At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 333 enrolled
Drug / intervention
Vaxelis +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children
Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jul 27, 2021·Updated Jun 24, 2024
In Brief
A Phase 4 clinical trial evaluating Vaxelis and PedvaxHIB for Haemophilus Influenzae Type B Infection. Completed, enrolled 333 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemophilus Influenzae Type B Infection
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartJan 2022
Primary CompletionOct 2023
TodayJul 2026
First PostedJul 27, 2021
Enrollment StartJan 27, 2022
Primary CompletionOct 26, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.9 years ago
Interventions
Vaxelisdrug
Eligible infants will be block randomized to one of two study arms.
PedvaxHIBdrug
Eligible infants will be block randomized to one of two study arms.