Status:
UNKNOWN
Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
Lead Sponsor:
Laval University
Conditions:
Hepatitis B
Eligibility:
All Genders
2-19 years
Phase:
PHASE3
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 ...
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 ne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04294433
Start Date
June 11 2018
End Date
December 30 2023
Last Update
March 4 2020
Active Locations (2)
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1
Laval University Research Hospital Center
Québec, Canada, G1E7G9
2
Équipe de recherche en vaccination
Québec, Canada, G1E7G9