GlaxoSmithKline's (GSK) Safety and Immunogenicity Study of GSK Meningococcal Group B and 13-valent Pneumococcal Vaccines Administered Together With Routine Infant Vaccines in Healthy Infants

  • STATUS
    Recruiting
  • End date
    Jul 22, 2024
  • participants needed
    1200
  • sponsor
    GlaxoSmithKline
Updated on 23 September 2020
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (0.7 mi away) Contact
+42 other location
vaccination
pneumococcal
varivax
conjugate vaccine
hiberix
bexsero

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 months of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).

Description

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 661) 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.

Details
Treatment Prevnar13, Rotarix, Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Pediarix, Hiberix, M-M-R II, Varivax, Varivax, Placebo (saline water)
Clinical Study IdentifierNCT03621670
SponsorGlaxoSmithKline
Last Modified on23 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 1 yrs and 1 yrs?
Gender: Male or Female
Do you have Meningococcal infection?
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)
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