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

NCT05082285 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2170432021-001367-242023-506449-40-00
• Study Type: interventional
• Target: 726
• Locations: 8 countries
• Sites: 33

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 (MenACWY-7b) 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

Keywords

MenACWY-7B; MenABCWY-1Gen; Bexsero; Nimenrix; Safety; Tolerability; Immunogenicity; Invasive Meningococcal Disease; Healthy infants

Outcome Measures

Primary Outcomes (24)

• Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1

  The solicited administration site events include tenderness (administration site pain), erythema (redness), induration and swelling. Any solicited administration site events = occurrence of the event regardless of intensity grade. Data for solicited administration site events is presented for each intervention administered in each arm group.

  From Day 1 to Day 7

• Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1

  The solicited systemic events included diarrhoea, drowsiness (somnolence), fever (pyrexia), irritability/fussiness, loss of appetite, and vomiting. Fever is defined as temperature \>38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.

  From Day 1 to Day 7

• Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61

  From Day 61 to Day 67

• Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61

  From Day 61 to Day 67

• Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301

  From Day 301 to Day 307

• Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301

  From Day 301 to Day 307

• Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1

  Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs (MAAEs). Any = occurrence of the event regardless of the intensity grade.

  From Day 1 to Day 30

• Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61

  From Day 61 to Day 90

• Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301

  From Day 301 to Day 330

• Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs

  MAAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. AEs leading to withdrawal are defined as AEs due which the participant is considered to have withdrawn from the study as no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact.

  From Day 1 to Day 481

• Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination

  The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine was evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains fHbp, NadA, NHBA, PorA, fHbp V1.13, fHbp V2 and fHbp V3.

  At Day 91 (1 month after the second vaccination)

• Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination

  At Day 301 (pre-third vaccination)

• Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination

  At Day 331 (1 month after the third vaccination)

• hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination

  The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs.

  At Day 91 (1 month after the second vaccination)

• hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination

  At Day 301 (pre-third vaccination)

• hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination

  At Day 331 (1 month after the third vaccination)

• hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain

  The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301.

  At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)

• Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination

  The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y.

  At Day 91 (1 month after the second vaccination)

• Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination

  At Day 301 (pre-third vaccination)

• Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination

  At Day 331 (1 month after the third vaccination)

• hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination

  The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs.

  At Day 91 (1 month after the second vaccination)

• hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination

  At Day 301 (pre-third vaccination)

• hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination

  At Day 331 (1 month after the third vaccination)

• hSBA GMRs for Each A, C, W and Y Serogroup

  At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)

Study Arms (4)

MenACWY-7B low dose Group

EXPERIMENTAL

Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.

Combination Product: MenACWY-7B low dose vaccine

MenB+MenACWY-TT Group

ACTIVE COMPARATOR

Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Combination Product: MenB vaccine; Combination Product: MenACWY-TT vaccine

MenACWY-7B high dose Group

EXPERIMENTAL

Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.

Combination Product: MenACWY-7B high dose vaccine

ABCWY-1Gen Group

EXPERIMENTAL

Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.

Combination Product: MenABCWY-1Gen vaccine

Interventions

MenABCWY-1Gen vaccine COMBINATION_PRODUCT

MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg.

ABCWY-1Gen Group

MenB vaccine COMBINATION_PRODUCT

MenB vaccine is administered intramuscularly in the upper thigh region of the right leg.

Also known as: Bexsero

MenB+MenACWY-TT Group

MenACWY-TT vaccine COMBINATION_PRODUCT

MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg.

Also known as: Nimenrix

MenB+MenACWY-TT Group

MenACWY-7B low dose vaccine COMBINATION_PRODUCT

MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg.

MenACWY-7B low dose Group

MenACWY-7B high dose vaccine COMBINATION_PRODUCT

MenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg.

MenACWY-7B high dose Group

Eligibility Criteria

• Age: 55 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (33)

GSK Investigational Site

Santo Domingo Este, Dominican Republic

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Gilching, 82205, Germany

Location

GSK Investigational Site

Schönau am Königssee, 83471, Germany

Location

GSK Investigational Site

San Pedro Sula, 21101, Honduras

Location

GSK Investigational Site

Bydgoszcz, 85-048, Poland

Location

GSK Investigational Site

Krakow, 30-348, Poland

Location

GSK Investigational Site

Krakow, 30-644, Poland

Location

GSK Investigational Site

Luboń, 62-030, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Torun, 87-100, Poland

Location

GSK Investigational Site

Trzebnica, 55-100, Poland

Location

GSK Investigational Site

Warsaw, 02-647, Poland

Location

GSK Investigational Site

Wroclaw, 50368, Poland

Location

GSK Investigational Site

Parow Valley, 7505, South Africa

Location

GSK Investigational Site

Soweto Gauteng, 2013, South Africa

Location

GSK Investigational Site

Almería, 04120, Spain

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Madrid, 28222, Spain

Location

GSK Investigational Site

Marbella, 29600, Spain

Location

GSK Investigational Site

Málaga, 29004, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Exeter, EX2 5DW, United Kingdom

Location

GSK Investigational Site

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Vaccines; 4CMenB vaccine; tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 18, 2021
• Study Start: November 29, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 26, 2026
• Results First Posted: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

HO (1); PL (9); ES (10); DE (2); ZA (2); FI (6); GB (2); DO (1)