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A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania (M3-ABMG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02582255
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : December 16, 2019
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Fidec Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Poliomyelitis
Intervention Biological: Sabin mOPV2
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description IPV-vaccinated children receiving 1 dose of SABIN mOPV2. IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
Period Title: Overall Study
Started 50 50
Completed 50 47
Not Completed 0 3
Reason Not Completed
Protocol Violation             0             3
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description IPV-vaccinated children receiving 1 dose of SABIN mOPV2. IPV-vaccinated children receiving 2 doses of SABIN mOPV2. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
50
 100.0%
50
 100.0%
100
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
26
  52.0%
19
  38.0%
45
  45.0%
Male
24
  48.0%
31
  62.0%
55
  55.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
50
 100.0%
50
 100.0%
100
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Lithuania Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title SAEs and Severe AEs
Hide 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of vaccine.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
Overall Number of Participants Analyzed 50 47
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Clopper-Pearson
Comments [Not Specified]
2.Primary Outcome
Title Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.
Hide Description Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received two doses of vaccines.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
Overall Number of Participants Analyzed 50 47
Measure Type: Count of Participants
Unit of Measure: Participants
50
 100.0%
47
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Clopper-Pearson
Comments [Not Specified]
3.Secondary Outcome
Title Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.
Hide Description Seroprotection rate for type 2 polio neutralizing antibodies measured at D 28 after the secon dose of mOPV2.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving two doses of vaccine.
Arm/Group Title Group 2
Hide Arm/Group Description:
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
Overall Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
47
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Clopper-Pearson
Comments [Not Specified]
4.Secondary Outcome
Title Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).
Hide 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving at least one dose of vaccine.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
Overall Number of Participants Analyzed 50 47
Measure Type: Count of Participants
Unit of Measure: Participants
6
  12.0%
9
  19.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Clopper-Pearson
Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description IPV-vaccinated children receiving 1 dose of SABIN mOPV2. IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      1/50 (2.00%)    
Respiratory, thoracic and mediastinal disorders     
Bronchitis  /50  1/50 (2.00%)  1
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/50 (12.00%)      12/50 (24.00%)    
Gastrointestinal disorders     
Vomiting  0/50 (0.00%)  0 1/50 (2.00%)  1
General disorders     
Appetite lost  1/50 (2.00%)  1 0/50 (0.00%)  0
Abnormal crying  1/50 (2.00%)  1 0/50 (0.00%)  0
Fever  0/50 (0.00%)  0 1/50 (2.00%)  1
Irritability  1/50 (2.00%)  1 1/50 (2.00%)  1
Infections and infestations     
Upper respiratory tract infection  1/50 (2.00%)  2 2/50 (4.00%)  3
Bronchitis  1/50 (2.00%)  1 2/50 (4.00%)  3
Pharyngitis  0/50 (0.00%)  0 2/50 (4.00%)  2
Respiratory Tract Infection  1/50 (2.00%)  2 0/50 (0.00%)  0
Nasopharyngitis  1/50 (2.00%)  1 1/50 (2.00%)  1
Conjunctivitis  0/50 (0.00%)  0 1/50 (2.00%)  1
Gastroenteritis Norovirus  0/50 (0.00%)  0 1/50 (2.00%)  1
Pharyngotonsilitis  0/50 (0.00%)  0 1/50 (2.00%)  1
Scarlet Fever  0/50 (0.00%)  0 1/50 (2.00%)  1
Sinusitis  0/50 (0.00%)  0 1/50 (2.00%)  1
Investigations     
Platelet Count Increased  0/50 (0.00%)  0 2/50 (4.00%)  2
Metabolism and nutrition disorders     
Dehydration  0/50 (0.00%)  0 1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders     
Tonsillar Hypertrophy  0/50 (0.00%)  0 2/50 (4.00%)  2
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ricardo Rüttimann
Organization: FIDEC
Phone: +13058540075
EMail: rruttimann@fidec-online.org
Layout table for additonal information
Responsible Party: Fidec Corporation
ClinicalTrials.gov Identifier: NCT02582255    
Other Study ID Numbers: M3-ABMG
First Submitted: August 4, 2015
First Posted: October 21, 2015
Results First Submitted: November 25, 2019
Results First Posted: December 16, 2019
Last Update Posted: January 14, 2020