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    Clinical Trial Results:
    Safety study of IMOVAX Polio in selected cities in China, an observational post marketing study

    Summary
    EudraCT number
    		 2015-005185-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Jul 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Apr 2016
    First version publication date
    16 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IPV29
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01244464
    WHO universal trial number (UTN)
    		 U1111-1114-3719
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur China
    Sponsor organisation address
    6th Floor, No. 112 Jianguo Road, Chao Yang District, Beijing, China, 100022
    Public contact
    Director, Clinical Development, Sanofi Pasteur China, 86 10 6568 5588 7386, jean-denis.shu@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur China, 86 10 6568 5588 7386, jean-denis.shu@sanofipasteur.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To describe the safety profile within 28 days after each dose of IMOVAX Polio administered at 2, 3 and 4 months of age in population aged over 2 months old living in the study city, China.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    15 Nov 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 800
    Worldwide total number of subjects
    800
    EEA total number of subjects
    0
    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)
    800
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 15 November 2010 to 7 March 2011 at 1 clinic center in China.

    Pre-assignment
    Screening details
    		 A total of 801 subjects were enrolled in the study; 800 subjects were vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 IMOVAX Polio™
    Arm description
    		 Infants at least 2 months of age received 3 doses of IMOVAX Polio™, 1 each at 2, 3, and 4 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMOVAX Polio™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral area of the thigh or upper arm, 1 injection each at 2, 3, and 4 months of age.

    Number of subjects in period 1
    		IMOVAX Polio™
    Started
    800
    Completed
    772
    Not completed
    28
         Consent withdrawn by subject
    18
         Adverse event, non-fatal
    2
         Lost to follow-up
    7
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IMOVAX Polio™
    Reporting group description
    		 Infants at least 2 months of age received 3 doses of IMOVAX Polio™, 1 each at 2, 3, and 4 months of age.

    Reporting group values
    		 IMOVAX Polio™ Total
    Number of subjects
    		 800 800
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 800 800
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 64.17 ± 7.61 -
    Gender categorical
    Units: Subjects
        Female
    		 368 368
        Male
    		 432 432

    End points

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    End points reporting groups
    Reporting group title
    IMOVAX Polio™
    Reporting group description
    		 Infants at least 2 months of age received 3 doses of IMOVAX Polio™, 1 each at 2, 3, and 4 months of age.

    Primary: Summary of Safety Endpoints After Any Vaccination Following A Three-Dose Primary Vaccination Series with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Summary of Safety Endpoints After Any Vaccination Following A Three-Dose Primary Vaccination Series with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [1]
    End point description
    The following safety endpoints were assessed using The China State Food and Drug Administration (SFDA) severity scale: Solicited adverse reaction (Solicited systemic reaction and Solicited Injection site reaction), Unsolicited adverse event/adverse drug reaction (AE/ADR) (Unsolicited Injection site reaction, Unsolicited systemic AE, Unsolicited systemic ADR), Immediate event (Immediate ADR), Serious adverse events, and AEs leading to early termination of the study. The rate is the percentage of subjects with at least 1 event reported after any vaccine dose of administration. The immediate event was defined as the event that presented in the 30 minutes following vaccination. Solicited reactions (Fever, Injection site Erythema, Injection site Swelling) were assessed by both the Sponsor and the SFDA severity scales.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 28 days post-any 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: Descriptive analyses were performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 IMOVAX Polio™
    Number of subjects analysed
    800
    Units: Percentage of subjects
    number (not applicable)
        Solicited Adverse Reaction
    47.63
        Solicited Systemic Reaction
    46.38
        Solicited Injection Site Reaction
    8.75
        Unsolicited Adverse Event/Adverse Drug Reaction
    4.25
        Unsolicited Injection Site Reaction
    0.12
        Unsolicited Systemic Adverse Event
    4.25
        Unsolicited Systemic Adverse Drug Reaction
    0.12
        Immediate Event
    0
        Immediate Adverse Drug Reaction
    0
        Serious Adverse Events
    0.12
        AEs leading to early termination of the study
    0.25
    No statistical analyses for this end point

    Primary: Time of Onset and Number of Subjects with Solicited Injection-site and Systemic Reactions Following Each Primary Series Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Time of Onset and Number of Subjects with Solicited Injection-site and Systemic Reactions Following Each Primary Series Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [2]
    End point description
    Solicited injection site and systemic reactions were assessed using the The China State Food and Drug Administration (SFDA) severity scale. Solicited Injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Somnolence, Anorexia, and Irritability. Fever, Injection site Erythema, Injection site Swelling were assessed by both the Sponsor and the SFDA severity scales.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 3 post-each and any vaccination, Day 4 up to Day 7 post-each and any vaccination, and Day 0 up to Day 7 post-each and any vaccination
    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: Descriptive analyses were performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 IMOVAX Polio™
    Number of subjects analysed
    800 [3]
    Units: Number of subjects
    number (not applicable)
        Injection site Tenderness; Day 0-Day 3;Post-dose 1
    29
        Injection site Tenderness; Day 0-Day 3;Post-dose 2
    18
        Injection site Tenderness; Day 0-Day 3;Post-dose 3
    16
        Any Injection site Tenderness; Day 0-Day 3
    47
        Injection site Tenderness; Day 4-Day 7;Post-dose 1
    0
        Injection site Tenderness; Day 4-Day 7;Post-dose 2
    0
        Injection site Tenderness; Day 4-Day 7;Post-dose 3
    0
        Any Injection site Tenderness; Day 4-Day 7
    0
        Injection site Erythema; Day 0-Day 3; Post-dose 1
    24
        Injection site Erythema; Day 0-Day 3; Post-dose 2
    18
        Injection site Erythema; Day 0-Day 3; Post-dose 3
    13
        Any Injection site Erythema; Day 0-Day 3
    41
        Injection site Erythema; Day 4-Day 7; Post-dose 1
    0
        Injection site Erythema; Day 4-Day 7; Post-dose 2
    0
        Injection site Erythema; Day 4-Day 7; Post-dose 3
    0
        Any Injection site Erythema; Day 4-Day 7
    0
        Injection site Swelling; Day 0-Day 3; Post-dose 1
    9
        Injection site Swelling; Day 0-Day 3; Post-dose 2
    6
        Injection site Swelling; Day 0-Day 3; Post-dose 3
    5
        Any Injection site Swelling; Day 0-Day 3
    18
        Injection site Swelling; Day 4-Day 7; Post-dose 1
    1
        Injection site Swelling; Day 4-Day 7; Post-dose 2
    0
        Injection site Swelling; Day 4-Day 7; Post-dose 3
    0
        Any Injection site Swelling; Day 4-Day 7
    1
        Fever; Day 0-Day 3; Post-dose 1
    55
        Fever; Day 0-Day 3; Post-dose 2
    33
        Fever; Day 0-Day 3; Post-dose 3
    11
        Any Fever; Day 0-Day 3
    87
        Fever; Day 4-Day 7; Post-dose 1
    6
        Fever; Day 4-Day 7; Post-dose 2
    4
        Fever; Day 4-Day 7; Post-dose 3
    3
        Any Fever; Day 4-Day 7
    13
        Vomiting; Day 0-Day 3; Post-dose 1
    62
        Vomiting; Day 0-Day 3; Post-dose 2
    30
        Vomiting; Day 0-Day 3; Post-dose 3
    16
        Any Vomiting; Day 0-Day 3
    84
        Vomiting; Day 4-Day 7; Post-dose 1
    5
        Vomiting; Day 4-Day 7; Post-dose 2
    0
        Vomiting; Day 4-Day 7; Post-dose 3
    1
        Any Vomiting; Day 4-Day 7
    6
        Crying abnormal; Day 0-Day 3; Post-dose 1
    146
        Crying abnormal; Day 0-Day 3; Post-dose 2
    117
        Crying abnormal; Day 0-Day 3; Post-dose 3
    70
        Any Crying abnormal; Day 0-Day 3
    230
        Crying abnormal; Day 4-Day 7; Post-dose 1
    7
        Crying abnormal; Day 4-Day 7; Post-dose 2
    3
        Crying abnormal; Day 4-Day 7; Post-dose 3
    2
        Any Crying abnormal; Day 4-Day 7
    11
        Somnolence; Day 0-Day 3; Post-dose 1
    108
        Somnolence; Day 0-Day 3; Post-dose 2
    90
        Somnolence; Day 0-Day 3; Post-dose 3
    40
        Any Somnolence; Day 0-Day 3
    183
        Somnolence; Day 4-Day 7; Post-dose 1
    13
        Somnolence; Day 4-Day 7; Post-dose 2
    6
        Somnolence; Day 4-Day 7; Post-dose 3
    0
        Any Somnolence; Day 4-Day 7
    19
        Anorexia; Day 0-Day 3; Post-dose 1
    95
        Anorexia; Day 0-Day 3; Post-dose 2
    78
        Anorexia; Day 0-Day 3; Post-dose 3
    50
        Any Anorexia; Day 0-Day 3
    168
        Anorexia; Day 4-Day 7; Post-dose 1
    7
        Anorexia; Day 4-Day 7; Post-dose 2
    2
        Anorexia; Day 4-Day 7; Post-dose 3
    2
        Any Anorexia; Day 4-Day 7
    11
        Irritability; Day 0-Day 3; Post-dose 1
    47
        Irritability; Day 0-Day 3; Post-dose 2
    50
        Irritability; Day 0-Day 3; Post-dose 3
    30
        Any Irritability; Day 0-Day 3
    103
        Irritability; Day 4-Day 7; Post-dose 1
    4
        Irritability; Day 4-Day 7; Post-dose 2
    3
        Irritability; Day 4-Day 7; Post-dose 3
    3
        Any Irritability; Day 4-Day 7
    10
    Notes
    [3] - N=786 Post-dose 2; N=772 Post-dose 3
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited Adverse Events Occurring Up to 28 Days After Any Primary Series Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Number of Subjects with Unsolicited Adverse Events Occurring Up to 28 Days After Any Primary Series Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [4]
    End point description
    For the reporting of unsolicited AEs, if a subject had more than one event for a particular SOC/Preferred Term he/she was counted only once for that SOC/Preferred Term according to the most severe category.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 28 post-any vaccination
    Notes
    [4] - 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: Descriptive analyses were performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 IMOVAX Polio™
    Number of subjects analysed
    800
    Units: Number of subjects
    number (not applicable)
        Any, Upper respiratory tract infection
    13
        Severe, Upper respiratory tract infection
    0
        Any, Bronchitis
    2
        Severe, Bronchitis
    0
        Any, Nasopharyngitis
    2
        Severe, Nasopharyngitis
    0
        Any, Pneumonia
    2
        Severe, Pneumonia
    1
        Any, Bronchopneumonia
    1
        Severe, Bronchopneumonia
    0
        Any, Cough
    1
        Severe, Cough
    0
        Any, Respiratory tract infection
    1
        Severe, Respiratory tract infection
    0
        Any, Eczema
    4
        Severe, Eczema
    0
        Any, Rash
    1
        Severe, Rash
    0
        Any, Diarrhoea
    4
        Severe, Diarrhoea
    0
        Any, Trichiasis
    1
        Severe, Trichiasis
    0
        Any, Pyrexia
    1
        Severe, Pyrexia
    0
        Any, Hypersensitivity
    1
        Severe, Hypersensitivity
    0
        Any, Urinary tract infection
    1
        Severe, Urinary tract infection
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 up to Day 28 post-any vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    IMOVAX Polio™
    Reporting group description
    		 Infants at least 2 months of age received 3 doses of IMOVAX Polio™, 1 each at 2, 3, and 4 months of age.

    Serious adverse events
    		 IMOVAX Polio™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 800 (0.13%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 800 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IMOVAX Polio™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    237 / 800 (29.63%)
    Nervous system disorders
    Any Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    195 / 800 (24.38%)
         occurrences all number
    195
    General disorders and administration site conditions
    Any Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    97 / 800 (12.13%)
         occurrences all number
    97
    Any Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    47 / 800 (5.88%)
         occurrences all number
    47
    Any Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 800 (5.13%)
         occurrences all number
    41
    Gastrointestinal disorders
    Any Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    87 / 800 (10.88%)
         occurrences all number
    87
    Psychiatric disorders
    Any Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    237 / 800 (29.63%)
         occurrences all number
    237
    Any Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    107 / 800 (13.38%)
         occurrences all number
    107
    Metabolism and nutrition disorders
    Any Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed
    175 / 800 (21.88%)
         occurrences all number
    175

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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