Trial Outcomes & Findings for Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies (NCT NCT02387164)
NCT ID: NCT02387164
Last Updated: 2020-11-17
Results Overview
Number of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm month 24
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
24 months
Results posted on
2020-11-17
Participant Flow
29 patients were screened for the study and 26 entered the study. Three patients were screening failures.
Participant milestones
| Measure |
Alum-GAD, Vitamin D3
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD (Glutamic Acid Decarboxylase): Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Alum-GAD, Vitamin D3
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD (Glutamic Acid Decarboxylase): Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Diagnosed
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alum-GAD, Vitamin D3
n=13 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=13 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
26 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Age, Continuous
|
9.0 years
STANDARD_DEVIATION 2.89 • n=13 Participants
|
9.4 years
STANDARD_DEVIATION 2.73 • n=13 Participants
|
9.2 years
STANDARD_DEVIATION 2.76 • n=26 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
11 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
15 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
13 participants
n=13 Participants
|
13 participants
n=13 Participants
|
26 participants
n=26 Participants
|
|
Weight
|
33.7 kg
STANDARD_DEVIATION 14.51 • n=13 Participants
|
36.6 kg
STANDARD_DEVIATION 14.99 • n=13 Participants
|
35.1 kg
STANDARD_DEVIATION 14.53 • n=26 Participants
|
|
Celiac disease
Yes
|
2 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Celiac disease
No
|
11 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
24 Participants
n=26 Participants
|
|
Thyroid disease
Yes
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Thyroid disease
No
|
13 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
26 Participants
n=26 Participants
|
|
Relatedness
First degree relative diagnosed with type 1 diabetes
|
4 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
6 Participants
n=26 Participants
|
|
Relatedness
General population (no relative diagnosed with type 1 diabetes)
|
9 Participants
n=13 Participants
|
11 Participants
n=13 Participants
|
20 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 24 monthsNumber of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm month 24
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=13 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=13 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Type 1 Diabetes Month 24
Yes
|
1 Participants
|
2 Participants
|
|
Type 1 Diabetes Month 24
No
|
12 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Over the entire study period up to 2 yearsNumber of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm overall. Including one patient diagnosed shortly after the month 24 visit.
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=13 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=13 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Type 1 Diabetes Status Overall
Yes
|
2 Participants
|
2 Participants
|
|
Type 1 Diabetes Status Overall
No
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: During 18 months follow-upPopulation: Only patients with normal glucose at baseline and glucose measured at month 18 are included.
Change in metabolic status from normal to impaired glucose metabolism during follow-up in the group of children with normal glucose metabolism at baseline screening. Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more.
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=8 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=6 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Number of Patients Developing Impaired Glucose Metabolism Until Month 18
Yes
|
3 Participants
|
1 Participants
|
|
Number of Patients Developing Impaired Glucose Metabolism Until Month 18
No
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During 18 months follow-upPopulation: Only patients with impaired glucose at baseline and glucose measured at month 18 are included.
Number of patients who have progression from already impaired glucose metabolism from one or several criteria to additional signs of reduced glucose metabolism (within children with impaired glucose metabolism at screening). Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more.
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=2 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=4 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Number of Patients With Progressive Impaired Glucose Metabolism Until Month 18
Yes
|
1 Participants
|
0 Participants
|
|
Number of Patients With Progressive Impaired Glucose Metabolism Until Month 18
No
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1Number of patients experiencing injection site reactions at day 1
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=13 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=13 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Injection Site Reactions Day 1
Erythema
|
0 participants
|
0 participants
|
|
Injection Site Reactions Day 1
Haematoma
|
0 participants
|
0 participants
|
|
Injection Site Reactions Day 1
Itching
|
0 participants
|
0 participants
|
|
Injection Site Reactions Day 1
Oedema
|
0 participants
|
0 participants
|
|
Injection Site Reactions Day 1
Pain
|
0 participants
|
0 participants
|
|
Injection Site Reactions Day 1
Tenderness
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Month 1Number of patients experiencing injection site reactions at month 1
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=13 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=13 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Injection Site Reactions Month 1
Erythema
|
1 participants
|
0 participants
|
|
Injection Site Reactions Month 1
Haematoma
|
1 participants
|
0 participants
|
|
Injection Site Reactions Month 1
Itching
|
0 participants
|
0 participants
|
|
Injection Site Reactions Month 1
Oedema
|
2 participants
|
0 participants
|
|
Injection Site Reactions Month 1
Pain
|
0 participants
|
0 participants
|
|
Injection Site Reactions Month 1
Tenderness
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Month 1Population: Only patients with GADA measured both at baseline and month 1 are included.
Change from baseline to month 1 in GADA (Glutamic Acid Decarboxylase Antibodies) titers
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=13 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=12 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Change From Baseline in GADA Month 1
|
1619.1 U/mL
Standard Deviation 2608.9
|
-51.9 U/mL
Standard Deviation 197.8
|
SECONDARY outcome
Timeframe: Month 12Population: Only patients with GADA measured at baseline and at month 12 are included.
Change from baseline to month 12 in GADA titers
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=10 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=10 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Change From Baseline in GADA Month 12
|
7916.9 U/mL
Standard Deviation 10694.55
|
-120.0 U/mL
Standard Deviation 592.09
|
SECONDARY outcome
Timeframe: Month 24Population: Only patients with GADA measured at baseline and month 24 are included.
Change from baseline to month 24 in GADA titers
Outcome measures
| Measure |
Alum-GAD, Vitamin D3
n=9 Participants
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=11 Participants
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Change From Baseline in GADA Month 24
|
3216.6 U/mL
Standard Deviation 4628.53
|
1062.7 U/mL
Standard Deviation 3380.26
|
Adverse Events
Alum-GAD, Vitamin D3
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo, Vitamin D3
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alum-GAD, Vitamin D3
n=13 participants at risk
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=13 participants at risk
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Renal and urinary disorders
Post streptococcal glomerulonephritis
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
Other adverse events
| Measure |
Alum-GAD, Vitamin D3
n=13 participants at risk
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
Placebo, Vitamin D3
n=13 participants at risk
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily
|
|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
23.1%
3/13 • Number of events 3 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Immune system disorders
Hypersensitivity
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Immune system disorders
Seasonal allergy
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Nervous system disorders
Headache
|
38.5%
5/13 • Number of events 13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
23.1%
3/13 • Number of events 9 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Nervous system disorders
Migraine
|
7.7%
1/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
General disorders
Pyrexia
|
30.8%
4/13 • Number of events 6 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
38.5%
5/13 • Number of events 11 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
General disorders
Pain
|
15.4%
2/13 • Number of events 3 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
General disorders
Fatigue
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
General disorders
Injection site rash
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Ear and labyrinth disorders
Ear pain
|
7.7%
1/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 3 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
15.4%
2/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Gastrointestinal disorders
Food poisoning
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
15.4%
2/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Nasopharyngitis
|
76.9%
10/13 • Number of events 49 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
69.2%
9/13 • Number of events 20 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Ear infection
|
23.1%
3/13 • Number of events 3 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Gastroenteritis
|
23.1%
3/13 • Number of events 3 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 3 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Influenza
|
15.4%
2/13 • Number of events 3 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Pharyngitis
|
15.4%
2/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Otitis media
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Tooth infection
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Varicella
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Viral infection
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Febrile infection
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Infections and infestations
Impetigo
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Psychiatric disorders
Attention deficit/hyperactivit
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 2 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
0.00%
0/13 • During the entire study period approximately 24 months.
At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place