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NCT04978818 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)
A Phase 4 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 333
- Enrollment target
NCT04978818: Completed Phase 4 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT04978818 is a Phase 4 study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 333 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04978818, a Phase 4 study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 333 participants
- Enrollment target
Study 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.
Primary Outcome
The non-inferiority of the anti-PRP IgG Geometric Mean Concentration (GMC) 30 days after dose 1 of Vaxelis administered at 2 months of age, compared to PedvaxHIB. GMC was modeled using constrained longitudinal analysis (cLDA) of anti-PRP IgG concentration at all study visits.
Interventions
- DRUG Vaxelis
- DRUG PedvaxHIB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2023-10-26 |
| Phase | Phase 4 |
What the finished NCT04978818 record still lists
NCT04978818 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Vaxelis is the first listed.
NCT04978818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04978818 about?
NCT04978818 is a clinical study titled "Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)". 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.
What is the current status of trial NCT04978818?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 333 participants. The study started on 2022-01-27. Estimated completion is 2023-10-26.
What interventions are being tested in trial NCT04978818?
The interventions under investigation include: Vaxelis (DRUG), PedvaxHIB (DRUG).
Who is sponsoring clinical trial NCT04978818?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04978818's enrollment target sits among peer trials
333 252nd of 2000 higher than 1,748 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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