study to evaluate gsk biologicals' gsk2197870a vaccine given as primary course in infants

Conditions: Neisseria Meningitidis; Haemophilus Influenzae Type b

Summary: the purpose of this phase ii study is to evaluate the feasibility of gsk biologicals' gsk2197870a vaccine co-administered with wyeth-lederle's prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of gsk biologicals' menitorix™ at 12 months of age.

this protocol posting has been updated following protocol amendment 1, 11-february-2010; the study design section is impacted by this amendment.

Eligibility criteria:
inclusion criteria: all subjects must satisfy the following criteria at study entry: * a male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination. * born after 36 to 42 weeks of gestation. * subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study. * 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. exclusion criteria: the following criteria should be checked at the time of study entry. if any apply, the subject must not be included in the study: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. for corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day. inhaled and topical steroids are allowed. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product . * evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hib, pneumococcal and/or group c meningococcal vaccination or disease. * history of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion). * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. the following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: • current febrile illness or axillary temperature ≥37.5ºc or other moderate to severe illness within 24 hours of study vaccine administration

Keywords: combined vaccines