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

NCT ID: NCT04294433

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 431 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2023-12-30

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).

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Infanrix-hexa+Infanrix-hexa+Infanrix-hexa

Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa

Group Type: ACTIVE_COMPARATOR

Infanrix-hexa

Intervention Type: BIOLOGICAL

Vaccines administrated according to product monographs' recommendations

Infanrix-hexa+Infanrix-hexa

Children vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa

Group Type: EXPERIMENTAL

Infanrix-hexa

Intervention Type: BIOLOGICAL

Vaccines administrated according to product monographs' recommendations

Infanrix-hexa+Twinrix Junior

Children vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively

Group Type: EXPERIMENTAL

Infanrix-hexa and Twinrix Junior

Intervention Type: BIOLOGICAL

Vaccines administrated according to product monographs' recommendations

Interventions

Infanrix-hexa

Vaccines administrated according to product monographs' recommendations

Intervention Type: BIOLOGICAL

Infanrix-hexa and Twinrix Junior

Vaccines administrated according to product monographs' recommendations

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 19 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laval University Research Hospital Center

Québec, Quebec, Canada

Équipe de recherche en vaccination

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

Study 11022017

Identifier Type: -

Identifier Source: org_study_id