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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

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor

417 Previous Clinical Trials

171,792 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

Frequently Asked Questions

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

Can octogenarians participate in this clinical research?

"This trial is for patients aged 2 months to 19 years old. Out of the 55 trials conducted for those under 18, this is one of 274 trials designed specifically for patients over 65."

Answered by AI

What are the FDA's most recent thoughts on Infanrix-hexa and Twinrix-Junior?

"Infanrix-hexa and Twinrix-Junior have both completed Phase 3 clinical trials, meaning that there is strong evidence to support both their efficacy and safety. As such, our team has given it a score of 3 out of 3."

Answered by AI

Are people who are sick currently able to enroll in this experiment?

"That is correct. Based on the information provided by clinicaltrials.gov, it appears as though this trial is still recruiting patients. This experiment was first posted on June 11th, 2018 and was updated most recently on March 2nd, 2020. They are looking for 480 individuals total between 2 locations."

Answered by AI

To whom does this opportunity to participate in the research open?

"We are looking for 480 individuals infected with hepatitis b that fall between the age ranges of 2 to 19 months old. Most importantly, these potential participants must have received Infanrix-hexa 3 times as part of their regular vaccinations at 2, 4, and 18 months old."

Answered by AI

How many people are receiving this medication as part of the trial?

"That is correct. The clinicaltrials.gov website indicates that this study, which was originally posted on 6/11/2018, is still recruiting patients as of 3/2/2020. A total of 480 individuals are needed for the trial at 2 locations."

Answered by AI

To what purpose are these vaccinations typically put to use?

"Infanrix-hexa and Twinrix-Junior are commonly used to treat haemophilus influenzae type b diseases. However, these vaccines are also effective in other cases such as viral hepatitis b, haemophilus influenzae, and pertussis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children

2018. "Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294433.

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