Back to resultsImmunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
Primary Purpose
Hepatitis B
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Infanrix-hexa, Twinrix-Junior
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Vaccination, Two doses, Infants
Eligibility Criteria
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.
Sites / Locations
- Laval University Research Hospital CenterRecruiting
- Équipe de recherche en vaccinationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Infanrix-hexa+Infanrix-hexa+Infanrix-hexa
Infanrix-hexa+Infanrix-hexa
Infanrix-hexa+Twinrix
Arm Description
Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa
Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa
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
Outcomes
Primary Outcome Measures
Immunogenicity
The proportion of children with an anti-HBs titer ≥10mIU/ml
Secondary Outcome Measures
Immune memory
Immune response to a booster dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04294433
Brief Title
Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
Official Title
Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Vaccination, Two doses, Infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomised 1:1 for 2 study groups. Non-randomised for comparator group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infanrix-hexa+Infanrix-hexa+Infanrix-hexa
Arm Type
Active Comparator
Arm Description
Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa
Arm Title
Infanrix-hexa+Infanrix-hexa
Arm Type
Experimental
Arm Description
Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa
Arm Title
Infanrix-hexa+Twinrix
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Infanrix-hexa, Twinrix-Junior
Intervention Description
Vaccines administrated according to product monographs' recommendations
Primary Outcome Measure Information:
Title
Immunogenicity
Description
The proportion of children with an anti-HBs titer ≥10mIU/ml
Time Frame
1 month post last dose of vaccine
Secondary Outcome Measure Information:
Title
Immune memory
Description
Immune response to a booster dose
Time Frame
36 months post last primary vaccine dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
19 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Laval University Research Hospital Center
City
Quebec
ZIP/Postal Code
G1E7G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Gilca, MD, PhD
Phone
4186667000
Ext
510
Email
vladimir.gilca@inspq.qc.ca
First Name & Middle Initial & Last Name & Degree
Chantal Sauvageau, MD, MSc
Phone
4186667000
Ext
368
Email
chantal.sauvageau@inspq.qc.ca
First Name & Middle Initial & Last Name & Degree
Vladimir Gilca, MD, PhD
Facility Name
Équipe de recherche en vaccination
City
Quebec
ZIP/Postal Code
G1E7G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Gilca, MD, PhD
Phone
418 666 7000
Ext
510
Email
vladimir.gilca@inspq.qc.ca
First Name & Middle Initial & Last Name & Degree
France Bouchard, RN
Phone
418 666 7000
Ext
323
Email
france.bouchard@ssss.gouv.qc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual data will be shared with any other researchers outside of this study
Learn more about this trial
Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
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