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V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01544478
First received: February 29, 2012
Last updated: June 8, 2017
Last verified: June 2017
Results First Received: June 8, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Adenocarcinoma in Situ
Intervention: Biological: V501

  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
A total of 1036 participants were screened and 1030 were enrolled in the study.

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
V501 Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6

Participant Flow:   Overall Study
    V501
STARTED   1030 
Vaccination 1   1030 
Vaccination 2   1026 
Vaccination 3   1019 
COMPLETED   912 
NOT COMPLETED   118 
Adverse Event                1 
Death                1 
Lost to Follow-up                48 
Physician Decision                15 
Pregnancy                1 
Withdrawal by Subject                52 



  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
V501 Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6

Baseline Measures
   V501 
Overall Participants Analyzed 
[Units: Participants]
 1030 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.9  (2.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1030 100.0% 
Male      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   1030 


  Outcome Measures

1.  Primary:   Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18   [ Time Frame: Up to Month 48 ]


  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
No text entered.


  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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01544478     History of Changes
Other Study ID Numbers: V501-110
132247 ( Registry Identifier: Japic-CTI )
2015-002932-42 ( EudraCT Number )
Study First Received: February 29, 2012
Results First Received: June 8, 2017
Last Updated: June 8, 2017