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

This study has been completed.

Study NCT00325130 Information provided by Merck

First Received on May 11, 2006. Last Updated on April 14, 2010 History of Changes

Results First Received: May 19, 2009

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 Meningitis
Interventions:	Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine Biological: Comparator: Menactra™ (Concomitant) Biological: Comparator: Adacel™ (Concomitant) Biological: Comparator: Menactra™ (Non-concomitant) Biological: Comparator: Adacel™

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
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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
Concomitant Administration	Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Non-concomitant Administration	Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™

Participant Flow: Overall Study

	Concomitant Administration	Non-concomitant Administration
STARTED	518	524
COMPLETED	499	494
NOT COMPLETED	19	30
Lost to Follow-up	6	14
Withdrawal by Subject	12	14
Protocol Deviation	0	1
Moved	0	1
Patient Discontinued for Other	1	0

Baseline Characteristics

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Reporting Groups

	Description
Concomitant Administration	Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Non-concomitant Administration	Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™

Baseline Measures

	Concomitant Administration	Non-concomitant Administration	Total
Number of Participants [units: participants]	518	524	1042
Age [units: years] Mean ± Standard Deviation	12.5 ± 1.84	12.7 ± 1.90	12.6 ± 1.88
Age, Customized [units: participants]
9 Years of Age and Under	0	0	0
10 to 17 Years of Age	518	524	1042
Over 17 Years of Age	0	0	0
Gender [units: participants]
Female	308	340	648
Male	210	184	394
Race/Ethnicity [units: participants]
Asian	5	7	12
Black	54	74	128
Hispanic American	42	29	71
Indian	1	1	2
Multi-Racial	9	6	15
Native American	1	3	4
White	406	404	810

Outcome Measures

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1. Primary:

Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) [ Time Frame: 7 Months ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months) [ Time Frame: 7 Months ]

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5. Primary:

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™ [ Time Frame: 7 Months ]

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6. Primary:

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™ [ Time Frame: 7 Months ]

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7. Primary:

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™ [ Time Frame: 7 Months ]

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8. Primary:

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™ [ Time Frame: 7 Months ]

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9. Primary:

Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ]

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10. Primary:

Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ]

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11. Primary:

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

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12. Primary:

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

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13. Primary:

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

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14. Primary:

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

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15. Primary:

Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ]

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16. Primary:

Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ]

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17. Primary:

Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ]

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18. Primary:

Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ]

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19. Secondary:

Acceptable Safety Profile [ Time Frame: 15 days post injection ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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
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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:	NCT00325130 History of Changes
Other Study ID Numbers:	2005_092, V501-025
Study First Received:	May 11, 2006
Results First Received:	May 19, 2009
Last Updated:	April 14, 2010
Health Authority:	United States: Food and Drug Administration