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 19 February 2024

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vaccination

hepatitis

infanrix

twinrix

Summary

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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 Identifier	NCT04294433
Sponsor	Laval University
Last Modified on	19 February 2024

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