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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 1 of vaxelis or pedvaxhib

Awards & highlights

Study Summary

This trial will compare the Hib antibody response in AI/AN infants who receive Vaxelis vs. PedvaxHIB.

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after dose 3 of vaxelis and 90 days after dose 2 of pedvaxhib

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after dose 3 of vaxelis and 90 days after dose 2 of pedvaxhib

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after dose 3 of vaxelis and 90 days after dose 2 of pedvaxhib for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

anti-PRP IgG Geometric Mean Concentration (GMC)

Secondary outcome measures

Proportion of anti-PRP IgG ≥0.15 µg/mL 30 days after dose 1

Proportion of anti-PRP IgG ≥0.15 µg/mL and ≥1.0 µg/mL on Day 121

Proportion of anti-PRP IgG ≥0.15 µg/mL and ≥1.0 µg/mL on Day 151

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor

410 Previous Clinical Trials

2,106,597 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,809 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are enrolled in the clinical trial?

"Indeed. As per clinicaltrials.gov, this research endeavor is actively enrolling volunteers since it was initially posted on January 27th 2022; the trial's last update occurred on March 29th of that same year. 330 participants must be sourced from 5 different sites for this experiment to reach its completion point."

Answered by AI

Has the FDA sanctioned Vaxelis for public use?

"Vaxelis was marked with a 3, as Phase 4 trials certify that the treatment is approved and has had multiple safety assessments."

Answered by AI

Is this investigation currently open to new participants?

"Based on the data posted to clinicaltrials.gov, this experimental trial is presently recruiting volunteers and has been continuously updated since its initial posting date of January 27th 2022."

Answered by AI

How many health facilities are playing host to this research project?

"At the moment, 5 medical centres are accepting participants for this trial. These locations are based in Fort Defiance, Whiteriver and Shiprock as well as other cities spread across the country. To reduce travel inconveniences, it is wise to select a site closest to you when signing up."

Answered by AI

What medical ailments is Vaxelis typically employed to address?

"Vaxelis has been approved to treat haemophilus influenzae type b illnesses, as well as viral hepatitis b, haemophilus influenzae related maladies and pertussis."

Answered by AI

What other research initiatives have been undertaken concerning Vaxelis?

"Vaxelis was first studied at Tel Aviv Sourasky Medical Center Dialysis Unit in 2012 and has since been subject to 492 completed trials. Currently, there are 47 active clinical studies taking place with a prominent portion of them located in Fort Defiance, Arizona."

Answered by AI

What type of individual is best suited to partake in this experiment?

"This study seeks 330 volunteers who are between six and twelve weeks old, diagnosed with influenza A/B. Alongside this condition, the infants must have been born after 35 weeks of gestation and be in good health prior to enrollment. Moreover, it is expected that their respective guardians can fulfill all protocol requirements such as returning for follow-up appointments or reporting adverse events throughout a five month period."

Answered by AI