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: May 11, 2006 Last Updated: October 1, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
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) [ 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) [ 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) [ 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) [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 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™ [ 7 Months ]

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