Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Laval University
- Enrollment
- 431
- Locations
- 4
- Primary Endpoint
- Immunogenicity
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 2 Months to 19 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
- •Considered immunosuppressed;
- •Have an autoimmune disease;
- •Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;
- •Have a bleeding disorder;
- •Have a significant developmental delay;
- •Have or plan to participate in other clinical studies with vaccines or products not licensed in Canada;
- •Have presented a serious clinical condition to the vaccines administered as part of the study.
Outcomes
Primary Outcomes
Immunogenicity
Time Frame: 1 month post last dose of vaccine
The proportion of children with an anti-HBs titer ≥10mIU/ml
Secondary Outcomes
- Immune memory(36 months post last primary vaccine dose)