Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

GlaxoSmithKline168 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

168

Conditions

Infections, Meningococcal

Interventions

Tritanrix™- HepBBIOLOGICAL

One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months

Hiberix™BIOLOGICAL

One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months

Mencevax™ ACWBIOLOGICAL

One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

Eligibility

Sex: ALLMin age: 15 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

GSK Investigational Site

Brits, South Africa

GSK Investigational Site

Ga-Rankuwa, South Africa

GSK Investigational Site

Rooihuiskraal, South Africa

Outcomes

Primary Outcomes

Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies

Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.

Time frame: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)

Secondary Outcomes

Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs

Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.

Time frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

Anti-rSBA-MenA, C, W-135 Antibody Titers

Antibody titers were expressed as geometric mean titers (GMTs).

Time frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values

Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).

Time frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

Anti-PSA and Anti-PSC Antibody Concentrations

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

Time frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31

Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values

Antibody concentrations were ≥ 0.3 µg/mL.

Time frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

Data from ClinicalTrials.gov

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