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

Completed · Phase 3 · Has a placebo group

Conditions studied: Infections, Meningococcal

In brief

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.

Key facts

Study ID

NCT04318548

Run by

GlaxoSmithKline

People needed

945

Starts

2020-08-25

Expected to finish

2023-11-21

Last updated by the study team

2025-03-04

Who can join

Age: 16 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' 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 participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
• Written informed assent obtained from the participant (if applicable) along with informed consent from the participant'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 participants as established by medical history and clinical examination before entering the study.
• Female participants 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 participants of childbearing potential may be enrolled in the study if the participant:
• 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.

You may not qualify if…

• 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 participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
• Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant 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, Menactra or MenQuadfi).
• Prior/Concurrent clinical study experience
• Participant concurrently participating in another clinical study, at any time during the study period, in which the participant 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.

Where it is running

• GSK Investigational Site — Bell Gardens, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Santa Clara, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Wellington, Florida, United States
• GSK Investigational Site — Boise, Idaho, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Lafayette, Louisiana, United States
• GSK Investigational Site — Lincoln, Nebraska, United States
• GSK Investigational Site — Lincoln, Nebraska, United States
• GSK Investigational Site — Lincoln, Nebraska, United States
• GSK Investigational Site — Lincoln, Nebraska, United States
• GSK Investigational Site — Cortland, New York, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Corvallis, Oregon, United States
• GSK Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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