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    Clinical Trial Results:
    Comparison of the immunogenicity and safety of a combined adsorbed low dose diphtheria, tetanus and inactivated poliomyelitis vaccine (REVAXIS®) with a combined diphtheria, tetanus and inactivated poliomyelitis vaccine (DT Polio®) when given as a booster dose at 6 years of age.

    Summary
    EudraCT number
    		 2005-001446-16
    Trial protocol
    		 FR  
    Global end of trial date
    16 Jan 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    29 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    F05-TdI-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00447525
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur MSD S.N.C.
    Sponsor organisation address
    162 avenue Jean Jaurès - CS 50712, Lyon Cedex 07, France, 69367
    Public contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C, ClinicalTrialsDisclosure@spmsd.com
    Scientific contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C, ClinicalTrialsDisclosure@spmsd.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
    16 Jan 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the Diphtheria seroprotection response (defined as anti-diphtheria antibody titre (SN) ≥0.1 IU/mL), the Tetanus seroprotection response (defined as an anti-tetanus antibody titre (EIA) ≥0.1 IU/mL), and the Poliomyelitis type 1, 2 & 3 seroprotection responses (defined as an anti-poliovirus antibody type 1, 2 & 3 titre (SN) ≥8 (1/dil)) 1 month (28 to 35 days) after a single dose of REVAXIS® (dT-IPV vaccine) is non inferior to the Diphtheria, Tetanus and Poliomyelitis type 1, 2 & 3 seroprotection responses 1 month after a single dose of DT Polio® (DT-IPV vaccine) when given as a second booster to healthy 6 year-old children who received 3-dose primary series within the first 6 months of life and a first booster at 16-18 months of life (+/-2 months) including DT-IPV vaccine.
    Protection of trial subjects
    Subjects in the study received a single dose of the study vaccine or comparator vaccine supplied in a pre-filled 0.5 mL syringe that was administered by qualified study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After each vaccination, subjects were also kept under observation for 20 minutes to ensure their safety. Appropriate equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Children were previously vaccinated with 3 doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16-18 months of life (+/-2 months).
    Evidence for comparator
    		 The comparator group (DT Polio Group) was added in order to answer the study objective. Indeed, this study was designed to provide comparative data of the immunogenicity and the safety of REVAXIS versus DT Polio when given as a booster dose at 6 years of age. DT Polio was a reference vaccine licensed and recommended as diphtheria, tetanus and poliovirus booster at 6 years of age in France.
    Actual start date of recruitment
    24 Jan 2007
    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
    France: 760
    Worldwide total number of subjects
    760
    EEA total number of subjects
    760
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    760
    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 participants were recruited for the study between 24 January 2007 and 10 December 2007 in 71 active centres in France.

    Pre-assignment
    Screening details
    		 788 subjects were screened in this study. 760 subjects were randomised. 759 subjects met all inclusion criteria and none of the non-inclusion criteria. 758 subjects were vaccinated and completed the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinding is not applicable as this study was an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 REVAXIS Group
    Arm description
    		 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)).
    Arm type
    		 Experimental

    Investigational medicinal product name
    REVAXIS®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose (intramuscular, deltoid) at 6 years of age.

    Arm title
    		 DT Polio Group
    Arm description
    		 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DT Polio®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose (intramuscular, deltoid) at 6 years of age.

    Number of subjects in period 1
    		REVAXIS Group DT Polio Group
    Started
    384
    376
    Vaccinated
    383
    375
    Completed
    383
    375
    Not completed
    1
    1
         Consent withdrawn by subject
    -
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    REVAXIS Group
    Reporting group description
    		 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)).

    Reporting group title
    DT Polio Group
    Reporting group description
    		 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine).

    Reporting group values
    		 REVAXIS Group DT Polio Group Total
    Number of subjects
    		 384 376 760
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 384 376 760
    Age continuous
    Age in years at vaccination (1 missing value in the REVAXIS group)
    Units: years
        arithmetic mean (standard deviation)
    		 6.4 ± 0.3 6.4 ± 0.3 -
    Gender categorical
    Female and male
    Units: Subjects
        Female
    		 182 180 362
        Male
    		 202 196 398
    Weight continuous
    Weight in kg at vaccination
    Units: kg
        arithmetic mean (standard deviation)
    		 22.4 ± 3.6 22.6 ± 3.8 -
    Height continuous
    Height in cm at vaccination
    Units: cm
        arithmetic mean (standard deviation)
    		 119 ± 5.3 119.2 ± 5.5 -

    End points

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    End points reporting groups
    Reporting group title
    REVAXIS Group
    Reporting group description
    		 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)).

    Reporting group title
    DT Polio Group
    Reporting group description
    		 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine).

    Primary: Seroprotection against diphtheria (SN), tetanus (EIA), and polio 1, 2 & 3 (SN) one month after one dose of REVAXIS vaccine or DT Polio vaccine

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    End point title
    		 Seroprotection against diphtheria (SN), tetanus (EIA), and polio 1, 2 & 3 (SN) one month after one dose of REVAXIS vaccine or DT Polio vaccine
    End point description
    On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (i.e., 28 to 35 days post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Seroprotection was defined as a titre ≥0.10 IU/mL for diphtheria (SN), ≥0.10 IU/mL for tetanus (EIA), ≥8 (1/dil) for polio 1, 2 & 3 (SN). Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
    End point type
    Primary
    End point timeframe
    One month (28 to 35 days) after vaccination.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    284
    283
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-Diphtheria ≥0.10 IU/mL (SN) (N=284, 283)
    98.6 (96.4 to 99.6)
    99.3 (97.5 to 99.9)
        Anti-Tetanus ≥0.10 IU/mL (EIA) (N=284, 283)
    99.6 (98.1 to 100)
    100 (98.7 to 100)
        Anti-Polio 1 ≥8 (1/dil) (SN) (N=284, 283)
    100 (98.7 to 100)
    100 (98.7 to 100)
        Anti-Polio 2 ≥8 (1/dil) (SN) (N=284, 283)
    100 (98.7 to 100)
    100 (98.7 to 100)
        Anti-Polio 3 ≥8 (1/dil) (SN) (N=284, 282)
    100 (98.7 to 100)
    100 (98.7 to 100)
    Statistical analysis title
    		 Non-inferiority analysis for diphtheria (SN)
    Statistical analysis description
    The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
    Comparison groups
    REVAXIS Group v DT Polio Group
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Wilson score method without CC
    Parameter type
    		 Difference in percentages of subjects
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 1.3
    Notes
    [1] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥0.10 IU/mL for diphtheria (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
    Statistical analysis title
    		 Non inferiority analysis for tetanus (EIA)
    Statistical analysis description
    The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
    Comparison groups
    REVAXIS Group v DT Polio Group
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 Wilson score method without CC
    Parameter type
    		 Difference in percentages of subjects
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 1
    Notes
    [2] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥0.10 IU/mL for tetanus (EIA) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
    Statistical analysis title
    		 Non inferiority analysis for Polio 1 (SN)
    Statistical analysis description
    The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
    Comparison groups
    REVAXIS Group v DT Polio Group
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 Wilson score method without CC
    Parameter type
    		 Difference in percentages of subjects
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Notes
    [3] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥8 (1/dil for polio 1 (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
    Statistical analysis title
    		 Non inferiority analysis for Polio 2 (SN)
    Statistical analysis description
    The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
    Comparison groups
    REVAXIS Group v DT Polio Group
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 Wilson score method without CC
    Parameter type
    		 Difference in percentages of subjects
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Notes
    [4] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥8 (1/dil) for polio 2 (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
    Statistical analysis title
    		 Non inferiority analysis for Polio 3 (SN)
    Statistical analysis description
    The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
    Comparison groups
    REVAXIS Group v DT Polio Group
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 Wilson score method without CC
    Parameter type
    		 Difference in percentages of subjects
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Notes
    [5] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥8 (1/dil) for polio 3 (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).

    Secondary: Geometric Mean Titres of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine

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    End point title
    		 Geometric Mean Titres of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine
    End point description
    On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (28 to 35 days, i.e., post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Antibody titres are expressed in IU/mL for diphtheria (SN), for diphtheria (EIA), and for tetanus (EIA), and 1/dil for polio 1, 2 & 3 (SN). Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
    End point type
    Secondary
    End point timeframe
    One month (28 to 35 days) after vaccination.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    284
    283
    Units: Titres
    geometric mean (confidence interval 95%)
        Anti-Diphtheria (SN) (N=284, 283)
    3.71 (3.14 to 4.38)
    23.32 (19.52 to 27.85)
        Anti-Diphtheria (EIA) (N=284, 281)
    1.9 (1.65 to 2.19)
    8.31 (7.24 to 9.54)
        Anti-Tetanus (EIA) (N=284, 283)
    9.38 (8.33 to 10.56)
    13.87 (12.21 to 15.76)
        Anti-Polio 1 (SN) (N=284, 283)
    4776.77 (4093.41 to 5574.21)
    7705.41 (6681.88 to 8885.73)
        Anti-Polio 2 (SN) (N=284, 283)
    5715.35 (4919.35 to 6640.16)
    4534.24 (3931.99 to 5228.73)
        Anti-Polio 3 (SN) (N=284, 282)
    6015.97 (5138.41 to 7043.41)
    2248.5 (1906.62 to 2651.69)
    No statistical analyses for this end point

    Secondary: Response rates for diphtheria (SN & EIA) and tetanus (EIA) one month after one dose of REVAXIS vaccine or DT Polio vaccine

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    End point title
    		 Response rates for diphtheria (SN & EIA) and tetanus (EIA) one month after one dose of REVAXIS vaccine or DT Polio vaccine
    End point description
    On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (28 to 35 days, i.e., post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Thresholds were defined as titres ≥1.0 IU/mL for diphtheria (SN), ≥0.10 IU/mL and ≥1.0 IU/mL for diphtheria (EIA), ≥1.0 IU/mL for tetanus (EIA). Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
    End point type
    Secondary
    End point timeframe
    One month (28 to 35 days) after vaccination.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    284
    283
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-Diphtheria ≥1.0 IU/mL (SN) (N=284, 283)
    85.9 (81.3 to 89.7)
    98.6 (96.4 to 99.6)
        Anti-Diphtheria ≥0.1 IU/mL (EIA) (N=284, 281)
    98.6 (96.4 to 99.6)
    99.6 (98 to 100)
        Anti-Diphtheria ≥1.0 IU/mL (EIA) (N=284, 281)
    71.1 (65.5 to 76.3)
    95 (91.8 to 97.2)
        Anti-Tetanus ≥1.0 IU/mL (EIA) (N=284, 283)
    98.6 (96.4 to 99.6)
    97.5 (95 to 99)
    No statistical analyses for this end point

    Secondary: Geometric Mean of (individual) Titres Ratios of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine

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    End point title
    		 Geometric Mean of (individual) Titres Ratios of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine
    End point description
    On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (28 to 35 days, i.e., post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Individual post (D28) / pre (D0) antibody titre ratios were measured for diphtheria, tetanus and polio 1, 2 & 3. Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
    End point type
    Secondary
    End point timeframe
    One month (28 to 35 days) after vaccination.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    284
    283
    Units: Not applicable
    geometric mean (confidence interval 95%)
        Anti-Diphtheria (SN) (N=284, 283)
    58.62 (47.59 to 72.2)
    307.62 (247.53 to 382.31)
        Anti-Diphtheria (EIA) (N=284, 280)
    27.79 (23.75 to 32.52)
    112.23 (97.28 to 129.47)
        Anti-Tetanus (EIA) (N=284, 283)
    38.7 (33.37 to 44.89)
    58.95 (51.61 to 67.32)
        Anti-Polio 1 (SN) (N=283, 282)
    63.52 (49.07 to 82.23)
    121.98 (93.58 to 159.02)
        Anti-Polio 2 (SN) (N=284, 283)
    56.92 (44.28 to 73.17)
    54.11 (42 to 69.71)
        Anti-Polio 3 (SN) (N=284, 282)
    51.51 (40.26 to 65.89)
    23.68 (18.88 to 29.68)
    No statistical analyses for this end point

    Secondary: Summary of safety (D0-D28)

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    End point title
    		 Summary of safety (D0-D28)
    End point description
    Adverse events (AEs) were reported onto the diary card by the parent(s) or legal representative: - From day 0 (D0) to D7 for solicited injection-site adverse reactions (ISRs: injection site pain, erythema, and swelling) and solicited systemic AEs (headache, myalgia, pyrexia); - From D0 to Visit 2 for unsolicited (spontaneously reported) ISRs and systemic AEs. AEs at injection sites were always considered as related to vaccine (Injection-Site Reactions (ISRs)). The investigator had to assess whether systemic AEs were related or not to the vaccine. All (related and unrelated) are displayed here. Descriptive analysis was done on the Safety Analysis set. One subject was randomised in the DT Polio Group but received REVAXIS vaccine. The subject was thus included in the REVAXIS Group in the Safety Analysis set, which therefore included 384 subjects in the REVAXIS group, and 374 subjects in the DT Polio Group.
    End point type
    Secondary
    End point timeframe
    One month (28 to 35 days) after vaccination.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    384
    374
    Units: Percentage of subjects
    number (not applicable)
        D0 to D28, any AE
    83.1
    85.6
        D0 to D7, any AE
    82.6
    84.2
        D0 to D7, ISR
    76
    78.6
        D0 to D7, solicited ISR
    76
    78.6
        D0 to D7, unsolicited ISR
    3.4
    5.6
        D0 to D7, systemic AE
    42.4
    40.9
        D0 to D7, solicited systemic AE
    35.4
    36.4
        D0 to D7, unsolicited systemic AE
    12.2
    12.3
        D0 to D7, vaccine-related systemic AE
    33.3
    34
        D0 to D7, vaccine-related solicited systemic AE
    31.3
    32.9
        D0 to D7, vaccine-related unsolicited systemic AE
    3.1
    2.9
        D8 to D28, any AE
    10.7
    11
        D8 to D28, ISR
    0
    0
        D8 to D28, systemic AE
    10.7
    11
        D8 to D28, vaccine-related systemic AE
    1.3
    0.5
    No statistical analyses for this end point

    Secondary: Proportion of subjects reporting solicited injection-site reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine

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    End point title
    		 Proportion of subjects reporting solicited injection-site reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine
    End point description
    Solicited injection-site adverse reactions (ISRs: injection-site pain, injection-site erythema, and injection-site swelling) were reported onto the diary card by the parent(s) or legal representative from day 0 (D0) to D7. AEs at injection sites were always considered as related to vaccine (Injection-Site Reactions (ISRs)). Descriptive analysis was done on the Safety Analysis set.
    End point type
    Secondary
    End point timeframe
    One month (28 to 35 days) after vaccination
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    384
    374
    Units: Percentage of subjects
    number (not applicable)
        Injection site erythema
    40.9
    47.1
        Injection site pain
    69.8
    69.8
        Injection site swelling
    32.3
    37.4
    No statistical analyses for this end point

    Secondary: Proportion of subjects reporting solicited systemic adverse events and reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine

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    End point title
    		 Proportion of subjects reporting solicited systemic adverse events and reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine
    End point description
    Solicited systemic adverse events (AEs: headache, myalgia, pyrexia) were reported onto the diary card by the parent(s) or legal representative from day 0 (D0) to D7. The investigator had to assess whether systemic AEs were related or not to the vaccine. All (related and unrelated) are displayed here. Pyrexia was defined in this study as an oral temperature of 37.5°C or over. From D0 to D7, temperature values were captured in the diary card. In case of an oral temperature of 37.5°C or over at D7, the maximum temperature value of the event was also captured. From D0 to D7, temperature had to be measured once daily at the same time every day, preferably in the evening, and at the time of any apparent fever. At any time during the study, the highest observed temperature of the day had to be recorded in the diary card. Descriptive analysis was done on the Safety Analysis set.
    End point type
    Secondary
    End point timeframe
    One month (28 to 35 days) after vaccination
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    384
    374
    Units: Percentage of subjects
    number (not applicable)
        Headache (all)
    15.1
    19.3
        Headache (related)
    12.2
    16.6
        Myalgia (all)
    21.4
    17.9
        Myalgia (related)
    19.3
    17.1
        Pyrexia (all)
    11.2
    14.4
        Pyrexia (related)
    9.6
    11.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event (AE) data were collected from Day 0 (D0) to Visit 2 (D28 to D35). Solicited AEs (collected from D0 to D7) are detailed in the "End points" section. Unsolicited AEs (collected from D0 to D28) are detailed in this section.
    Adverse event reporting additional description
    One subject was randomised in the DT Polio Group but received REVAXIS vaccine. The subject was thus included in the REVAXIS Group in the Safety Analysis set, which therefore included 384 subjects in the REVAXIS group, and 374 subjects in the DT Polio Group.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    REVAXIS Group
    Reporting group description
    		 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)). The number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% are presented hereafter. If each unsolicited ISR or AE with incidence ≥1% was reported by a different subject, the number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% would have been 67.

    Reporting group title
    DT Polio Group
    Reporting group description
    		 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine). The number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% are presented hereafter. If each unsolicited ISR or AE with incidence ≥1% was reported by a different subject, the number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% would have been 59.

    Serious adverse events
    		 REVAXIS Group DT Polio Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 384 (0.00%)
    1 / 374 (0.27%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Nose fracture
    Additional description: Subject 9500002 experienced accidental severe nose fracture 14 days after receiving one dose of DT Polio vaccine. He was hospitalised to treat the fracture by surgery. SAE assessed as unrelated with the study vaccine.
         subjects affected / exposed
    0 / 384 (0.00%)
    1 / 374 (0.27%)
         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: 1%
    Non-serious adverse events
    		 REVAXIS Group DT Polio Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 384 (17.45%)
    59 / 374 (15.78%)
    Nervous system disorders
    D8-D28, Headache
         subjects affected / exposed
    5 / 384 (1.30%)
    2 / 374 (0.53%)
         occurrences all number
    6
    2
    General disorders and administration site conditions
    D8-D28, Pyrexia
         subjects affected / exposed
    6 / 384 (1.56%)
    4 / 374 (1.07%)
         occurrences all number
    7
    4
    D0-D7, Pruritus
         subjects affected / exposed
    5 / 384 (1.30%)
    11 / 374 (2.94%)
         occurrences all number
    5
    11
    Gastrointestinal disorders
    D0-D7, Abdominal pain
         subjects affected / exposed
    4 / 384 (1.04%)
    8 / 374 (2.14%)
         occurrences all number
    4
    8
    D0-D7, Vomiting
         subjects affected / exposed
    4 / 384 (1.04%)
    4 / 374 (1.07%)
         occurrences all number
    4
    4
    Respiratory, thoracic and mediastinal disorders
    D0-D7, Cough
         subjects affected / exposed
    8 / 384 (2.08%)
    6 / 374 (1.60%)
         occurrences all number
    8
    6
    D8-D28, Cough
         subjects affected / exposed
    6 / 384 (1.56%)
    3 / 374 (0.80%)
         occurrences all number
    7
    3
    Infections and infestations
    D8-D28, Ear infection
         subjects affected / exposed
    3 / 384 (0.78%)
    7 / 374 (1.87%)
         occurrences all number
    3
    7
    D8-D28, Gastroenteritis
         subjects affected / exposed
    1 / 384 (0.26%)
    4 / 374 (1.07%)
         occurrences all number
    1
    4
    D8-D28, Nasopharyngitis
         subjects affected / exposed
    5 / 384 (1.30%)
    0 / 374 (0.00%)
         occurrences all number
    5
    0
    D0-D7, Rhinitis
         subjects affected / exposed
    7 / 384 (1.82%)
    5 / 374 (1.34%)
         occurrences all number
    7
    5
    D8-D28, Pharyngitis
         subjects affected / exposed
    5 / 384 (1.30%)
    2 / 374 (0.53%)
         occurrences all number
    5
    2
    D0-D7, Tonsillitis
         subjects affected / exposed
    4 / 384 (1.04%)
    1 / 374 (0.27%)
         occurrences all number
    4
    1
    D8-D28, Tonsillitis
         subjects affected / exposed
    4 / 384 (1.04%)
    2 / 374 (0.53%)
         occurrences all number
    4
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2007
    Administrative changes
    31 May 2007
    Extension of the recruitment period for 4 additional months
    13 Jul 2007
    Opening of 6 new sites and closure of 6 inactive sites

    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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