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

March 2, 2020 updated by: Laval University

Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months

The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the province of Quebec, Canada, hepatitis B vaccination of infants involves three doses of vaccine, 2, 4 and 18 months of age. However, in the current epidemiological context (virtual absence of new cases in young Quebecers) and taking into account scientific data which consistently show a high immunogenicity and efficacy of two doses of hepatitis B vaccine, the relevance of the second dose given at the age of 4 months is questionable.

this study is designed to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1E7G9
        • Recruiting
        • Laval University Research Hospital Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vladimir Gilca, MD, PhD
      • Quebec, Canada, G1E7G9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Comparator group :

  • have received 3 doses of Infanrix-hexa as part of the regular vaccination program at the age of 2, 4 and 18 months.

    • Study groups:

  • have received 1 dose of Infanrix-hexa as part of the regular vaccination program at the age of 2 months.

Exclusion Criteria:

  • Have received other doses of hepatitis B vaccine;

    • Be considered immunosuppressed;
    • Have an autoimmune disease;
    • Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;
    • Have a bleeding disorder;
    • Be significantly delayed in development;
    • Have or plan to participate in other clinical studies with vaccines or products not approved in Canada;
    • Have presented a serious clinical condition to the vaccines administered as part of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infanrix-hexa+Infanrix-hexa+Infanrix-hexa
Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa
Biological: Infanrix-hexa, Twinrix-Junior
Vaccines administrated according to product monographs' recommendations
Experimental: Infanrix-hexa+Infanrix-hexa
Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa
Biological: Infanrix-hexa, Twinrix-Junior
Vaccines administrated according to product monographs' recommendations
Experimental: Infanrix-hexa+Twinrix
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
Biological: Infanrix-hexa, Twinrix-Junior
Vaccines administrated according to product monographs' recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: 1 month post last dose of vaccine
The proportion of children with an anti-HBs titer ≥10mIU/ml
1 month post last dose of vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune memory
Time Frame: 36 months post last primary vaccine dose
Immune response to a booster dose
36 months post last primary vaccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2018

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study 11022017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual data will be shared with any other researchers outside of this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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