Trial Outcomes & Findings for Diabetes Prevention - Immune Tolerance (NCT NCT01122446)
NCT ID: NCT01122446
Last Updated: 2019-05-06
Results Overview
Adverse events, serious adverse events, hematology, chemistry, autoantibody titles by treatment group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
During 5 years follow up from treatment
Results posted on
2019-05-06
Participant Flow
Participant milestones
| Measure |
Placebo Comparator
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo Comparator
n=25 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=25 Participants
|
11 Participants
n=25 Participants
|
23 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants
|
14 Participants
n=25 Participants
|
27 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: During 5 years follow up from treatmentAdverse events, serious adverse events, hematology, chemistry, autoantibody titles by treatment group
Outcome measures
| Measure |
Placebo Comparator
n=25 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
Adverse Events
|
2 Serious adverse events
|
2 Serious adverse events
|
SECONDARY outcome
Timeframe: During 5 years follow up from treatmentPopulation: Number of participants developing diabetes during 5 year follow up in each group
Onset of Type 1 diabetes, defined according to ADA criteria, by treatment
Outcome measures
| Measure |
Placebo Comparator
n=25 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
Number of Participants With Type 1 Diabetes
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During 5 year follow-up from treatmentPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.
Fasting glucose is measured at baseline and every 6 months within the study. Glucose is analysed by Hemocue.
Outcome measures
| Measure |
Placebo Comparator
n=25 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
Fasting Glucose Over Time
0 months
|
4.67 mmol/L
Standard Deviation 0.56
|
4.74 mmol/L
Standard Deviation 0.49
|
|
Fasting Glucose Over Time
6 months
|
4.98 mmol/L
Standard Deviation 0.77
|
5.04 mmol/L
Standard Deviation 0.60
|
|
Fasting Glucose Over Time
18 months
|
5.23 mmol/L
Standard Deviation 1.65
|
4.87 mmol/L
Standard Deviation 0.71
|
|
Fasting Glucose Over Time
30 months
|
5.10 mmol/L
Standard Deviation 0.61
|
5.05 mmol/L
Standard Deviation 0.68
|
|
Fasting Glucose Over Time
42 months
|
5.13 mmol/L
Standard Deviation 0.66
|
4.88 mmol/L
Standard Deviation 0.71
|
|
Fasting Glucose Over Time
54 months
|
5.29 mmol/L
Standard Deviation 0.50
|
5.36 mmol/L
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: During 5 year follow-up from treatmentPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.
OGTT is performed at baseline, after 6 months and thereafter annually. Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.
Outcome measures
| Measure |
Placebo Comparator
n=24 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
120 Minutes Glucose From OGTT Over Time
0 months
|
6.88 mmol//L
Standard Deviation 1.61
|
6.82 mmol//L
Standard Deviation 2.12
|
|
120 Minutes Glucose From OGTT Over Time
6 months
|
7.00 mmol//L
Standard Deviation 1.86
|
7.30 mmol//L
Standard Deviation 1.87
|
|
120 Minutes Glucose From OGTT Over Time
18 months
|
7.19 mmol//L
Standard Deviation 2.05
|
6.41 mmol//L
Standard Deviation 1.85
|
|
120 Minutes Glucose From OGTT Over Time
30 months
|
6.54 mmol//L
Standard Deviation 1.38
|
6.31 mmol//L
Standard Deviation 1.65
|
|
120 Minutes Glucose From OGTT Over Time
42 months
|
6.63 mmol//L
Standard Deviation 2.41
|
6.54 mmol//L
Standard Deviation 1.30
|
|
120 Minutes Glucose From OGTT Over Time
54 months
|
6.67 mmol//L
Standard Deviation 2.38
|
7.04 mmol//L
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: During 5 year follow-up from treatmentPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. One child did not do OGTT at baseline and therefore the placebo group only contains 24 participants in this analysis. At 42 months one additional child only did 2 point OGTT.
OGTT is performed at baseline, after 6 months and thereafter annually.
Outcome measures
| Measure |
Placebo Comparator
n=24 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
AUC Glucose From OGTT Over Time
0 months
|
989.63 mmol*min/L
Standard Deviation 207.07
|
938.72 mmol*min/L
Standard Deviation 190.87
|
|
AUC Glucose From OGTT Over Time
6 months
|
973.48 mmol*min/L
Standard Deviation 188.48
|
960.04 mmol*min/L
Standard Deviation 182.05
|
|
AUC Glucose From OGTT Over Time
18 months
|
1005.0 mmol*min/L
Standard Deviation 234.99
|
904.71 mmol*min/L
Standard Deviation 210.34
|
|
AUC Glucose From OGTT Over Time
30 months
|
970.81 mmol*min/L
Standard Deviation 198.96
|
946.16 mmol*min/L
Standard Deviation 175.60
|
|
AUC Glucose From OGTT Over Time
42 months
|
965.43 mmol*min/L
Standard Deviation 323.95
|
967.41 mmol*min/L
Standard Deviation 131.75
|
|
AUC Glucose From OGTT Over Time
54 months
|
949.20 mmol*min/L
Standard Deviation 263.67
|
994.88 mmol*min/L
Standard Deviation 229.35
|
SECONDARY outcome
Timeframe: During 5 year follow-up from treatmentPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. At 42 months one value is missing due to missed sampling.
Fasting C-peptide is performed at baseline and thereafter every 6 months
Outcome measures
| Measure |
Placebo Comparator
n=25 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
Fasting C-peptide Over Time
0 months
|
0.18 nmol/L
Standard Deviation 0.09
|
0.21 nmol/L
Standard Deviation 0.10
|
|
Fasting C-peptide Over Time
6 months
|
0.21 nmol/L
Standard Deviation 0.17
|
0.26 nmol/L
Standard Deviation 0.10
|
|
Fasting C-peptide Over Time
18 months
|
0.27 nmol/L
Standard Deviation 0.18
|
0.30 nmol/L
Standard Deviation 0.13
|
|
Fasting C-peptide Over Time
30 months
|
0.34 nmol/L
Standard Deviation 0.14
|
0.39 nmol/L
Standard Deviation 0.20
|
|
Fasting C-peptide Over Time
42 months
|
0.37 nmol/L
Standard Deviation 0.17
|
0.40 nmol/L
Standard Deviation 0.23
|
|
Fasting C-peptide Over Time
54 months
|
0.48 nmol/L
Standard Deviation 0.25
|
0.45 nmol/L
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: During 5 year follow-up from treatmentPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. 120 min C-peptide missing at some endpoints due to missed sample
OGTT is performed at baseline, after 6 months and thereafter annually
Outcome measures
| Measure |
Placebo Comparator
n=24 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
120 Min C-peptide on OGTT Over Time
0 months
|
1.09 nmol//L
Standard Deviation 0.60
|
1.22 nmol//L
Standard Deviation 0.46
|
|
120 Min C-peptide on OGTT Over Time
6 months
|
1.04 nmol//L
Standard Deviation 0.41
|
1.31 nmol//L
Standard Deviation 0.50
|
|
120 Min C-peptide on OGTT Over Time
18 months
|
1.27 nmol//L
Standard Deviation 0.33
|
1.25 nmol//L
Standard Deviation 0.39
|
|
120 Min C-peptide on OGTT Over Time
30 months
|
1.30 nmol//L
Standard Deviation 0.56
|
1.30 nmol//L
Standard Deviation 0.39
|
|
120 Min C-peptide on OGTT Over Time
42 months
|
1.43 nmol//L
Standard Deviation 0.58
|
1.50 nmol//L
Standard Deviation 0.49
|
|
120 Min C-peptide on OGTT Over Time
54 months
|
1.58 nmol//L
Standard Deviation 0.70
|
1.45 nmol//L
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: During 5 year follow-up from treatmentPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.
OGTT is performed at baseline, after 6 months and thereafter annually
Outcome measures
| Measure |
Placebo Comparator
n=24 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=24 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
AUC C-peptide From OGTT Over Time
0 months
|
134.82 nmol*min/L
Standard Deviation 55.36
|
146.98 nmol*min/L
Standard Deviation 62.12
|
|
AUC C-peptide From OGTT Over Time
6 months
|
121.07 nmol*min/L
Standard Deviation 34.37
|
149.01 nmol*min/L
Standard Deviation 54.66
|
|
AUC C-peptide From OGTT Over Time
18 months
|
149.88 nmol*min/L
Standard Deviation 47.40
|
152.02 nmol*min/L
Standard Deviation 52.66
|
|
AUC C-peptide From OGTT Over Time
30 months
|
157.35 nmol*min/L
Standard Deviation 59.83
|
172.23 nmol*min/L
Standard Deviation 50.24
|
|
AUC C-peptide From OGTT Over Time
42 months
|
169.48 nmol*min/L
Standard Deviation 65.87
|
182.14 nmol*min/L
Standard Deviation 76.33
|
|
AUC C-peptide From OGTT Over Time
54 months
|
183.23 nmol*min/L
Standard Deviation 64.78
|
184.14 nmol*min/L
Standard Deviation 65.59
|
SECONDARY outcome
Timeframe: During 5 year follow-upPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. Some data missing
At all visits in the study HbA1c is measured. The change in HbA1c from baseline HbA1c is analysed at Laboratory of Clinical Chemistry, Skåne University Hospital, Malmö
Outcome measures
| Measure |
Placebo Comparator
n=25 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
HbA1c
0 months
|
33.84 mmol/mol
Standard Deviation 3.52
|
32.76 mmol/mol
Standard Deviation 3.13
|
|
HbA1c
6 months
|
34.88 mmol/mol
Standard Deviation 2.68
|
33.28 mmol/mol
Standard Deviation 2.92
|
|
HbA1c
12 months
|
34.92 mmol/mol
Standard Deviation 4.16
|
33.13 mmol/mol
Standard Deviation 3.0
|
|
HbA1c
18 months
|
36.63 mmol/mol
Standard Deviation 9.46
|
33.64 mmol/mol
Standard Deviation 3.36
|
|
HbA1c
24 months
|
34.14 mmol/mol
Standard Deviation 3.23
|
34.95 mmol/mol
Standard Deviation 6.09
|
|
HbA1c
30 months
|
35.19 mmol/mol
Standard Deviation 4.07
|
33.25 mmol/mol
Standard Deviation 2.81
|
|
HbA1c
36 months
|
33.94 mmol/mol
Standard Deviation 4.04
|
33.58 mmol/mol
Standard Deviation 4.34
|
|
HbA1c
42 months
|
33.19 mmol/mol
Standard Deviation 3.08
|
32.44 mmol/mol
Standard Deviation 3.03
|
|
HbA1c
48 months
|
32.40 mmol/mol
Standard Deviation 2.95
|
32.17 mmol/mol
Standard Deviation 2.62
|
|
HbA1c
54 months
|
33.73 mmol/mol
Standard Deviation 3.97
|
33.75 mmol/mol
Standard Deviation 2.74
|
|
HbA1c
60 months
|
34.56 mmol/mol
Standard Deviation 4.23
|
34 mmol/mol
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: During 5 year follow-up from treatmentPopulation: Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. Some data missing
As secondary variables of effect we will measure the change in first-phase insulin response. In all children a baseline IvGTT is performed and after that annual IvGTT´s are performed within the study. First phase insulin response is calculated from insulin 1 and 3 minutes after the given glucose solution. Insulin is measured by Laboratory of Clinical Chemistry at Skåne University Hospital, Malmö. Change in first phase insulin response will be calculated for each individual and compared between the groups.
Outcome measures
| Measure |
Placebo Comparator
n=25 Participants
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 Participants
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
First-phase Insulin Response From IvGTT Over Time
60 months
|
97.60 nmol/L
Standard Deviation 63.15
|
89.60 nmol/L
Standard Deviation 63.60
|
|
First-phase Insulin Response From IvGTT Over Time
0 months
|
47.40 nmol/L
Standard Deviation 42.42
|
55.52 nmol/L
Standard Deviation 35.89
|
|
First-phase Insulin Response From IvGTT Over Time
12 months
|
68.57 nmol/L
Standard Deviation 54.17
|
66.00 nmol/L
Standard Deviation 39.91
|
|
First-phase Insulin Response From IvGTT Over Time
24 months
|
77.45 nmol/L
Standard Deviation 61.36
|
70.27 nmol/L
Standard Deviation 36.61
|
|
First-phase Insulin Response From IvGTT Over Time
36 months
|
70.19 nmol/L
Standard Deviation 38.55
|
81.06 nmol/L
Standard Deviation 37.34
|
|
First-phase Insulin Response From IvGTT Over Time
48 months
|
106.92 nmol/L
Standard Deviation 66.97
|
84.75 nmol/L
Standard Deviation 37.77
|
Adverse Events
Placebo Comparator
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Alum-GAD (Diamyd)
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Comparator
n=25 participants at risk
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 participants at risk
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Injury, poisoning and procedural complications
arm fracture
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
Other adverse events
| Measure |
Placebo Comparator
n=25 participants at risk
Two doses of placebo day 1 and 30
Placebo comparator: Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.
|
Alum-GAD (Diamyd)
n=25 participants at risk
20 microgram Diamyd day 1 and 30
Diamyd: 20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Eye disorders
Eye pruritus
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
5/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
24.0%
6/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
12.0%
3/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Tootache
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
5/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
16.0%
4/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
General disorders
Injection site reaction
|
92.0%
23/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
96.0%
24/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
General disorders
Malaise
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
General disorders
Pyrexia
|
76.0%
19/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
40.0%
10/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Immune system disorders
Celiac disease
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Immune system disorders
Allergic conjunctivitis
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Immune system disorders
Henoch Shoenlein Purpura
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
12.0%
3/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Immune system disorders
Seasonal allergy
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
12.0%
3/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Chlamydia infection
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Conjunctivitis
|
16.0%
4/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Coxachie viral infection
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Immune system disorders
Ear infection
|
24.0%
6/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
12.0%
3/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Enterobiasis
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Ebstein Barr Virus
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Erythema Infectiosum
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Gastoenteritis
|
68.0%
17/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
76.0%
19/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Impetigo
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Infected bite
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Influenza
|
16.0%
4/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
28.0%
7/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
84.0%
21/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
84.0%
21/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Otitis externa
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Otitis media
|
12.0%
3/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Pneumonia
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Pseudocroup
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Scarlet fever
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
0.00%
0/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
|
Infections and infestations
Skin infection
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
4.0%
1/25 • Adverse events and serious adverse events were recorded during 5 year follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place