Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
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).
- All subjects must satisfy all the following criteria at study entry:
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- 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).
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- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
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- 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.
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- Healthy subjects as established by medical history and clinical examination before entering into the study.
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- Born full-term (i.e. after a gestation period of = 38 weeks).
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- If any exclusion criterion applies, the subject must not be included in the study:
• Child in care
Each subject must not have:
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- Progressive, unstable or uncontrolled clinical conditions.
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- Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study.
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- Hypersensitivity to latex.
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- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
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- Abnormal function of the immune system resulting from:
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- Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth.
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- Administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth.
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- Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders
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- lupus erythematosus and associated conditions
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- rheumatoid arthritis and associated conditions
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- scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
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- Received immunoglobulins or any blood products from birth.
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- Received an investigational or non-registered medicinal product from birth.
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- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
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- 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).
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- Congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
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- Study personnel as an immediate family or household member.
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- Current or previous, confirmed or suspected disease caused by N. meningitidis
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- Household contact with and/or intimate exposure from birth to an individual with laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or colonization.
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- Previous administration of meningococcal B or pneumococcal vaccine at any time prior to informed consent.
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- 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.
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- Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
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