Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En undersøgelse af denguevaccine hos raske børn, teenagere og voksne i Indien

4. maj 2026 opdateret af: Takeda

Et randomiseret, dobbeltblindt, placebokontrolleret, fase 3-forsøg for at undersøge sikkerheden og immunogeniciteten af ​​en tetravalent denguevaccine (levende, svækket) (TDV) administreret subkutant til raske forsøgspersoner i alderen 4 til 60 år i Indien

Hovedformålet med undersøgelsen er at lære om bivirkninger og en deltagers immunrespons på Takedas denguevaccine, når den gives to gange inden for 3 måneder.

Deltagerne vil modtage 2 doser af deres randomiserede behandling (vaccine eller placebo). Børn, teenagere og voksne vil modtage én dosis af enten vaccinen eller placebo på dag 1 og den anden dosis af enten vaccinen eller placebo 3 måneder senere. Der vil blive taget op til 4 blodprøver gennem hele undersøgelsen.

I løbet af undersøgelsen vil deltagerne besøge deres studieklinik 6 gange.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Vaccinen, der testes i denne undersøgelse, kaldes TDV (Live, Attenuated). TDV bliver testet for at forhindre dengue. Denne undersøgelse vil vurdere sikkerheden og immunogeniciteten af ​​TDV hos raske deltagere.

Undersøgelsen vil omfatte cirka 480 patienter. Deltagerne vil blive tilfældigt tildelt (tilfældigt, som f.eks. at vende en mønt) til at modtage enten TDV eller placebo- som forbliver uoplyst for deltageren, og investigator under undersøgelsen:

  • Kohorte 1, ≥18 til ≤60 Aldersgruppe: TDV
  • Kohorte 1, ≥18 til ≤60 Aldersgruppe: Placebo
  • Kohorte 2, ≥4 til <18 Aldersgruppe: TDV
  • Kohorte 2, ≥4 til <18 Aldersgruppe: Placebo

Dette multicenterforsøg vil blive gennemført i Indien. Den samlede varighed af undersøgelsen er cirka 9 måneder.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

480

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indien
      • Bhubaneswar, Indien, 751003
        • Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar
      • Kattankulathur, Indien, 603203
        • SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri
      • Kolkata, Indien, 700020
        • IPGME&R and SSKM Hospital, 244 AJC Bose Road
      • Lucknow, Indien, 226003
        • King George's Medical University, Department of Medicine, Chowk
      • Nashik, Indien, 422003
        • Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati
      • New Delhi, Indien, 110002
        • Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center
      • Pune, Indien, 411011
        • KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth
      • Visakhapatnam, Indien, 530002
        • King George Hospital
    • Karnataka
      • Bangalore, Karnataka, Indien, 560060
        • BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri
    • Tamil Nadu
      • Pudupākkam, Tamil Nadu, Indien, 603 103
        • Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Nøgleinklusionskriterier:

1. Deltagere, der kan overholde forsøgsprocedurer og er til rådighed under opfølgningens varighed.

Nøgleekskluderingskriterier:

Ved screening og ved vaccination:

  1. Et kropsmasseindeks (BMI) ≥35 kg/m^2.
  2. Har til hensigt at deltage i et andet klinisk forsøg på et hvilket som helst tidspunkt under udførelsen af ​​dette forsøg.

  3. Planlægger at modtage et af følgende:

    1. En godkendt vaccine inden for 14 dage (for inaktiverede vacciner) eller 28 dage (for levende vacciner) før TDV- eller placeboadministration.
    2. En coronavirus-vaccine inden for 14 dage før TDV eller placebo-administration.
    3. En vaccine godkendt til brug i nødstilfælde inden for 28 dage efter TDV eller placeboadministration.
  4. Kendt stof- eller alkoholmisbrug inden for de seneste 2 år, der kan forstyrre hans/hendes evne til at overholde kravene til forsøgsdeltagelse.
  5. Modtagelse af tidligere vaccination mod dengue-virus.
  6. Tidligere deltagelse i ethvert klinisk forsøg med en dengue-kandidatvaccine.

Ved vaccination:

  1. Deltagere med febersygdom eller moderat eller svær akut sygdom eller infektion på tidspunktet for tilfældig tildeling.
  2. Deltagere medicineret med febernedsættende og/eller smertestillende medicin(er) inden for 24 timer før TDV eller placeboadministration.

BEMÆRK: Andre protokoldefinerede Inklusions-/udelukkelseskriterier kan være gældende.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1: ≥18 to ≤60 Years Age Group: TDV
Participants received TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
Biologisk: TDV
TDV SC-injektion på dag 1 og dag 90 af undersøgelsen
Andre navne:
  • TAK-003
Placebo komparator: Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
Biologisk: Placebo
Normal saltvand (0,9% NaCl) SC-injektion på dag 1 og dag 90 af undersøgelsen
Eksperimentel: Cohort 2: ≥4 to <18 Years Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
Biologisk: TDV
TDV SC-injektion på dag 1 og dag 90 af undersøgelsen
Andre navne:
  • TAK-003
Placebo komparator: Cohort 2: ≥4 to <18 Years Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
Biologisk: Placebo
Normal saltvand (0,9% NaCl) SC-injektion på dag 1 og dag 90 af undersøgelsen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Tidsramme: Within 7 days post-vaccination at Day 1
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (<6 years of age).
Within 7 days post-vaccination at Day 1
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Tidsramme: Within 7 days post-vaccination at Day 1
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).
Within 7 days post-vaccination at Day 1
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Tidsramme: Within 7 days post-vaccination at Day 90
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (<6 years of age).
Within 7 days post-vaccination at Day 90
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Tidsramme: Within 7 days post-vaccination at Day 90
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).
Within 7 days post-vaccination at Day 90
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Tidsramme: Within 14 days post-vaccination at Day 1
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old comprised: irritability/fussiness, drowsiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
Within 14 days post-vaccination at Day 1
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Tidsramme: Within 14 days post-vaccination at Day 1
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
Within 14 days post-vaccination at Day 1
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Tidsramme: Within 14 days post-vaccination at Day 90
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old comprised: drowsiness, irritability/fussiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe). Data for drowsiness, irritability/fussiness and loss of appetite has been reported in this outcome measure.
Within 14 days post-vaccination at Day 90
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Tidsramme: Within 14 days post-vaccination at Day 90
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old also comprised of fever in °C (collected by temperature ranges as indicated). Data for fever has been reported in this outcome measure.
Within 14 days post-vaccination at Day 90
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Tidsramme: Within 14 days post-vaccination at Day 90
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
Within 14 days post-vaccination at Day 90
Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 1
Tidsramme: Within 28 days post-vaccination at Day 1
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Within 28 days post-vaccination at Day 1
Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 90
Tidsramme: Within 28 days post-vaccination at Day 90
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Within 28 days post-vaccination at Day 90
Percentage of Participants With an AE Leading to Participant Withdrawal From Trial
Tidsramme: From first vaccination on Day 1 through the end of trial (up to Day 270)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
From first vaccination on Day 1 through the end of trial (up to Day 270)
Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation
Tidsramme: From first vaccination on Day 1 through the end of trial (up to Day 270)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
From first vaccination on Day 1 through the end of trial (up to Day 270)
Percentage of Participants With a Medically-attended AE (MAAE)
Tidsramme: From first vaccination on Day 1 through the end of trial (up to Day 270)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department but not fulfilling seriousness criteria.
From first vaccination on Day 1 through the end of trial (up to Day 270)
Percentage of Participants With a Serious Adverse Event (SAE)
Tidsramme: From first vaccination on Day 1 through the end of trial (up to Day 270)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.
From first vaccination on Day 1 through the end of trial (up to Day 270)
GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120
Tidsramme: Day 120 (Month 4)
GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 120 (Month 4)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med serokonvertering for hver af de 4 dengue-virusserotyper
Tidsramme: Dag 1, dag 120 og dag 270
Serokonverteringsraten, defineret som procentdelen af ​​deltagere, der er seropositive, er afledt af titrene af dengue-neutraliserende antistoffer. Seropositiv er defineret som en reciprok neutraliserende titer ≥10. De 4 dengue-virusserotyper er DENV-1, DENV-2, DENV-3 og DENV-4.
Dag 1, dag 120 og dag 270
Procentdel af deltagere med serokonvertering for flere (2, 3 eller 4) dengue virus serotyper
Tidsramme: Dag 1, dag 120 og dag 270
Serokonverteringsraten, defineret som procentdelen af ​​deltagere, der er seropositive, er afledt af titrene af dengue-neutraliserende antistoffer. Seropositiv er defineret som en reciprok neutraliserende titer ≥10. De 4 dengue-virusserotyper er DENV-1, DENV-2, DENV-3 og DENV-4.
Dag 1, dag 120 og dag 270
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Tidsramme: Day 1 and 270
GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 1 and 270

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Takeda

Efterforskere

  • Studieleder: Medical Director, Takeda

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. marts 2024

Primær færdiggørelse (Faktiske)

5. maj 2025

Studieafslutning (Faktiske)

5. maj 2025

Datoer for studieregistrering

Først indsendt

22. september 2023

Først indsendt, der opfyldte QC-kriterier

22. september 2023

Først opslået (Faktiske)

29. september 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DEN-302
  • 2023-000134-15 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Takeda giver adgang til de afidentificerede individuelle deltagerdata (IPD) for kvalificerede undersøgelser for at hjælpe kvalificerede forskere med at løse legitime videnskabelige mål (Takedas tilsagn om datadeling er tilgængelig på https://clinicaltrials.takeda.com/takedas-commitment?commitment= 5). Disse IPD'er vil blive leveret i et sikkert forskningsmiljø efter godkendelse af en anmodning om datadeling og under betingelserne i en datadelingsaftale.

IPD-delingsadgangskriterier

IPD fra kvalificerede undersøgelser vil blive delt med kvalificerede forskere i henhold til kriterierne og processen beskrevet på https://vivli.org/ourmember/takeda/. For godkendte anmodninger vil forskerne få adgang til anonymiserede data (for at respektere patientens privatliv i overensstemmelse med gældende love og regler) og med oplysninger, der er nødvendige for at opfylde forskningsmålene i henhold til vilkårene i en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner