ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03158220
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 27- to 45-year-old women, and will complete the evaluation of GARDASIL®9 in the extended age range of female participants for whom GARDASIL® was proven to be effective. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 titers at 4 weeks postdose 3 are non-inferior in adult women as compared with titers in young adult women.

Condition or disease Intervention/treatment Phase
Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection Biological: V503 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : November 23, 2018
Estimated Study Completion Date : November 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: V503
V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
Other Name: GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Active Comparator: 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.
Biological: V503
V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
Other Name: GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58




Primary Outcome Measures :
  1. Anti-HPV Geometric Mean Titers [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    Antibodies to the HPV types contained in V503 are measured using a competitive Luminex immunoassay. Antibody titers are expressed as milli Merck units/mL (mMU/mL).


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 1 month after Dose 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 that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants with one or more adverse events will be assessed.

  2. Study Discontinuations Due to an Adverse Event [ Time Frame: Up to 1 month after Dose 3 (up to 7 months) ]
    The percentage of participants who discontinue the study due to an adverse event will be assessed.

  3. Solicited Injection-site Adverse Events [ Time Frame: Up to 5 days after any vaccination ]
    Participants will be 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 one or more solicited injection-site adverse events will be assessed.

  4. Elevated Temperature (Fever) [ Time Frame: Up to 5 days after any vaccination ]
    Participants will be 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) will be assessed.

  5. Anti-HPV Seroconversion [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    Antibodies to the HPV types contained in V503 are 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 will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158220


Locations
Austria
Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)
Graz, Austria
Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001)
Wien, Austria
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, Belgium
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, Finland
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, Germany
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, Italy
Spain
CAP Centelles ( Site 0027)
Centelles, Barcelona, Spain
Complejo Hospitalario de Torrecardenas ( Site 0030)
Almeria, 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, Spain
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03158220     History of Changes
Other Study ID Numbers: V503-004
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vaginal Diseases
Tumor Virus Infections
Papillomavirus Infections
Condylomata Acuminata
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
DNA Virus Infections
Virus Diseases
Warts
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs