Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children

IRB00011170

The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.

2022-01-27

2023-10-26

2023-10-26

Completed

Early phase I

333

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization of participants will be done at the site level. Participants will be assigned randomly 1:1, to the Vaxelis arm or the PedvaxHIB arm. This is an unblinded study. Study staff will log into a secure system to randomize the participant. The study vaccine associated with that randomization will be selected. A verifier will confirm that the correct vaccine was selected. After verification, study staff will administer the dose.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an unblinded, post-licensure study; study staff will not be blinded to participant intervention status.'}}, 'enrollmentInfo': {'count': 333, 'type': 'ACTUAL'}}

2023-12-15