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    Clinical Trial Results:
    A Phase 4 study to evaluate the safety and immunogenicity of trivalent oral polio vaccine in adults previously vaccinated with oral polio vaccine

    Summary
    EudraCT number
    		 2015-003324-32
    Trial protocol
    		 BE  
    Global end of trial date
    01 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UAT1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Antwerp
    Sponsor organisation address
    Universiteitsplein 1, Wilrijk, Belgium, 2610
    Public contact
    Ilse De Coster, MD, University of Antwerp, +32 (0)3265 26 52, ilse.decoster@uantwerpen.be
    Scientific contact
    Prof. Dr. PhD. Pierre Van Damme, University of Antwerp, +32 (0)3265 26 58, pierre.vandamme@uantwerpen.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    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]) and immunogenicity (seroprotection rate) of SABIN tOPV in healthy OPV-vaccinated adults.
    Protection of trial subjects
    In this study only healthy adults are enrolled who received at least 3 doses of OPV in the past (more than 12 months before the start of the study) Exclusion criteria (among others): . Having Crohn’s disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel; . A known allergy, hypersensitivity, or intolerance to the study vaccine, or to any of its components or to any antibiotics; . Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus [HIV] infection); . Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete priming) within 28 days after vaccination; . Neonatal nurses or others having professional contact with children under 6 months old within 28 days after vaccination; . Chronic administration (i.e., longer than 14 days) of immunosuppressant drugs or other immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study. For instance, for corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day (inhaled and topical steroids are allowed whereas intra-articular and epidural injection/administration of steroids are not allowed); . Presence of contraindications to administration of the study vaccine on Day 0: acute severe febrile illness deemed by the Investigator to be a contraindication for vaccination or persistent diarrhea or vomiting;
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 128
    Worldwide total number of subjects
    128
    EEA total number of subjects
    128
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    128
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study has been conducted in 2 centres in Belgium (Centre for the Evaluation of vaccination, Vaccine & Infectious Disease Institute, University of Antwerp and Military Hospital Koningin Astrid) between December 2015 and June 2016.

    Pre-assignment
    Screening details
    		 In this study a total of 144 subjects were screened of whom 128 were enrolled in Group 1 (79 subjects) or Group 2 (49 subjects). Only subjects who had received at least 3 vaccinations with OPV in the past were enrolled. No contact with unimmunized or unvaccinated persons (including children <6 months old)

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: One dose of tOPV
    Arm description
    		 participants previously vaccinated with oral poliovaccine (OPV) received one dose of trivalent oral polio vaccine (tOPV) on Day 0, administered orally as two drops (0.1 ml)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Polio Sabin™ (oral)
    Investigational medicinal product code
    tOPV
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container.

    Arm title
    		 Group 2: three doses of tOPV
    Arm description
    		 Participants received three doses of tOPV 28 days apart (Day0, Day 28 and Day 56), administered orally as 2 drops (0.1 ml)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Polio Sabin™ (oral)
    Investigational medicinal product code
    tOPV
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    . One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container. Subjects in Group 2 received 3 doses of the vaccine, 28 days apart.

    Number of subjects in period 1
    		Group 1: One dose of tOPV Group 2: three doses of tOPV
    Started
    79
    49
    Completed
    79
    49

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: One dose of tOPV
    Reporting group description
    		 participants previously vaccinated with oral poliovaccine (OPV) received one dose of trivalent oral polio vaccine (tOPV) on Day 0, administered orally as two drops (0.1 ml)

    Reporting group title
    Group 2: three doses of tOPV
    Reporting group description
    		 Participants received three doses of tOPV 28 days apart (Day0, Day 28 and Day 56), administered orally as 2 drops (0.1 ml)

    Reporting group values
    		 Group 1: One dose of tOPV Group 2: three doses of tOPV Total
    Number of subjects
    		 79 49 128
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.1 ± 10.37 35.1 ± 10.72 -
    Gender categorical
    Units: Subjects
        Female
    		 48 20 68
        Male
    		 31 29 60
    Ethnicity
    Units: Subjects
        Caucasian/White
    		 79 47 126
        Asian
    		 0 1 1
        Black/African American
    		 0 1 1
        Other
    		 0 0 0
    Number of prior tOPV vaccinations
    Units: Subjects
        Three
    		 8 6 14
        Four
    		 69 43 112
        Five or more
    		 2 0 2
    Number of prior IPV vaccinations
    Units: Subjects
        none
    		 49 30 79
        one
    		 30 18 48
        three
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Group 1: One dose of tOPV
    Reporting group description
    		 participants previously vaccinated with oral poliovaccine (OPV) received one dose of trivalent oral polio vaccine (tOPV) on Day 0, administered orally as two drops (0.1 ml)

    Reporting group title
    Group 2: three doses of tOPV
    Reporting group description
    		 Participants received three doses of tOPV 28 days apart (Day0, Day 28 and Day 56), administered orally as 2 drops (0.1 ml)

    Subject analysis set title
    Group 2 Pre-Dose 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    participants in Group 2 received 1 dose of tOPV on study Day 0

    Subject analysis set title
    Group 2 Post-Dose 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Group 2 received 2 doses of tOPV 28 days apart (Day 0 and Day 28)

    Subject analysis set title
    Group 2 Post-Dose 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Group 2 received 3 doses of tOPV, 28 days apart ( Day 0, D28 and Day 56)

    Subject analysis set title
    Groups 1+2: tOPV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    participants received one dose of tOPV on study Day 0

    Subject analysis set title
    Group 1+ Group 2 Pre-dose 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received one dose of tOPV on study Day 0

    Subject analysis set title
    Group 1+2: tOPV Post-Dose1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    participants received one dose of tOPV on Study Day 0

    Primary: Number of participants with Serious Adverse Events and severe Adverse Events

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    End point title
    		 Number of participants with Serious Adverse Events and severe Adverse Events [1]
    End point description
    An SAE is any untoward medical occurrence that at any dose met any of the following conditions: • Resulted in death; • Was life-threatening; • Required inpatient hospitalization or prolongation of existing inpatient hospitalization; • Resulted in persistent or significant disability/incapacity; • Was a congenital anomaly/birth defect; • Was medically important. A solicited AE is a pre-selected sign or symptom that occurred within 7 days after each dose, whereas unsolicited AEs were collected throughout the study. Solicited AEs included headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea, abdominal pain, and fever. A severe AE is an AE that prevented normal everyday activities and which was not classified as an SAE. A related AE is an AE the investigator considered probably or possibly caused by the study vaccine, meaning that there was a reasonable temporal association or the AE was not attributable to other conditions.
    End point type
    Primary
    End point timeframe
    up to 42 days after last vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In this study to establish a historical control for future testing of new tOPV all analyses were descriptive.
    End point values
    		 Group 1: One dose of tOPV Group 2: three doses of tOPV Group 2 Pre-Dose 2 Group 2 Post-Dose 2 Group 2 Post-Dose 3
    Number of subjects analysed
    79
    49
    49
    49
    48
    Units: participants
        >= 1 SAE or Severe AE
    14
    11
    4
    4
    8
        >= 1 SAE
    0
    1
    0
    0
    1
        >= 1 SAE Probable/Possible/Unlikely
    0
    0
    0
    0
    0
        >= 1 Severe AE
    14
    11
    4
    4
    8
        >= 1 Severe AE Probable/Possible/Unlikely
    7
    8
    3
    3
    5
    No statistical analyses for this end point

    Primary: Seroprotection Rate after a single dose of tOPV

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    End point title
    		 Seroprotection Rate after a single dose of tOPV [2]
    End point description
    Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibody titers ≥ 1:8. Neutralizing antibodies against poliovirus type 2 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). The lower limit of quantitation (LLOQ) was 5.7 and the upper limit of quantitation (ULOQ) was 1448. Analysis Population Description: Participants in the per-protocol population. The per-protocol population excluded participants with missed doses or major protocol deviations considered to have a potential impact on immunogenicity from the time of the deviation and at all time points thereafter. This endpoint was analyzed after one dose of nOPV hence Groups 1 and 2 are combined for analysis, as specified in the study protocol.
    End point type
    Primary
    End point timeframe
    Baseline ( Day 0 prior to vaccination) and Day 28
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In this study to establish a historical control for future testing of new tOPV all analyses were descriptive. Therefore no statistical analyses are reported.
    End point values
    		 Groups 1+2: tOPV
    Number of subjects analysed
    126
    Units: percentage of participants
    number (confidence interval 95%)
        Day 0 (pre-vaccination) type 1
    89.7 (83.0 to 94.4)
        Day 0 (pre-vaccination) type 2
    93.7 (87.9 to 97.2)
        Day 0 (pre-vaccination) type 3
    79.4 (71.2 to 86.1)
        Day 28 type 1
    98.4 (94.4 to 99.8)
        Day 28 type 2
    99.2 (95.7 to 100)
        Day 28 type 3
    93.7 (87.9 to 97.2)
    No statistical analyses for this end point

    Secondary: Number of Solicited Adverse Events Within 7 Days of Vaccination with mOPV2

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    End point title
    		 Number of Solicited Adverse Events Within 7 Days of Vaccination with mOPV2
    End point description
    Participants completed 7-day diary cards soliciting systemic adverse events and daily oral temperature. Solicited events comprised selected signs and symptoms including headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea and abdominal pain, or fever defined as a temperature ≥37.0°C. AEs were graded as mild (easily tolerated with minimal discomfort or temp. 37.5°C to 38.0°C), moderate (sufficiently discomforting to interfere with normal everyday activities, or temp. 38.1°C to 39.0°C), or severe (preventing normal everyday activities, or temperatures > 39.0°C). AEs were assessed by the investigator for causality as probable, possible, unlikely or unrelated. Analysis Population Description Participants in the total vaccinated population
    End point type
    Secondary
    End point timeframe
    Up to 7 days after each dose (Day 0-7 post-dose 1, Day 28-35 post-dose 2 and Day 56-63 post-dose 3)
    End point values
    		 Group 2 Post-Dose 2 Group 2 Post-Dose 3 Group 1+ Group 2 Pre-dose 2
    Number of subjects analysed
    49
    48
    128
    Units: solicited adverse events
        Any solicited adverse event
    27
    22
    86
        Mild
    24
    21
    80
        Moderate
    8
    8
    31
        Severe
    1
    2
    3
        Probably/Possibly/Unlikely related to vaccination
    26
    22
    83
    No statistical analyses for this end point

    Secondary: Number of Participants With Unsolicited Adverse Events

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    End point title
    		 Number of Participants With Unsolicited Adverse Events
    End point description
    Unsolicited events comprised other signs and symptoms that participants reported through the end of the study. Each unsolicited AE was rated on a 3-point scale of increasing intensity: • Grade 1: Mild; an AE that was easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. • Grade 2: Moderate; an AE that was sufficiently discomforting to interfere with normal everyday activities. • Grade 3: Severe; an AE that prevented normal everyday activities. Each adverse event was assessed by the investigator for causality as unrelated, unlikely, possibly, or probably related to the vaccination. Analysis Population Description: Total vaccinated population
    End point type
    Secondary
    End point timeframe
    Upt to 42 days after last vaccination
    End point values
    		 Group 1: One dose of tOPV Group 2: three doses of tOPV Group 2 Pre-Dose 2 Group 2 Post-Dose 2 Group 2 Post-Dose 3
    Number of subjects analysed
    79
    49
    49
    49
    48
    Units: participants
        >=1 Unsolicited adverse event
    59
    40
    32
    25
    23
        Mild
    37
    36
    25
    20
    11
        Moderate
    27
    18
    9
    9
    10
        Severe
    13
    10
    4
    3
    6
        Probable/Possible/Unlikely related to vaccination
    39
    28
    19
    18
    12
    No statistical analyses for this end point

    Secondary: Number of participants with Clinically Relevant Laboratory Abnormalities Up to 28 days after Each Vaccination

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    End point title
    		 Number of participants with Clinically Relevant Laboratory Abnormalities Up to 28 days after Each Vaccination [3]
    End point description
    Measure Description: Laboratory assessments were collected at Day 0 , Day 7, Day 28 after first vaccination and at Days 35, 56, 63 and 84 for participants in Group 2 who received a 2nd and 3thdose. The Investigator reviewed laboratory values outside the normal range and assessed their clinical relevance. Any clinically relevant abnormal lab values that occurred at any visit up to 28 days after the first vaccination (in combined Groups 1 and 2) and up to 28 days (Day 84) after the third dose (Group 2) are reported. Analysis Population Description Participants in the total vaccinated population
    End point type
    Secondary
    End point timeframe
    Day 0, Day 7, Day 28 for Groups 1 and 2 and day 35, 56, 63 and 84 for participants in Group 2
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For this endpoint data after first vaccination are combined for both groups
    End point values
    		 Group 2: three doses of tOPV Group 1+2: tOPV Post-Dose1
    Number of subjects analysed
    47
    128
    Units: participants
        any clinically relevant hematology deviation
    4
    8
        any causally related hematology deviation
    0
    0
        clinical relevant chemistry/coagulation deviation
    8
    13
        causally related chemistry/coagulation deviation
    0
    0
    No statistical analyses for this end point

    Secondary: Anti-Poliovirus Neutralizing Antibody titers after a single dose of tOPV2

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    End point title
    		 Anti-Poliovirus Neutralizing Antibody titers after a single dose of tOPV2
    End point description
    Measure Description: Neutralizing antibodies against poliovirus types 1, 2, 3 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). . Analysis Population Description Per-protocol population. The per-protocol population excluded participants with missed doses or major protocol deviations considered to have a potential impact on immunogenicity from the time of the deviation and at all time points thereafter. This endpoint was analyzed after one dose of nOPV hence Groups 1 and 2 are combined for analysis, as specified in the study protocol.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 28
    End point values
    		 Groups 1+2: tOPV
    Number of subjects analysed
    126
    Units: titer
    geometric mean (confidence interval 95%)
        Day 0 (prevaccination) Type 1
    197.4 (140.6 to 276.1)
        Day 0 (pre-vaccination) Type 2
    187.9 (138.4 to 255.2)
        Day 0 (pre-vaccination) Type 3
    107.5 (72.6 to 159.0)
        Day 28 Type 1
    657.1 (522.5 to 814.5)
        Day 28 Type 2
    471.5 (368.0 to 594.5)
        Day 28 Type 3
    234.9 (169.4 to 324.9)
    No statistical analyses for this end point

    Secondary: Seroprotection Rate 28 Days After Two Doses and After Three Doses of tOPV

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    End point title
    		 Seroprotection Rate 28 Days After Two Doses and After Three Doses of tOPV [4]
    End point description
    Measure Description: Seroprotection rate was defined as the percentage of participants with anti-type 1, 2, 3-specific poliovirus neutralizing antibodies titers ≥ 1:8. Analysis Population Description Participants in the per-protocol population who received 2 and 3 doses of tOPV (Group 2).
    End point type
    Secondary
    End point timeframe
    Day 56 and Day 84
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint involves only 1 arm as this is the only arm with 3 doses
    End point values
    		 Group 2: three doses of tOPV
    Number of subjects analysed
    47
    Units: percentage of participants
    number (confidence interval 95%)
        Day 56 Type1
    95.7 (85.5 to 99.5)
        Day 56 Type 2
    100 (92.5 to 100)
        Day 56 Type 3
    93.6 (82.5 to 98.7)
        Day 84 Type 1
    97.9 (88.7 to 99.9)
        Day 84 Type 2
    100 (92.5 to 100)
        Day 84 Type 3
    97.9 (88.7 to 99.9)
    No statistical analyses for this end point

    Secondary: Seroconversion Rate After a Single Dose of tOPV

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    End point title
    		 Seroconversion Rate After a Single Dose of tOPV [5]
    End point description
    Measure Description: Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer. Analysis Population Description Participants in the seroconversion subset of the per-protocol population. The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase. Since this endpoint was analyzed after 1 dose of tOPV, Groups 1 and 2 are combined for analysis
    End point type
    Secondary
    End point timeframe
    Day 28
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: for this endpoint Day 28 data have been reported combined for both Groups and for Group 2
    End point values
    		 Group 2: three doses of tOPV Groups 1+2: tOPV
    Number of subjects analysed
    47
    126
    Units: percentage of participants
    number (confidence interval 95%)
        Day 28 Type 1
    36.2 (22.7 to 51.5)
    34.1 (25.9 to 43.1)
        Day 28 Type 2
    29.8 (17.3 to 44.9)
    27.0 (19.5 to 35.6)
        Day 28 Type 3
    25.5 (13.9 to 40.3)
    25.4 (18.1 to 33.9)
    No statistical analyses for this end point

    Secondary: Seroconversion Rate After Two Doses and After Three doses of tOPV

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    End point title
    		 Seroconversion Rate After Two Doses and After Three doses of tOPV [6]
    End point description
    Measure description: Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-1,2,3-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer. Analysis Population Description: Participants in the seroconversion subset of the per-protocol population and who received 2 and 3 doses of tOPV (Group 2). The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase.
    End point type
    Secondary
    End point timeframe
    Day 56 and Day 84
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For this endpoint only Group 2 is applicable as this is the only Group with 3 doses
    End point values
    		 Group 2: three doses of tOPV
    Number of subjects analysed
    47
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 56 Type 1
    38.3 (24.5 to 53.6)
        Day 56 Type 2
    38.3 (24.5 to 53.6)
        Day 56 Type 3
    23.4 (12.3 to 38.0)
        Day 84 Type 1
    44.7 (30.2 to 59.9)
        Day 84 Type 2
    40.4 (26.4 to 55.7)
        Day 84 Type 3
    27.7 (15.6 to 42.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events up to 7 days after each vaccination. Unsolicited events up to 42 Days after last vaccination (42 days in Group 1 and 84 days in Group 2). SAEs during the whole study period ( 42 days in Group 1 and 84 days in Group 2)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Group 1 one dose of tOPV
    Reporting group description
    		 participants received one dose of trivalent oral polio vaccine (tOPV) on study Day 0.

    Reporting group title
    Group 2: Three doses of tOPV
    Reporting group description
    		 -

    Serious adverse events
    		 Group 1 one dose of tOPV Group 2: Three doses of tOPV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1 one dose of tOPV Group 2: Three doses of tOPV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 79 (87.34%)
    46 / 49 (93.88%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Schwannoma
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Vasodilatation
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Haematoma
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    29 / 79 (36.71%)
    32 / 49 (65.31%)
         occurrences all number
    35
    65
    Pyrexia
         subjects affected / exposed
    4 / 79 (5.06%)
    4 / 49 (8.16%)
         occurrences all number
    4
    6
    Influenza like illness
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    0
    4
    Chills
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 49 (2.04%)
         occurrences all number
    3
    1
    menorrhagia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    9 / 79 (11.39%)
    10 / 49 (20.41%)
         occurrences all number
    11
    10
    Cough
         subjects affected / exposed
    1 / 79 (1.27%)
    7 / 49 (14.29%)
         occurrences all number
    1
    7
    Rhinorrhoea
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 49 (4.08%)
         occurrences all number
    1
    2
    Nasal congestion
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 49 (2.04%)
         occurrences all number
    4
    1
    Asthma exercise induced
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    Throat irritation
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Nasal dryness
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    0
    3
    Insomnia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Mood swings
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 49 (4.08%)
         occurrences all number
    1
    2
    Ligament sprain
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 49 (4.08%)
         occurrences all number
    1
    2
    Ligament rupture
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Wound
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Facial bones fracture
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    Tooth fracture
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    41 / 79 (51.90%)
    28 / 49 (57.14%)
         occurrences all number
    57
    87
    Paraesthesia
         subjects affected / exposed
    3 / 79 (3.80%)
    7 / 49 (14.29%)
         occurrences all number
    3
    8
    Anaesthesia
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 49 (4.08%)
         occurrences all number
    1
    2
    Dizziness
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    Migraine
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Microcytic anaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Motion sickness
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    18 / 79 (22.78%)
    20 / 49 (40.82%)
         occurrences all number
    21
    28
    Abdominal pain
         subjects affected / exposed
    11 / 79 (13.92%)
    19 / 49 (38.78%)
         occurrences all number
    13
    30
    Nausea
         subjects affected / exposed
    8 / 79 (10.13%)
    12 / 49 (24.49%)
         occurrences all number
    8
    15
    Vomiting
         subjects affected / exposed
    5 / 79 (6.33%)
    2 / 49 (4.08%)
         occurrences all number
    5
    2
    Constipation
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    Flatulence
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 49 (2.04%)
         occurrences all number
    1
    1
    Gastritis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 49 (2.04%)
         occurrences all number
    1
    1
    Gingival pain
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Abdominal distension
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Bowel movement irregularity
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 49 (2.04%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    13 / 79 (16.46%)
    16 / 49 (32.65%)
         occurrences all number
    17
    24
    Arthralgia
         subjects affected / exposed
    7 / 79 (8.86%)
    10 / 49 (20.41%)
         occurrences all number
    8
    22
    Back pain
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 49 (4.08%)
         occurrences all number
    2
    3
    Muscle spasms
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    4
    Tendonitis
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 49 (4.08%)
         occurrences all number
    1
    2
    Torticollis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 49 (2.04%)
         occurrences all number
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 79 (10.13%)
    13 / 49 (26.53%)
         occurrences all number
    8
    18
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 79 (3.80%)
    4 / 49 (8.16%)
         occurrences all number
    3
    4
    Pharyngitis
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 49 (6.12%)
         occurrences all number
    1
    4
    Rhinitis
         subjects affected / exposed
    2 / 79 (2.53%)
    3 / 49 (6.12%)
         occurrences all number
    4
    3
    Bronchitis
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 49 (4.08%)
         occurrences all number
    2
    2
    Cystitis
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 49 (4.08%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 49 (2.04%)
         occurrences all number
    3
    1
    Influenza
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 49 (2.04%)
         occurrences all number
    3
    1
    Viral infection
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 49 (4.08%)
         occurrences all number
    1
    2
    Folliculitis
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    Angular cheilitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Wound infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    Tracheitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Oct 2015
    . Change of Sponsor representative . Coordinating investigator’s name added . Change to multicenter study by adding 1 adidtional centre . Important medical events (IMEs) will be considered serious and be processed like SAEs, definition has been added. . Secondary endpoints of immunogenicity: Median titers and seroconversion rateof type-specific polio antibodies at day 28 will be described for both groups combined and D 56 is added for seroconversion rate of type-specific polio antibodies in Group 2. . Exploratory objectives and endpoints: ‘in a subset of stool samples’ has been added and assessment of the genetic sequence heterogeneity and potential for neurovirulence. . Statistical methods: ‘Cumulative rates of seroconversion and sero-protection will be tabulated’ has been deleted in synopsis and section 10.2 . Information about the Data Safety Monitoring board has been added .Time and events schedule : Blood samples for polio antibodies on D63 and 70 have been removed Remote daily contact during 14 days after each vaccination has been changed to 10 days after each vaccination . criteria for elimination from per-protocol poulation adapted . exclusion criterium 12 corrected to prevent administration of a vaccine other than the study vaccine during the entire study period . randomization and blinding: use of randomization envelopes HCG testing at Day 0 and at Days 28 and 56 for Group 2 has been added .grading of fever added recovering/resolving and not recovered added as possible outcome descriptin of solicited adverse events added section 13.14 Confidentialty adapted: data of subjects will only be forwarded in a coded way section 10.2: term 'indepently has been deleted as both groups will be assessed combined until Day 28
    30 Dec 2015
    . Synopsis + page 32: Inclusion criterium 2 has been changed because in Belgium it is difficult to objectify 4 OPV doses for this age category (18-50y) and to be in accordance with the similar studies for children and infants in Lithuania and Latin-America. . Study Administrative Structure: As the project manager has been changed, the name of the new project manager has been added on page 24. . Section 11.2, grading of fever: a typo has been corrected

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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