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

Hepatitis B Clinical Trial

Official title:

Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04294433
• Other study ID #: Study 11022017
• Status: Recruiting
• Phase: Phase 3
• Start date: June 11, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2020
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 19 Months

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Infanrix-hexa, Twinrix-Junior
Vaccines administrated according to product monographs' recommendations

Locations

Country	Name	City	State
Canada	Équipe de recherche en vaccination	Quebec
Canada	Laval University Research Hospital Center	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	The proportion of children with an anti-HBs titer =10mIU/ml	1 month post last dose of vaccine
Secondary	Immune memory	Immune response to a booster dose	36 months post last primary vaccine dose