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

NCT03158220 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V503-004
• Study Type: interventional
• Target: 1,212
• Locations: 6 countries
• Sites: 24

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

Outcome Measures

Primary Outcomes (1)

• Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type

  Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).

  4 weeks post vaccination 3 (Month 7)

Secondary Outcomes (6)

• Percentage of Participants That Experienced at Least 1 Adverse Event (AE)

  Up to 1 month post vaccination 3 (up to 7 months)

• Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.

  Up to 1 month post vaccination 3 (up to 7 months)

• Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event

  Up to 5 days post any vaccination

• Percentage of Participants That Reported at Least 1 Systemic Adverse Event

  Up to 15 days post any vaccination

• Percentage of Participants With Elevated Temperature (Fever)

  Up to 5 days post any vaccination

Study Arms (2)

Adult Women 27- to 45-years Old

EXPERIMENTAL

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.

Biological: V503

Young Adult Women 16- to 26-years Old

ACTIVE COMPARATOR

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.

Biological: V503

Interventions

V503 BIOLOGICAL

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

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

Adult Women 27- to 45-years Old; Young Adult Women 16- to 26-years Old

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• good physical health

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (24)

Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)

Graz, Austria

Location

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

Vienna, Austria

Location

Universitair Ziekenhuis Antwerpen ( Site 0007)

Edegem, Belgium

Location

Universitair Ziekenhuis Gent ( Site 0006)

Ghent, Belgium

Location

Universitair Ziekenhuis Gasthuisberg ( Site 0005)

Leuven, Belgium

Location

University of Antwerp ( Site 0004)

Wilrijk, Belgium

Location

HUS Katiloopiston sairaala ( Site 0009)

Helsinki, Finland

Location

Ita-Helsingin Rokotetutkimuskeskus ( Site 0011)

Helsinki, Finland

Location

Porin Rokotetutkimusklinikka ( Site 0012)

Pori, Finland

Location

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010)

Tampere, Finland

Location

Turun rokotetutkimusklinikka ( Site 0037)

Turku, Finland

Location

Universitaetsmedizin Berlin Charite ( Site 0016)

Berlin, Germany

Location

Universitaetsklinikum Duesseldorf ( Site 0014)

Düsseldorf, Germany

Location

Praxis Dr. Peters ( Site 0015)

Hamburg, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf ( Site 0017)

Hamburg, Germany

Location

Universitaetsklinikum Tuebingen ( Site 0013)

Tübingen, Germany

Location

Istituto Nazionale dei tumori ( Site 0020)

Milan, Milan, Italy

Location

Ospedale San Raffaele ( Site 0022)

Milan, Italy

Location

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

Palermo, Italy

Location

CAP Centelles ( Site 0027)

Centelles, Barcelona, Spain

Location

Complejo Hospitalario de Torrecardenas ( Site 0030)

Almería, Spain

Location

Institut Catala Oncologia de Bellvitge - ICO ( Site 0026)

L'Hospitalet de Llobregat, Spain

Location

Hospital Sanitas La Moraleja ( Site 0031)

Madrid, Spain

Location

Hospital Universitario Infanta Leonor ( Site 0028)

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 33676783 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Condylomata Acuminata; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Vaginal Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: September 20, 2017
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: November 21, 2019
• Results First Posted: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); BE (4); FI (5); AU (2); ES (5); DE (5)