Clinical trial NCT05082285: A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
Official title: A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Keywords: MenABCWY-2Gen
MenABCWY-1Gen
Bexsero
Nimenrix
Safety
Tolerability
Immunogenicity
Invasive Meningococcal Disease
Healthy infants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 724
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
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-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.


Eligibility criteria: Inclusion Criteria:

* 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 parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
* Healthy participants as established by medical history and clinical examination before entering into the study.
* A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
* Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.

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 from birth.
* Progressive, unstable or uncontrolled clinical conditions.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures.
* Congenital or peripartum disorders resulting in a chronic condition
* Major congenital defects, as assessed by the investigator.
* 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 starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
* Administration of antineoplastic and immunomodulating agents or radiotherapy from birth.
* 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 vaccines from birth, or planned use during the study period.
* Previous vaccination with any meningococcal vaccine.
* Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. 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.
* Study personnel as an immediate family or household member.
* For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.

Primary outcomes:
measure: Percentage of participants with solicited administration site events
timeFrame: During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
measure: Percentage of participants with solicited systemic events
timeFrame: During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
measure: Percentage of participants with any unsolicited adverse events (AEs), including all medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal, and adverse events of special interest (AESIs)
timeFrame: During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
measure: Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs
timeFrame: During the study period (Day 1 through Day 481)
measure: Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each serogroup B indicator strain
timeFrame: At 1 month after the second vaccination (Day 91)
measure: Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
timeFrame: At pre-third vaccination (Day 301)
measure: Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
timeFrame: At 1 month after the third vaccination (Day 331)
measure: hSBA geometric mean titers (GMTs) for each serogroup B indicator strain
timeFrame: At 1 month after the second vaccination (Day 91)
measure: hSBA GMTs for each serogroup B indicator strain
timeFrame: At pre-third vaccination (Day 301)
measure: hSBA GMTs for each serogroup B indicator strain
timeFrame: At 1 month after the third vaccination (Day 331)
measure: Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain
timeFrame: At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)
measure: Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
timeFrame: At 1 month after the second vaccination (Day 91)
measure: Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
timeFrame: At pre-third vaccination (Day 301)
measure: Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
timeFrame: At 1 month after the third vaccination (Day 331)
measure: hSBA GMTs for each A, C, W and Y serogroup
timeFrame: At 1 month after the second vaccination (Day 91)
measure: hSBA GMTs for each A, C, W and Y serogroup
timeFrame: At pre-third vaccination (Day 301)
measure: hSBA GMTs for each A, C, W and Y serogroup
timeFrame: At 1 month after the third vaccination (Day 331)
measure: Within group hSBA GMRs for each A, C, W and Y serogroup
timeFrame: At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Domingo Este
country: Dominican Republic
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Gilching
country: Germany
facility: GSK Investigational Site
city: Schoenau Am Koenigssee
country: Germany
facility: GSK Investigational Site
city: San Pedro Sula
country: Honduras
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lubon
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Trzebnica
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Parow Valley
country: South Africa
facility: GSK Investigational Site
city: Soweto Gauteng
country: South Africa
facility: GSK Investigational Site
city: Almeria
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Exeter
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References: