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    Summary
    EudraCT Number:2019-004721-24
    Sponsor's Protocol Code Number:QHD00014
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-004721-24
    A.3Full title of the trial
    Efficacy, Immunogenicity, and Safety of High-Dose Quadrivalent Influenza Vaccine Compared with Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months through 35 Months of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on a High-Dose Quadrivalent Influenza Vaccine Compared with Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months through 35 Months of Age
    A.4.1Sponsor's protocol code numberQHD00014
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1243-5993
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/023/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur Inc
    B.5.2Functional name of contact pointLee-Jah Chang
    B.5.3 Address:
    B.5.3.1Street AddressDiscovery Drive
    B.5.3.2Town/ citySwiftwater
    B.5.3.3Post codePA 18370-0187
    B.5.3.4CountryUnited States
    B.5.4Telephone number15709570255
    B.5.5Fax number15709570934
    B.5.6E-mailLee-Jah.Chang@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fluzone High-Dose Quadrivalent
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluzone High-Dose Quadrivalent
    D.3.2Product code 522
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H1N1-like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H3N2 -like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Victoria Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Yamagata Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fluarix Quadrivalent
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluarix Quadrivalent
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H1N1-like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameA/H3N2 -like strain
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Victoria Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
    D.3.9.3Other descriptive nameB/Yamagata Lineage
    D.3.9.4EV Substance CodeSUB12066MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of influenza infection in children 6 months through 35 months of age
    E.1.1.1Medical condition in easily understood language
    Active immunisation of children 6 months through 35 months of age against Influenza infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical efficacy of QIV-HD to QIV-SD in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type
    E.2.2Secondary objectives of the trial
    - To compare QIV-HD to QIV-SD:
    - in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type using a more stringent threshold
    - in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine.
    - in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types.
    - To compare HAI immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age
    - To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response
    - To describe the immune response to revaccination in Season 3 (Northern Hemisphere)
    - To describe the safety profile of each vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 6 through 35 months on the day of the first study visit
    - Informed consent form has been signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations.
    - Participant and parent / guardian are able to attend all scheduled visits and to comply with all study procedures.
    - Covered by health insurance if required by local regulations.
    - For Season 3 Re-vaccination Cohort: eligible particpants must have been enrolled in the Season 1 (2021-2022 Northern Hemisphere season) immunogenicity subset and must have completed all study procedures (ie, blood draws and vaccinations) in Season 1.
    E.4Principal exclusion criteria
    - Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
    - For all participants: Receipt of any vaccine in the 30 days preceding the first study vaccination. For participants in immunogenicity subset: Planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
    - Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another influenza vaccine
    - Receipt of immune globulins, blood or blood-derived products in the past 3 months.
    - Known or suspected congenital or acquired immunodeficiency (eg, HIV); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
    - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. Exception: participants with an egg allergy are allowed to enroll in the study.
    - Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator’s judgment contraindicate intramuscular vaccination
    - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
    - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
    - Identified as natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
    - Personal or family history of Guillain-Barre Syndrome.
    - Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
    - Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
    - For Season 3 (2022-2023 Northern Hemisphere) main cohort: participants who were enrolled in a previous study season are excluded from Season 3, with the exception of the Re-vaccination Cohort.
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants with laboratory-confirmed influenza illness caused by any influenza viral types/subtypes, in association with a protocol-defined ILI : Laboratory-confirmed influenza is a positive influenza result on either PCR or viral. A protocol-defined ILI is occurrence of fever concurrently with protocol pre-defined clinical symptoms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From 14 days after the first injection to 6 months after the last injection
    E.5.2Secondary end point(s)
    Number of participants with ILI laboratory-confirmed as positive:
    1 -for viral strains similar to those contained in the vaccine: Laboratoryconfirmed influenza is a positive influenza result on either polymerase chain reaction (PCR) or viral culture
    2 -in participants aged 6 through 23 months for any influenza A or B type
    3 -for any influenza A or B type, according to previous vaccination status
    4 -for similar to those contained in the vaccine, according to previous vaccination status: Viral strains are deemed similar to one of the vaccine components according to genomic sequence and antigenicity testing of laboratory-confirmed isolate
    5 -for any influenza A or B type, and associated with acute otitis media (AOM): AOM is based on clinical diagnosis
    6 -for viral strains similar to those contained in the vaccine, and associated with AOM: Laboratory-confirmed influenza is a positive influenza result on either PCR or viral culture. AOM is based on clinical diagnosis
    7 -any influenza A or B type, and associated with acute lower respiratory infection (ALRI): Laboratory-confirmed influenza is a positive influenza result on either PCR or viral culture
    8 -viral strains similar to those contained in the vaccine, and associated with ALRI: Laboratory-confirmed influenza is a positive influenza result on either PCR or viral culture
    1,2,3,4,5,6,7,8 : Laboratory-confirmed influenza is a positive influenza result on either PCR or viral culture

    Number of participants with ILI PCR-confirmed as positive for:
    9 -viral strains similar to those contained in the vaccine: PCR-confirmed influenza is a positive influenza result on PCR
    10 -any influenza A or B types: PCR-confirmed influenza is a positive influenza result on PCR

    Number of participants with ILI culture-confirmed as positive :
    11 -for viral strains similar to those contained in the vaccine : Cultureconfirmed influenza is a positive influenza result on viral culture
    12 -for any influenza A or B types: Culture-confirmed influenza is a positive influenza result on viral culture
    13 -for any influenza A or B types and associated with hospitalization: Laboratory-confirmed influenza is a positive influenza result on either PCR or viral culture.
    14 -for viral strains similar to those contained in the vaccine and associated with hospitalization: Laboratory-confirmed influenza is a positive influenza result on either PCR or viral culture
    15 -GMT of influenza vaccine antibodies
    16 -Number of participants with seroconversion or significant increase: Seroconversion for participants with a pre-vaccination titer < 10 (1/dil): post-injection titer ≥ 40 (1/dil) on 28 days after the last vaccination or significant increase for participants with a pre-vaccination titer ≥ 10 (1/dil): ≥ 4-fold increase from pre- to post-injection titer on 28 days after the last vaccination
    17 -Number of participants with influenza vaccine antibody titer ≥ 10 (1/dilution [dil])
    18 -Influenza vaccine antibody titer ratio: Individual antibody titer ratio 28 days after the last vaccination /Day 0
    19 -Participant with influenza vaccine antibody titer ≥ 40 (1/dil)
    16,17,18,19 : Antibody titers are measured by HAI assay
    20 -Influenza SN antibody titer
    21 -Influenza SN antibody titer ratio: Ratio is calculated as fold increase in serum SN post-vaccination relative to Day 0
    22 -Influenza SN antibody titer. Titers levels assessed are ≥ 20 (1/dil), ≥ 40 (1/dil), and ≥ 80 (1/dil) Increase of titer [post/pre] ≥2 and ≥ 4
    20,21,22: Antibody titers are measured by the SN method
    23 -Detectable influenza SN antibody titer
    24 -Anti-NA immune response: same endpoints as SN but with ELLA method

    Number of participants with:
    25 -immediate adverse events: it includes unsolicited systemic adverse events occurring within 30 minutes after vaccination
    26 -solicited injection site and systemic reactions : tenderness, erythema, swelling, induration, and bruising. Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
    27 -unsolicited adverse events: events other than solicited reactions
    28 -serious adverse events
    29 -adverse events of special interest
    28,29 : collected throughout the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 : From 14 days to maximum 6 months after the last injection
    15, 16, 17, 18, 19, 20, 24 : Day 0 and 28 days after the last vaccination
    21, 22, 23 : 28 days after the last vaccination
    25 : Within 30 minutes after vaccination
    26 : Within 7 days after vaccination
    27 : Within 28 days after vaccination
    28, 29 : From Day 0 to Day 180
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    120 participants (subjects) from Season 1 will participate in Season 3.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    Brazil
    Chile
    Colombia
    Czech Republic
    Finland
    Germany
    Italy
    Mexico
    Philippines
    Poland
    South Africa
    Spain
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last contact of the last subject through telephone call 6 months after last vaccination
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 13320
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 9000
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4320
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants, toddlers and Children
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Participant incapable of giving consent personally
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 13320
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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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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