Hepatitis B
Conditions
Keywords
Vaccination, Two doses, Infants, Clinical trial, Hepatitis B, Heterologous schedule, Immunogenicity, Randomization, Reduced-dose schedule
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).
Interventions
BIOLOGICALInfanrix-hexa
Vaccines administrated according to product monographs' recommendations
BIOLOGICALInfanrix-hexa and Twinrix Junior
Vaccines administrated according to product monographs' recommendations
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomised 1:1 for 2 study groups. Non-randomised for comparator group.
Eligibility
Sex/Gender
ALL
Age
2 Months to 19 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity - Seroprotection | 1 month after the primary series | The proportion of children with an anti-HBs titer ≥10mIU/ml |
| Immune memory - Anamnestic response | 1 month after a challenge dose administered 36 months after the end of the primary series | Immune response to a challenge dose: anti-HBs titers at least 10 mIU/mL and a fourfold increase in titers |
Countries
Canada
Outcome results
None listed