Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone
Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone
The purpose of the current study is to evaluate whether there is immune interference when MenABCWY [consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component] is administered to healthy adolescents and adults following a 2-dose vaccination schedule with MenABCWY administered 2 months apart.
Inclusion Criteria:
Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the paper diary (pDiary), return for follow-up visits, availability for all visits scheduled in the study).
Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure.
A male or female between, and including, 10 to 25 years of age at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Female planning to become pregnant or planning to discontinue contraceptive precautions
Pregnant or lactating female
Child in care
Current or previous, confirmed or suspected disease caused by N. meningitidis.
Known contact to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to enrolment.
Previous vaccination against N. meningitidis at any time prior to informed consent.
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 IM vaccination and blood draws.
Abnormal function of the immune system resulting from:
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 interfere with the results of the study or pose additional risk to the subject due to participation in the study.
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.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Are obese at screening.
Family history of congenital or hereditary immunodeficiency.
History of neuroinflammatory or autoimmune condition.
History of significant neurological disorder or seizure.
Serious chronic illness.
History of chronic alcohol consumption and/or drug abuse.
Any study personnel as an immediate family or household member.
Administration of a vaccine not foreseen by the study protocol in the period starting 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) before each dose and ending 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) after each dose of study vaccine(s) administration.
Thrombocytopenia, bleeding disorders, or be receiving anticoagulant therapy.