Phase IV, open-label, randomized study to enrol healthy adult volunteers, naïve to any previous meningococcal vaccination or meningococcal disease, aged 18-50 years, to be either vaccinated with GSK MenACWY vaccine (Menveo) or GSK rMenB+OMV NZ vaccine (Bexsero), and serve as donors of human blood for conversion into serum to use in the development, qualification, validation and maintenance of immunological assays and to support preclinical research activities, clinical development and life cycle management of GSK Biologicals vaccines. - MENB REC 2ND GEN-079 HBS

GlaxoSmithKline Biologicals0 sites1,020 target enrollmentNovember 22, 2017

Overview

No summary available.

Registry

who.int

Start Date

November 22, 2017

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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.

•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.