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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01047345
First received: January 11, 2010
Last updated: October 31, 2016
Last verified: October 2016
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   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
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Reporting Groups
  Description
9vHPV Vaccine - Base Study Blinded 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 - Base Study Blinded 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 open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
9vHPV Vaccine - Extension Study Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.

Participant Flow for 2 periods

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

Period 2:   Extension
    9vHPV Vaccine - Base Study   Placebo - Base Study   9vHPV Vaccine - Extension Study
STARTED   0   0   102 [1] 
Vaccination 4   0   0   102 
Vaccination 5   0   0   99 
Vaccination 6   0   0   95 [2] 
COMPLETED   0   0   96 
NOT COMPLETED   0   0   6 
Withdrawal by Subject                0                0                1 
Lost to Follow-up                0                0                5 
[1] Not all eligible participants elected to participate in extension
[2] 1 participant received 6th vaccination outside the context of study but completed the study.



  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
9vHPV Vaccine - Base Study Blinded 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 - Base Study Blinded 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 open-label 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 - Base Study   Placebo - Base Study   Total 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      618 100.0%      306 100.0%      924 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
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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 Any Time During Study– Base Study   [ Time Frame: Up to 7 months - 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 ]


  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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01047345     History of Changes
Other Study ID Numbers: V503-006
2010_504 ( Other Identifier: Merck Registration Number )
Study First Received: January 11, 2010
Results First Received: December 12, 2014
Last Updated: October 31, 2016