Meningitis MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: BEXSERO
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: NHBA
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTE
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. •Written informed consent obtained from the subject prior to performing any study specific procedure. •A male or female between, and including, 18 and 50 years of age at the time of the first study visit. •Healthy subjects as established by medical history and clinical examination before entering into the study. Healthy subjects with no medical conditions that, in the opinion of the investigator, prevents the subject from participating in the study. •Subjects must weigh at least 110 pounds (50 kg), but not to present obesity (BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Progressive, unstable or uncontrolled clinical conditions. •Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. •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) within 90 days prior to informed consent. ?Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. •Received immunoglobulins or any blood products within 180 days prior to informed consent. •Received an investigational or non-registered medicinal product within 30 days prior to informed consent. •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study. •Any history of meningococcal vaccination or meningococcal and gonorrhoea diseases. •Enrolment in any activity requiring a blood donation greater than 50 mL during the period starting 30 days before the first study visit (Day -83, Day -60 or Day -30) or for the duration of the study period. •Administration of long-acting immune-modifying drugs at any time during the study period •Subjects with blood disorders. •Subjects with a history of difficulty in providing blood samples •Any antibiotic intake 7 days prior to blood collection. •Subjects who donated >450 mL of blood within 60 days prior to any blood collection visits. •Subjects who lost >200 mL during a single apheresis or who lost red blood cells on more than one occasion during apheresis within the previous 60 days. •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product •Ongoing anaemia as indicated by haemoglobin values below the lower limit of the laboratory-specified reference range. If the finger prick method demonstrates an anaemia, no further protocol procedures will be performed, and the subject will be referred for appropriate medical management. The subject may participate in this study following therapy and evidence that the anaemia has been resolved. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions. •Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination •Family history of congenital or hereditary immunodeficiency. •Serious chronic illness. •History of chronic alcohol consumption and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect baseline (Visit 1, Visit 2 or Visit 3, depending on the study group) and post vaccination (Visits 5, 8; Visits 5, 9; Visits 6, 9 or Visits 7, 9, depending on the study group) blood sample donations to serve for the development, qualification, validation and maintenance of immunological assays and to support the preclinical research activities, clinical development and life cycle management of GSK Biologicals’ vaccines.;Secondary Objective: To descriptively assess the safety of each subject given one of the 2 meningococcal vaccines as per the recommended dosage and schedule during their participation in the study.;Primary end point(s): Collection of human blood for conversion into serum.;Timepoint(s) of evaluation of this end point: At visit 1 (83 days prior to first vaccination) At visit 2(60 days prior to first vaccination) At visit 3 (30 days prior to first vaccination) At visit 5 (Day 8) At visit 6 (Day 31) At visit 7 (Day 61) At visit 8 (Day 98) At visit 9 (Day 151) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of the occurrence of SAEs related to vaccination ;Timepoint(s) of evaluation of this end point: Subjects will be followed throughout the study duration, approximately 8 months | — |
Countries
Australia, Germany
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed