Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT02534935
Eligibility Criteria:
Inclusion Criteria:
* Male or female subject aged 12 to \<15 months or 18 to \<24 months during sentinel-cohort enrollment, Or,12 to \<24 months during expanded-cohort enrollment.
* Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
* Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
* Previous vaccination with any meningococcal serogroup B vaccine.
* Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
* Contraindication to vaccination with any HAV vaccine or known latex allergy.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* A known or suspected disorder of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.
* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
* Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
* Current chronic use of systemic antibiotics.
* Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
* Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
24 Months
Study:
NCT02534935
Study Brief:
Protocol Section:
NCT02534935