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: May 5, 2014
Last verified: May 2014
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

This study was conducted at 17 sites in Europe: 1 in Belgium, 2 in Denmark, 4 in Germany, and 10 in

Finland.

The first subject was vaccinated on 09-June-2006 and the last subject was vaccinated on 02-May-2007.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were healthy boys or girls, 11-17 years old, with 0 lifetime sexual partners, vaccinated against diphtheria, tetanus, pertussis and polio but had not received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years or any prior human papillomavirus (HPV) vaccine.

Reporting Groups
  Description
qHPV Vaccine + REPEVAX™ (Concomitant) Quadrivalent Human Papillomavirus (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
qHPV Vaccine + REPEVAX™ (Non-Concomitant) Quadrivalent Human Papillomavirus (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 [1]   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  
[1] One randomized subject was discontinued for Anorexia, a non-vaccine related condition.



  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 (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
qHPV Vaccine + REPEVAX™ (Non-Concomitant) Quadrivalent Human Papillomavirus (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  
Number of Participants  
[units: participants]
  419     424     843  
Age  
[units: years]
Mean ± Standard Deviation
  12.1  ± 1.45     12.1  ± 1.54     12.1  ± 1.50  
Age, Customized  
[units: participants]
     
9 Years of age and Under     0     0     0  
10 to 17 Years of age     419     424     843  
Over 17 Years of age     0     0     0  
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:   Number of Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

2.  Primary:   Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

3.  Primary:   Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

4.  Primary:   Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 20 mMU/mL) by Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

5.  Primary:   Number of Subjects Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥ 0.1 IU/mL) One Month Postvaccination With REPEVAX™   [ Time Frame: One month postvaccination with REPEVAX™ ]

6.  Primary:   Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination With REPEVAX™   [ Time Frame: One month postvaccination with REPEVAX™ ]

7.  Primary:   Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥ 1:8) One Month Postvaccination With REPEVAX™   [ Time Frame: one month postvaccination with REPEVAX™ ]

8.  Primary:   Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥ 1:8) One Month Postvaccination With REPEVAX™   [ Time Frame: One month postvaccination with REPEVAX™ ]

9.  Primary:   Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥ 1:8) One Month Postvaccination With REPEVAX™   [ Time Frame: one month postvaccination with REPEVAX™ ]

10.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

11.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

12.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

13.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 of qHPV   [ Time Frame: 7 Months (Week 4 Postdose 3) ]

14.  Primary:   Geometric Mean Titers (GMTs) for Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™   [ Time Frame: One month postvaccination with REPEVAX™ ]

15.  Primary:   Geometric Mean Titers (GMTs) for Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™   [ Time Frame: One month postvaccination with REPEVAX™ ]

16.  Primary:   Geometric Mean Titers (GMTs) for Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™   [ Time Frame: One month postvaccination with REPEVAX™ ]

17.  Primary:   Geometric Mean Titers (GMTs) for Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™   [ Time Frame: One month postvaccination with REPEVAX™ ]


  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: Vice President, Late Stage Development Group Leader
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: May 5, 2014
Health Authority: Denmark: Danish Medicines Agency