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    Summary
    EudraCT Number:2022-003483-25
    Sponsor's Protocol Code Number:V181-005
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-06-16
    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 number2022-003483-25
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Immunogenicity, and Efficacy of V181 in Pediatric Participants
    A.3.2Name or abbreviated title of the trial where available
    Safety, Immunogenicity, and Efficacy of V181 in Pediatric Participants
    A.4.1Sponsor's protocol code numberV181-005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT07013487
    A.5.4Other Identifiers
    Name:INDNumber:17780
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/165/2024
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme LLC
    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 supportMerck Sharp & Dohme LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC
    B.5.2Functional name of contact pointSoumya Chatterjee
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Avenue
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code07065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267-305-6995
    B.5.6E-mailsoumya.chatterjee@merck.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 No
    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 nameDengue quadrivalent vaccine rDENVĪ”30 (live, attenuated)
    D.3.2Product code V181
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive namerDEN1delta30
    D.3.9.4EV Substance CodeSUB206687
    D.3.10 Strength
    D.3.10.1Concentration unit Infectious unit
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1100 to 17000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive namerDEN2/4delta30
    D.3.9.4EV Substance CodeSUB206686
    D.3.10 Strength
    D.3.10.1Concentration unit Infectious unit
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3800 to 170000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive namerDEN3delta30/31
    D.3.9.4EV Substance CodeSUB206688
    D.3.10 Strength
    D.3.10.1Concentration unit Infectious unit
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4700 to 68000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive namerDEN4delta30
    D.3.9.4EV Substance CodeSUB206689
    D.3.10 Strength
    D.3.10.1Concentration unit Infectious unit
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1100 to 29000
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dengue fever
    E.1.1.1Medical condition in easily understood language
    Dengue fever
    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 LLT
    E.1.2Classification code 10012309
    E.1.2Term Dengue
    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
    All Participants: To evaluate the safety of V181 with respect to the proportion of participants experiencing medically attended adverse events (MAAEs), serious adverse events (SAEs), and vaccine-related SAEs.
    Reactogenicity and Immunogenicity Subset: To evaluate the tolerability of V181 with respect to the proportion of participants experiencing solicited adverse events (AEs).
    All Participants: To evaluate the efficacy of a single dose of V181 in preventing symptomatic (requiring fever on at least 2 of 3 consecutive days) virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline, from Day 29 postvaccination onwards until meeting criteria for Primary Efficacy Phase.
    E.2.2Secondary objectives of the trial
    All Participants: To evaluate the efficacy of a single dose of V181 in preventing symptomatic (requiring fever on at least 2 of 3 consecutive days) VCD of any severity, due to each of the 4 dengue serotypes, regardless of dengue serostatus at baseline, from Day 29 postvaccination onwards until meeting criteria for Primary Efficacy Phase.
    All Participants: To evaluate the efficacy of a single dose of V181 in preventing symptomatic (requiring fever on at least 2 of 3 consecutive days) VCD of any severity, due to any of the 4 dengue serotypes:
    -by dengue serostatus at baseline, from Day 29 postvaccination onwards until meeting criteria for Primary Efficacy Phase
    -regardless of dengue serostatus at baseline, from Day 29 through Year 5 postvaccination
    -by dengue serostatus at baseline, from Day 29 through Year 5 postvaccination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The key Inclusion Criteria include but are not limited to:
    •Is generally healthy based on medical history and physical examination.
    E.4Principal exclusion criteria
    The key Exclusion Criteria include but are not limited to:
    •Has a known or suspected impairment of immunological function.
    •Has a history of congenital or acquired immunodeficiency.
    •Has a documented human immunodeficiency virus (HIV) infection or is breastfeeding from a mother with documented HIV infection.
    •Has a documented history of hepatitis B or C infection.
    •Has a bleeding disorder contraindicating subcutaneous vaccination or repeated venipuncture.
    •Has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, or systemic autoimmune or neurologic disorders.
    •Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
    •Previous receipt of a dengue vaccine or plans to receive any dengue vaccine (investigational or approved) for the duration of the study (other than the study vaccine).
    •Is expected to require systemic corticosteroids ≤28 days after receipt of study intervention.
    •Has received a blood transfusion or blood products, including immunoglobulins, ≤6 months before receipt of study intervention or plans to receive a blood transfusion or blood products (including immunoglobulins) ≤28 days after receipt of study intervention.
    •Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, ≤6 months before receipt of study intervention or plans to receive immunosuppressive therapies ≤28 days after receipt of study intervention.
    E.5 End points
    E.5.1Primary end point(s)
    1.Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE)
    2.Percentage of Participants Experiencing a Serious Adverse Event (SAE)
    3.Percentage of Participants Experiencing a Vaccine-Related SAE
    4.Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs
    5.Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs
    6.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Any of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Up to approximately 6 months postvaccination
    2.Up to approximately 1 year postvaccination
    3.Up to approximately 5 years postvaccination
    4.Up to approximately 5 days postvaccination
    5.Up to approximately 28 days postvaccination
    6.Up to approximately 3 years postvaccination
    E.5.2Secondary end point(s)
    1.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Each of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline
    2.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
    3.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
    4.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline
    5.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
    6.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
    7.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
    8.Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
    9.Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
    10.Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
    11.Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
    12.Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
    13.Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
    14.Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
    15.Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
    16.Percentage of Participants Experiencing Symptomatic (Regardless of Fever Duration) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination







    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Up to approximately 3 years postvaccination
    2.Up to approximately 3 years postvaccination
    3.Up to approximately 5 years postvaccination
    4.Up to approximately 5 years postvaccination
    5.Up to approximately 3 years postvaccination
    6.Up to approximately 3 years postvaccination
    7.Up to approximately 5 years postvaccination
    8.Up to approximately 5 years postvaccination
    9.Up to approximately 3 years postvaccination
    10.Up to approximately 3 years postvaccination
    11.Up to approximately 5 years postvaccination
    12.Up to approximately 5 years postvaccination
    13.Up to approximately 3 years postvaccination
    14.Up to approximately 3 years postvaccination
    15.Up to approximately 5 years postvaccination
    16.Up to approximately 5 years postvaccination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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
    Indonesia
    Malaysia
    Singapore
    Thailand
    Viet Nam
    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
    The overall study ends when the last participant completes the last study-related contact, withdraws consent, or is lost to follow-up. For purposes of analysis and reporting, the overall study ends when the Sponsor receives the last laboratory test result or at the time of final contact with the last participant, whichever comes last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years7
    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: 12000
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8200
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3800
    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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12000
    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: Singapore
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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
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