ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00943722
Recruitment Status : Active, not recruiting
First Posted : July 22, 2009
Results First Posted : January 13, 2015
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Cervical Cancers
Vulvar Cancer
Vaginal Cancer
Genital Lesions
PAP Test Abnormalities
HPV Infections
Intervention: Biological: V503

  Participant Flow

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
No text entered.

Reporting Groups
  Description
9- to 15-Year-Old Females (Lot 1) 9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9- to 15-Year-Old Females (Lot 2) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
9- to 15-Year-Old Females (Lot 3) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
9- to 15-Year-Old Males (Lot 1) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
16- to 26-Year-Old Females (Lot 1) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.

Participant Flow:   Overall Study
    9- to 15-Year-Old Females (Lot 1)   9- to 15-Year-Old Females (Lot 2)   9- to 15-Year-Old Females (Lot 3)   9- to 15-Year-Old Males (Lot 1)   16- to 26-Year-Old Females (Lot 1)
STARTED   648   643   644   669   470 
Vaccination 1   646   642   644   666   468 
Vaccination 2   637   633   638   658   462 
Vaccination 3   635   627   637   653   455 
COMPLETED   623   621   631   647   448 [1] 
NOT COMPLETED   25   22   13   22   22 
Adverse Event                0                0                0                1                0 
Lost to Follow-up                12                8                10                8                11 
Physician Decision                1                0                0                0                1 
Pregnancy                0                0                1                0                0 
Protocol Violation                0                1                0                0                2 
Withdrawal by Subject                12                13                2                13                8 
[1] Includes 4 participants for whom completion status is unknown



  Baseline Characteristics

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
9- to 15-Year-Old Females (Lot 1) 9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9- to 15-Year-Old Females (Lot 2) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
9- to 15-Year-Old Females (Lot 3) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
9- to 15-Year-Old Males (Lot 1) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
16- to 26-Year-Old Females (Lot 1) 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Total Total of all reporting groups

Baseline Measures
   9- to 15-Year-Old Females (Lot 1)   9- to 15-Year-Old Females (Lot 2)   9- to 15-Year-Old Females (Lot 3)   9- to 15-Year-Old Males (Lot 1)   16- to 26-Year-Old Females (Lot 1)   Total 
Overall Participants Analyzed 
[Units: Participants]
 648   643   644   669   470   3074 
Age, Customized 
[Units: Participants]
           
9 to 12 years   440   432   432   450   0   1754 
13 to 15 years   208   211   212   219   0   850 
16 to 26 years   0   0   0   0   470   470 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      648 100.0%      643 100.0%      644 100.0%      0   0.0%      470 100.0%      2405  78.2% 
Male      0   0.0%      0   0.0%      0   0.0%      669 100.0%      0   0.0%      669  21.8% 


  Outcome Measures

1.  Primary:   Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])   [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]

2.  Primary:   GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])   [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]

3.  Primary:   GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)   [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]

4.  Primary:   Percentage of Participants With Injection Site Adverse Experiences (AEs)   [ Time Frame: up to 5 days after any vaccination ]

5.  Primary:   Percentage of Participants With Systemic AEs   [ Time Frame: up to 15 days after any vaccination ]

6.  Primary:   Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)   [ Time Frame: up to 5 days after any vaccination ]

7.  Secondary:   Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])   [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]

8.  Secondary:   Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])   [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]

9.  Secondary:   Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)   [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943722     History of Changes
Other Study ID Numbers: V503-002
2009_611
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: December 12, 2014
Results First Posted: January 13, 2015
Last Update Posted: October 16, 2017