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Cancer Vaccine

Hib Vaccines for Haemophilus Influenzae Infection

Phase 4
Waitlist Available
Led By Laura Hammitt, MD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after dose 3 of vaxelis and 90 days after dose 2 of pedvaxhib
Awards & highlights

Summary

This trial aims to determine which of two vaccines better protects American Indian and Alaska Native infants from a bacterial infection. These infants are at higher risk and need early protection. The vaccines help the immune system recognize and fight the bacteria.

Who is the study for?
This trial is for healthy American Indian and Alaska Native infants aged 6 to 12 weeks, born at ≥35 weeks of gestation. They must be able to complete a 5-month follow-up and have parental consent. Infants with severe heart disease, immunocompromising conditions, or those who've received blood products or certain medications are excluded.
What is being tested?
The HibVax Study aims to compare the immune response in AI/AN infants given two different licensed vaccines: Vaxelis and PedvaxHIB. The study will monitor how well these vaccines stimulate defense against Haemophilus influenzae type b.
What are the potential side effects?
Potential side effects from the vaccines may include redness or swelling at the injection site, fever, irritability, sleepiness, allergic reactions to vaccine components like latex, or other mild symptoms typically associated with infant vaccinations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after dose 1 of vaxelis or pedvaxhib
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after dose 1 of vaxelis or pedvaxhib for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anti-PRP IgG Geometric Mean Concentration (GMC)
Secondary study objectives
Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151
+3 more

Trial Design

2Treatment groups
Active Control
Group I: VaxelisActive Control1 Intervention
165 infants will be randomized to the Vaxelis group, which is licensed for primary vaccination at 2, 4 and 6 months of age.
Group II: PedvaxHIB armActive Control1 Intervention
165 infants will be randomized to the PedvaxHIB group, which is licensed for primary vaccination at 2 and 4 months of age.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Haemophilus influenzae infection, particularly type b (Hib), involve vaccination with vaccines like Vaxelis and PedvaxHIB. These vaccines work by stimulating the immune system to produce specific antibodies against the polysaccharide capsule of Haemophilus influenzae type b. This immune response is crucial as it provides long-term protection by enabling the body to recognize and combat the bacteria more effectively if exposed in the future. For patients, this means a significantly reduced risk of severe infections such as meningitis, pneumonia, and epiglottitis, which are associated with Hib.

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
423 Previous Clinical Trials
2,123,183 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,966 Previous Clinical Trials
5,176,340 Total Patients Enrolled
Laura Hammitt, MDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
3 Previous Clinical Trials
764 Total Patients Enrolled

Media Library

PedvaxHIB (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04978818 — Phase 4
Haemophilus Influenzae Infection Research Study Groups: Vaxelis, PedvaxHIB arm
Haemophilus Influenzae Infection Clinical Trial 2023: PedvaxHIB Highlights & Side Effects. Trial Name: NCT04978818 — Phase 4
PedvaxHIB (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04978818 — Phase 4
~91 spots leftby Oct 2025