Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania (NCT NCT02582255)
NCT ID: NCT02582255
Last Updated: 2020-01-14
Results Overview
Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
3 months
Results posted on
2020-01-14
Participant Flow
Participant milestones
| Measure |
Group 1
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Group 1
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
Baseline characteristics by cohort
| Measure |
Group 1
n=50 Participants
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
n=50 Participants
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants who received at least one dose of vaccine.
Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.
Outcome measures
| Measure |
Group 1
n=50 Participants
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
n=47 Participants
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
SAEs and Severe AEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: All participants who received two doses of vaccines.
Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.
Outcome measures
| Measure |
Group 1
n=50 Participants
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
n=47 Participants
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.
|
50 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All subjects receiving two doses of vaccine.
Seroprotection rate for type 2 polio neutralizing antibodies measured at D 28 after the secon dose of mOPV2.
Outcome measures
| Measure |
Group 1
n=47 Participants
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.
|
47 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All subjects receiving at least one dose of vaccine.
Incidence, severity and relationship) of any serious adverse events (SAEs), any solicited AEs, any unsolicited AEs, and any Important Medical Events (IMEs) with the exception of severe related AEs. (primary objective), as well as any laboratory deviations of one or two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years.
Outcome measures
| Measure |
Group 1
n=50 Participants
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
n=47 Participants
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).
|
6 Participants
|
9 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=50 participants at risk
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
n=50 participants at risk
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Group 1
n=50 participants at risk
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
|
Group 2
n=50 participants at risk
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
|
|---|---|---|
|
General disorders
Appetite lost
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
|
General disorders
Abnormal crying
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
|
General disorders
Fever
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
General disorders
Irritability
|
2.0%
1/50 • Number of events 1 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Number of events 2 • 3 months
|
4.0%
2/50 • Number of events 3 • 3 months
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • Number of events 1 • 3 months
|
4.0%
2/50 • Number of events 3 • 3 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50 • 3 months
|
4.0%
2/50 • Number of events 2 • 3 months
|
|
Infections and infestations
Respiratory Tract Infection
|
2.0%
1/50 • Number of events 2 • 3 months
|
0.00%
0/50 • 3 months
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Number of events 1 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Infections and infestations
Gastroenteritis Norovirus
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Infections and infestations
Pharyngotonsilitis
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Infections and infestations
Scarlet Fever
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
|
Investigations
Platelet Count Increased
|
0.00%
0/50 • 3 months
|
4.0%
2/50 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
0.00%
0/50 • 3 months
|
4.0%
2/50 • Number of events 2 • 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI and/or the institution does not have the right to publish or perform presentations, which contain partial or complete summaries, data, results or any other information obtained as a result of this investigation, without prior written authorization by FIDEC.
- Publication restrictions are in place
Restriction type: OTHER