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

Phase 3

Completed

• Conditions: Vulvar Cancer; Cervical Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
• Interventions: Biological: V503

• Registration Number: NCT03158220
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Study Start: 2017-09-20
• Primary Completion: 2018-11-19
• Study Completion: 2018-11-19
• Status Verified: 2019-11
• Results First Submitted: 2019-11-04
• Results First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Results First Posted: 2019-11-21
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Young Adult Women 16- to 26-years Old	V503	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.
Adult Women 27- to 45-years Old	V503	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.

Primary Outcome Measures

Name	Time	Method
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	4 weeks post vaccination 3 (Month 7)	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event	Up to 5 days post any vaccination	Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.
Percentage of Participants With Elevated Temperature (Fever)	Up to 5 days post any vaccination	Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.
Percentage of Participants That Experienced at Least 1 Adverse Event (AE)	Up to 1 month post vaccination 3 (up to 7 months)	An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.
Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.	Up to 1 month post vaccination 3 (up to 7 months)	An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.
Percentage of Participants That Reported at Least 1 Systemic Adverse Event	Up to 15 days post any vaccination	An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed
Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types	4 weeks post vaccination 3 (Month 7)	Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.

Trial Locations

Locations (24)

University of Antwerp ( Site 0004); 🇧🇪 Wilrijk, Belgium

CAP Centelles ( Site 0027); 🇪🇸 Centelles, Barcelona, Spain

Universitair Ziekenhuis Gasthuisberg ( Site 0005); 🇧🇪 Leuven, Belgium

Turun rokotetutkimusklinikka ( Site 0037); 🇫🇮 Turku, Finland

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010); 🇫🇮 Tampere, Finland

Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002); 🇦🇹 Graz, Austria

HUS Katiloopiston sairaala ( Site 0009); 🇫🇮 Helsinki, Finland

Universitair Ziekenhuis Antwerpen ( Site 0007); 🇧🇪 Edegem, Belgium

Universitair Ziekenhuis Gent ( Site 0006); 🇧🇪 Gent, Belgium

Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001); 🇦🇹 Wien, Austria

Ita-Helsingin Rokotetutkimuskeskus ( Site 0011); 🇫🇮 Helsinki, Finland

Porin Rokotetutkimusklinikka ( Site 0012); 🇫🇮 Pori, Finland

Praxis Dr. Peters ( Site 0015); 🇩🇪 Hamburg, Germany

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023); 🇮🇹 Palermo, Italy

Universitaetsklinikum Duesseldorf ( Site 0014); 🇩🇪 Dusseldorf, Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0017); 🇩🇪 Hamburg, Germany

Universitaetsklinikum Tuebingen ( Site 0013); 🇩🇪 Tuebingen, Germany

Ospedale San Raffaele ( Site 0022); 🇮🇹 Milano, Italy

Istituto Nazionale dei tumori ( Site 0020); 🇮🇹 Milano, Milan, Italy

Institut Catala Oncologia de Bellvitge - ICO ( Site 0026); 🇪🇸 Hospitalet de Llobregat, Spain

Hospital Universitario Infanta Leonor ( Site 0028); 🇪🇸 Madrid, Spain

Hospital Sanitas La Moraleja ( Site 0031); 🇪🇸 Madrid, Spain

Universitaetsmedizin Berlin Charite ( Site 0016); 🇩🇪 Berlin, Germany

Complejo Hospitalario de Torrecardenas ( Site 0030); 🇪🇸 Almeria, Spain