CompletedNCT02917577Updated Oct 3, 2024Results posted

Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy

An interventional study of Avaxim Pediatric® and Avaxim ® (adult) in Autoimmune Rheumatologic Disease, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by University of Calgary · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 19
Allocation: Randomized
Ages: 12 Years to 15 Years
Sex: All

Study 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.

Read the detailed 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.

Conditions studied

Autoimmune Rheumatologic Disease

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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 19 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 15 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 doses. When Twinrix® has been studied, the response to Hepatitis B is amplified by the presence of Hepatitis A. It is unknown whether the reverse is also true.
Routine childhood vaccines (except MMR and Varicella) must be separated from a study vaccination by at least 7 days.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 19 participants (actual)

Study arms

Active comparator
Avaxim Pediatric®
2 doses (0.5 mL each) six months apart of Avaxim Pediatric®
Biological: Avaxim Pediatric®
Active comparator
Avaxim ® (adult)
2 doses (0.5 mL each) six months apart of Avaxim ® (adult)
Biological: Avaxim ® (adult)

Interventions

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

What researchers measure

Primary outcomes

Hepatitis A Antibodies Titre
Time frame: 6 to 7 months

Results

Posted Oct 3, 2024

Participant flow

Participant flow — Overall Study
Milestone	Avaxim Pediatric®	Avaxim ® (Adult)
Started	10	9
Completed	9	7
Not completed	1	2

Outcome measures

PrimaryHepatitis A Antibodies Titre

Time frame:: 6 to 7 months
Reported as:: Median · IU/L

Hepatitis A Antibodies Titre
IU/L	Avaxim Pediatric®	Avaxim ® (Adult)
Baseline (t1)	9.4 (9.1 to 11)	9.0 (7.8 to 9.4)
First dose (t2)	394.7 (218.65 to 738.4)	810.6 (317.6 to 2222)
1 month after (t3)	343.0 (148.8 to 719.35)	310.2 (103.45 to 413.45)
Second dose (t4)	3975.0 (2282.25 to 21515)	9372.0 (1676.6 to 17722.5)

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Avaxim Pediatric®	0/10 (0%)	0/10 (0%)	2/10 (20%)
Avaxim ® (Adult)	0/9 (0%)	0/9 (0%)	1/9 (11.1%)

Most frequent other events

Most frequent other events
Event	Avaxim Pediatric®	Avaxim ® (Adult)
NaseauGeneral disorders	2/10	0/9
Chest TightnessRespiratory, thoracic and mediastinal disorders	0/10	1/9
Shortness of BreathRespiratory, thoracic and mediastinal disorders	0/10	1/9
Abdominal CrampingGastrointestinal disorders	0/10	1/9
FeverGeneral disorders	1/10	0/9
HeadacheGeneral disorders	1/10	0/9
WeaknessGeneral disorders	1/10	0/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Avaxim Pediatric®	Avaxim ® (Adult)	Total
<=18 years	10	9	19
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Avaxim Pediatric®	Avaxim ® (Adult)	Total
Female	7	4	11
Male	3	5	8

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Avaxim Pediatric®	Avaxim ® (Adult)	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Avaxim Pediatric®	Avaxim ® (Adult)	Total
Canada	10	9	19

Diagnosis
Diagnosis(participants)	Avaxim Pediatric®	Avaxim ® (Adult)	Total
JIA	9	7	16
Crohn	1	2	3

Conventional and Biologic Disease Modifying Anti-Rheumatic Drugs
Conventional and Biologic Disease Modifying Anti-Rheumatic Drugs(Participants)	Avaxim Pediatric®	Avaxim ® (Adult)	Total
Number	10	9	19

Study locations

1 site

Alberta Children's Hospital/University of Calgary
Calgary, Alberta T3B6A8, Canada

References and documents

Study documents

Protocol and statistical analysis plan · Jun 9, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02917577
Lead sponsor: University of Calgary
Responsible party: Heinrike Schmeling (Associate Professor, University of Calgary) — Principal investigator
First posted: Sep 28, 2016
Start date: Nov 22, 2016
Primary completion: Jun 2023
Completion: Jun 2023
Results posted: Oct 3, 2024
Last update: Oct 3, 2024

Study contacts

Heinrike Schmeling, MD

principal investigator · University of Calgary

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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