A Study on the Safety Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

  • STATUS
    Recruiting
  • End date
    Sep 29, 2023
  • participants needed
    1258
  • sponsor
    GlaxoSmithKline
Updated on 11 December 2021
Accepts healthy volunteers

Summary

The purpose of this study is to assess the safety, effectiveness and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study will be conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and will serve as a safety lead-in to the Phase II study. The Phase II part of the study will be conducted in 2 parts: The 'formulation and schedule-finding' part will follow in healthy adolescents and young adults and it is designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part will be conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.

Details
Condition Meningococcal infection
Treatment Placebo, MenACWY vaccine, MenB vaccine, MenABCWY-2Gen low dose vaccine, MenABCWY-2Gen high dose vaccine
Clinical Study IdentifierNCT04886154
SponsorGlaxoSmithKline
Last Modified on11 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All inclusion criteria are applicable for both study phases, except where
specified otherwise
Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the eDiaries, return for follow-up visits)
Written or witnessed/thumb printed informed consent obtained from the participant or /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
Phase I only: A male or female between, and including, 18 and 40 years of age (i.e. 40 years + 364 days) at the time of the first study intervention administration
Phase II (Formulation and Schedule-finding) only: A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first study intervention administration
Phase II (Sourcing) only: A male or female between, and including, 18 and 50 years of age (i.e. 50 years + 364 days) at the time of the first study intervention administration
Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at 24 months of age)
Healthy participants as established by medical history and clinical examination 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 1 month prior to study intervention administration, and
has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration

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 (e.g. for participants from 20 years of age a body mass index (BMI) 30 kg/m2, for participants up to 19 years of age a BMI 95th percentile for age and gender or as applicable per country recommendations)
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, generalised tonic-clonic seizures, partial complex seizures, partial simple 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 study interventions
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 (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 (PO/IV/IM) for more than 14 consecutive days within 3 months prior to study vaccination until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding). 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
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 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 intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their 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
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding)
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 the first study intervention dose(s) until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding). 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 intervention (drug/invasive medical
device)
Other exclusions
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions
History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator
Any study personnel or immediate dependents, family, or household member
Phase II (Formulation and Schedule-finding): Child in care. Please refer to the Glossary of terms for the definition of child in care
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