Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02917577 |
Other study ID # |
HEP-2016 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 22, 2016 |
Est. completion date |
June 2023 |
Study information
Verified date |
July 2023 |
Source |
University of Calgary |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study is a prospective, single centre, double-blinded randomized controlled trial whose
goal is to compare the immune response of a population of immunosuppressed pediatric
rheumatology patients on immunosuppressive medications to two different doses of Hepatitis A
vaccine. The objectives are (a) to confirm that adolescents, like their adult counterparts,
have a reduced immune response to hepatitis A vaccine, and (b) to compare the immunogenicity
of two different dosing options of vaccine for this age group after one and two doses. A
total of 60 adolescents aged 12 - 15 years with confirmed chronic rheumatologic conditions
for which they are being treated with an immunosuppressive therapy will be recruited from the
Rheumatology Clinic at Alberta Children's Hospital (ACH). Those found to have no immunity to
hepatitis A will be enrolled. Informed, written consent will be obtained from the parent or
guardian of subject, with assent obtained from the study subjects. Subjects will be randomly
assigned to two doses of either Avaxim Pediatric® or Avaxim ® (adult) vaccine (Sanofi Pasteur
Canada), six months apart, with hepatitis A titres done at baseline and one month after each
dose. Both formulations are licensed for this age group.
Description:
This is a prospective, single centre, randomized, controlled trial comparing immune responses
to two doses of a licensed Hepatitis A vaccine in children. Subjects will receive 2 doses
(0.5 mL each) of the assigned study vaccine (Avaxim Pediatric® or Avaxim ® (adult) vaccine).
One lot of each vaccine formulation will be studied. All subjects will provide safety
observations using a diary and sequential blood samples will be obtained to measure
serologic/immunologic responses.
The study population will include 60 subjects with confirmed rheumatologic condition on
immunosuppressive medication, males and females, in the age range 12 - 15 years. The maximum
age at enrollment is 15 years and 5 months, to allow for up to 7 months in which to complete
2 doses of vaccine before age 16 years.Both vaccine formulations used in this trial has been
licensed for use in Canada in the age range of the subjects being studied.