Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT04294433
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
19 Months
Study:
NCT04294433
Study Brief:
Protocol Section:
NCT04294433