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

Phase 3

• Conditions: Hepatitis B
• Interventions: Biological: Infanrix-hexa, Twinrix-Junior

• Registration Number: NCT04294433
• Lead Sponsor: Laval University

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).

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2020-01-29
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-02
• Last Update Submitted: 2020-03-02
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04
• Primary Completion: 2020-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infanrix-hexa+Twinrix	Infanrix-hexa, Twinrix-Junior	Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively
Infanrix-hexa+Infanrix-hexa	Infanrix-hexa, Twinrix-Junior	Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa
Infanrix-hexa+Infanrix-hexa+Infanrix-hexa	Infanrix-hexa, Twinrix-Junior	Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa

Primary Outcome Measures

Name	Time	Method
Immunogenicity	1 month post last dose of vaccine	The proportion of children with an anti-HBs titer ≥10mIU/ml

Secondary Outcome Measures

Name	Time	Method
Immune memory	36 months post last primary vaccine dose	Immune response to a booster dose

Trial Locations

Locations (2)

Laval University Research Hospital Center; 🇨🇦 Quebec, Canada

Équipe de recherche en vaccination; 🇨🇦 Quebec, Canada