Last updated: 05/16/2025 06:11:05
A study on the safety, tolerability and immune response of meningococcal combined ABCWY vaccine in healthy infants
GSK study ID
217043
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
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 (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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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)
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)
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)
Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs
Timeframe: During the study period (Day 1 through Day 481)
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)
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
Timeframe: At pre-third vaccination (Day 301)
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
Timeframe: At 1 month after the third vaccination (Day 331)
hSBA geometric mean titers (GMTs) for each serogroup B indicator strain
Timeframe: At 1 month after the second vaccination (Day 91)
hSBA GMTs for each serogroup B indicator strain
Timeframe: At pre-third vaccination (Day 301)
hSBA GMTs for each serogroup B indicator strain
Timeframe: At 1 month after the third vaccination (Day 331)
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)
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)
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
Timeframe: At pre-third vaccination (Day 301)
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)
hSBA GMTs for each A, C, W and Y serogroup
Timeframe: At 1 month after the second vaccination (Day 91)
hSBA GMTs for each A, C, W and Y serogroup
Timeframe: At pre-third vaccination (Day 301)
hSBA GMTs for each A, C, W and Y serogroup
Timeframe: At 1 month after the third vaccination (Day 331)
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:
Not applicable
Interventions:
Enrollment:
724
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
Location
GSK Investigational Site
Santo Domingo Este, Dominican Republic, N/A
Status
Study Complete
Location
GSK Investigational Site
Bristol, United Kingdom, BS2 8AE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2025-31-03
Actual study completion date
2025-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website