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

  • STATUS
    Recruiting
  • End date
    Nov 9, 2023
  • participants needed
    1258
  • sponsor
    GlaxoSmithKline
Updated on 19 June 2022
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 Infections, Meningococcal
Treatment Placebo, MenACWY vaccine, MenB vaccine, MenABCWY-2Gen low dose vaccine, MenABCWY-2Gen high dose vaccine
Clinical Study IdentifierNCT04886154
SponsorGlaxoSmithKline
Last Modified on19 June 2022

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
Female participants of childbearing potential may be enrolled in the study, if the
years + 364 days) at the time of the first study intervention administration
participant
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
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
Progressive, unstable or uncontrolled clinical conditions
Abnormal function or modification of the immune system resulting from
Prior/Concomitant therapy
Prior/Concurrent clinical study experience
Household contact with and/or intimate exposure to an individual with laboratory
confirmed N. meningitidis infection within 60 days of enrolment
Other exclusions
Clinical conditions representing a contraindication to intramuscular vaccination and
Pregnant or lactating female
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
Any study personnel or immediate dependents, family, or household member
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
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
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
• 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)
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
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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