Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)

• Status: Not yet recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborator: Merck Sharp & Dohme Corp.

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)