Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

  • STATUS
    Recruiting
  • End date
    Oct 25, 2022
  • participants needed
    1206
  • sponsor
    GlaxoSmithKline
Updated on 11 September 2021

Summary

The purpose of this study is to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine

Details
Condition Meningococcal meningitis
Treatment Placebo, MenABCWY vaccine, MenACWY vaccine, MenB vaccine
Clinical Study IdentifierNCT04707391
SponsorGlaxoSmithKline
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants and/or participants' parents/LARs, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits)
Written or witnessed/thumb printed informed consent obtained from the participant/participant's parent(s)/LAR(s) of the participant prior to performance of any study specific procedure
Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure
Previous vaccination with 1 dose of MenACWY vaccine at an age of 10 years or older, with an interval of at least 4 years and not more than 6 years (intended as up to 6 years and 364 days) between the previous MenACWY vaccine and enrollment (informed consent and assent [as applicable]) into this study
A male or female between, and including, 15 and 25 years of age (i.e., 25 years and 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, 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 intervention period and for 30 days after completion of the vaccination series

Exclusion Criteria

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 enrollment
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product
Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study
Progressive, unstable or uncontrolled clinical conditions
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Abnormal function or modification of the immune system resulting from
Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes)
Systemic administration of corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to study vaccination until the following post vaccination blood sample. This will mean prednisone 20 mg/day (for adult participants and 0.5 mg/kg/day with maximum 20 mg/day for pediatric 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 (e.g., infliximab)
Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study vaccine(s)/product during the period beginning 30 days before the first dose of study vaccine(s)/product (Day -29 to Day 1), or planned use during the study period
Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable (according to the participant's age)
Previous vaccination with 2 or more doses of MenACWY vaccine
Administration/planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before any dose of study vaccine(s)/product until the following post-vaccination blood sample
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to any vaccine/product dose until the following post-vaccination blood sample. For corticosteroids, this will mean prednisone equivalent 20 mg/day for adult participants and 0.5 mg/kg/day with maximum 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed
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)
Child in care
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions
History of/current chronic alcohol and/or drug abuse
Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member
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