Last updated: 04/03/2026 07:40:42
A study on the safety, tolerability and immune response of meningococcal combined ABCWY vaccine in healthy infants
EudraCT ID
EU CT Number
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of participants reporting any solicited administration site events after the first vaccination administered on Day 1
Timeframe: From Day 1 to Day 7
Number of participants reporting any solicited systemic events after the first vaccination administered on Day 1
Timeframe: From Day 1 to Day 7
Number of participants reporting any solicited administration site events after the second vaccination administered on Day 61
Timeframe: From Day 61 to Day 67
Number of participants reporting any solicited systemic events after the second vaccination administered on Day 61
Timeframe: From Day 61 to Day 67
Number of participants reporting any solicited administration site events after the third vaccination administered on Day 301
Timeframe: From Day 301 to Day 307
Number of participants reporting any solicited systemic events after the third vaccination administered on Day 301
Timeframe: From Day 301 to Day 307
Number of participants reporting any unsolicited adverse events (AEs) after the first vaccination administered on Day 1
Timeframe: From Day 1 to Day 30
Number of participants reporting any unsolicited AEs after the second vaccination administered on Day 61
Timeframe: From Day 61 to Day 90
Number of participants reporting any unsolicited AEs after the third vaccination administered on Day 301
Timeframe: From Day 301 to Day 330
Number of participants reporting MAAEs, SAEs, AEs leading to withdrawal, and AESIs
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: At Day 91 (1 month after the second vaccination)
hSBA GMTs for each serogroup B indicator strain at pre-third vaccination
Timeframe: At Day 301 (pre-third vaccination)
hSBA GMTs for each serogroup B indicator strain at 1 month after the third vaccination
Timeframe: At Day 331 (1 month after the third vaccination)
hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: At Day 91 (1 month after the second vaccination)
hSBA GMTs for each A, C, W and Y serogroup at pre-third vaccination
Timeframe: At Day 301 (pre-third vaccination)
hSBA GMTs for each A, C, W and Y serogroup at 1 month after the third vaccination
Timeframe: At Day 331 (1 month after the third vaccination)
hSBA GMRs for each A, C, W and Y serogroup
Timeframe: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)
Secondary outcomes:
Not applicable
Interventions:
Combination product: MenACWY-7B low dose vaccine
Combination product: MenACWY-7B high dose vaccine
Combination product: MenABCWY-1Gen vaccine
Combination product: MenB vaccine
Combination product: MenACWY-TT vaccine
Enrollment:
726
Observational study model:
Not applicable
Primary completion date:
2025-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2021 to March 2025
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
55 - 89 Days
Accepts healthy volunteers
Yes
- 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.
- Medical conditions
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Schoenau am Koenigssee, Germany, 83471
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2025-31-03
Actual study completion date
2025-31-03
Plain language summaries
Summary of results in plain language
Available language(s): English, Afrikaans, Finnish, German, Polish, Sesotho, Spanish (Dominican Republic), Spanish (Honduras), Spanish, Xhosa, Zulu
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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