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Virus Vaccine

Hepatitis B Vaccine Dosing for Children

Phase 3
Waitlist Available
Research Sponsored by Laval University
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 36 months post last primary vaccine dose
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing different vaccination schedules for hepatitis B in young children to see which is most immunogenic.

Who is the study for?
This trial is for children aged 2-18 months who have started their regular vaccination program. They must not be immunosuppressed, have autoimmune or bleeding disorders, contraindications to HBV vaccine, significant developmental delays, or participation in other clinical studies with unapproved vaccines or products.
What is being tested?
The study aims to compare the effectiveness of hepatitis B immunization using different schedules: (I) two doses of Infanrix-hexa at 2 and 12 months; (II) one dose of Infanrix-hexa and one dose of Twinrix-Junior at the same ages; versus (III) three doses of Infanrix-hexa given at 2, 4 and 18 months.
What are the potential side effects?
Possible side effects from the vaccines may include soreness at injection site, fever, irritability in infants after receiving shots. Serious side effects are rare but can include allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months post last primary vaccine dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months post last primary vaccine dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Immunogenicity
Secondary study objectives
Immune memory

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Infanrix-hexa+TwinrixExperimental Treatment1 Intervention
Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively
Group II: Infanrix-hexa+Infanrix-hexaExperimental Treatment1 Intervention
Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa
Group III: Infanrix-hexa+Infanrix-hexa+Infanrix-hexaActive Control1 Intervention
Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor
430 Previous Clinical Trials
177,915 Total Patients Enrolled
1 Trials studying Hepatitis B
1,129 Patients Enrolled for Hepatitis B

Media Library

Infanrix-hexa (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04294433 — Phase 3
Hepatitis B Research Study Groups: Infanrix-hexa+Infanrix-hexa+Infanrix-hexa, Infanrix-hexa+Infanrix-hexa, Infanrix-hexa+Twinrix
Hepatitis B Clinical Trial 2023: Infanrix-hexa Highlights & Side Effects. Trial Name: NCT04294433 — Phase 3
Infanrix-hexa (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294433 — Phase 3
~65 spots leftby Nov 2025
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