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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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Prevention
Condition: HPV 16 Infection
Interventions: Biological: Comparator: HPV 16 L1 Vaccine
Biological: Comparator: Placebo

  Participant Flow


  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.
No text entered.

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.

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.

Total Total of all reporting groups

Baseline Measures
   HPV 16 L1 VLP (Group 1)   Placebo (Group 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 1204   1205   2409 
Age 
[Units: Years]
Mean (Full Range)
 20.0 
 (16 to 25) 
 20.1 
 (16 to 23) 
 20.1 
 (16 to 25) 
Gender 
[Units: Participants]
     
Female   1204   1205   2409 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   69   73   142 
Black   94   114   208 
Hispanic American   89   93   182 
Native American   9   14   23 
White   918   889   1807 
Other   25   22   47 


  Outcome Measures
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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