Clinical Trial Results:
A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania
Summary
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EudraCT number |
2015-003544-39 |
Trial protocol |
LT |
Global end of trial date |
12 May 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Dec 2019
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First version publication date |
18 Dec 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
M3-ABMG
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02582255 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fighting Infectious Diseases in Emerging Countries (FIDEC)
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Sponsor organisation address |
2050 Coral Way, Suite 407, MIami, United States, 33145
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Public contact |
Clinic of Children Diseases, Vilnius University, Santariskiu Clinic, +37 052492414, vytautas.usonis@mf.vu.lt
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Scientific contact |
Clinic of Children Diseases, Vilnius University, Santariskiu Clinic, +37 052492414, vytautas.usonis@mf.vu.lt
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Apr 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 May 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
12 May 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objectives of the study are to assess the safety (serious adverse events [SAEs] and severe adverse events [AEs] grade 3 according to CTCAE 4.03) and immunogenicity (seroprotection rate) of one dose of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years.
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Protection of trial subjects |
A DSMB monitored the safety aspects of this trial.
The composition and functioning of the DSMB was documented in the DSMB charter, which was approved prior to the initiation of the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Oct 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Lithuania: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
40
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Children (2-11 years) |
60
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
100 subjects enrolled - 50 subjects were enrolled in Group 1 (1 dose of mOPV2) and 50 subjects were enrolled in Group 2 (2 doses of mOPV2). | |||||||||||||||
Pre-assignment
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Screening details |
101 subjects were available for screening. | |||||||||||||||
Period 1
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Period 1 title |
FPI-LPO (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 | |||||||||||||||
Arm description |
IPV-vaccinated children to receive 1 dose of SABIN mOPV2 | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
mOPV2
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
All subjects were to receive mOPV2 at the same dose level. Half of the subjects (n=50, Group 1) were to receive a single dose, with the other half (n=50, Group 2) to receive a second dose, 28 days after the first dose.
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Arm title
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Group 2 | |||||||||||||||
Arm description |
IPV-vaccinated children to receive 2 doses of SABIN mOPV2, administered 28 days apart . | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
mOPV2
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
All subjects were to receive mOPV2 at the same dose level. Half of the subjects (n=50, Group 1) were to receive a single dose, with the other half (n=50, Group 2) to receive a second dose, 28 days after the first dose.
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Baseline characteristics reporting groups
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Reporting group title |
Group 1
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Reporting group description |
IPV-vaccinated children to receive 1 dose of SABIN mOPV2 | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2
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Reporting group description |
IPV-vaccinated children to receive 2 doses of SABIN mOPV2, administered 28 days apart . | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
IPV-vaccinated children to receive 1 dose of SABIN mOPV2 | ||
Reporting group title |
Group 2
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Reporting group description |
IPV-vaccinated children to receive 2 doses of SABIN mOPV2, administered 28 days apart . |
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End point title |
SAEs and Severe AEs | |||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
3 months
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Statistical analysis title |
Baseline safety | |||||||||
Comparison groups |
Group 1 v Group 2
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Number of subjects included in analysis |
97
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Clopper-Pearson | |||||||||
Confidence interval |
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End point title |
Seroprotection Rate of Type 2 Polio Neutralizing Antibodies | |||||||||
End point description |
Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.
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End point type |
Primary
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End point timeframe |
1 month
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Statistical analysis title |
Baseline immunogenicity seroprotection rate | |||||||||
Comparison groups |
Group 1 v Group 2
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Number of subjects included in analysis |
97
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.025 | |||||||||
Method |
Clopper-Pearson | |||||||||
Confidence interval |
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End point title |
Seroprotection Rate for Type 2 Polio Neutralizing Antibodies | |||||||||
End point description |
Seroprotection rate for type 2 polio neutralizing antibodies measured at D 28 after the second dose of mOPV2.
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End point type |
Secondary
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End point timeframe |
3 months
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Statistical analysis title |
Baseline immunogenicity seroprotection rate | |||||||||
Comparison groups |
Group 2 v Group 1
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Number of subjects included in analysis |
97
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.025 | |||||||||
Method |
Clopper-Pearson | |||||||||
Confidence interval |
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End point title |
Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs). | |||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
3 months
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Statistical analysis title |
Baseline safety | |||||||||
Comparison groups |
Group 1 v Group 2
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Number of subjects included in analysis |
97
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Clopper-Pearson | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
3 months
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
Group 1
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Reporting group description |
IPV-vaccinated children receiving 1 dose of SABIN mOPV2. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2
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Reporting group description |
IPV-vaccinated children receiving 2 doses of SABIN mOPV2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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14 Oct 2015 |
Clarification of:
• Primary and secondary objectives
• Study endpoints
• Clinical laboratory samples
• TV and PP populations
• IME reporting
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None |