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
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 11, 2010 | ||||||
First Posted Date ICMJE | January 12, 2010 | ||||||
Results First Submitted Date ICMJE | December 12, 2014 | ||||||
Results First Posted Date ICMJE | December 22, 2014 | ||||||
Last Update Posted Date | November 27, 2018 | ||||||
Actual Study Start Date ICMJE | February 24, 2010 | ||||||
Actual Primary Completion Date | June 10, 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Number of participants who experience serious or non-serious adverse events [ Time Frame: Day 1 to Month 7 ] | ||||||
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Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
Number of participants who are seropositive to each of the HPV types contained in V503 [ Time Frame: Month 7 ] | ||||||
Current Other Pre-specified Outcome Measures |
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.
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | 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) | ||||||
Official Title ICMJE | 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™ | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
924 | ||||||
Original Estimated Enrollment ICMJE |
900 | ||||||
Actual Study Completion Date ICMJE | November 28, 2015 | ||||||
Actual Primary Completion Date | June 10, 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Participants Age 12 to 15 Years:
Participants Age 16 to 26 Years:
Exclusion Criteria: All participants:
Participants Age 16 to 26 Only:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 26 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | Canada, Colombia, Denmark, Hong Kong, Mexico, Puerto Rico, Sweden, United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01047345 | ||||||
Other Study ID Numbers ICMJE | V503-006 2010_504 ( Other Identifier: Merck Registration Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | ||||||
Verification Date | October 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |