Trial Outcomes & Findings for Live Enterovirus Vaccine and Type 1 Diabetes (NCT NCT02961595)
NCT ID: NCT02961595
Last Updated: 2024-08-13
Results Overview
Appearance of multiple type 1 diabetes associated auto-antibodies (2-4 of the measured four auto-antibodies ICA, IAA, GADA, IA-2A)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
315 participants
Primary outcome timeframe
Through study completion, an average of 11 years
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Inactivated Polio Vaccine (IPV)
The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.
|
Oral Polio Vaccine (OPV)
Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.
Oral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
64
|
|
Overall Study
COMPLETED
|
251
|
64
|
|
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 |
Inactivated Polio Vaccine (IPV)
n=251 Participants
The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.
|
Oral Polio Vaccine (OPV)
n=64 Participants
Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.
Oral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
251 Participants
n=251 Participants
|
64 Participants
n=64 Participants
|
315 Participants
n=315 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=251 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=315 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=251 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=315 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=251 Participants
|
30 Participants
n=64 Participants
|
158 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=251 Participants
|
34 Participants
n=64 Participants
|
157 Participants
n=315 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Finland
|
251 participants
n=251 Participants
|
64 participants
n=64 Participants
|
315 participants
n=315 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 11 yearsAppearance of multiple type 1 diabetes associated auto-antibodies (2-4 of the measured four auto-antibodies ICA, IAA, GADA, IA-2A)
Outcome measures
| Measure |
Inactivated Polio Vaccine (IPV)
n=251 Participants
The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.
|
Oral Polio Vaccine (OPV)
n=64 Participants
Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.
Oral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).
|
|---|---|---|
|
Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum
|
17 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months of agePopulation: Overall 1488 stools samples were collected and analysed from 3 to 24 months in both IPV and OPV groups
Percentage of enterovirus RNA positive stool samples during the follow-up of 24 months in IPV and OPV vaccinated children
Outcome measures
| Measure |
Inactivated Polio Vaccine (IPV)
n=744 stool samples
The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.
|
Oral Polio Vaccine (OPV)
n=744 stool samples
Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.
Oral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).
|
|---|---|---|
|
Number of Enterovirus RNA Positive Stool Samples During the Follow-up of 24 Months
|
89 stool samples
|
221 stool samples
|
Adverse Events
Inactivated Polio Vaccine (IPV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Polio Vaccine (OPV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place