An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00496626
First received: July 3, 2007
Last updated: October 15, 2013
Last verified: October 2013
Results First Received: February 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Papillomavirus Infections
Interventions: Biological: Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)
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
No text entered.

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
Vaccine (Gardasil®) Group Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Placebo Group Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Participant Flow:   Overall Study
    Vaccine (Gardasil®) Group     Placebo Group  
STARTED     302     298  
COMPLETED     296     292  
NOT COMPLETED     6     6  
Lost to Follow-up                 0                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 5                 4  
Relocated                 0                 1  



  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
Vaccine (Gardasil®) Group Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Placebo Group Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Total Total of all reporting groups

Baseline Measures
    Vaccine (Gardasil®) Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  302     298     600  
Age  
[units: years]
Mean ± Standard Deviation
  24.5  ± 10.9     24.8  ± 11.0     24.6  ± 10.9  
Age, Customized  
[units: Participants]
     
9-15 Years of Age     101     99     200  
16-26 Years of Age     76     74     150  
27-34 Years of Age     63     62     125  
35-45 Years of Age     62     63     125  
Gender  
[units: Participants]
     
Female     251     249     500  
Male     51     49     100  
Body Temperature  
[units: Degrees Celsius]
Mean ± Standard Deviation
  36.5  ± 0.31     36.5  ± 0.31     36.5  ± 0.31  
Pulse  
[units: Beats per minute (BPM)]
Mean ± Standard Deviation
  74.4  ± 11.9     74.6  ± 11.2     74.5  ± 11.2  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)   [ Time Frame: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7 ]

2.  Secondary:   Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7   [ Time Frame: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7 ]

3.  Secondary:   Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination   [ Time Frame: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination ]


  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: 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: NCT00496626     History of Changes
Obsolete Identifiers: NCT00926822
Other Study ID Numbers: V501-030, 2007_021
Study First Received: July 3, 2007
Results First Received: February 8, 2010
Last Updated: October 15, 2013
Health Authority: China: Food and Drug Administration