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    Clinical Trial Results:
    Immunogenicity and Safety of the Aventis Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 2, 4 and 6 Months of Age and Followed by a Booster Dose at 18 to 19 Months of Age in Healthy Infants in Thailand. All Infants Receiving Recombinant Hepatitis B Vaccine at 0, 2 and 6 Months of Age.

    Summary
    EudraCT number
    		 2015-005352-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Sep 2007

    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
    E2I34
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00255021
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Medical Team Leader, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.vidor@sanofipasteur.com
    Scientific contact
    Medical Team 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?
    Yes
    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
    24 Sep 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity: To assess the seroprotection rates (Diphtheria, Tetanus, polio types 1, 2 and 3, and Polyribosyl Ribitol Phosphate conjugated to Tetanus protein) and seroconversion rates (Pertussis Toxoid, Filamentous Hemagglutinin) of Aventis Pasteur’s DTacP-IPV//PRP~T combined vaccine, one month after the three-dose primary vaccination. To describe the immunogenicity of the study combined vaccine (PENTAXIM™) one month after the three-dose primary vaccination (Visit 4), prior to the booster dose (at Visit 5) and one month after the booster dose (Visit 6). To describe the immunogenicity of the recombinant hepatitis B vaccine antigen one month after the three-dose primary vaccination (Visit 4) and approximately 11 to 12 months later (Visit 5). Safety: To describe the safety after each dose of the study combined vaccine (PENTAXIM™). To describe the safety after each study dose of recombinant hepatitis B vaccine
    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
    06 Dec 2005
    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
    Thailand: 186
    Worldwide total number of subjects
    186
    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)
    186
    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 06 December 2005 to 03 April 2006 at 2 clinic centers in Thailand.

    Pre-assignment
    Screening details
    		 A total of 186 infants who met all inclusion and none of the exclusion criteria were enrolled and vaccinated in the trial.

    Period 1
    Period 1 title
    Primary Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 DTacP-IPV//PRP~T vaccine
    Arm description
    		 All subjects had previously received the first dose of the recombinant 10 µg hepatitis B vaccine at birth according to the National Expanded Program on Immunization (EPI). In this trial, subjects received the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 4, and 6 months of age as well as two subsequent doses of the recombinant 10 µg hepatitis B vaccine at 2 and 6 months of age according to the National EPI. Subjects received a booster dose of the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 19 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right anterolateral external aspect of the upper thigh, 1 injection each at 2,4, and 6 months of age and a booster dose at 18 to 19 months of age.

    Investigational medicinal product name
    EUVAX B™ (recombinant hepatitis B vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the left anterolateral external aspect of the upper thigh, 1 injection each at birth and at 2 and 6 months of age.

    Number of subjects in period 1
    		DTacP-IPV//PRP~T vaccine
    Started
    186
    Completed
    175
    Not completed
    11
         Consent withdrawn by subject
    4
         Lost to follow-up
    3
         Protocol deviation
    4
    Period 2
    Period 2 title
    Booster phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 DTacP-IPV//PRP~T vaccine
    Arm description
    		 Subjects received a booster dose of the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 19 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right anterolateral external aspect of the upper thigh, booster dose at 18 to 19 months of age.

    Number of subjects in period 2
    		DTacP-IPV//PRP~T vaccine
    Started
    175
    Completed
    163
    Not completed
    12
         Lost to follow-up
    10
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTacP-IPV//PRP~T vaccine
    Reporting group description
    		 All subjects had previously received the first dose of the recombinant 10 µg hepatitis B vaccine at birth according to the National Expanded Program on Immunization (EPI). In this trial, subjects received the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 4, and 6 months of age as well as two subsequent doses of the recombinant 10 µg hepatitis B vaccine at 2 and 6 months of age according to the National EPI. Subjects received a booster dose of the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 19 months of age.

    Reporting group values
    		 DTacP-IPV//PRP~T vaccine Total
    Number of subjects
    		 186 186
    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)
    		 186 186
        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)
    		 1.9 ( 0.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 81 81
        Male
    		 105 105
    Subject analysis sets

    Subject analysis set title
    Immunogenicity Analysis Set Post-Dose 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Post-Dose 3 was defined as all subjects who had followed the vaccination schedule until Visit 3 (6 months of age) and all subjects for whom injections had been performed and blood samples had been drawn within the tolerated time limits.

    Subject analysis set title
    Immunogenicity Analysis Set Pre-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Pre-Booster was defined as all subjects who had followed the vaccination schedule until Visit 3 (6 months of age) and all subjects for whom a blood sample had been drawn at Visit 5 (blood sample 3), with an age at blood sample on Visit 5 less than 17 months (no older than 20 months), and had an antibody titer available for Visit 5 (blood sample 3).

    Subject analysis set title
    Immunogenicity Analysis Set Post-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Post-Booster was defined as all subjects who had followed the vaccination schedule until Visit 5 (blood sample 3) with an age at blood sample on Visit 5 less than 17 months (no older than 20 months).

    Subject analysis sets values
    		 Immunogenicity Analysis Set Post-Dose 3 Immunogenicity Analysis Set Pre-Booster Immunogenicity Analysis Set Post-Booster
    Number of subjects
    173
    166
    161
    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)
    173
    166
    161
        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
    Units: months
        arithmetic mean (standard deviation)
    1.9 ( 0.1 )
    1.9 ( 0.1 )
    1.9 ( 0.1 )
    Gender categorical
    Units: Subjects
        Female
    76
    73
    71
        Male
    97
    93
    90

    End points

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    End points reporting groups
    Reporting group title
    DTacP-IPV//PRP~T vaccine
    Reporting group description
    		 All subjects had previously received the first dose of the recombinant 10 µg hepatitis B vaccine at birth according to the National Expanded Program on Immunization (EPI). In this trial, subjects received the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 4, and 6 months of age as well as two subsequent doses of the recombinant 10 µg hepatitis B vaccine at 2 and 6 months of age according to the National EPI. Subjects received a booster dose of the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 19 months of age.
    Reporting group title
    DTacP-IPV//PRP~T vaccine
    Reporting group description
    		 Subjects received a booster dose of the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 19 months of age.

    Subject analysis set title
    Immunogenicity Analysis Set Post-Dose 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Post-Dose 3 was defined as all subjects who had followed the vaccination schedule until Visit 3 (6 months of age) and all subjects for whom injections had been performed and blood samples had been drawn within the tolerated time limits.

    Subject analysis set title
    Immunogenicity Analysis Set Pre-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Pre-Booster was defined as all subjects who had followed the vaccination schedule until Visit 3 (6 months of age) and all subjects for whom a blood sample had been drawn at Visit 5 (blood sample 3), with an age at blood sample on Visit 5 less than 17 months (no older than 20 months), and had an antibody titer available for Visit 5 (blood sample 3).

    Subject analysis set title
    Immunogenicity Analysis Set Post-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Post-Booster was defined as all subjects who had followed the vaccination schedule until Visit 5 (blood sample 3) with an age at blood sample on Visit 5 less than 17 months (no older than 20 months).

    Primary: Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens One Month after Three Dose Primary Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™)

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    End point title
    		 Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens One Month after Three Dose Primary Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) [1]
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay and Anti-Hepatitis B surface antigen were assessed by radioimmunoassay. Seroprotection for Anti-Diphtheria and Anti-Tetanus was defined as antibody titers ≥ 0.1 IU/mL, ≥ 8 (dil) for Anti-Polio types 1, 2, and 3, ≥ 0.15 µg/mL for Anti-PRP, and ≥ 10 mIU/mL for Hepatitis B. Seroconversion for Anti-Pertussis toxoid and Anti-FHA was defined as antibody titers ≥ 4-fold increase EU/mL.
    End point type
    Primary
    End point timeframe
    1 month post-dose 3 of primary vaccination (Day 140)
    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.
    End point values
    		 Immunogenicity Analysis Set Post-Dose 3
    Number of subjects analysed
    173
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    99.4
        Anti-Tetanus
    100
        Anti-Polio 1
    100
        Anti-Polio 2
    100
        Anti-Polio 3
    100
        Anti-PRP
    100
        Anti-Pertussis Toxoid
    94.1
        Anti-FHA
    93
        Anti-Hepatitis B
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection/Seroconversion Before and After A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Following A Three Dose Primary Vaccination

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    End point title
    		 Percentage of Subjects with Seroprotection/Seroconversion Before and After A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Following A Three Dose Primary Vaccination
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay and Anti-Hepatitis B surface antigen were assessed by radioimmunoassay. Seroprotection for Anti-Diphtheria and Anti-Tetanus was defined as antibody titers ≥ 0.1 IU/mL, ≥ 8 (dil) for Anti-Polio types 1, 2, and 3, ≥ 0.15 µg/mL for Anti-PRP, and ≥ 10 mIU/mL for Hepatitis B. Seroconversion for Anti-Pertussis toxoid and Anti-FHA was defined as antibody titers ≥ 4-fold increase EU/mL. Seroconversion rates are not available for Anti-Pertussis toxoid or Anti-FHA pre-booster and for Anti-Hepatitis B post-booster injection.
    End point type
    Other pre-specified
    End point timeframe
    Day 140 + 11-12 months (Visit 05) pre-booster and Visit 05 + 28-42 days post-booster (Visit 06)
    End point values
    		 Immunogenicity Analysis Set Pre-Booster Immunogenicity Analysis Set Post-Booster
    Number of subjects analysed
    166
    161
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    72.7
    100
        Anti-Tetanus
    100
    100
        Anti-Polio 1
    97.5
    100
        Anti-Polio 2
    99.4
    100
        Anti-Polio 3
    95
    100
        Anti-PRP
    94.4
    100
        Anti-Pertussis toxoid
    0
    96.3
        Anti-FHA
    0
    93.1
        Anti-Hepatitis B
    98.2
    0
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Antibodies Against Vaccine Antigens Following A Three Dose Primary Vaccination Series, Before and Following A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™)

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens Following A Three Dose Primary Vaccination Series, Before and Following A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™)
    End point description
    Anti-Diphtheria and Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay and Anti-Hepatitis B surface antigen were assessed by radioimmunoassay. Geometric mean titer data were not available for Anti-Hepatitis B post-booster injection.
    End point type
    Other pre-specified
    End point timeframe
    1 month post-dose 3 of primary vaccination (Day 140) and Day 140 + 11-12 months (Visit 05) pre-booster and Visit 05 + 28-42 days post-booster (Visit 06)
    End point values
    		 Immunogenicity Analysis Set Post-Dose 3 Immunogenicity Analysis Set Pre-Booster Immunogenicity Analysis Set Post-Booster
    Number of subjects analysed
    166
    165
    161
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    0.12 (0.1 to 0.14)
    0.02 (0.02 to 0.03)
    2.67 (2.1 to 3.41)
        Anti-Tetanus
    1.13 (1.03 to 1.23)
    0.3 (0.26 to 0.35)
    9.99 (8.97 to 11.13)
        Anti-Pertussis toxoid
    181.49 (163.05 to 201.01)
    14.01 (11.98 to 16.37)
    307.35 (281.01 to 336.16)
        Anti-FHA
    119.13 (108.12 to 131.26)
    13.94 (11.7 to 16.6)
    271.86 (246.91 to 299.32)
        Anti-Polio 1
    1267.23 (1033.98 to 1553.09)
    166.46 (130.17 to 212.87)
    4620.75 (3901.03 to 5473.27)
        Anti-Polio 2
    1602.34 (1311.06 to 1958.34)
    250.01 (198.31 to 315.18)
    6086.64 (5179.62 to 7152.49)
        Anti-Polio 3
    3078.57 (2478.53 to 3823.88)
    156.07 (121.15 to 201.06)
    5596.51 (4598.79 to 6810.69)
        Anti-PRP
    9.62 (7.91 to 11.7)
    1.21 (0.98 to 1.5)
    62.23 (52.81 to 73.33)
        Anti-Hepatitis B
    1512.82 (1319 to 1735.12)
    180.91 (152.04 to 215.27)
    0 (0 to 0)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Following A Three Dose Primary Vaccination

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Following A Three Dose Primary Vaccination
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay.
    End point type
    Other pre-specified
    End point timeframe
    Day 140 + 11-12 months (Visit 05) pre-booster and Visit 05 + 28-42 days post-booster (Visit 06)
    End point values
    		 Immunogenicity Analysis Set Post-Booster
    Number of subjects analysed
    161
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    128.55 (106.81 to 154.72)
        Anti-Tetanus
    33.15 (28.9 to 38.01)
        Anti-Pertussis toxoid
    21.95 (18.92 to 25.45)
        Anti-FHA
    19.54 (16.8 to 22.71)
        Anti-Polio 1
    27.76 (21.39 to 36.02)
        Anti-Polio 2
    24.35 (18.78 to 31.57)
        Anti-Polio 3
    35.86 (27.71 to 46.41)
        Anti-PRP
    51.23 (41.16 to 63.76)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any Primary Series Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™)

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any Primary Series Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™)
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-any primary injection
    End point values
    		 DTacP-IPV//PRP~T vaccine
    Number of subjects analysed
    186
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness
    48.6
        Injection site Erythema
    57
        Injection site Swelling
    33.5
        Fever
    27
        Vomiting
    28.6
        Crying abnormal
    55.1
        Drowsiness
    25.9
        Appetite lost
    28.6
        Irritability
    51.4
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any and Each of Three-Dose Primary Series Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™)

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any and Each of Three-Dose Primary Series Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™)
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 systemic reactions: Fever, ≥ 39.0°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 or refuses most feeds; Irritability, Inconsolable. For solicited injection site reactions, data are reported post-PENTAXIM and post-Hepatitis B. Solicited injection site data were not collected post-dose 2 (Hepatitis B) and severe data were not available for any solicited injection site reaction post-any injection. For solicited systemic reactions, data are reported post-DTacP-IPV//PRP-T + Hepatitis B.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 8 post-any and each primary injection
    End point values
    		 DTacP-IPV//PRP~T vaccine
    Number of subjects analysed
    186
    Units: Percentage of subjects
    number (not applicable)
        Any Inj. site Tenderness; Post-Any; PENTAXIM
    44.3
        Grade 3 Inj. site Tenderness; Post-Any; PENTAXIM
    0
        Any Inj. site Tenderness; Post-Any; Hepatitis B
    41.6
        Grade 3 Inj. site Tenderness; Post-Any;Hepatitis B
    0
        Any Inj. site Tenderness; Post-dose 1; PENTAXIM
    29.2
        Grade 3 Inj. site Tenderness; Post-dose 1;PENTAXIM
    0
        Any Inj. site Tenderness; Post-dose 1; Hepatitis B
    32.4
        Grade 3 Inj. site Tenderness;Post-dose1;HepatitisB
    0
        Any Inj. site Tenderness; Post-dose 2; PENTAXIM
    25.4
        Grade 3 Inj. site Tenderness; Post-dose 2;PENTAXIM
    0.6
        Any Inj. site Tenderness; Post-dose 2; Hepatitis B
    0
        Grade 3 Inj. site Tenderness;Post-dose2;HepatitisB
    0
        Any Inj. site Tenderness; Post-dose 3; PENTAXIM
    26.9
        Grade 3 Inj. site Tenderness; Post-dose 3;PENTAXIM
    0
        Any Inj. site Tenderness; Post-dose 3; Hepatitis B
    26.9
        Grade 3 Inj. site Tenderness;Post-dose3;HepatitisB
    0
        Any Inj. site Erythema; Post-Any; PENTAXIM
    27.1
        Grade 3 Inj. site Erythema; Post-Any; PENTAXIM
    0.2
        Any Inj. site Erythema; Post-Any; Hepatitis B
    29.6
        Grade 3 Inj. site Erythema; Post-Any; Hepatitis B
    0
        Any Inj. site Erythema; Post-dose 1; PENTAXIM
    52.7
        Grade 3 Inj. site Erythema; Post-dose 1; PENTAXIM
    0
        Any Inj. site Erythema; Post-dose 1; Hepatitis B
    44.6
        Grade 3 Inj. site Erythema; Post-dose 1;HepatitisB
    0
        Any Inj. site Erythema; Post-dose 2; PENTAXIM
    23.1
        Grade 3 Inj. site Erythema; Post-dose 2; PENTAXIM
    0
        Any Inj. site Erythema; Post-dose 2; Hepatitis B
    28
        Grade 3 Inj. site Erythema; Post-dose 2;HepatitisB
    0
        Any Inj. site Erythema; Post-dose 3; PENTAXIM
    32.2
        Grade 3 Inj. site Erythema; Post-dose 3; PENTAXIM
    0
        Any Inj. site Erythema; Post-dose 3; Hepatitis B
    0
        Grade 3 Inj. site Erythema; Post-dose 3;HepatitisB
    0
        Any Inj. site Swelling; Post-Any; PENTAXIM
    29.2
        Grade 3 Inj. site Swelling; Post-Any; PENTAXIM
    0
        Any Inj. site Swelling; Post-Any; Hepatitis B
    29.4
        Grade 3 Inj. site Swelling; Post-Any; Hepatitis B
    0
        Any Inj. site Swelling; Post-dose 1; PENTAXIM
    30.8
        Grade 3 Inj. site Swelling; Post-dose 1; PENTAXIM
    0
        Any Inj. site Swelling; Post-dose 1; Hepatitis B
    20
        Grade 3 Inj. site Swelling; Post-dose 1;HepatitisB
    0
        Any Inj. site Swelling; Post-dose 2; PENTAXIM
    13
        Grade 3 Inj. site Swelling; Post-dose 2; PENTAXIM
    0
        Any Inj. site Swelling; Post-dose 2; Hepatitis B
    14.1
        Grade 3 Inj. site Swelling; Post-dose 2;HepatitisB
    0.5
        Any Inj. site Swelling; Post-dose 3; PENTAXIM
    12.4
        Grade 3 Inj. site Swelling; Post-dose 3; PENTAXIM
    0
        Any Inj. site Swelling; Post-dose 3; Hepatitis B
    0
        Grade 3 Inj. site Swelling; Post-dose 3;HepatitisB
    0
        Any Fever; Post-Any injection
    13.8
        Grade 3 Any Fever; Post-Any injection
    0
        Any Fever; Post-dose 1
    11.9
        Grade 3 Fever; Post-dose 1
    0.6
        Any Fever; Post-dose 2 (PENTAXIM)
    27
        Grade 3 Fever; Post-dose 2 (PENTAXIM)
    0
        Any Fever; Post-dose 3
    9.2
        Grade 3 Fever; Post-dose 3
    0
        Any Vomiting; Post-Any injection
    13.7
        Grade 3 Vomiting; Post-Any injection
    1.1
        Any Vomiting; Post-dose 1
    11.5
        Grade 3 Vomiting; Post-dose 1
    0.9
        Any Vomiting; Post-dose 2 (PENTAXIM)
    28.6
        Grade 3 Vomiting; Post-dose 2 (PENTAXIM)
    0
        Any Vomiting; Post-dose 3
    21.6
        Grade 3 Vomiting; Post-dose 3
    0
        Any Crying abnormal; Post-Any injection
    10.9
        Grade 3 Crying abnormal; Post-Any injection
    0
        Any Crying abnormal; Post-dose 1
    14.7
        Grade 3 Crying abnormal; Post-dose 1
    0
        Any Crying abnormal; Post-dose 2 (PENTAXIM)
    55.1
        Grade 3 Crying abnormal; Post-dose 2 (PENTAXIM)
    0
        Any Crying abnormal; Post-dose 3
    39.5
        Grade 3 Crying abnormal; Post-dose 3
    0
        Any Drowsiness; Post-Any injection
    29.1
        Grade 3 Drowsiness; Post-Any injection
    0.6
        Any Drowsiness; Post-dose 1
    34.9
        Grade 3 Drowsiness; Post-dose 1
    0.2
        Any Drowsiness; Post-dose 2 (PENTAXIM)
    25.9
        Grade 3 Drowsiness; Post-dose 2 (PENTAXIM)
    0
        Any Drowsiness; Post-dose 3
    16.2
        Grade 3 Drowsiness; Post-dose 3
    0
        Any Appetite lost; Post-Any injection
    10.9
        Grade 3 Appetite lost; Post-Any injection
    0
        Any Appetite lost; Post-dose 1
    13.2
        Grade 3 Appetite lost; Post-dose 1
    0
        Any Appetite lost; Post-dose 2 (PENTAXIM)
    28.6
        Grade 3 Appetite lost; Post-dose 2 (PENTAXIM)
    0
        Any Appetite lost; Post-dose 3
    13
        Grade 3 Appetite lost; Post-dose 3
    0
        Any Irritability; Post-Any injection
    14.3
        Grade 3 Irritability; Post-Any injection
    0
        Any Irritability; Post-dose 1
    13.6
        Grade 3 Irritability; Post-dose 1
    0.2
        Any Irritability; Post-dose 2 (PENTAXIM)
    51.4
        Grade 3 Irritability; Post-dose 2 (PENTAXIM)
    0
        Any Irritability; Post-dose 3
    36.2
        Grade 3 Irritability; Post-dose 3
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Solicited Injection-site and Systemic Reactions After A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Following A Three Dose Primary Vaccination

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions After A Booster Injection with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Following A Three Dose Primary Vaccination
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
    End point type
    Other pre-specified
    End point timeframe
    Post-booster injection (Visit 05 + 28-42 days post-booster [Visit 06], where Visit 05 was Day 140 + 11-12 months)
    End point values
    		 DTacP-IPV//PRP~T vaccine
    Number of subjects analysed
    164
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness
    55.5
        Injection site Erythema
    36.6
        Injection site Swelling
    22
        Fever
    25.6
        Vomiting
    14
        Crying abnormal
    34.1
        Drowsiness
    14.6
        Appetite lost
    22
        Irritability
    29.3
    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 pre-vaccination up to post-booster vaccination (Visit 05 + 28-42 days post-booster [Visit 06], where Visit 05 was Day 140 + 11-12 months).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9
    Reporting groups
    Reporting group title
    DTacP-IPV//PRP~T vaccine
    Reporting group description
    		 All subjects had previously received the first dose of the recombinant 10 µg hepatitis B vaccine at birth according to the National Expanded Program on Immunization (EPI). In this trial, subjects received the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 4, and 6 months of age as well as two subsequent doses of the recombinant 10 µg hepatitis B vaccine at 2 and 6 months of age according to the National EPI. Subjects received the booster dose of the DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 19 months of age.

    Serious adverse events
    		 DTacP-IPV//PRP~T vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 186 (5.38%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pharyngeal ulcers
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Infective diarrhea
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic attack
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Difficult urination
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acute gastroenteritis
         subjects affected / exposed
    6 / 186 (3.23%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute bronchitis
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 186 (1.61%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Bacterial pneumonia
         subjects affected / exposed
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suspected viral myocarditis
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral croup
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpetic gingivostomatitis
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral pneumonia
         subjects affected / exposed
    3 / 186 (1.61%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Viral gastroenteritis
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute bronchiolitis
         subjects affected / exposed
    1 / 186 (0.54%)
         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
    		 DTacP-IPV//PRP~T vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 186 (56.99%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    48 / 186 (25.81%)
         occurrences all number
    48
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    91 / 186 (48.92%)
         occurrences all number
    91
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    106 / 186 (56.99%)
         occurrences all number
    106
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    62 / 186 (33.33%)
         occurrences all number
    62
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    50 / 186 (26.88%)
         occurrences all number
    50
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    53 / 186 (28.49%)
         occurrences all number
    53
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    102 / 186 (54.84%)
         occurrences all number
    102
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    95 / 186 (51.08%)
         occurrences all number
    95
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    11 / 186 (5.91%)
         occurrences all number
    11
    Upper respiratory tract infection
         subjects affected / exposed
    30 / 186 (16.13%)
         occurrences all number
    30
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    53 / 186 (28.49%)
         occurrences all number
    53

    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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