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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avaxim Pediatric® | Active Comparator | 2 doses (0.5 mL each) six months apart of Avaxim Pediatric® |
|
| Avaxim ® (adult) | Active Comparator | 2 doses (0.5 mL each) six months apart of Avaxim ® (adult) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avaxim Pediatric® | Biological | 2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis A Antibodies Titre | 6 to 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Heinrike Schmeling, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital/University of Calgary | Calgary | Alberta | T3B6A8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Avaxim Pediatric® | 2 doses (0.5 mL each) six months apart of Avaxim Pediatric® Avaxim Pediatric®: 2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine. |
| FG001 | Avaxim ® (Adult) | 2 doses (0.5 mL each) six months apart of Avaxim ® (adult) Avaxim ® (adult): 2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avaxim Pediatric® | 2 doses (0.5 mL each) six months apart of Avaxim Pediatric® Avaxim Pediatric®: 2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine. |
| BG001 | Avaxim ® (Adult) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hepatitis A Antibodies Titre | Received both vaccinations and serum sample at 4 time-points. | Posted | Median | Inter-Quartile Range | IU/L | 6 to 7 months |
|
Start of adverse event data collection began when participant first signed consent form. End of adverse event data collection finished 28 days after last dosing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avaxim Pediatric® | 2 doses (0.5 mL each) six months apart of Avaxim Pediatric® Avaxim Pediatric®: 2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Tightness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heinrike Schmeling | UCalgary | 4039553194 | schmelingresearch@albertahealthservices.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2017 | Jun 4, 2024 | Prot_SAP_000.pdf |
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| Avaxim ® (adult) | Biological | 2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine. |
|
2 doses (0.5 mL each) six months apart of Avaxim ® (adult)
Avaxim ® (adult): 2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Number | participants |
|
| Conventional and Biologic Disease Modifying Anti-Rheumatic Drugs | Number | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Avaxim ® (Adult) | 2 doses (0.5 mL each) six months apart of Avaxim ® (adult) Avaxim ® (adult): 2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine. | 0 | 9 | 0 | 9 | 1 | 9 |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abdominal Cramping | Gastrointestinal disorders | Non-systematic Assessment |
|
| Naseau | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Weakness | General disorders | Non-systematic Assessment |
|
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