Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children

  • STATUS
    Recruiting
  • participants needed
    480
  • sponsor
    Laval University
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Updated on 16 February 2024
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vaccination
hepatitis
infanrix
twinrix

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).

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).

Details
Condition Hepatitis B, Hepatitis B
Age 1years - 1years
Treatment Infanrix-hexa, Twinrix-Junior
Clinical Study IdentifierNCT04294433
SponsorLaval University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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