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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00337428

First received: June 14, 2006

Last updated: April 14, 2010

Last verified: April 2010

History of Changes

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.

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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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, 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
Age [units: years] Mean ± Standard Deviation	12.1 ± 1.45	12.1 ± 1.54	12.1 ± 1.50
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

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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) ]

Show Outcome Measure 1

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) ]

Show Outcome Measure 2

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) ]

Show Outcome Measure 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) ]

Show Outcome Measure 4

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™ ]

Show Outcome Measure 5

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™ ]

Show Outcome Measure 6

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™ ]

Show Outcome Measure 7

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™ ]

Show Outcome Measure 8

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™ ]

Show Outcome Measure 9

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) ]

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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) ]

Show Outcome Measure 11

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) ]

Show Outcome Measure 12

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) ]

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14. Primary:

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

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15. Primary:

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

Show Outcome Measure 15

16. Primary:

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

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17. Primary:

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

Show Outcome Measure 17

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
Safety results have been previously reported in the literature.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00337428 History of Changes
Other Study ID Numbers:	2005_093, V501-024
Study First Received:	June 14, 2006
Results First Received:	January 14, 2010
Last Updated:	April 14, 2010
Health Authority:	Denmark: Danish Medicines Agency

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