Study to Assess the Immunogenicity and Safety of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

• Status: Not yet recruiting
• Trial end date: 2022-03-31
• Target enrollment: 945
• Participant gender: All

Summary

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and 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.

• Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.

• Written or /witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.

• Written informed assent obtained from the subject (if applicable) along with informed consent from the subject's parent(s)/LAR(s) prior to performing any study specific procedure.

• A male or female between, and including, 16 and 18 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. 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 2 months after completion of the vaccination series.

Exclusion Criteria:

Medical conditions

• Progressive, unstable or uncontrolled clinical conditions.

• 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 within 90 days prior to study vaccination. This will mean prednisone ≥ 20 mg/day (for adult subjects) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for paediatric subjects, or equivalent. Inhaled and topical steroids are allowed.

• Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.

• Are obese at screening (obesity is defined as a BMI of ≥ 95th percentile for age and gender).

• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

• History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.

• 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.

• History of neuroinflammatory or autoimmune condition.

• Recurrent history or un-controlled neurological disorders or seizures.

Prior/Concomitant therapy

• Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the informed consent or planned use during the study period.

• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the informed consent or planned administration during the study period.

• Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.

• Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra).

Prior/Concurrent clinical study experience

• Subject 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, will not be enrolled.

Other exclusions

• Child in care.

• Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Any study personnel or immediate dependants, family, or household member.