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

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).

This study is divided into three timepoints:

Epoch 1 - Primary: Day 1 to Day 301 Epoch 2 - Secondary: Day 301 to Day 331 Epoch 3 - Safety follow-up: Day 331 to the end of the study (Day 481 or Day 661). For participants who have not yet reached the 6-month safety follow-up after their last dose at the time Protocol Amendment 7 takes effect, visit 7 takes place on Day 481.

In addition to receiving the study vaccines, infants 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 minimize disruption to the standard infant vaccination schedule caused by participation in this study.

Participants receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prevnar13) and other routine infant vaccines (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6, and 12 months of age. Participants who have received three PCV13 doses before 12 months of age but have not yet received their fourth booster dose receive either PCV13 or PCV20 at 12 months of age (Visit 5).

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).