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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. července 2018 aktualizováno: 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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

1518

Fáze

  • Fáze 3

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

9 let až 26 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Biologický: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimentální: 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.
Biologický: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimentální: 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.
Biologický: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimentální: 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.
Biologický: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Aktivní komparátor: 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.
Biologický: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Merck Sharp & Dohme LLC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

12. prosince 2013

Primární dokončení (Aktuální)

19. června 2015

Dokončení studie (Aktuální)

24. července 2017

Termíny zápisu do studia

První předloženo

8. listopadu 2013

První předloženo, které splnilo kritéria kontroly kvality

14. listopadu 2013

První zveřejněno (Odhad)

15. listopadu 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. srpna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. července 2018

Naposledy ověřeno

1. července 2018

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • V503-010 (Jiný identifikátor: Merck Protocol Number)
  • 2013-001314-15 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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