Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

  • STATUS
    Recruiting
  • End date
    Nov 13, 2026
  • participants needed
    300
  • sponsor
    GlaxoSmithKline
Updated on 27 May 2022
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (0.8 mi away) Contact
+21 other location
Accepts healthy volunteers

Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

Details
Condition Meningitis, Meningococcal
Treatment Placebo, MenABCWY vaccine
Clinical Study IdentifierNCT05087056
SponsorGlaxoSmithKline
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants 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
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) prior to performing any study specific procedure
A male or female between, and including, 11 and 14 years of age (i.e. 14 years + 364 days) at the time of the first vaccination
Healthy participants as established by medical history, physical examination and clinical judgment of the investigator before entering into 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 or bilateral ovariectomy
Female participants of childbearing potential may be enrolled in the study, if the
participant
has practiced adequate contraception for 30 days prior to first vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to follow adequate contraception for 30 days before each of the 2 subsequent vaccinations and for 30 days after each vaccination Urine samples for pregnancy testing will be collected from female participants of childbearing potential at Visit 1, Visit 3 and Visit 5 prior to the vaccination

Exclusion Criteria

Medical conditions
Current or previous, confirmed or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment
Progressive, unstable or uncontrolled clinical conditions
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Are obese at enrolment
Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. History of febrile convulsions should not lead to exclusion
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s)
Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study
Abnormal function or modification of the immune system resulting from
Autoimmune disorders or immunodeficiency syndromes
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum 20 mg/day for paediatric participants. Inhaled and topical steroids are allowed
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination
Administration of long-acting immune-modifying drugs at any time during the study period
Any other clinical condition that, in the opinion of the investigator, might pose
additional risk to the participant due to participation in the study
Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period
Previous vaccination with any meningococcal (MenB or MenACWY) vaccine at any time prior to informed consent/ assent (as applicable) with the exception of meningococcal C (conjugated or polysaccharide) vaccination, if the last dose of MenC was received at ≤24 months of age
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of study vaccine/product or planned administration before the next blood sampling visit
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/product dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants. Inhaled and topical steroids are allowed
Prior/Concurrent clinical study experience
• 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 (drug or medical device)
Other exclusions
Child in care
Pregnant or lactating female
Female planning to become pregnant / planning to discontinue contraceptive precautions
during the windows reported in the inclusion criterion
History of /current chronic alcohol abuse and/or drug abuse as determined by the
investigator
Any study personnel or immediate dependants, family, or household members
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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