSC Antibody Concentrations
timeFrame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
measure: Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
timeFrame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
measure: Anti-PSW Antibody Concentrations
timeFrame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
measure: Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
timeFrame: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
measure: Anti-HBs Antibody Concentrations
timeFrame: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
measure: Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
timeFrame: At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
measure: Number of Subjects With Fever
timeFrame: During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
measure: Number of Subjects With Solicited Local Symtoms
timeFrame: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Months 15-18 and up to Months 25-31 post vaccination
Other outcomes:
Locations:
city: Brits
country: South Africa
facility: GSK Investigational Site
city: Ga-Rankuwa
country: South Africa
facility: GSK Investigational Site
city: Rooihuiskraal
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: