Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01047345
First received: January 11, 2010
Last updated: December 12, 2014
Last verified: December 2014
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Cervical Cancers
Vulvar Cancers
Vaginal Cancers
Genital Warts
Interventions: Biological: V503
Biological: Placebo to V503

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
9vHPV Vaccine 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.
Placebo 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 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.

Participant Flow:   Overall Study
    9vHPV Vaccine     Placebo  
STARTED     618     306  
Vaccination 1     615     306  
Vaccination 2     604     304  
Vaccination 3     597     300  
COMPLETED     596 [1]   300  
NOT COMPLETED     22     6  
Adverse Event                 3                 0  
Lost to Follow-up                 4                 1  
Protocol Violation                 3                 1  
Withdrawal by Subject                 12                 4  
[1] Includes 1 participant for whom completion status is unknown



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
9vHPV Vaccine 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.
Placebo 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 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Total Total of all reporting groups

Baseline Measures
    9vHPV Vaccine     Placebo     Total  
Number of Participants  
[units: participants]
  618     306     924  
Age, Customized  
[units: Participants]
     
12 to 15 years     122     60     182  
16 to 26 years     496     246     742  
Gender  
[units: Participants]
     
Female     618     306     924  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Experience an Injection-site Adverse Event (AE) – Base Study   [ Time Frame: up to 5 days after any vaccination - Base Study ]

2.  Primary:   Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) – Base Study   [ Time Frame: up to 5 days after any vaccination - Base Study ]

3.  Primary:   Percentage of Participants Who Experience a Systemic AE – Base Study   [ Time Frame: up to 14 days after any vaccination - Base Study ]

4.  Primary:   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 ]

5.  Primary:   Percentage of Participants Who Experience a Vaccine-related SAE Within 15 Days of Any Vaccination – Base Study   [ Time Frame: up to 14 days after any vaccination - Base Study ]

6.  Primary:   Percentage of Participants Who Experience a Severe Injection-site AE – Base Study   [ Time Frame: up to 5 days after any vaccination - Base Study ]

7.  Secondary:   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) ]

8.  Other Pre-specified:   Percentage of Participants Who Experience an SAE- Extension Study   [ Time Frame: up to Month 7 - Extension Study ]
Results not yet reported.   Anticipated Reporting Date:   11/2016   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01047345     History of Changes
Other Study ID Numbers: V503-006, 2010_504
Study First Received: January 11, 2010
Results First Received: December 12, 2014
Last Updated: December 12, 2014
Health Authority: United States: Food and Drug Administration