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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090220
First received: August 25, 2004
Last updated: January 20, 2016
Last verified: January 2016
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
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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.
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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 
Overall Participants Analyzed 
[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) 
[1] Although the upper age limit for this study was 45 years old, one subject 46 years of age was randomized into the study.
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 


  Outcome Measures
  Show All Outcome Measures

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


  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: 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 by ClinicalTrials.gov Identifier (NCT Number):

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: January 20, 2016
Health Authority: United States: Food and Drug Administration