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

Cervical Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158220
• Other study ID #: V503-004
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2017
• Est. completion date: November 19, 2018

Study information

• Verified date: November 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1212
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Condylomata Acuminata
• Genital Warts
• Human Papillomavirus Infection
• Papillomavirus Infections
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
Austria	Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)	Graz
Austria	Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001)	Wien
Belgium	Universitair Ziekenhuis Antwerpen ( Site 0007)	Edegem
Belgium	Universitair Ziekenhuis Gent ( Site 0006)	Gent
Belgium	Universitair Ziekenhuis Gasthuisberg ( Site 0005)	Leuven
Belgium	University of Antwerp ( Site 0004)	Wilrijk
Finland	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
Germany	Universitaetsmedizin Berlin Charite ( Site 0016)	Berlin
Germany	Universitaetsklinikum Duesseldorf ( Site 0014)	Dusseldorf
Germany	Praxis Dr. Peters ( Site 0015)	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf ( Site 0017)	Hamburg
Germany	Universitaetsklinikum Tuebingen ( Site 0013)	Tuebingen
Italy	Istituto Nazionale dei tumori ( Site 0020)	Milano	Milan
Italy	Ospedale San Raffaele ( Site 0022)	Milano
Italy	Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023)	Palermo
Spain	Complejo Hospitalario de Torrecardenas ( Site 0030)	Almeria
Spain	CAP Centelles ( Site 0027)	Centelles	Barcelona
Spain	Institut Catala Oncologia de Bellvitge - ICO ( Site 0026)	Hospitalet de Llobregat
Spain	Hospital Sanitas La Moraleja ( Site 0031)	Madrid
Spain	Hospital Universitario Infanta Leonor ( Site 0028)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

Austria,  Belgium,  Finland,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants That Experienced at Least 1 Adverse Event (AE)	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.	Up to 1 month post vaccination 3 (up to 7 months)
Secondary	Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.	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.	Up to 1 month post vaccination 3 (up to 7 months)
Secondary	Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event	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.	Up to 5 days post any vaccination
Secondary	Percentage of Participants That Reported at Least 1 Systemic Adverse Event	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	Up to 15 days post any vaccination
Secondary	Percentage of Participants With Elevated Temperature (Fever)	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.	Up to 5 days post any vaccination
Secondary	Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types	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.	4 weeks post vaccination 3 (Month 7)