Clinical trial NCT04294433: Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Vaccination
Two doses
Infants
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 480
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised 1:1 for 2 study groups. Non-randomised for comparator group.
Primary purpose: PREVENTION

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).

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;

  * 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.

Primary outcomes:
measure: Immunogenicity
timeFrame: 1 month post last dose of vaccine
Secondary outcomes:
measure: Immune memory
timeFrame: 36 months post last primary vaccine dose
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Laval University Research Hospital Center
city: Quebec
country: Canada
facility: Équipe de recherche en vaccination
Study officials:
References: