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    Clinical Trial Results:
    Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

    Summary
    EudraCT number
    		 2015-005404-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2016
    First version publication date
    09 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E2I60
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01491087
    WHO universal trial number (UTN)
    		 U1111-1117-7233
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur, SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Medical Product Leader, Sanofi Pasteur, SA, 33 4 37 65 67 99, Emmanuel.vidor@sanofipasteur.com
    Scientific contact
    Medical Product Leader, Sanofi Pasteur, SA, 33 4 37 65 67 99, Emmanuel.vidor@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
    20 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.
    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 kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    02 Dec 2011
    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: 900
    Worldwide total number of subjects
    900
    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)
    900
    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 02 December 2011 to 14 May 2012 in 3 Chinese provinces/cities.

    Pre-assignment
    Screening details
    		 A total of 900 subjects who met the inclusion, but none of the exclusion criteria were enrolled and vaccinated.

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

    Arms
    Arm title
    		 Study Group
    Arm description
    		 Subjects received DTacP-IPV//PRP~T Combined Vaccine (Pentaxim®) as a three-dose primary vaccination at 2, 3, and 4 Months of Age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP-T combined vaccine
    Investigational medicinal product code
    Other name
    PENTAXIM™
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular into the anterolateral external aspect of the upper thigh (right or left)

    Number of subjects in period 1
    		Study Group
    Started
    900
    Completed
    871
    Not completed
    29
         Consent withdrawn by subject
    9
         Lost to follow-up
    9
         Adverse event, non-fatal
    9
         Serious adverse events
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 900 900
    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)
    		 900 900
        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: months
        arithmetic mean (standard deviation)
    		 2.2 ± 0.1 -
    Gender categorical
    Units: Subjects
        Female
    		 443 443
        Male
    		 457 457

    End points

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    End points reporting groups
    Reporting group title
    Study Group
    Reporting group description
    		 Subjects received DTacP-IPV//PRP~T Combined Vaccine (Pentaxim®) as a three-dose primary vaccination at 2, 3, and 4 Months of Age.

    Primary: Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions After Any Injection with DTacP-IPV//PRP~T Combined Vaccine (Pentaxim®) Given as a Three-Dose Primary Vaccination.

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    End point title
    		 Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions After Any Injection with DTacP-IPV//PRP~T Combined Vaccine (Pentaxim®) Given as a Three-Dose Primary Vaccination. [1]
    End point description
    Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection-site: Tenderness, Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling > 30 mm. Grade 3: Fever, > 39°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite Lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 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 was performed based on the study vaccine administered for this outcome.
    End point values
    		 Study Group
    Number of subjects analysed
    900
    Units: Percentage of Subjects
    number (not applicable)
        Injection-site Tenderness
    41.3
        Grade 3 injection-site Tenderness
    1
        Injection-site Erythema
    44.7
        Grade 3 injection-site Erythema
    1.4
        Injection-site Swelling
    34.4
        Grade 3 injection-site Swelling
    2.9
        Fever
    35.9
        Grade 3 Fever
    0.6
        Vomiting
    37
        Grade 3 Vomiting
    1.4
        Crying Abnormal
    60
        Grade 3 Crying Abnormal
    4.7
        Drowsiness
    49.6
        Grade 3 Drowsiness
    1.8
        Appetite Lost
    43.5
        Grade 3 Appetite Lost
    1.7
        Irritability
    45.8
        Grade 3 Irritability
    3
    No statistical analyses for this end point

    Primary: Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions After Each Injection with DTacP-IPV//PRP~T Combined Vaccine (Pentaxim®) Given as a Three-Dose Primary Vaccination.

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    End point title
    		 Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions After Each Injection with DTacP-IPV//PRP~T Combined Vaccine (Pentaxim®) Given as a Three-Dose Primary Vaccination. [2]
    End point description
    Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection-site: Tenderness, Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling > 30 mm. Grade 3: Fever, > 39°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite Lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 up Day 7 post-each 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 was performed based on the study vaccine administered for this outcome.
    End point values
    		 Study Group
    Number of subjects analysed
    900
    Units: Percentage of Subjects
    number (not applicable)
        Injection-site Tenderness (Post-first injection)
    27.7
        Grade 3 Inj-site Tenderness (Post-first injection)
    0.4
        Injecting-site Tenderness (Post-second injection)
    24.1
        Grade 3 Inj.-site Tenderness (Post-second inj.)
    0.5
        Injecting-site Tenderness (Post-third injection)
    23.6
        Grade 3 Inj.-site Tenderness (Post-third inj.)
    0.5
        Injecting-site Swelling (Post-first injection)
    10.6
        Grade 3 Injecting-site Swelling (Post-first inj.)
    0.9
        Injecting-site Swelling (Post-second injection)
    22.4
        Grade 3 Injecting-site Swelling (Post-second inj.)
    1.7
        Injecting-site Swelling (Post-third injection)
    24.2
        Grade 3 Injecting-site Swelling (Post-third inj.)
    0.8
        Injecting-site Erythema (Post-first injection)
    14.1
        Grade 3 Injecting-site Erythema (Post-first inj.)
    0.3
        Injecting-site Erythema (Post-second injection)
    29.9
        Grade 3 Injecting-site Erythema (Post-second inj.)
    0.5
        Injecting-site Erythema (Post-third injection)
    33
        Grade 3 Injecting-site Erythema (Post-third inj.)
    0.7
        Fever (Post-first injection)
    20.5
        Grade 3 Fever (Post-first injection)
    0.1
        Fever (Post-second injection)
    14.8
        Grade 3 Fever (Post-second injection)
    0.2
        Fever (Post-third injection)
    15
        Grade 3 Fever (Post-third injection)
    0.2
        Vomiting (Post-first injection)
    29.1
        Grade 3 Vomiting (Post-first injection)
    1
        Vomiting (Post-second injection)
    17.5
        Grade 3 Vomiting (Post-second injection)
    0.2
        Vomiting (Post-third injection)
    11.7
        Grade 3 Vomiting (Post-third injection)
    0.5
        Crying Abnormal (Post-first injection)
    40.6
        Grade 3 Crying Abnormal (Post-first injection)
    2.3
        Crying Abnormal (Post-second injection)
    37.1
        Grade 3 Crying Abnormal (Post-second injection)
    1.7
        Crying Abnormal (Post-third injection)
    26.6
        Grade 3 Crying Abnormal (Post-third injection)
    1.4
        Drowsiness (Post-first injection)
    35.2
        Grade 3 Drowsiness (Post-first injection)
    1.1
        Drowsiness (Post-second injection)
    24.1
        Grade 3 Drowsiness (Post-second injection)
    0.5
        Drowsiness (Post-third injection)
    19
        Grade 3 Drowsiness (Post-third injection)
    0.3
        Appetite Lost (Post-first injection)
    26.8
        Grade 3 Appetite Lost (Post-first injection)
    0.7
        Appetite Lost (Post-second injection)
    23.3
        Grade 3 Appetite Lost (Post-second injection)
    0.8
        Appetite Lost (Post-third injection)
    19
        Grade 3 Appetite Lost (Post-third injection)
    0.5
        Irritability (Post-first injection)
    30.6
        Grade 3 Irritability (Post-first injection)
    1.4
        Irritability (Post-second injection)
    26.8
        Grade 3 Irritability (Post-second injection)
    1.4
        Irritability (Post-third injection)
    20.9
        Grade 3 Irritability (Post-third injection)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from Day 0 (post-vaccination) up to Day 42 post-third vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Study Group
    Reporting group description
    		 Subjects received DTacP-IPV//PRP~T Combined Vaccine (Pentaxim®) as a three-dose primary vaccination at 2, 3, and 4 Months of Age.

    Serious adverse events
    		 Study Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 900 (1.78%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    1 / 900 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 900 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 900 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    6 / 900 (0.67%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 900 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 900 (0.33%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 900 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 900 (0.11%)
         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
    		 Study Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    539 / 900 (59.89%)
    Nervous system disorders
    Drowsiness
         subjects affected / exposed
    445 / 900 (49.44%)
         occurrences all number
    445
    Crying Abnormal
         subjects affected / exposed
    539 / 900 (59.89%)
         occurrences all number
    539
    General disorders and administration site conditions
    Injection-site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    371 / 900 (41.22%)
         occurrences all number
    371
    Injection-site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    401 / 900 (44.56%)
         occurrences all number
    401
    Injection-site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    309 / 900 (34.33%)
         occurrences all number
    309
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    322 / 900 (35.78%)
         occurrences all number
    322
    Irritability
         subjects affected / exposed
    411 / 900 (45.67%)
         occurrences all number
    411
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    332 / 900 (36.89%)
         occurrences all number
    332
    Metabolism and nutrition disorders
    Appetite Lost
         subjects affected / exposed
    391 / 900 (43.44%)
         occurrences all number
    391

    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.
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