A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women (V501-019)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090220
First received: August 25, 2004
Last updated: March 31, 2014
Last verified: March 2014
Results First Received: October 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Healthy
Papillomavirus Infection
Interventions: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: Comparator: Placebo

  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
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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
qHPV Vaccine in Base Study

The vaccination period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 48.

Placebo in Base Study

The vaccination period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 48.

EXT1: Placebo in Base Study Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at EXT1 Day 1, Month 2 and Month 6. Participants were followed to EXT1 Month 7
EXT1: Incomplete qHPV Regimen in Base Study Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

Participant Flow for 3 periods

Period 1:   Base Study Vaccination Period
    qHPV Vaccine in Base Study     Placebo in Base Study     EXT1: Placebo in Base Study     EXT1: Incomplete qHPV Regimen in Base Study  
STARTED     1911     1908     0     0  
Vaccinated     1910     1907     0     0  
COMPLETED     1847     1845     0     0  
NOT COMPLETED     64     63     0     0  
Randomized not Vaccinated                 1                 1                 0                 0  
Adverse Event                 6                 1                 0                 0  
Lost to Follow-up                 24                 28                 0                 0  
Withdrawal by Subject                 23                 27                 0                 0  
Patient Moved                 6                 2                 0                 0  
Deviation from Protocol                 1                 0                 0                 0  
Unspecified                 3                 4                 0                 0  

Period 2:   Base Study Follow-up Period
    qHPV Vaccine in Base Study     Placebo in Base Study     EXT1: Placebo in Base Study     EXT1: Incomplete qHPV Regimen in Base Study  
STARTED     1855 [1]   1851 [2]   0     0  
COMPLETED     1684 [3]   1677 [4]   0     0  
NOT COMPLETED     171     174     0     0  
Adverse Event                 6                 1                 0                 0  
Lost to Follow-up                 88                 78                 0                 0  
Physician Decision                 0                 1                 0                 0  
Withdrawal by Subject                 27                 36                 0                 0  
Patient Moved                 20                 28                 0                 0  
No Final Visit before study cutoff date                 12                 12                 0                 0  
Unspecified                 7                 8                 0                 0  
Study Still Ongoing                 11                 10                 0                 0  
[1] 8 participants did not complete the Vaccination Period but did enter the Follow-up Period.
[2] 5 participants did not complete the Vaccination Period but did enter the Follow-up Period.
[3] 11 participants continued in base study follow-up as of 30 April 2009
[4] 10 participants continued in base study follow-up as of 30 April 2009

Period 3:   Extension 1 (EXT1)
    qHPV Vaccine in Base Study     Placebo in Base Study     EXT1: Placebo in Base Study     EXT1: Incomplete qHPV Regimen in Base Study  
STARTED     0     0     1322 [1]   7 [1]
Vaccinated     0     0     1321     7  
COMPLETED     0     0     1267     5  
NOT COMPLETED     0     0     55     2  
Adverse Event                 0                 0                 4                 0  
Lost to Follow-up                 0                 0                 22                 0  
Pregnancy                 0                 0                 1                 0  
Moved                 0                 0                 2                 1  
Withdrawal by Subject                 0                 0                 25                 0  
Protocol Violation                 0                 0                 0                 1  
Other reason                 0                 0                 1                 0  
[1] Participation in EXT1 was voluntary; not all participants eligible for EXT1 enrolled.



  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
qHPV Vaccine in Base Study Participants who started the base study vaccination period
Placebo in Base Study Participants who started the base study vaccination period
Total Total of all reporting groups

Baseline Measures
    qHPV Vaccine in Base Study     Placebo in Base Study     Total  
Number of Participants  
[units: participants]
  1911     1908     3819  
Age  
[units: years]
Mean ± Standard Deviation
  34.3  ± 6.3     34.3  ± 6.3     34.3  ± 6.3  
Age [1]
[units: Years]
Median ( Full Range )
  35  
  ( 24 to 45 )  
  34  
  ( 21 to 46 )  
  34  
  ( 21 to 46 )  
Gender  
[units: participants]
     
Female     1911     1908     3819  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     596     596     1192  
Black     100     82     182  
Hispanic American     822     827     1649  
Native American     2     1     3  
White     388     397     785  
Multi-Racial     3     4     7  
Polynesian     0     1     1  
[1] Although the upper age limit for this study was 45 years old, one subject 46 years of age was randomized into the study.



  Outcome Measures
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1.  Primary:   Combined Incidence of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, Vulvar Intraepithelial Neoplasia (VIN), Vaginal Intraepithelial Neoplasia (VaIN), Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, AIS, and Cervical Cancer   [ Time Frame: Base Study: through Month 48 ]

2.  Primary:   Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)   [ Time Frame: Base Study: through Month 48 ]

3.  Secondary:   Combined Incidence of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Adenocarcinoma In Situ (AIS), and Cervical Cancer   [ Time Frame: Base Study: through Month 48 ]

4.  Secondary:   Combined Incidence of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer   [ Time Frame: Base Study: through Month 48 ]

5.  Other Pre-specified:   Combined Incidence of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer   [ Time Frame: Base Study: through Month 48 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


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


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00090220     History of Changes
Other Study ID Numbers: V501-019, 2004_013
Study First Received: August 25, 2004
Results First Received: October 30, 2009
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration