- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01984697
A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
12. Juli 2018 aktualisiert von: Merck Sharp & Dohme LLC
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age.
From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
1518
Phase
- Phase 3
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
9 Jahre bis 26 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
All Participants:
-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
Boys and Girls 9 to 14 Years:
-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
Exclusion Criteria:
All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Girls 9 to 14 Years V503 at Months 0 and 6
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
Experimental: Boys 9 to 14 Years V503 at Months 0 and 6
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
Experimental: Girls and Boys 9 to 14 Years V503 at Months 0 and 12
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
Experimental: Girls 9 to 14 Years V503 at Months 0, 2, and 6
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
Aktiver Komparator: Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Zeitfenster: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Zeitfenster: Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 24
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Zeitfenster: Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 24
|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Zeitfenster: Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 36
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Zeitfenster: Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 36
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Iversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K, Block SL, Skrivanek A, Nur Azurah AG, Fong SM, Dvorak V, Kim KH, Cestero RM, Berkovitch M, Ceyhan M, Ellison MC, Ritter MA, Yuan SS, DiNubile MJ, Saah AJ, Luxembourg A. Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women. JAMA. 2016 Dec 13;316(22):2411-2421. doi: 10.1001/jama.2016.17615.
- Bornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, Diez-Domingo J, Schilling A, Ariffin H, Tytus R, Rupp R, Senders S, Engel E, Ferris D, Kim YJ, Tae Kim Y, Kurugol Z, Bautista O, Nolan KM, Sankaranarayanan S, Saah A, Luxembourg A. Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine. Pediatrics. 2021 Jan;147(1):e20194035. doi: 10.1542/peds.2019-4035. Epub 2020 Dec 22.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
12. Dezember 2013
Primärer Abschluss (Tatsächlich)
19. Juni 2015
Studienabschluss (Tatsächlich)
24. Juli 2017
Studienanmeldedaten
Zuerst eingereicht
8. November 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. November 2013
Zuerst gepostet (Schätzen)
15. November 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. August 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juli 2018
Zuletzt verifiziert
1. Juli 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- V503-010 (Andere Kennung: Merck Protocol Number)
- 2013-001314-15 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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