Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

NCT ID: NCT03158220

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2018-11-19

Brief Summary

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

Conditions

Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Adult Women 27- to 45-years Old

Adult women 27- to 45-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

Group Type: EXPERIMENTAL

V503

Intervention Type: BIOLOGICAL

V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6

Young Adult Women 16- to 26-years Old

Young adult women 16- to 26-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

Group Type: ACTIVE_COMPARATOR

V503

Intervention Type: BIOLOGICAL

V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6

Interventions

V503

V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6

Intervention Type: BIOLOGICAL

Other Intervention Names

GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Eligibility Criteria

Inclusion Criteria

• good physical health

Exclusion Criteria

• history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results
• history of HPV-related condition
• history of known prior vaccination with an HPV vaccine
• pregnant
• user of recreational or illicit drugs
• history of severe allergic reaction, including known allergy to any vaccine component
• immunocompromised
• history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)
• has thrombocytopenia or other coagulation disorder
• concurrently enrolled in a clinical study of investigational agent

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)

Graz, , Austria

Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001)

Vienna, , Austria

Universitair Ziekenhuis Antwerpen ( Site 0007)

Edegem, , Belgium

Universitair Ziekenhuis Gent ( Site 0006)

Ghent, , Belgium

Universitair Ziekenhuis Gasthuisberg ( Site 0005)

Leuven, , Belgium

University of Antwerp ( Site 0004)

Wilrijk, , Belgium

HUS Katiloopiston sairaala ( Site 0009)

Helsinki, , Finland

Ita-Helsingin Rokotetutkimuskeskus ( Site 0011)

Helsinki, , Finland

Porin Rokotetutkimusklinikka ( Site 0012)

Pori, , Finland

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010)

Tampere, , Finland

Turun rokotetutkimusklinikka ( Site 0037)

Turku, , Finland

Universitaetsmedizin Berlin Charite ( Site 0016)

Berlin, , Germany

Universitaetsklinikum Duesseldorf ( Site 0014)

Düsseldorf, , Germany

Praxis Dr. Peters ( Site 0015)

Hamburg, , Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0017)

Hamburg, , Germany

Universitaetsklinikum Tuebingen ( Site 0013)

Tübingen, , Germany

Istituto Nazionale dei tumori ( Site 0020)

Milan, Milan, Italy

Ospedale San Raffaele ( Site 0022)

Milan, , Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023)

Palermo, , Italy

CAP Centelles ( Site 0027)

Centelles, Barcelona, Spain

Complejo Hospitalario de Torrecardenas ( Site 0030)

Almería, , Spain

Institut Catala Oncologia de Bellvitge - ICO ( Site 0026)

L'Hospitalet de Llobregat, , Spain

Hospital Sanitas La Moraleja ( Site 0031)

Madrid, , Spain

Hospital Universitario Infanta Leonor ( Site 0028)

Madrid, , Spain

Countries

Austria; Belgium; Finland; Germany; Italy; Spain

References

Joura EA, Ulied A, Vandermeulen C, Rua Figueroa M, Seppa I, Hernandez Aguado JJ, Ahonen A, Reich O, Virta M, Perino A, Peris Tuser M, Peters K, Origoni M, Raspagliesi F, Tjalma WAA, Tummers P, Woelber L, Nieminen P, van Damme P, Sehouli J, Fiol Ruiz G, Brucker S, Fehm T, Cheon K, Rawat S, Luxembourg A, Wittke F. Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study. Vaccine. 2021 May 12;39(20):2800-2809. doi: 10.1016/j.vaccine.2021.01.074. Epub 2021 Mar 3.

Reference Type: DERIVED

PMID: 33676783 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V503-004

Identifier Type: -

Identifier Source: org_study_id