A Sourcing Study to Collect Human Blood Samples From Healthy Adults
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: rMenB+OMV NZ vaccine; Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Intervention description: Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.; One dose of MenACWY vaccine were administered intramuscularly at Day 1.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1021.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunological assays; Human blood donors; Meningococcal vaccination; Meningococcal disease

Summary:

      The purpose of this study was to collect large volumes of matched pairs of pre- and
      post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK)
      Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine
      (Bexsero), which serves for the development, qualification, validation, and maintenance of
      immunological assays which supports the preclinical research activities and clinical
      development of GSK Biologicals' vaccines. The safety of the subjects given one of the two
      vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during
      their participation in the study.
    

Eligibility 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 <
             32kg/m2).

          -  Female subjects of non-childbearing potential may be enrolled in the study.
             Non-childbearing potential is defined as pre-menarche, current bilateral tubal
             ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 1 month, after completion of the vaccination series.

        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.