safety and immunogenicity of gsk meningococcal group b vaccine and 13-valent pneumococcal vaccine administered concomitantly with routine infant vaccines to healthy infants

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to evaluate the safety and immunogenicity of bexsero (meningococcal group b vaccine-rmenb+omv nz) in north american infants 6 weeks through 12 weeks of age, when administered concomitantly with pneumococcal conjugate vaccine (pcv 13) and other recommended routine infant vaccines(riv).

this study will be divided into 3 timepoints: * epoch 1- primary- from day 1 to day 301 * epoch 2-secondary-from day 301 to day 331 * epoch 3-safety follow up -from day 331 to study end (day 481 or day 661). for subjects who have not yet reached the 6-month safety follow-up after the last dose at the time protocol amendment 7 takes effect, visit 7 will take place on day 481. in addition to receiving the study vaccines, infants will also receive non-study vaccines such as diphtheria, tetanus toxoids and acellular pertussis adsorbed vaccine (dtpa, infanrix) and haemophilus influenzae type b conjugate vaccine (hib, hiberix), to ease the disruption to the standard infant vaccine schedule caused by participating in this study.

Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * subjects' parent(s)/legally acceptable representative(s) \[lar(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the ediary, return for follow-up visits). * written informed consent obtained from the parent(s)/lar(s) of the subject prior to performing any study specific procedure. * a male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination. * healthy subjects as established by medical history and clinical examination before entering into the study. * born full-term (i.e. after a gestation period of ≥ 38 weeks). exclusion criteria: if any exclusion criterion applies, the subject must not be included in the study: • child in care each subject must not have: * progressive, unstable or uncontrolled clinical conditions. * hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study. * hypersensitivity to latex. * clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * abnormal function of the immune system resulting from: * clinical conditions. * systemic administration of corticosteroids (po/iv/im) for more than 14 consecutive days from birth. * administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth. * autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes). * received immunoglobulins or any blood products from birth. * received an investigational or non-registered medicinal product from birth. * any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study. * neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions). * congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders). * study personnel as an immediate family or household member. * current or previous, confirmed or suspected disease caused by n. meningitidis * household contact with and/or intimate exposure from birth to an individual with laboratory confirmed n. meningitidis and/or streptococcus pneumoniae infection or colonization. * previous administration of meningococcal b or pneumococcal vaccine at any time prior to informed consent. * received a dose of dtpa-hbv-ipv, hrv, mmr, vv and/or hib at any time prior to informed consent. receipt of one dose of hbv up to 4 weeks prior to informed con-sent is allowed. * serious chronic illness. * uncorrected congenital malformation (such as meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception (is).

Keywords: meningitis immune response sufficiency neisseria meningitides bexsero