Clinical trial NCT05087056: Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Official title: A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Meningitis, Meningococcal
Keywords: MenABCWY
Safety
Tolerability
Immunogenicity
Healthy adolescents
Invasive meningococcal disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 300
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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, hysterectomy, bilateral-salpingectomy 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.
* 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.

Primary outcomes:
measure: Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains
timeFrame: At Baseline (Day 1)
measure: Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains
timeFrame: At 1 month after the second dose of MenABCWY (Day 751 for the ABCWY-24 Group and Day 1471 for the ABCWY-48 Group)
measure: Percentage of participants with solicited administration site events
timeFrame: During the 7 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)
measure: Percentage of participants with solicited systemic events
timeFrame: During the 7 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)
measure: Percentage of participants with any unsolicited adverse events (AEs) including all serious adverse events (SAEs), AEs leading to withdrawal, adverse events of special interest (AESIs) and medically attended AEs
timeFrame: During the 30 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)
measure: Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
timeFrame: During the 6 months (including the day of vaccination) following the first vaccination (Vaccine administered at Day 1)
measure: Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
timeFrame: During the 6 months (including the day of vaccination) following the second vaccination (Vaccine administered at Day 721)
Secondary outcomes:
measure: Percentage of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y
timeFrame: At Baseline (Day 1), 1 month after the first dose of MenABCWY (Day 31) and 1 month after second dose of MenABCWY (Day 751 for the ABCWY-24 Group and Day 1471 for the ABCWY-48 Group)
measure: Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains and for serogroups A, C, W and Y
timeFrame: At 25 months after the second dose of MenABCWY (Day 1471 for the ABCWY-24 Group)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Grand Junction
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Macon
country: United States
facility: GSK Investigational Site
state: Georgia
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Haughton
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Hastings
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Endwell
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Gresham
country: United States
facility: GSK Investigational Site
state: Oregon
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Galveston
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Kaysville
country: United States
facility: GSK Investigational Site
state: Utah
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schoenau Am Koenigssee
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Herxheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Bramsche
country: Germany
facility: GSK Investigational Site
city: Schweigen-Rechtenbach
country: Germany
facility: GSK Investigational Site
Study officials:
References: