MedTrace Logo

Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy

NCT02917577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-10-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Autoimmune Rheumatologic Disease

Interventions

BIOLOGICAL

Avaxim Pediatric®

2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine.

BIOLOGICAL

Avaxim ® (adult)

2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Heinrike Schmeling, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-22
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02917577 on ClinicalTrials.gov