Overview
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).
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).
Eligibility
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.