A Phase I/II, randomised, controlled study to assess the safety, effectiveness and immune response of meningococcal combined ABCWY vaccine when administered to healthy adults (Phase I) and to healthy adolescents and adults (Phase II)

GlaxoSmithKline Biologicals0 sites1,379 target enrollmentDecember 7, 2021

ConditionsHealthy volunteers (Active immunization against IMD caused by Neisseria Meningitidis (N.meningitidis) serogroups A, B, C, W and Y)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers (Active immunization against IMD caused by Neisseria Meningitidis (N.meningitidis) serogroups A, B, C, W and Y)
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 1379
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 7, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

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.

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: