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

NCT04978818 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2024-06-24

Study results available
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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.

Conditions

  • Haemophilus Influenzae Type B Infection

Interventions

DRUG

Vaxelis

Eligible infants will be block randomized to one of two study arms.

DRUG

PedvaxHIB

Eligible infants will be block randomized to one of two study arms.

Sponsors & Collaborators

Principal Investigators

  • Laura Hammitt, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2023-10-26
Completion
2023-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04978818 on ClinicalTrials.gov