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    Clinical Trial Results:
    Safety and Immunogenicity of Sanofi Pasteur's Diphtheria, Tetanus, and Acellular Pertussis (DTaP)-Inactivated Poliovirus (IPV)-Hepatitis B (HB)-polyribosyl ribitol phosphate conjugated to tetanus protein (PRP-T) combined vaccine (DTaP-IPV-HB-PRP-T) Given as a Primary Series of Vaccination in Infants

    Summary
    EudraCT number
    2013-003267-55
    Trial protocol
    PL  
    Global end of trial date
    29 Aug 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Sep 2017
    First version publication date
    16 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L45
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1143-8252
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2 avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Global Medical Affairs, Sanofi Pasteur SA, 33 (0)4 37 37 7464, olga.lyabis@sanofi.com
    Scientific contact
    Global Medical Affairs, Sanofi Pasteur SA, 33 (0)4 37 37 74 64, olga.lyabis@sanofi.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
    31 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Russian Federation: To describe the safety and reactogenicity of the study vaccine after a single dose in infants 6 months of age who had previously received 2 vaccinations of Pentaxim and 2 doses of HB vaccine and to evaluate the immunogenicity of the study vaccine 1 month after vaccination Poland: To describe the safety and reactogenicity after each and all doses of the study vaccine administered as a 3-dose primary series
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were enrolled 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
    27 Aug 2015
    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
    Poland: 50
    Country: Number of subjects enrolled
    Russian Federation: 100
    Worldwide total number of subjects
    150
    EEA total number of subjects
    50
    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)
    150
    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 27 August 2015 to 09 February 2016 (Russia) and 12 January 2016 to 13 April 2016 (Poland) at 5 clinic centers in the Russian Federation and 2 clinic centers in Poland.

    Pre-assignment
    Screening details
    A total of 150 subjects who met all inclusion criteria and no exclusion criteria were enrolled and 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
    Are arms mutually exclusive
    Yes

    Arm title
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation)
    Arm description
    Infants received a single dose of DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation).
    Arm type
    Experimental

    Investigational medicinal product name
    DTaP-IPV-HB-PRP~T combined vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the upper outer surface in the middle of the thigh, single dose (Russian Federation).

    Arm title
    DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Arm description
    Infants received a 3-dose primary vaccination series of DTaP-IPV-HB-PRP~T (Poland) at Day 0, Day 45, and Day 90.
    Arm type
    Experimental

    Investigational medicinal product name
    DTaP-IPV-HB-PRP~T combined vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the upper outer surface in the middle of the thigh, 1 dose each at Day 0, Day 45, and Day 90 (Poland)

    Number of subjects in period 1
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation) DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Started
    100
    50
    Completed
    100
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation)
    Reporting group description
    Infants received a single dose of DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation).

    Reporting group title
    DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Reporting group description
    Infants received a 3-dose primary vaccination series of DTaP-IPV-HB-PRP~T (Poland) at Day 0, Day 45, and Day 90.

    Reporting group values
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation) DTaP-IPV-HB-PRP~T combined vaccine (Poland) Total
    Number of subjects
    100 50 150
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    100 50 150
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Age is reported in months for infants in the Russian Federation group and in weeks for infants in the Poland group.
    Units: months
        arithmetic mean (standard deviation)
    6.6 ± 0.3 7 ± 0.6 -
    Gender categorical
    Units: Subjects
        Female
    50 26 76
        Male
    50 24 74

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation)
    Reporting group description
    Infants received a single dose of DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation).

    Reporting group title
    DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Reporting group description
    Infants received a 3-dose primary vaccination series of DTaP-IPV-HB-PRP~T (Poland) at Day 0, Day 45, and Day 90.

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions After Vaccination with a Single Dose of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Russian Federation

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions After Vaccination with a Single Dose of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Russian Federation [1] [2]
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Decreased appetite, Irritability. Grade 3 Injection site reactions: Pain, Cries when injected limb is moved, or the movement of the limb is reduced; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Pyrexia, >39.5°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-vaccination (Russian Federation)
    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 study vaccine administered for this outcome.
    [2] - 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: Only solicited injection-site and systemic reactions that occurred after a single dose of the combined vaccine (Russian Federation) are reported for this outcome.
    End point values
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation)
    Number of subjects analysed
    100
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Pain
    26
        Grade 3 Injection site Pain
    4
        Any Injection site Erythema
    25
        Grade 3 Injection site Erythema
    0
        Any Injection site Swelling
    17
        Grade 3 Injection site Swelling
    2
        Any Pyrexia
    11
        Grade 3 Pyrexia
    0
        Any Vomiting
    4
        Grade 3 Vomiting
    0
        Any Crying abnormal
    23
        Grade 3 Crying abnormal
    4
        Any Somnolence
    27
        Grade 3 Somnolence
    0
        Any Decreased appetite
    19
        Grade 3 Decreased appetite
    0
        Any Irritability
    38
        Grade 3 Irritability
    5
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions After Any and Each Dose of a Three-Dose Primary Series of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Poland

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions After Any and Each Dose of a Three-Dose Primary Series of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Poland [3] [4]
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Decreased appetite, Irritability. Grade 3 Injection site reactions: Pain, Cries when injected limb is moved, or the movement of the limb is reduced; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Pyrexia, >39.5°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-any and each vaccination
    Notes
    [3] - 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 study vaccine administered for this outcome.
    [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: Only solicited injection-site and systemic reactions that occurred after a three-dose primary series of the combined vaccine (Poland) are reported for this outcome.
    End point values
    DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Number of subjects analysed
    50
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Pain
    78
        Grade 3 Injection site Pain
    8
        Any Injection site Pain; Post Injection 1
    60
        Grade 3 Injection site Pain; Post Injection 1
    6
        Any Injection site Pain; Post Injection 2
    52
        Grade 3 Injection site Pain; Post Injection 2
    2
        Any Injection site Pain; Post Injection 3
    54
        Grade 3 Injection site Pain; Post Injection 3
    2
        Any Injection site Erythema
    72
        Grade 3 Injection site Erythema
    8
        Any Injection site Erythema; Post Injection 1
    42
        Grade 3 Injection site Erythema; Post Injection 1
    6
        Any Injection site Erythema; Post Injection 2
    46
        Grade 3 Injection site Erythema; Post Injection 2
    4
        Any Injection site Erythema; Post Injection 3
    56
        Grade 3 Injection site Erythema; Post Injection 3
    0
        Any Injection site Swelling
    58
        Grade 3 Injection site Swelling
    8
        Any Injection site Swelling; Post Injection 1
    32
        Grade 3 Injection site Swelling; Post Injection 1
    6
        Any Injection site Swelling; Post Injection 2
    28
        Grade 3 Injection site Swelling; Post Injection 2
    2
        Any Injection site Swelling; Post Injection 3
    40
        Grade 3 Injection site Swelling; Post Injection 3
    2
        Any Pyrexia
    28
        Grade 3 Pyrexia
    2
        Any Pyrexia; Post Injection 1
    10
        Grade 3 Pyrexia; Post Injection 1
    0
        Any Pyrexia; Post Injection 2
    12
        Grade 3 Pyrexia; Post Injection 2
    0
        Any Pyrexia; Post Injection 3
    14
        Grade 3 Pyrexia; Post Injection 3
    2
        Any Vomiting
    30
        Grade 3 Vomiting
    0
        Any Vomiting; Post Injection 1
    16
        Grade 3 Vomiting; Post Injection 1
    0
        Any Vomiting; Post Injection 2
    14
        Grade 3 Vomiting; Post Injection 2
    0
        Any Vomiting; Post Injection 3
    8
        Grade 3 Vomiting; Post Injection 3
    0
        Any Crying abnormal
    92
        Grade 3 Crying abnormal
    8
        Any Crying abnormal; Post Injection 1
    84
        Grade 3 Crying abnormal; Post Injection 1
    2
        Any Crying abnormal; Post Injection 2
    62
        Grade 3 Crying abnormal; Post Injection 2
    6
        Any Crying abnormal; Post Injection 3
    54
        Grade 3 Crying abnormal; Post Injection 3
    0
        Any Somnolence
    76
        Grade 3 Somnolence
    4
        Any Somnolence; Post Injection 1
    62
        Grade 3 Somnolence; Post Injection 1
    4
        Any Somnolence; Post Injection 2
    50
        Grade 3 Somnolence; Post Injection 2
    0
        Any Somnolence; Post Injection 3
    38
        Grade 3 Somnolence; Post Injection 3
    0
        Any Decreased appetite
    48
        Grade 3 Decreased appetite
    2
        Any Decreased appetite; Post Injection 1
    24
        Grade 3 Decreased appetite; Post Injection 1
    0
        Any Decreased appetite; Post Injection 2
    26
        Grade 3 Decreased appetite; Post Injection 2
    0
        Any Decreased appetite; Post Injection 3
    22
        Grade 3 Decreased appetite; Post Injection 3
    2
        Any Irritability
    90
        Grade 3 Irritability
    10
        Any Irritability; Post Injection 1
    74
        Grade 3 Irritability; Post Injection 1
    2
        Any Irritability; Post Injection 2
    66
        Grade 3 Irritability; Post Injection 2
    6
        Any Irritability; Post Injection 3
    56
        Grade 3 Irritability; Post Injection 3
    4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroprotection After Vaccination with a Single Dose of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Russian Federation

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    End point title
    Percentage of Subjects with Seroprotection After Vaccination with a Single Dose of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Russian Federation [5]
    End point description
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus was assessed using an enzyme-linked immunosorbent assay. Anti-Haemophilus influenza type b (Hib) capsular PRP antibodies were assessed by a Farr-type radioimmunoassay. Anti-Hepatitis B was measured using the commercially available VITROS ECi/ECIQ Immunodiagnostic System using chemiluminescence. Anti-Poliovirus (Polio) types 1, 2, and 3 antibodies were assessed by a neutralization assay. Seroprotection was defined as the following: Anti-Diphtheria ≥0.01 International Units (IU)/mL, ≥0.1 IU/mL, and ≥1.0 IU/mL; Anti-Tetanus ≥0.01 IU/mL, ≥0.1 IU/mL, ≥1.0 IU/mL; Anti-PRP ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-Polio types 1, 2, and 3 ≥8 (1/dilution), Anti-Hepatitis B ≥10 mIU/mL and ≥100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 1
    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: Immunogenicity data are only available in infants who received a single dose of the combined vaccine (Russian Federation).
    End point values
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation)
    Number of subjects analysed
    97
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; ≥0.01 IU/mL
    100
        Anti-Diphtheria; ≥0.1 IU/mL
    68.8
        Anti-Diphtheria; ≥1.0 IU/mL
    20.4
        Anti-Tetanus; ≥0.01 IU/mL
    100
        Anti-Tetanus; ≥0.1 IU/mL
    100
        Anti-Tetanus; ≥1.0 IU/mL
    82
        Anti-Polio 1; ≥8 (1/dilution)
    100
        Anti-Polio 2; ≥8 (1/dilution)
    100
        Anti-Polio 3; ≥8 (1/dilution)
    100
        Anti-Hepatitis B; ≥10 mIU/mL
    100
        Anti-Hepatitis B; ≥100 mIU/mL
    96.9
        Anti-PRP; ≥0.15 µg/mL
    97.9
        Anti-PRP; ≥1.0 µg/mL
    92.6
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigens After Vaccination with a Single Dose of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Russian Federation

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    End point title
    Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigens After Vaccination with a Single Dose of Hexavalent DTaP-IPV-HB-PRP-T Combined Vaccine in Russian Federation [6]
    End point description
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus, Anti-Pertussis toxoid, and Anti-Filamentous hemagglutinin (FHA) antibodies were assessed using an enzyme-linked immunosorbent assay. Anti-Hib capsular PRP antibodies were assessed by a Farr-type radioimmunoassay. Anti-Hepatitis B was measured using the commercially available VITROS ECi/ECIQ Immunodiagnostic System using chemiluminescence. Anti-Polio types 1, 2, and 3 antibodies were assessed by a neutralization assay.
    End point type
    Secondary
    End point timeframe
    1 month post-dose 1
    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: Immunogenicity data are only available in infants who received a single dose of the combined vaccine (Russian Federation).
    End point values
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation)
    Number of subjects analysed
    97
    Units: Concentration (1/dilution)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    0.278 (0.205 to 0.377)
        Anti-Tetanus
    2.08 (1.76 to 2.46)
        Anti-Pertussis toxoid
    123 (104 to 145)
        Anti-FHA
    154 (135 to 177)
        Anti-Polio 1
    1358 (1035 to 1782)
        Anti-Polio 2
    2597 (2010 to 3355)
        Anti-Polio 3
    2749 (1904 to 3969)
        Anti-Hepatitis B
    1679 (1254 to 2248)
        Anti-PRP
    6.25 (4.58 to 8.53)
    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 30 post-dose 3.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation)
    Reporting group description
    Infants received a single dose of DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation).

    Reporting group title
    DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Reporting group description
    Infants received a 3-dose primary vaccination series of DTaP-IPV-HB-PRP~T (Poland) at Day 0, Day 45, and Day 90.

    Serious adverse events
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation) DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    5 / 50 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 50 (2.00%)
         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: 5%
    Non-serious adverse events
    DTaP-IPV-HB-PRP~T combined vaccine (Russian Federation) DTaP-IPV-HB-PRP~T combined vaccine (Poland)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 100 (38.00%)
    46 / 50 (92.00%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 100 (27.00%)
    38 / 50 (76.00%)
         occurrences all number
    27
    38
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 100 (26.00%)
    39 / 50 (78.00%)
         occurrences all number
    26
    39
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    25 / 100 (25.00%)
    36 / 50 (72.00%)
         occurrences all number
    25
    36
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 100 (17.00%)
    29 / 50 (58.00%)
         occurrences all number
    17
    29
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 100 (11.00%)
    14 / 50 (28.00%)
         occurrences all number
    11
    14
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 100 (23.00%)
    46 / 50 (92.00%)
         occurrences all number
    23
    46
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    38 / 100 (38.00%)
    45 / 50 (90.00%)
         occurrences all number
    38
    45
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 100 (4.00%)
    15 / 50 (30.00%)
         occurrences all number
    4
    15
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 100 (19.00%)
    24 / 50 (48.00%)
         occurrences all number
    19
    24
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 100 (1.00%)
    6 / 50 (12.00%)
         occurrences all number
    1
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2015
    Clarified the age of infants to be included in the study from 6 months to 6 months and 29 days, excluded infants under 6 months of age, included a recommendation to start the study in a limited group of subjects; if satisfactory results were observed (absence of SAEs), then the study would continue, and revised the wording describing the site of injection from "anterolateral thigh" to "upper outer part of the middle thigh" to be consistent with local Russian guidelines.

    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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