Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Antibody persistence in 11 to 13-year-old children previously vaccinated at 6 years old with either REVAXIS® or DT Polio®, and immune response to a booster dose of TETRAVAC-ACELLULAIRE®

    Summary
    EudraCT number
    		 2011-004458-25
    Trial protocol
    		 FR  
    Global end of trial date
    17 Dec 2012

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RVX01C
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01546909
    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, ClinicalTrialsDisclosure@spmsd.com
    Scientific contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD, 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
    17 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    # To describe in 11 to 13-year-old children who received 1 dose of either REVAXIS® or DT Polio® at 6 years of age the antibody persistence in terms of proportions of subjects with antibody concentrations ≥0.01 IU/mL against diphtheria and tetanus, and antibody titres ≥8 (1/dilution) against poliovirus types 1, 2 & 3. # To describe 1 month after a booster dose of TETRAVAC-ACELLULAIRE® when given to 11 to 13-year-old children who received 1 dose of either REVAXIS® or DT Polio® at 6 years of age the immune responses in terms of proportions of subjects with antibody concentrations ≥0.1 IU/mL against diphtheria and tetanus, and antibody titres ≥8 (1/dilution) against poliovirus types 1, 2 & 3.
    Protection of trial subjects
    Children in the study received a single booster dose of TETRAVAC-ACELLULAIRE supplied in a pre-filled 0.5 mL syringe. Children with known true hypersensitity to at least 1 of the components of the vaccine components were not vaccinated. The sheduled administration was in accordance with the European Summary of Product Characteristics and French recommendations. Vaccine was administered by qualified study personnel. After each vaccination, children were kept under observation for 20 minutes.
    Background therapy
    		 The present study was a 5-year follow-up of study F05-TdI-301. Children (11 to 13 years of age) were therefore vaccinated with either REVAXIS (diphtheria, tetanus and polio 1, 2 & 3 (inactivated) vaccine (adsorbed, reduced antigen(s) content)) or DT Polio (diphtheria, tetanus and polio 1, 2 & 3 (inactivated) vaccine) at 6 years of age.
    Evidence for comparator
    		 Children received 1 dose of TETRAVAC-ACELLULAIRE. No comparator product was thus used during study RVX01C. However, children were previously vaccinated with either REVAXIS or DT Polio at 6 years of age in study F05-TdI-301. There were thus 2 groups of subjects in the present study: REVAXIS group and DT Polio group.
    Actual start date of recruitment
    22 Feb 2012
    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: 274
    Worldwide total number of subjects
    274
    EEA total number of subjects
    274
    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)
    270
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The present study was a follow-up of study F05-TdI-301. Study participants were recruited among the participants of the F05-TdI-301 study between 22 February 2012 and 30 June 2012 in 44 active centres in France.

    Pre-assignment
    Screening details
    		 277 subjects were screened out. 274 subjects who met all the inclusion criteria but none of the exclusion criteria were included. 272 subjects had blood serological results for blood sample 1 (i.e., before TETRAVAC-ACELLULAIRE administration). 274 subjects were vaccinated with TETRAVAC-ACELLULAIRE.

    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
    This is not applicable, as this study was an open-label study and all subjects received the same vaccine, TETRAVAC-ACELLULAIRE. Serology tests were performed by laboratory staffs that were blinded to which group each subject was allocated to (previous vaccination with REVAXIS or DT Polio at 6 years of age).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 REVAXIS Group
    Arm description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of REVAXIS (diphtheria, tetanus and poliovirus (inactivated) vaccine (adsorbed, reduced antigen(s) content)), given at 6 years of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TETRAVAC-ACELLULAIRE®
    Investigational medicinal product code
    DTaP-IPV
    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 11-13 years of age.

    Arm title
    		 DT Polio Group
    Arm description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine), given at 6 years of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TETRAVAC-ACELLULAIRE®
    Investigational medicinal product code
    DTaP-IPV
    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 11-13 years of age.

    Number of subjects in period 1
    		REVAXIS Group DT Polio Group
    Started
    129
    145
    Completed
    128
    142
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    2
         Lost to follow-up
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    REVAXIS Group
    Reporting group description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of REVAXIS (diphtheria, tetanus and poliovirus (inactivated) vaccine (adsorbed, reduced antigen(s) content)), given at 6 years of age.

    Reporting group title
    DT Polio Group
    Reporting group description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine), given at 6 years of age.

    Reporting group values
    		 REVAXIS Group DT Polio Group Total
    Number of subjects
    		 129 145 274
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 128 142 270
        Adolescents (12-17 years)
    		 1 3 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.4 ± 0.3 11.3 ± 0.3 -
    Gender categorical
    Units: Subjects
        Female
    		 61 77 138
        Male
    		 68 68 136
    Weight continuous
    Units: kg
        arithmetic mean (standard deviation)
    		 40.2 ± 8.8 41.4 ± 10.1 -
    Height continuous
    Units: cm
        arithmetic mean (standard deviation)
    		 147.3 ± 7.1 148.3 ± 7.7 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    REVAXIS Group
    Reporting group description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of REVAXIS (diphtheria, tetanus and poliovirus (inactivated) vaccine (adsorbed, reduced antigen(s) content)), given at 6 years of age.

    Reporting group title
    DT Polio Group
    Reporting group description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine), given at 6 years of age.

    Primary: Antibody persistence # Proportion of subjects with anti-diphtheria and anti-tetanus concentrations ≥0.01 IU/mL and anti-polio 1, 2 & 3 titres ≥8 (1/dil) approximately 5 years after vaccination with either REVAXIS or DT Polio at 6 years of age

    		 Close Top of page
    End point title
    		 Antibody persistence # Proportion of subjects with anti-diphtheria and anti-tetanus concentrations ≥0.01 IU/mL and anti-polio 1, 2 & 3 titres ≥8 (1/dil) approximately 5 years after vaccination with either REVAXIS or DT Polio at 6 years of age [1]
    End point description
    Percentage of subjects with an anti-diphtheria concentration ≥0.01 IU/mL (measured by seroneutralisation (SN)), an anti-tetanus concentration ≥0.01 IU/mL (measured by Enzyme-Linked ImmunoSorbent Assay (ELISA)), and anti-poliomyelitis types 1, 2 & 3 (IPV1, 2 & 3) titres ≥8 (1/dilution (1/dil)) (measured by SN), approximately 5 years after vaccination with 1 dose of either REVAXIS or DT Polio. Analysis was done on the Antibody Persistence Full Analysis set (i.e., all subjects with pre-vaccination immunogenicity evaluation, N= 272). Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
    End point type
    Primary
    End point timeframe
    Approximately 5 years after vaccination with 1 dose of either REVAXIS or DT Polio, given at 6 years of age.
    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: No hypothesis was defined as this study was only descriptive.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    128
    144
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-diphtheria ≥0.01 IU/mL (SN) (N= 128, 144)
    98.4 (94.5 to 99.8)
    99.3 (96.2 to 100)
        Anti-tetanus ≥0.01 IU/mL (ELISA) (N= 128, 144)
    100 (97.2 to 100)
    100 (97.5 to 100)
        Anti-IPV1 ≥8 (1/dil) (SN) (N= 128, 144)
    98.4 (94.5 to 99.8)
    100 (97.5 to 100)
        Anti-IPV2 ≥8 (1/dil) (SN) (N= 128, 144)
    100 (97.2 to 100)
    100 (97.5 to 100)
        Anti-IPV3 ≥8 (1/dil) (SN) (N= 128, 144)
    99.2 (95.7 to 100)
    96.5 (92.1 to 98.9)
    No statistical analyses for this end point

    Primary: Post-booster immune response # Proportion of subjects with anti-diphtheria and anti-tetanus concentrations ≥0.1 IU/mL and anti-polio 1, 2 & 3 titres ≥8 (1/dil) 1 month after a booster dose of TETRAVAC-ACELLULAIRE

    		 Close Top of page
    End point title
    		 Post-booster immune response # Proportion of subjects with anti-diphtheria and anti-tetanus concentrations ≥0.1 IU/mL and anti-polio 1, 2 & 3 titres ≥8 (1/dil) 1 month after a booster dose of TETRAVAC-ACELLULAIRE [2]
    End point description
    Percentage of subjects with an anti-diphtheria concentration ≥0.1 IU/mL (measured by seroneutralisation (SN)), an anti-tetanus concentration ≥0.1 IU/mL (measured by Enzyme-Linked ImmunoSorbent Assay (ELISA)), and anti-poliomyelitis types 1, 2 & 3 (IPV1, 2 & 3) titres ≥8 (1/dilution (1/dil)) (measured by SN), 1 month after a booster dose of TETRAVAC-ACELLULAIRE in 11-13 years of age children who received 1 dose of either REVAXIS or DT Polio at 6 years of age. Analysis was done on the Post-Booster Per Protocol set (i.e., all included subjects excluding subjects with protocol violation which may interfere with the immunogenicity evaluation of the study vaccine, N= 255). 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 after a booster dose of TETRAVAC-ACELLULAIRE, given approximately 5 years after 1 dose of either REVAXIS or DT Polio.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No hypothesis was defined as this study was only descriptive.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    124
    131
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-diphtheria ≥0.1 IU/mL (SN) (N= 124, 131)
    100 (97.1 to 100)
    100 (97.2 to 100)
        Anti-tetanus ≥0.1 IU/mL (ELISA) (N= 124, 131)
    100 (97.1 to 100)
    100 (97.2 to 100)
        Anti-IPV1 ≥8 (1/dil) (SN) (N= 124, 131)
    100 (97.1 to 100)
    100 (97.2 to 100)
        Anti-IPV2 ≥8 (1/dil) (SN) (N= 124, 131)
    100 (97.1 to 100)
    100 (97.2 to 100)
        Anti-IPV3 ≥8 (1/dil) (SN) (N= 124, 131)
    100 (97.1 to 100)
    100 (97.2 to 100)
    No statistical analyses for this end point

    Secondary: Antibody persistence # Proportion of subjects with anti-diphtheria and anti-tetanus concentrations ≥0.1 IU/mL approximately 5 years after vaccination with either REVAXIS or DT Polio at 6 years of age

    		 Close Top of page
    End point title
    		 Antibody persistence # Proportion of subjects with anti-diphtheria and anti-tetanus concentrations ≥0.1 IU/mL approximately 5 years after vaccination with either REVAXIS or DT Polio at 6 years of age
    End point description
    Percentage of subjects with an anti-diphtheria concentration ≥0.1 IU/mL (measured by seroneutralisation (SN) and Enzyme-Linked ImmunoSorbent Assay (ELISA)), and an anti-tetanus concentration ≥0.1 IU/mL (measured by ELISA), approximately 5 years after vaccination with 1 dose of either REVAXIS or DT Polio, given at 6 years of age. Analysis was done on the Antibody Persistence Full Analysis set (i.e., all subjects with pre-vaccination immunogenicity evaluation, N= 272). Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
    End point type
    Secondary
    End point timeframe
    Approximately 5 years after vaccination with 1 dose of either REVAXIS or DT Polio, given at 6 years of age.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    128
    144
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-diphtheria ≥0.1 IU/mL (SN) (N= 128, 144)
    63.3 (54.3 to 71.6)
    86.1 (79.4 to 91.3)
        Anti-diphtheria ≥0.1 IU/mL (ELISA) (N= 128, 144)
    67.2 (58.3 to 75.2)
    89.6 (83.4 to 94.1)
        Anti-tetanus ≥0.1 IU/mL (ELISA) (N= 128, 144)
    96.1 (91.1 to 98.7)
    94.4 (89.3 to 97.6)
    No statistical analyses for this end point

    Secondary: Antibody persistence # Geometric Mean Concentrations (GMCs) or Titres (GMTs) of anti-diphtheria, anti-tetanus, and anti-polio 1, 2 & 3 antibodies approximately 5 years after vaccination with either REVAXIS or DT Polio at 6 years of age

    		 Close Top of page
    End point title
    		 Antibody persistence # Geometric Mean Concentrations (GMCs) or Titres (GMTs) of anti-diphtheria, anti-tetanus, and anti-polio 1, 2 & 3 antibodies approximately 5 years after vaccination with either REVAXIS or DT Polio at 6 years of age
    End point description
    Antibody concentrations (diphtheria and tetanus) or titres (poliovirus types 1, 2 & 3) were measured for diphtheria by seroneutralisation (SN) and Enzyme-Linked ImmunoSorbent Assay (ELISA), for tetanus by ELISA, and for poliomyelitis types 1, 2 & 3 (IPV1, 2 & 3) by SN, approximately 5 years after vaccination with 1 dose of either REVAXIS or DT Polio, given at 6 years of age. Analysis was done on the Antibody Persistence Full Analysis set (i.e., all subjects with pre-vaccination immunogenicity evaluation, N= 272). Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
    End point type
    Secondary
    End point timeframe
    Approximately 5 years after vaccination with 1 dose of either REVAXIS or DT Polio, given at 6 years of age.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    128
    144
    Units: Concentrations or Titres
    geometric mean (confidence interval 95%)
        Anti-diphtheria GMC (SN) (N= 128, 144)
    0.24 (0.18 to 0.33)
    0.62 (0.48 to 0.81)
        Anti-diphtheria GMC (ELISA) (N= 128,144)
    0.22 (0.17 to 0.28)
    0.46 (0.37 to 0.58)
        Anti-tetanus GMC (ELISA) (N= 128, 143)
    0.73 (0.61 to 0.88)
    0.91 (0.76 to 1.09)
        Anti-IPV1 GMT (SN) (N= 128, 144)
    233 (186 to 291)
    259 (216 to 311)
        Anti-IPV2 GMT (SN) (N= 128, 144)
    405 (338 to 484)
    276 (231 to 331)
        Anti-IPV3 GMT (SN) (N= 128, 144)
    314 (255 to 388)
    134 (108 to 166)
    No statistical analyses for this end point

    Secondary: Post-booster immune response # Proportion of subjects with anti-diphtheria concentration ≥0.1 IU/mL, and anti-diphtheria and anti-tetanus concentrations ≥1.0 IU/mL 1 month after a booster dose of TETRAVAC-ACELLULAIRE

    		 Close Top of page
    End point title
    		 Post-booster immune response # Proportion of subjects with anti-diphtheria concentration ≥0.1 IU/mL, and anti-diphtheria and anti-tetanus concentrations ≥1.0 IU/mL 1 month after a booster dose of TETRAVAC-ACELLULAIRE
    End point description
    Percentage of subjects with an anti-diphtheria concentration ≥0.1 IU/mL (measured by Enzyme-Linked ImmunoSorbent Assay (ELISA)), an anti-diphtheria concentration ≥1.0 IU/mL (measured by Seroneutralisation (SN) and ELISA), and an anti-tetanus concentration ≥1.0 IU/mL (measured by ELISA), 1 month after a booster dose of TETRAVAC-ACELLULAIRE in 11-13 years of age children who received 1 dose of either REVAXIS or DT Polio at 6 years of age. Analysis was done on the Post-Booster Per Protocol set (i.e., all included subjects excluding subjects with protocol violation which may interfere with the immunogenicity evaluation of the study vaccine, N= 255). 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 after a booster dose of TETRAVAC-ACELLULAIRE, given approximately 5 years after 1 dose of either REVAXIS or DT Polio.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    124
    131
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-diphtheria ≥0.1 IU/mL (ELISA) (N= 124, 131)
    100 (97.1 to 100)
    100 (97.2 to 100)
        Anti-diphtheria ≥1.0 IU/mL (SN) (N= 124, 131)
    98.4 (94.3 to 99.8)
    96.9 (92.4 to 99.2)
        Anti-diphtheria ≥1.0 IU/mL (ELISA) (N= 124, 131)
    99.2 (95.6 to 100)
    95.4 (90.3 to 98.3)
        Anti-tetanus ≥1.0 IU/mL (ELISA) (N= 124, 131)
    100 (97.1 to 100)
    99.2 (95.8 to 100)
    No statistical analyses for this end point

    Secondary: Post-booster immune response # Geometric Mean Concentrations (GMCs) or Titres (GMTs) of anti-diphtheria, anti-tetanus, and anti-polio 1, 2 & 3 antibodies 1 month after a booster dose of TETRAVAC-ACELLULAIRE

    		 Close Top of page
    End point title
    		 Post-booster immune response # Geometric Mean Concentrations (GMCs) or Titres (GMTs) of anti-diphtheria, anti-tetanus, and anti-polio 1, 2 & 3 antibodies 1 month after a booster dose of TETRAVAC-ACELLULAIRE
    End point description
    Antibody concentrations (diphtheria and tetanus) or titres (poliovirus types 1, 2 & 3) were measured for diphtheria by Seroneutralisation (SN) and Enzyme-Linked ImmunoSorbent Assay (ELISA), for tetanus by ELISA, and for poliomyelitis types 1, 2 & 3 (IPV1,2 & I) by SN, 1 month after a booster dose of TETRAVAC-ACELLULAIRE in 11-13 years of age children who received 1 dose of either REVAXIS or DT Polio at 6 years of age. Analysis was done on the Post-Booster Per Protocol set (i.e., all included subjects excluding subjects with protocol violation which may interfere with the immunogenicity evaluation of the study vaccine, N= 255). 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 after a booster dose of TETRAVAC-ACELLULAIRE, given approximately 5 years after 1 dose of either REVAXIS or DT Polio.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    124
    131
    Units: Concentrations or Titres
    geometric mean (confidence interval 95%)
        Anti-diphtheria GMC (SN) (N= 124, 131)
    7.36 (6.08 to 8.92)
    7.57 (6.25 to 9.17)
        Anti-diphtheria GMC (ELISA) (N= 124, 131)
    5.07 (4.36 to 5.91)
    5.45 (4.68 to 6.34)
        Anti-tetanus GMC (ELISA) (N= 124, 131)
    8.08 (7.16 to 9.11)
    7.83 (6.96 to 8.8)
        Anti-IPV1 GMT (SN) (N= 124, 131)
    1557 (1245 to 1948)
    1483 (1236 to 1779)
        Anti-IPV2 GMT (SN) (N= 124, 131)
    2491 (2028 to 3058)
    2432 (2051 to 2884)
        Anti-IPV3 GMT (SN) (N= 124, 131)
    1948 (1607 to 2360)
    2356 (1924 to 2885)
    No statistical analyses for this end point

    Secondary: Post-booster immune response # Geometric Mean of individual post/pre-booster Concentration (GMC) or Titre (GMT) Ratios of anti-diphtheria, anti-tetanus, and anti-polio 1, 2 & 3 antibodies 1 month after a booster dose of TETRAVAC-ACELLULAIRE

    		 Close Top of page
    End point title
    		 Post-booster immune response # Geometric Mean of individual post/pre-booster Concentration (GMC) or Titre (GMT) Ratios of anti-diphtheria, anti-tetanus, and anti-polio 1, 2 & 3 antibodies 1 month after a booster dose of TETRAVAC-ACELLULAIRE
    End point description
    Study participants were blood sampled between Day -7 (D-7) and D0 before receiving 1 dose of TETRAVAC-ACELLULAIRE. One month later (D28 to D35, i.e., post-vaccination), study participants were blood sampled again. Antibody concentrations (diphtheria and tetanus) or titres (poliovirus types 1, 2 & 3) were measured for diphtheria by Seroneutralisation (SN) and Enzyme-Linked ImmunoSorbent Assay (ELISA), for tetanus by ELISA, and for poliomyelitis types 1, 2 & 3 (IPV1, 2 & 3) by SN. Individual post- (D28-D35) / pre-booster (D0) antibody concentrations or titres ratios were measured for diphtheria, tetanus and poliomyelitis types 1, 2 & 3. Analysis was done on the Post-Booster Per Protocol set (i.e., all included subjects excluding subjects with protocol violation which may interfere with the immunogenicity evaluation of the study vaccine, N= 255). 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 after a booster dose of TETRAVAC-ACELLULAIRE, given approximately 5 years after 1 dose of either REVAXIS or DT Polio.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    124
    131
    Units: Not applicable
    geometric mean (confidence interval 95%)
        Anti-diphtheria GMCR (SN) (N= 123, 130)
    32.2 (24.2 to 42.8)
    11.6 (9.1 to 14.6)
        Anti-diphtheria GMCR (ELISA) (N= 123, 130)
    24.6 (19.4 to 31)
    11.7 (9.5 to 14.3)
        Anti-tetanus GMCR (ELISA) (N= 123, 129)
    11.5 (9.3 to 14.3)
    8.2 (6.8 to 10)
        Anti-IPV1 GMTR (SN) (N= 123, 130)
    6.9 (5.2 to 9.2)
    5.9 (4.5 to 7.7)
        Anti-IPV2 GMTR (SN) (N= 123, 130)
    6.4 (4.9 to 8.3)
    8.7 (6.8 to 11.1)
        Anti-IPV3 GMTR (SN) (N= 123, 130)
    6.5 (5.1 to 8.4)
    17.2 (13.1 to 22.7)
    No statistical analyses for this end point

    Secondary: Proportion of subjects reporting solicited injection-site reactions from D0 to D7 after 1 booster dose of TETRAVAC-ACELLULAIRE

    		 Close Top of page
    End point title
    		 Proportion of subjects reporting solicited injection-site reactions from D0 to D7 after 1 booster dose of TETRAVAC-ACELLULAIRE
    End point description
    The subject’s parent(s)/legal representative recorded all adverse events (AEs) on the diary card. Solicited Injection-Site Reactions (ISRs) (injection-site erythema, injection-site pain and injection-site swelling) were collected from Day 0 to Day 7 following vaccination with TETRAVAC-ACELLULAIRE. AEs at injection sites were always considered as related to vaccine (Injection-Site Reactions (ISRs)). Analysis was done on the Safety set (i.e., all subjects who received the study vaccine and who have safety follow-up data, N= 272).
    End point type
    Secondary
    End point timeframe
    From D0 to D7 following vaccination with 1 booster dose of TETRAVAC-ACELLULAIRE, received approximately 5 years after 1 dose of either REVAXIS or DT Polio.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    129
    143
    Units: Percentage of subjects
    number (not applicable)
        At least 1 ISR
    86.8
    88.1
        Injection site erythema
    55
    39.2
        Injection site pain
    85.3
    87.4
        Injection site swelling
    45.7
    37.1
    No statistical analyses for this end point

    Secondary: Proportion of subjects reporting solicited systemic reactions from D0 to D7 after 1 booster dose of TETRAVAC-ACELLULAIRE

    		 Close Top of page
    End point title
    		 Proportion of subjects reporting solicited systemic reactions from D0 to D7 after 1 booster dose of TETRAVAC-ACELLULAIRE
    End point description
    The subject’s parent(s)/legal representative recorded all adverse events (AEs) on the diary card. Solicited systemic reactions (headache, malaise, myalgia and pyrexia) were collected from Day 0 to Day 7 following vaccination with TETRAVAC-ACELLULAIRE. Pyrexia was defined in this study as a temperature of 38.0°C or over. The highest temperature was recorded in the diary card. All of these solicited systemic reactions (headache, malaise, myalgia and pyrexia) were assessed as vaccine-related by the investigator. Analysis was done on the Safety set (i.e., all subjects who received the study vaccine and who have safety follow-up data, N= 272).
    End point type
    Secondary
    End point timeframe
    From D0 to D7 following vaccination with 1 booster dose of TETRAVAC-ACELLULAIRE, received approximately 5 years after 1 dose of either REVAXIS or DT Polio.
    End point values
    		 REVAXIS Group DT Polio Group
    Number of subjects analysed
    129
    143
    Units: Percentage of subjects
    number (not applicable)
        At least 1 solicited systemic reaction
    46.5
    37.1
        Headache
    25.6
    18.2
        Malaise
    8.5
    4.2
        Myalgia
    35.7
    28
        Pyrexia
    7
    2.1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse events were collected in the diary card from D0 to D28 after vaccination with TETRAVAC-ACELLULAIRE, in subjects previously vaccinated with either REVAXIS or DT Polio at 6 years of age (i.e. approximately 5 years before).
    Adverse event reporting additional description
    Pyrexia was defined in this study as a temperature of 38.0°C or over. Analysis of adverse events was done on the Safety set (i.e., all subjects who received the study vaccine and who have safety follow-up data, N= 272).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    REVAXIS Group
    Reporting group description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of REVAXIS (diphtheria, tetanus and poliovirus (inactivated) vaccine (adsorbed, reduced antigen(s) content)), given at 6 years of age. The number of subjects reporting at least 1 unsolicited non-serious 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 19.

    Reporting group title
    DT Polio Group
    Reporting group description
    		 Participants received a single dose of booster TETRAVAC-ACELLULAIRE approximately 5 years after vaccination with 1 dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine), given at 6 years of age. The number of subjects reporting at least 1 unsolicited non-serious 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 19.

    Serious adverse events
    		 REVAXIS Group DT Polio Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 143 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    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
    19 / 129 (14.73%)
    19 / 143 (13.29%)
    Nervous system disorders
    D0-D28, Headache
         subjects affected / exposed
    3 / 129 (2.33%)
    4 / 143 (2.80%)
         occurrences all number
    3
    4
    General disorders and administration site conditions
    D0-D28, Pyrexia
         subjects affected / exposed
    1 / 129 (0.78%)
    4 / 143 (2.80%)
         occurrences all number
    1
    4
    D0-D28, Pruritus
         subjects affected / exposed
    3 / 129 (2.33%)
    1 / 143 (0.70%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    D0-D28, Nausea
         subjects affected / exposed
    2 / 129 (1.55%)
    1 / 143 (0.70%)
         occurrences all number
    2
    1
    D0-D28, Diarrhoea
         subjects affected / exposed
    2 / 129 (1.55%)
    0 / 143 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    D0-D28, Oropharyngeal pain
         subjects affected / exposed
    1 / 129 (0.78%)
    3 / 143 (2.10%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    D0-D28, Myalgia
         subjects affected / exposed
    1 / 129 (0.78%)
    2 / 143 (1.40%)
         occurrences all number
    1
    2
    Infections and infestations
    D0-D28, Nasopharyngitis
         subjects affected / exposed
    2 / 129 (1.55%)
    2 / 143 (1.40%)
         occurrences all number
    2
    2
    D0, D28 Bronchitis
         subjects affected / exposed
    0 / 129 (0.00%)
    2 / 143 (1.40%)
         occurrences all number
    0
    2
    D0-D28, Pharyngitis
         subjects affected / exposed
    2 / 129 (1.55%)
    0 / 143 (0.00%)
         occurrences all number
    2
    0
    D0-D28, Rhinitis
         subjects affected / exposed
    2 / 129 (1.55%)
    0 / 143 (0.00%)
         occurrences all number
    2
    0

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 15:42:46 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA