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Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
CompletedPhase 3
Sponsor: GlaxoSmithKline
Conditions: Infections, Meningococcal
Interventions: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, Pediarix, Hiberix, Rotarix
Countries: United States, Puerto Rico
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 vaccinesv(RIV).
Eligibility overview
Sex: ALL
Age: 6 Weeks to 12 Weeks
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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).
Locations (57)
- Birmingham, Alabama, United States
- Fayetteville, Arkansas, United States
- Jonesboro, Arkansas, United States
- Anaheim, California, United States
- Oakland, California, United States
- Roseville, California, United States
- Walnut Creek, California, United States
- West Covina, California, United States
- Lake Mary, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Nampa, Idaho, United States
- Nampa, Idaho, United States
- Newton, Kansas, United States
- Topeka, Kansas, United States
- Bardstown, Kentucky, United States
- Louisville, Kentucky, United States
- Louisville, Kentucky, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Fall River, Massachusetts, United States
- Bingham Farms, Michigan, United States
- Kansas City, Missouri, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- Liverpool, New York, United States
- Syracuse, New York, United States
- Boone, North Carolina, United States
- Raleigh, North Carolina, United States
- Cincinnati, Ohio, United States
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