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A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

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ClinicalTrials.gov Identifier: NCT01047345
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : December 22, 2014
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

Condition or disease Intervention/treatment Phase
Cervical Cancers Vulvar Cancers Vaginal Cancers Genital Warts Biological: V503 Biological: Placebo to V503 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™
Actual Study Start Date : February 24, 2010
Actual Primary Completion Date : June 10, 2011
Actual Study Completion Date : November 28, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 9vHPV Vaccine
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
 Biological: V503
V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension
Placebo Comparator: Placebo
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
 Biological: V503
V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension

Biological: Placebo to V503
Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study [ Time Frame: up to 5 days after any vaccination - Base Study ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.

  2. Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study [ Time Frame: up to 5 days after any vaccination - Base Study ]
    Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.

  3. Percentage of Participants Who Experience a Systemic AE - Base Study [ Time Frame: up to 14 days after any vaccination - Base Study ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.

  4. Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study [ Time Frame: up to 14 days after any vaccination - Base Study ]
    An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.

  5. Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study [ Time Frame: Up to 7 months - Base Study ]
    An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" is defined as a vaccine-related SAE.

  6. Percentage of Participants Who Experience a Severe Injection-site AE - Base Study [ Time Frame: up to 5 days after any vaccination - Base Study ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.


Secondary Outcome Measures :
  1. Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study [ Time Frame: 4 weeks post-vaccination 3 (Month 7; End of Base Study) ]
    Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.


Other Outcome Measures:
  1. Percentage of Participants Who Experience an SAE- Extension Study [ Time Frame: up to Month 7 - Extension Study ]
    An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants Age 12 to 15 Years:

  • Participant is in good health
  • Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
  • Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
  • Participant has not received any other HPV vaccine
  • Participant is not yet sexually active

Participants Age 16 to 26 Years:

  • Participant is in good health
  • Participant agrees to provide a primary telephone number for follow-up
  • Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
  • Participant has not received any other HPV vaccine
  • Participant has never had Papanicolaou (Pap) testing or has only had normal results
  • Participant has a history of 0 to 4 lifetime sexual partners at enrollment

Exclusion Criteria:

All participants:

  • Participant has a history of severe allergic reaction that required medical intervention
  • Participant has any disorder that would contraindicate intramuscular injections
  • Participant is pregnant
  • Participant is immunocompromised or has an autoimmune condition
  • Participant has had a splenectomy
  • Participant has received any immune globulin product or blood-derived product
  • Participant has participated in a HPV vaccine clinical trial

Participants Age 16 to 26 Only:

  • Participant expects to donate eggs during the study
  • Participant has a history of abnormal cervical biopsy result
  • Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer
Contacts and Locations
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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): NCT01047345


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01047345    
Other Study ID Numbers: V503-006
2010_504 ( Other Identifier: Merck Registration Number )
First Posted: January 12, 2010    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: November 27, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Merck Sharp & Dohme Corp.:
Cervical cancer
Genital warts
Human papillomavirus vaccine
GARDASIL™
Additional relevant MeSH terms:
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Condylomata Acuminata
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
 Vulvar Diseases
Vaginal Diseases
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases