Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).

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.