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
Study complete
Study complete
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:
Enrollment:
726
Primary completion date:
2025-31-03
Observational study model:
Not applicable
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
Study complete
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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