immunogenicity and safety study of glaxosmithkline biologicals' gsk2202083a vaccine administered as a booster dose

Conditions: Tetanus; Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis; Acellular Pertussis; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni

Summary: 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).


Eligibility criteria:
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.

Keywords: booster vaccination combined vaccine