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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT04978818
Eligibility Criteria:
Inclusion Criteria:
* Born at gestational age of ≥35 weeks
* AI/AN infant between 6 to 12 weeks of age (42-90 days) at the time of the first vaccination (i.e., Study Day 1)
* Written informed consent provided by parent(s)/Legally Authorized Representative(s) (LARs)
* Investigators believe that the parent(s)/LARs can and will comply with the requirements of the protocol (i.e., return for follow-up visits, recall of adverse events)
* Infant is available to complete the follow-up period of 5 months
* Healthy infant, as established by medical history and clinical examination before entering the study
Exclusion Criteria:
* History of receipt of blood, blood products, or immunoglobulin products since birth or expected receipt through the duration of the study
* Chronic seizure or evolving or unstable neurologic disorder
* Congenital Heart Disease, except for uncomplicated CHD (e.g., PDA, small septal defect)
* Infant of mother with HIV infection
* History of reaction or hypersensitivity likely to be exacerbated by any vaccine component, or to latex
* Infant with confirmed or suspected immunocompromising medical condition, based on medical history, including chronic administration (more than 14 days in the lifetime) of immunosuppressants or other immune-modifying drugs since birth
* Administration of infant vaccines other than birth dose Hepatitis B, prior to the time of enrollment
* Any condition which might interfere with the evaluation of the investigational product, or interpretation of subject safety or study results, in the opinion of the investigator
* Child of an employee of the sponsor, clinical study site, or any other individual involved with the conduct of the study, or an immediate family member of such individuals
* Acute illness and/or fever (temperature ≥100.4 F or ≥38.0 C) at time of enrollment (Note: Participant with fever may be enrolled at later date if symptoms have resolved and all other criteria for inclusion are met at that time)
* Current (or within the past 7 days) or expected receipt of immunosuppressive agents, including steroids, except topical or inhaled steroids (Note: For oral corticosteroids, this will mean prednisone (≥ 0.5 mg/kg/day, or equivalent; participant may be enrolled at a later date if medication use ends and all other criteria for inclusion are met at that time)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
12 Weeks
Study:
NCT04978818
Study Brief:
Protocol Section:
NCT04978818