NCT01171989 - Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose | Crick

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 18 MonthsHealthy volunteers:

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Inclusion Criteria: * Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol. * Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157). * A male or female between, and including, 12 and 18 months of age at the time of booster vaccination. * Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: * Child in care. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. * Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period. * Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose. * Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product. * Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * The following adverse event having occurred after previous administration of DTP vaccine: * Encephalopathy. * Temperature of \>= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause. * Collapse or shock-like state within 48 hours of vaccination. * Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting \>= 3 hours. * Seizures with or without fever occurring within 3 days of vaccination. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: • Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

Outcomes

Primary Outcomes

Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)

A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).

Time frame: At Month 1, post-booster dose

Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)

A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.

Time frame: At Month 1, post-booster dose

Secondary Outcomes

Number of Seropositive Subjects for Anti-PRP

A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.

Time frame: At Month 0, before the booster dose

Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off

The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.