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Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337428
First received: June 14, 2006
Last updated: September 27, 2016
Last verified: September 2016
Results First Received: January 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Neoplasms, Glandular and Epithelial
Diphtheria
Tetanus
Whooping Cough
Poliomyelitis
Interventions: Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
Biological: Comparator: REPEVAX™ (Concomitant)
Biological: Comparator: REPEVAX™ (Non-Concomitant)

  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
The study enrolled healthy participants, 11-17 years old, with 0 lifetime sexual partners, vaccinated against diphtheria, tetanus, pertussis and polio but had not received the vaccine in the past 5 years or any prior human papillomavirus (HPV) vaccine. Additional inclusion and exclusion criteria applied.

Reporting Groups
  Description
qHPV Vaccine + REPEVAX™ (Concomitant) Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
qHPV Vaccine + REPEVAX™ (Non-Concomitant) Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.

Participant Flow:   Overall Study
    qHPV Vaccine + REPEVAX™ (Concomitant)   qHPV Vaccine + REPEVAX™ (Non-Concomitant)
STARTED   419   424 
COMPLETED   415   421 
NOT COMPLETED   4   3 
Withdrawal by Subject                1                2 
Lack of Time                1                1 
Unwilling to Continue                1                0 
Anorexia                1                0 



  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
qHPV Vaccine + REPEVAX™ (Concomitant) Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
qHPV Vaccine + REPEVAX™ (Non-Concomitant) Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
Total Total of all reporting groups

Baseline Measures
   qHPV Vaccine + REPEVAX™ (Concomitant)   qHPV Vaccine + REPEVAX™ (Non-Concomitant)   Total 
Overall Participants Analyzed 
[Units: Participants]
 419   424   843 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.1  (1.5)   12.1  (1.5)   12.1  (1.5) 
Gender 
[Units: Participants]
     
Female   295   288   583 
Male   124   136   260 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   1   3   4 
Black   3   3   6 
Multi-racial   2   3   5 
White   413   415   828 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

2.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

3.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

4.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

5.  Primary:   Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

6.  Primary:   Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

7.  Primary:   Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

8.  Primary:   Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)   [ Time Frame: Up to 7 Months (4 Weeks Postdose 3) ]

9.  Primary:   Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

10.  Primary:   Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

11.  Primary:   Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

12.  Primary:   Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

13.  Primary:   Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

14.  Primary:   Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

15.  Primary:   Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

16.  Primary:   Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]

17.  Primary:   Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™   [ Time Frame: Up to 1 Month (1 Month Postdose 1) ]


  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
Safety results have been previously reported in the literature.


  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: NCT00337428     History of Changes
Other Study ID Numbers: V501-024
2005_093
Study First Received: June 14, 2006
Results First Received: January 14, 2010
Last Updated: September 27, 2016
Health Authority: Denmark: Danish Medicines Agency