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

Sponsor

Laval University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04294433

Collaborator

(none)

480

Enrollment

Locations

Arms

66.6

Anticipated Duration (Months)

240

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Biological: Infanrix-hexa, Twinrix-Junior	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised 1:1 for 2 study groups. Non-randomised for comparator group.Randomised 1:1 for 2 study groups. Non-randomised for comparator group.

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jun 11, 2018

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Infanrix-hexa+Infanrix-hexa+Infanrix-hexa Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa	Biological: Infanrix-hexa, Twinrix-Junior Vaccines administrated according to product monographs' recommendations
Experimental: Infanrix-hexa+Infanrix-hexa Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa	Biological: Infanrix-hexa, Twinrix-Junior Vaccines administrated according to product monographs' recommendations
Experimental: Infanrix-hexa+Twinrix 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	Biological: Infanrix-hexa, Twinrix-Junior Vaccines administrated according to product monographs' recommendations

Arm

Intervention/Treatment

Active Comparator: Infanrix-hexa+Infanrix-hexa+Infanrix-hexa

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

Biological: Infanrix-hexa, Twinrix-Junior

Vaccines administrated according to product monographs' recommendations

Experimental: Infanrix-hexa+Infanrix-hexa

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

Biological: Infanrix-hexa, Twinrix-Junior

Vaccines administrated according to product monographs' recommendations

Experimental: Infanrix-hexa+Twinrix

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

Biological: Infanrix-hexa, Twinrix-Junior

Vaccines administrated according to product monographs' recommendations

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Immune memory [36 months post last primary vaccine dose]
Immune response to a booster dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 19 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.