Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy (NCT02917577) | Clinical Trial Compass
CompletedNot Applicable
Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy
Canada19 participantsStarted 2016-11-22
Plain-language 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.
Who can participate
Age range
12 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent provided for the subject by a parent or legal guardian.
* Written informed assent from the participants themselves.
* Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel and contactable by telephone).
* Age 12 years to 15 years and 5 months
* Confirmed chronic rheumatologic condition
* Maintained on any immunosuppressive medication with the exception of pulse steroids
Exclusion Criteria:
* Systemic hypersensitivity to any Hepatitis A vaccine component such as neomycin, 2-phenoxyethanol, formaldehyde, aluminum hydroxide, Medium 199 Hanks, or Polysorbate 80.
* Thrombocytopenia or any bleeding disorder that contraindicates IM injection or blood collection.
* Receipt of blood or any blood-derived products (including IVIG) within the past 3 months.
* Previous laboratory-confirmed infection with Hepatitis A
* Previous vaccination with any Hepatitis A vaccine
The following conditions are temporary or self-limiting exclusions so a subject can be vaccinated once the condition has resolved and no other exclusion criteria exist:
* Current febrile illness or oral temperature of ≥ 38.5 °C (or equivalent by other route) or other moderate to severe illness within 24 hours before study vaccine administration
* Receipt of any Hepatitis B vaccine within 28 days of planned study vaccine dos…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.