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

Primary Purpose

Cervical Cancer, Vulvar Cancer, Vaginal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V503
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)
  • Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001)
  • Universitair Ziekenhuis Antwerpen ( Site 0007)
  • Universitair Ziekenhuis Gent ( Site 0006)
  • Universitair Ziekenhuis Gasthuisberg ( Site 0005)
  • University of Antwerp ( Site 0004)
  • HUS Katiloopiston sairaala ( Site 0009)
  • Ita-Helsingin Rokotetutkimuskeskus ( Site 0011)
  • Porin Rokotetutkimusklinikka ( Site 0012)
  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010)
  • Turun rokotetutkimusklinikka ( Site 0037)
  • Universitaetsmedizin Berlin Charite ( Site 0016)
  • Universitaetsklinikum Duesseldorf ( Site 0014)
  • Praxis Dr. Peters ( Site 0015)
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0017)
  • Universitaetsklinikum Tuebingen ( Site 0013)
  • Istituto Nazionale dei tumori ( Site 0020)
  • Ospedale San Raffaele ( Site 0022)
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023)
  • CAP Centelles ( Site 0027)
  • Complejo Hospitalario de Torrecardenas ( Site 0030)
  • Institut Catala Oncologia de Bellvitge - ICO ( Site 0026)
  • Hospital Sanitas La Moraleja ( Site 0031)
  • Hospital Universitario Infanta Leonor ( Site 0028)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adult Women 27- to 45-years Old

Young Adult Women 16- to 26-years Old

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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
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.
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.

Full Information

First Posted
May 16, 2017
Last Updated
November 4, 2019
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03158220
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
November 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult Women 27- to 45-years Old
Arm Type
Experimental
Arm Description
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.
Arm Title
Young Adult Women 16- to 26-years Old
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
V503
Other Intervention Name(s)
GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Intervention Description
V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
Primary Outcome Measure Information:
Title
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
Description
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).
Time Frame
4 weeks post vaccination 3 (Month 7)
Secondary Outcome Measure Information:
Title
Percentage of Participants That Experienced at Least 1 Adverse Event (AE)
Description
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.
Time Frame
Up to 1 month post vaccination 3 (up to 7 months)
Title
Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.
Description
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.
Time Frame
Up to 1 month post vaccination 3 (up to 7 months)
Title
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
Description
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.
Time Frame
Up to 5 days post any vaccination
Title
Percentage of Participants That Reported at Least 1 Systemic Adverse Event
Description
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
Time Frame
Up to 15 days post any vaccination
Title
Percentage of Participants With Elevated Temperature (Fever)
Description
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.
Time Frame
Up to 5 days post any vaccination
Title
Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types
Description
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.
Time Frame
4 weeks post vaccination 3 (Month 7)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)
City
Graz
Country
Austria
Facility Name
Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001)
City
Wien
Country
Austria
Facility Name
Universitair Ziekenhuis Antwerpen ( Site 0007)
City
Edegem
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent ( Site 0006)
City
Gent
Country
Belgium
Facility Name
Universitair Ziekenhuis Gasthuisberg ( Site 0005)
City
Leuven
Country
Belgium
Facility Name
University of Antwerp ( Site 0004)
City
Wilrijk
Country
Belgium
Facility Name
HUS Katiloopiston sairaala ( Site 0009)
City
Helsinki
Country
Finland
Facility Name
Ita-Helsingin Rokotetutkimuskeskus ( Site 0011)
City
Helsinki
Country
Finland
Facility Name
Porin Rokotetutkimusklinikka ( Site 0012)
City
Pori
Country
Finland
Facility Name
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010)
City
Tampere
Country
Finland
Facility Name
Turun rokotetutkimusklinikka ( Site 0037)
City
Turku
Country
Finland
Facility Name
Universitaetsmedizin Berlin Charite ( Site 0016)
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf ( Site 0014)
City
Dusseldorf
Country
Germany
Facility Name
Praxis Dr. Peters ( Site 0015)
City
Hamburg
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 0017)
City
Hamburg
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen ( Site 0013)
City
Tuebingen
Country
Germany
Facility Name
Istituto Nazionale dei tumori ( Site 0020)
City
Milano
State/Province
Milan
Country
Italy
Facility Name
Ospedale San Raffaele ( Site 0022)
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023)
City
Palermo
Country
Italy
Facility Name
CAP Centelles ( Site 0027)
City
Centelles
State/Province
Barcelona
Country
Spain
Facility Name
Complejo Hospitalario de Torrecardenas ( Site 0030)
City
Almeria
Country
Spain
Facility Name
Institut Catala Oncologia de Bellvitge - ICO ( Site 0026)
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Hospital Sanitas La Moraleja ( Site 0031)
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor ( Site 0028)
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
33676783
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.
Results Reference
derived

Learn more about this trial

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

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