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

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 interp…