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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months post last primary vaccine dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months post last primary vaccine dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunogenicity
Secondary outcome measures
Immune memory
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
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Who is running the clinical trial?
Laval UniversityLead Sponsor
420 Previous Clinical Trials
172,247 Total Patients Enrolled
1 Trials studying Hepatitis B
1,129 Patients Enrolled for Hepatitis B
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your immune system is not functioning properly.You have an autoimmune disease, which means your immune system attacks your own body.You are experiencing a significant delay in your growth and development.You had a severe reaction to a vaccine given during the study.You have already received a hepatitis B vaccine dose.
Research Study Groups:
This trial has the following groups:- Group 1: Infanrix-hexa+Infanrix-hexa+Infanrix-hexa
- Group 2: Infanrix-hexa+Infanrix-hexa
- Group 3: Infanrix-hexa+Twinrix
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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