Phase 4
Completed N=333
Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)
Source: ClinicalTrials.gov NCT04978818 ↗Enrolled (actual)
333
Serious AEs
6.3%
Results posted
Jun 2024
Primary outcomePrimary: Anti-PRP IgG Geometric Mean Concentration (GMC) — 0.40; 0.41 μg/mL — p=0.85
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-PRP IgG Geometric Mean Concentration (GMC) |
0.40; 0.41 | 0.85 |
| SECONDARY Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1 |
104; 115 | 0.39 |
| SECONDARY Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1 |
40; 38 | 0.64 |
| SECONDARY Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121 |
115; 126 | 0.87 |
| SECONDARY Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121 |
100; 102 | 0.3 |
| SECONDARY Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151 |
106; 122 | 0.15 |
| SECONDARY Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 151 |
84; 107 | 0.03 sig |
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)
Data sourced from ClinicalTrials.gov (NCT04978818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.