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    Clinical Trial Results:
    A pivotal open label, two-arm, multi-center trial to evaluate the safety and immunogenicity of a single dose of Adacel® vaccine in persons 10 to <11 years of age with the intent to extend the licensure of Adacel vaccine for use in children 10 years of age.

    Summary
    EudraCT number
    		 2015-005627-84
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Jun 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    20 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Td519
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01311557
    WHO universal trial number (UTN)
    		 U1111-1115-6619
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Medical Team Leader, Sanofi Pasteur Inc., 1 570-957-3289, david.greenberg@sanofipasteur.com
    Scientific contact
    Medical Team Leader, Sanofi Pasteur Inc., 1 570-957-3289, david.greenberg@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Sep 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To compare pertussis antibody responses induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age. 2) To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.
    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
    07 Mar 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1302
    Worldwide total number of subjects
    1302
    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)
    0
    Children (2-11 years)
    1302
    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 07 March 2011 to 19 May 2011 at 36 clinical centers in the United States.

    Pre-assignment
    Screening details
    		 A total of 1302 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Subjects 10 to <11 Years of Age
    Arm description
    		 Subjects received 1 dose of Adacel® vaccine at Visit 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0 (Visit 1).

    Arm title
    		 Subjects 11 to <12 Years of Age
    Arm description
    		 Subjects received 1 dose of Adacel® vaccine at Visit 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0 (Visit 1).

    Number of subjects in period 1
    		Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Started
    651
    651
    Completed
    646
    645
    Not completed
    5
    6
         Consent withdrawn by subject
    1
    2
         Serious adverse event
    -
    1
         Lost to follow-up
    -
    1
         Protocol deviation
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Subjects 10 to <11 Years of Age
    Reporting group description
    		 Subjects received 1 dose of Adacel® vaccine at Visit 1.

    Reporting group title
    Subjects 11 to <12 Years of Age
    Reporting group description
    		 Subjects received 1 dose of Adacel® vaccine at Visit 1.

    Reporting group values
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age Total
    Number of subjects
    		 651 651 1302
    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)
    		 0 0 0
        Children (2-11 years)
    		 651 651 1302
        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: years
        arithmetic mean (standard deviation)
    		 10.5 ( 0.3 ) 11.4 ( 0.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 305 315 620
        Male
    		 346 336 682

    End points

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    End points reporting groups
    Reporting group title
    Subjects 10 to <11 Years of Age
    Reporting group description
    		 Subjects received 1 dose of Adacel® vaccine at Visit 1.

    Reporting group title
    Subjects 11 to <12 Years of Age
    Reporting group description
    		 Subjects received 1 dose of Adacel® vaccine at Visit 1.

    Primary: Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine

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    End point title
    		 Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
    End point description
    Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM] geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 30 post-vaccination
    End point values
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Number of subjects analysed
    613
    608
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Pertussis toxoid
    30.1 (28 to 32.4)
    32 (29.6 to 34.7)
        Anti-Filamentous hemagglutinin
    232 (218 to 247)
    225 (211 to 239)
        Anti-Pertactin
    464 (426 to 506)
    444 (408 to 482)
        Anti-Fimbriae types 2 and 3
    477 (413 to 550)
    540 (478 to 611)
    Statistical analysis title
    		 Non-inferiority (PT; GMT Ratio)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination anti-Pertussis geometric mean titers between groups.
    Comparison groups
    Subjects 10 to <11 Years of Age v Subjects 11 to <12 Years of Age
    Number of subjects included in analysis
    1221
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.843
         upper limit
    		 1.05
    Notes
    [1] - A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1/GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025. The post-vaccination anti-PT GMTs in Adacel recipients in Group 1 were non-inferior to the post-vaccination GMTs in Adacel recipients in Group 2.
    Statistical analysis title
    		 Non-inferiority (FHA; GMT Ratio)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination anti-Filamentous hemagglutinin geometric mean titers between groups.
    Comparison groups
    Subjects 10 to <11 Years of Age v Subjects 11 to <12 Years of Age
    Number of subjects included in analysis
    1221
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.944
         upper limit
    		 1.13
    Notes
    [2] - A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Filamentous hemagglutinin (FHA) GMT Group 1/GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025. The post-vaccination anti-FHA GMTs in Adacel recipients in Group 1 were non-inferior to the post-vaccination GMTs in Adacel recipients in Group 2.
    Statistical analysis title
    		 Non-inferiority (PRN; GMT Ratio)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination anti-Pertactin geometric mean titers between groups.
    Comparison groups
    Subjects 10 to <11 Years of Age v Subjects 11 to <12 Years of Age
    Number of subjects included in analysis
    1221
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.928
         upper limit
    		 1.18
    Notes
    [3] - A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertactin (PRN) GMT Group 1/GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025. The post-vaccination anti-PRN GMTs in Adacel recipients in Group 1 were non-inferior to the post-vaccination GMTs in Adacel recipients in Group 2.
    Statistical analysis title
    		 Non-inferiority (FIM; GMT Ratio)
    Statistical analysis description
    Non-inferiority comparison of post-vaccination anti-Fimbriae types 2 and 3 geometric mean titers between groups.
    Comparison groups
    Subjects 10 to <11 Years of Age v Subjects 11 to <12 Years of Age
    Number of subjects included in analysis
    1221
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.882
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.731
         upper limit
    		 1.06
    Notes
    [4] - A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Fimbriae types 2 and 3 (FIM) GMT Group 1/GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025. The post-vaccination anti-FIM GMTs in Adacel recipients in Group 1 were non-inferior to the post-vaccination GMTs in Adacel recipients in Group 2.

    Primary: Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine

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    End point title
    		 Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine [5]
    End point description
    Anti-Pertussis booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). For pertusiss antigens (Pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM], a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for subjects with pre-vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU/mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU/mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.
    End point type
    Primary
    End point timeframe
    30 days post-vaccination
    Notes
    [5] - 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 groups and the study vaccine administered for this outcome.
    End point values
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Number of subjects analysed
    613
    608
    Units: Percentage of subjects
    number (not applicable)
        Anti-Pertussis toxoid
    56.7
    56.1
        Anti-Filamentous hemagglutinin
    84.2
    84.8
        Anti-Pertactin
    98
    97.5
        Anti-Fimbriae types 2 and 3
    93.7
    97.1
    No statistical analyses for this end point

    Primary: Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine

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    End point title
    		 Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine [6]
    End point description
    Anti-Tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were > 2.56 EU/mL for diphtheria or > 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.
    End point type
    Primary
    End point timeframe
    30 days post-vaccination
    Notes
    [6] - 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 groups and the study vaccine administered for this outcome.
    End point values
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Number of subjects analysed
    613
    608
    Units: Percentage of subjects
    number (not applicable)
        Anti-Tetanus
    98.5
    98.8
        Anti-Diphtheria
    97.7
    98
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection To Tetanus and Diphtheria Following a Single Dose of Adacel® Vaccine

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    End point title
    		 Percentage of Subjects With Seroprotection To Tetanus and Diphtheria Following a Single Dose of Adacel® Vaccine
    End point description
    Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 30 days post-vaccination
    End point values
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Number of subjects analysed
    613
    608
    Units: Percentage of subjects
    number (not applicable)
        Anti-Tetanus (Pre-vaccination)
    90.3
    91.2
        Anti-Tetanus (Post-vaccination)
    99.7
    100
        Anti-Diphtheria (Pre-vaccination)
    83.6
    75.9
        Anti-Diphtheria (Post-vaccination)
    99.7
    100
    No statistical analyses for this end point

    Secondary: Summary of Anti-Pertussis Geometric Mean Titers Before and Post-vaccination With a Single Dose of Adacel® Vaccine

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    End point title
    		 Summary of Anti-Pertussis Geometric Mean Titers Before and Post-vaccination With a Single Dose of Adacel® Vaccine
    End point description
    Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Number of subjects analysed
    613
    608
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Pertussis toxoid; Day 0
    4.96 (4.54 to 5.42)
    4.85 (4.41 to 5.34)
        Anti-Pertussis toxoid; Day 30
    30.1 (28 to 32.4)
    32 (29.6 to 34.7)
        Anti-Filamentous hemagglutinin; Day 0
    22.1 (20.1 to 24.2)
    20.3 (18.5 to 22.3)
        Anti-Filamentous hemagglutinin; Day 30
    232 (218 to 247)
    225 (211 to 239)
        Anti-Pertactin; Day 0
    15.6 (14.2 to 17.1)
    14.8 (13.5 to 16.2)
        Anti-Pertactin; Day 30
    464 (426 to 506)
    444 (408 to 482)
        Anti-Fimbriae types 2 and 3; Day 0
    6.77 (6.05 to 7.57)
    7.07 (6.33 to 7.89)
        Anti-Fimbriae types 2 and 3; Day 30
    477 (413 to 550)
    540 (478 to 611)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions Following A Single Dose of Adacel® Vaccine

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions Following A Single Dose of Adacel® Vaccine
    End point description
    Solicited injection-site: Pain, Erythema and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 50 mm. Grade 3 Solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Number of subjects analysed
    650
    649
    Units: Percentage of subjects
    number (not applicable)
        Injection-site Pain
    80.9
    80.9
        Grade 3 Injection-site Pain
    3.3
    2.2
        Injection-site Erythema
    39.4
    38.4
        Grade 3 Injection-site Erythema
    7.9
    7.4
        Injection-site Swelling
    35.2
    33.5
        Grade 3 Injection-site Swelling
    8.4
    7.3
        Fever
    1.6
    0.6
        Grade 3 Fever
    0
    0.2
        Headache
    33.1
    37.6
        Grade 3 Headache
    2
    1.9
        Malaise
    26.2
    29.3
        Grade 3 Malaise
    1.9
    2.8
        Myalgia
    49.1
    56.4
        Grade 3 Myalgia
    3.3
    1.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 up to Day 30 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Subjects 10 to <11 Years of Age
    Reporting group description
    		 Subjects received 1 dose of Adacel® vaccine on Day 0 (Visit 1).

    Reporting group title
    Subjects 11 to <12 Years of Age
    Reporting group description
    		 Subjects received 1 dose of Adacel® vaccine on Day 0 (Visit 1).

    Serious adverse events
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 650 (0.00%)
    1 / 649 (0.15%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 650 (0.00%)
    1 / 649 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Subjects 10 to <11 Years of Age Subjects 11 to <12 Years of Age
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    521 / 650 (80.15%)
    522 / 649 (80.43%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    213 / 650 (32.77%)
    243 / 649 (37.44%)
         occurrences all number
    213
    243
    General disorders and administration site conditions
    Injection-site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    254 / 650 (39.08%)
    248 / 649 (38.21%)
         occurrences all number
    254
    248
    Injection-site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    521 / 650 (80.15%)
    522 / 649 (80.43%)
         occurrences all number
    521
    522
    Injection-site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    227 / 650 (34.92%)
    216 / 649 (33.28%)
         occurrences all number
    227
    216
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    169 / 650 (26.00%)
    189 / 649 (29.12%)
         occurrences all number
    169
    189
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    316 / 650 (48.62%)
    364 / 649 (56.09%)
         occurrences all number
    316
    364

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2011
    The planned trial period was revised; booster responses (tetanus and diphtheria) were updated as primary objectives; non-inferiority analysis of booster response rates was added as a primary endpoint; booster response rates (tetanus and diphtheria) were updated to primary endpoints; primary hypothesis was revised; planned sample size and schedule of procedures were amended to include a time window for post-vaccination and recording of safety data, respectively; exclusion criteria were modified; and statistical and assessment methods were revised.
    11 Mar 2011
    Exclusion criterion was modified to improve clarity.

    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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    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.

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