Trial Outcomes & Findings for Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy (NCT NCT02917577)
NCT ID: NCT02917577
Last Updated: 2024-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
6 to 7 months
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Avaxim Pediatric®
n=10 Participants
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.
|
Avaxim ® (Adult)
n=9 Participants
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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
4 Participants
n=9 Participants
|
11 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
8 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
19 participants
n=19 Participants
|
|
Diagnosis
JIA
|
9 participants
n=10 Participants
|
7 participants
n=9 Participants
|
16 participants
n=19 Participants
|
|
Diagnosis
Crohn
|
1 participants
n=10 Participants
|
2 participants
n=9 Participants
|
3 participants
n=19 Participants
|
|
Conventional and Biologic Disease Modifying Anti-Rheumatic Drugs
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: 6 to 7 monthsPopulation: Received both vaccinations and serum sample at 4 time-points.
Outcome measures
| Measure |
Avaxim Pediatric®
n=9 Participants
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.
|
Avaxim ® (Adult)
n=7 Participants
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.
|
|---|---|---|
|
Hepatitis A Antibodies Titre
Baseline (t1)
|
9.4 IU/L
Interval 9.1 to 11.0
|
9.0 IU/L
Interval 7.8 to 9.4
|
|
Hepatitis A Antibodies Titre
First dose (t2)
|
394.7 IU/L
Interval 218.65 to 738.4
|
810.6 IU/L
Interval 317.6 to 2222.0
|
|
Hepatitis A Antibodies Titre
1 month after (t3)
|
343.0 IU/L
Interval 148.8 to 719.35
|
310.2 IU/L
Interval 103.45 to 413.45
|
|
Hepatitis A Antibodies Titre
Second dose (t4)
|
3975.0 IU/L
Interval 2282.25 to 21515.0
|
9372.0 IU/L
Interval 1676.6 to 17722.5
|
Adverse Events
Avaxim Pediatric®
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Avaxim ® (Adult)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Avaxim Pediatric®
n=10 participants at risk
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.
|
Avaxim ® (Adult)
n=9 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest Tightness
|
0.00%
0/10 • 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.
|
11.1%
1/9 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/10 • 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.
|
11.1%
1/9 • 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.
|
|
Gastrointestinal disorders
Abdominal Cramping
|
0.00%
0/10 • 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.
|
11.1%
1/9 • 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.
|
|
General disorders
Naseau
|
20.0%
2/10 • 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.
|
0.00%
0/9 • 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.
|
|
General disorders
Fever
|
10.0%
1/10 • 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.
|
0.00%
0/9 • 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.
|
|
General disorders
Headache
|
10.0%
1/10 • 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.
|
0.00%
0/9 • 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.
|
|
General disorders
Weakness
|
10.0%
1/10 • 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.
|
0.00%
0/9 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place