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
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.