Clinical trial NCT03158220: Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
Official title: An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Genital Warts
Human Papillomavirus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-05-18
Enrollment: 1212
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
timeFrame: 4 weeks post vaccination 3 (Month 7)
Secondary outcomes:
measure: Percentage of Participants That Experienced at Least 1 Adverse Event (AE)
timeFrame: Up to 1 month post vaccination 3 (up to 7 months)
measure: Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.
timeFrame: Up to 1 month post vaccination 3 (up to 7 months)
measure: Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
timeFrame: Up to 5 days post any vaccination
measure: Percentage of Participants That Reported at Least 1 Systemic Adverse Event
timeFrame: Up to 15 days post any vaccination
measure: Percentage of Participants With Elevated Temperature (Fever)
timeFrame: Up to 5 days post any vaccination
measure: Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types
timeFrame: 4 weeks post vaccination 3 (Month 7)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)
city: Wien
country: Austria
facility: Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001)
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen ( Site 0007)
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent ( Site 0006)
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg ( Site 0005)
city: Wilrijk
country: Belgium
facility: University of Antwerp ( Site 0004)
city: Helsinki
country: Finland
facility: HUS Katiloopiston sairaala ( Site 0009)
city: Helsinki
country: Finland
facility: Ita-Helsingin Rokotetutkimuskeskus ( Site 0011)
city: Pori
country: Finland
facility: Porin Rokotetutkimusklinikka ( Site 0012)
city: Tampere
country: Finland
facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010)
city: Turku
country: Finland
facility: Turun rokotetutkimusklinikka ( Site 0037)
city: Berlin
country: Germany
facility: Universitaetsmedizin Berlin Charite ( Site 0016)
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf ( Site 0014)
city: Hamburg
country: Germany
facility: Praxis Dr. Peters ( Site 0015)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0017)
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 0013)
city: Milano
country: Italy
facility: Istituto Nazionale dei tumori ( Site 0020)
state: Milan
city: Milano
country: Italy
facility: Ospedale San Raffaele ( Site 0022)
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023)
city: Centelles
country: Spain
facility: CAP Centelles ( Site 0027)
state: Barcelona
city: Almeria
country: Spain
facility: Complejo Hospitalario de Torrecardenas ( Site 0030)
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catala Oncologia de Bellvitge - ICO ( Site 0026)
city: Madrid
country: Spain
facility: Hospital Sanitas La Moraleja ( Site 0031)
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor ( Site 0028)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.