A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

NCT ID: NCT05082285

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 724 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2025-03-31

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.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ABCWY-2Gen low dose Group

Participants receive 3 doses of the MenABCWY-2Gen low dose vaccine.

Group Type: EXPERIMENTAL

MenABCWY-2Gen low dose vaccine

Intervention Type: COMBINATION_PRODUCT

MenABCWY-2Gen low dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and study Part II.

MenB+MenACWY-TT Group

Participants receive 3 doses of both the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine.

Group Type: ACTIVE_COMPARATOR

MenB vaccine

Intervention Type: COMBINATION_PRODUCT

MenB vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.

MenACWY-TT vaccine

Intervention Type: COMBINATION_PRODUCT

MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.

ABCWY-2Gen high dose Group

Participants receive 3 doses of the MenABCWY-2Gen high dose vaccine in.

Group Type: EXPERIMENTAL

MenABCWY-2Gen high dose vaccine

Intervention Type: COMBINATION_PRODUCT

MenABCWY-2Gen high dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 2 and study Part II.

ABCWY-1Gen Group

Participants receive 3 doses of the MenABCWY-1Gen vaccine.

Group Type: EXPERIMENTAL

MenABCWY-1Gen vaccine

Intervention Type: COMBINATION_PRODUCT

MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part II.

Interventions

MenABCWY-2Gen low dose vaccine

MenABCWY-2Gen low dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and study Part II.

Intervention Type: COMBINATION_PRODUCT

MenABCWY-2Gen high dose vaccine

MenABCWY-2Gen high dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 2 and study Part II.

Intervention Type: COMBINATION_PRODUCT

MenABCWY-1Gen vaccine

MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part II.

Intervention Type: COMBINATION_PRODUCT

MenB vaccine

MenB vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.

Intervention Type: COMBINATION_PRODUCT

MenACWY-TT vaccine

MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Bexsero; Nimenrix

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.

• Minimum Eligible Age: 55 Days
• Maximum Eligible Age: 89 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Santo Domingo Este, , Dominican Republic

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Kokkola, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Gilching, , Germany

GSK Investigational Site

Schönau am Königssee, , Germany

GSK Investigational Site

San Pedro Sula, , Honduras

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Luboń, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Torun, , Poland

GSK Investigational Site

Trzebnica, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Parow Valley, , South Africa

GSK Investigational Site

Soweto Gauteng, , South Africa

GSK Investigational Site

Almería, , Spain

GSK Investigational Site

Burgos, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marbella, , Spain

GSK Investigational Site

Málaga, , Spain

GSK Investigational Site

Santiago de Compostela, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Exeter, , United Kingdom

GSK Investigational Site

Oxford, , United Kingdom

Countries

Dominican Republic; Finland; Germany; Honduras; Poland; South Africa; Spain; United Kingdom

Other Identifiers

2021-001367-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

217043

Identifier Type: -

Identifier Source: org_study_id