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

Completed · Phase 4

Conditions studied: Haemophilus Influenzae Type B Infection

In brief

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.

Key facts

Study ID

NCT04978818

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

333

Starts

2022-01-27

Expected to finish

2023-10-26

Last updated by the study team

2024-06-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Alaska Native Medical Center — Anchorage, Alaska, United States
• Chinle Center for Indigenous Health — Chinle, Arizona, United States
• Fort Defiance Center for Indigenous Health — Fort Defiance, Arizona, United States
• Gallup Center for Indigenous Health — Gallup, New Mexico, United States
• Shiprock Center for Indigenous Health — Shiprock, New Mexico, United States

Full record on ClinicalTrials.gov

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