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Die klinische Studie NCT05450705 für Papillomavirus-Infektionen ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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MerckV503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071) Phase 3 1.500 Impfstoff
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Die klinische Studie NCT05450705 untersucht Prävention im Zusammenhang mit Papillomavirus-Infektionen. Diese interventionsstudie der Phase 3 hat den Status aktiv, nicht rekrutierend und startete am 22. Juli 2022. Es ist geplant, 1.500 Teilnehmer aufzunehmen. Durchgeführt von Merck wird der Abschluss für 3. August 2029 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 2. September 2022 aktualisiert.
Kurzbeschreibung
This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a ...Mehr anzeigen
Offizieller Titel
A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age
Erkrankungen
Papillomavirus-InfektionenWeitere Studien-IDs
- V503-071
- V503-071 (Andere Kennung) (Merck)
NCT-Nummer
Studienbeginn (tatsächlich)
2022-07-22
Zuletzt aktualisiert
2022-09-02
Studienende (vorauss.)
2029-08-03
Geplante Rekrutierung
1.500
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Experimentell9 to 14 Years Old: Day 1 and Month 6 Chinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 6 | 9vHPV vaccine A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
Experimentell9 to 14 Years Old: Day 1 and Month 12 Chinese females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12 | 9vHPV vaccine A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
Experimentell20 to 26 Years Old: Day 1, Month 2 and Month 6 Chinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6 | 9vHPV vaccine A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL. | One month after last dose (Up to Month 13) |
Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 84 |
Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized. | Up to Month 84 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Stage I: cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | One month after last dose (Up to Month 13) |
Stage I: Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose | IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL. | One month after last dose (Up to Month 13) |
Stage I: IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | One month after last dose (Up to Month 13) |
Stage I: Percentage of participants experiencing solicited injection-site adverse events (AEs) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded. | Day 1 through Day 8 following any study vaccination |
Stage I: Percentage of participants experiencing solicited systemic AEs | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs. | Day 1 through Day 8 following any study vaccination |
Stage I: Percentage of participants experiencing serious AEs (SAEs) Up to Month 13 | A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. | Up to Month 13 |
Stage II: Percentage of participants experiencing SAEs Up to Month 84 | A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. | Month 18 up to Month 84 |
Stage II: IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 84 |
Stage II: IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized | Up to Month 84 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
9 Years
Zugelassene Geschlechter
Weiblich
Akzeptiert gesunde Freiwillige
Ja
INCLUSION CRITERIA:
- Is a healthy Chinese female.
- Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception during Day 1 through 1 month post last dose.
Exclusion Criteria:
- Has a history of known prior vaccination with an HPV vaccine.
- Has a history of severe allergic reaction that required medical intervention.
- Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
- Has a history of abnormal Pap test or external genital wart, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia, vulvar cancer, vaginal cancer, or anal cancer.
- Has a history of a positive test for HPV.
- Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
- Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
MerckKeine Kontaktdaten vorhanden
2 Studienstandorte in 1 Ländern
Zhejiang
Jiangshan Center for Disease Control and Prevention ( Site 0001), Quzhou, Zhejiang, 324100, China
Yuhuan Center for Disease Control and Prevention ( Site 0002), Taizhou, Zhejiang, 317600, China