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Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00365378
First received: August 16, 2006
Last updated: October 22, 2015
Last verified: October 2015
Results First Received: March 22, 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: HPV 16 Infection
Interventions: Biological: Comparator: HPV 16 L1 Vaccine
Biological: Comparator: Placebo

  Participant Flow
  Hide Participant Flow

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
HPV 16 L1 VLP (Group 1)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)

Placebo (Group 2)

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)

Extension This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.

Participant Flow for 3 periods

Period 1:   Vaccination (Day 1 to Month 7)
    HPV 16 L1 VLP (Group 1)   Placebo (Group 2)   Extension
STARTED   1204   1205   0 
Entered Vaccination Period   1193   1198   0 
COMPLETED   993   1038   0 
NOT COMPLETED   211   167   0 
Randomized Not Vaccinated                11                7                0 
Adverse Event                4                5                0 
Lost to Follow-up                88                75                0 
Pregnancy                19                14                0 
Protocol Violation                22                13                0 
Withdrawal by Subject                50                44                0 
Unspecified                17                9                0 

Period 2:   Follow-up (Month 7 Though Month 48)
    HPV 16 L1 VLP (Group 1)   Placebo (Group 2)   Extension
STARTED   993   1038   0 
COMPLETED   835   836   0 
NOT COMPLETED   158   202   0 
Moved                6                5                0 
Lost to Follow-up                67                69                0 
Pregnancy                0                1                0 
Protocol Violation                1                2                0 
Withdrawal by Subject                73                104                0 
Unspecified                11                21                0 

Period 3:   Extension
    HPV 16 L1 VLP (Group 1)   Placebo (Group 2)   Extension
STARTED   0   0   400 
COMPLETED   0   0   203 
NOT COMPLETED   0   0   197 
Adverse Event                0                0                1 
Moved                0                0                8 
Lost to Follow-up                0                0                57 
Protocol Violation                0                0                2 
Withdrawal by Subject                0                0                98 
Unspecified                0                0                31 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Persistent HPV 16 Infection   [ Time Frame: Through Month 48 ]

2.  Primary:   Incidence of HPV 16-related CIN1, CIN2 or C1N3   [ Time Frame: Through Month 48 ]

3.  Primary:   Serum Anti-HPV 16 Geometric Mean Titers   [ Time Frame: Month 7 ]


  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
Of note, the number of subjects reported in the results posting is slightly different than that specified in the publication by Koutsky, et al (2002). The data provided here is based on final data.


  More Information