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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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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™

Other Adverse Events

	Concomitant Administration	Non-concomitant Administration
Total, other (not including serious) adverse events
# participants affected	475	448
Gastrointestinal disorders
Abdominal Pain Upper * ^A # participants affected / at risk	27/520 (5.19%)	26/498 (5.22%)
General disorders
Injection Site Pain quadrivalent HPV Vaccine postvaccination 1 * ^A # participants affected / at risk	315/514 (61.28%)	228/406 (56.16%)
Injection Site Swelling HPV Vaccine postvaccination 1 * ^A # participants affected / at risk	56/514 (10.89%)	28/406 (6.90%)
Injection Site Erythema qHPV Vaccine (postvaccination 2) * ^A # participants affected / at risk	53/506 (10.47%)	61/492 (12.40%)
Injection Site Pain qHPV Vaccine (postvaccination 2) * ^A # participants affected / at risk	210/506 (41.50%)	194/492 (39.43%)
Injection Site Erythema qHPV Vaccine (postvaccination 3) * ^A # participants affected / at risk	68/503 (13.52%)	60/485 (12.37%)
Injection Site Pain qHPV Vaccine (postvaccination 3) * ^A # participants affected / at risk	253/503 (50.30%)	234/485 (48.25%)
Injection Site Swelling qHPV Vaccine (postvaccination 3) * ^A # participants affected / at risk	52/503 (10.34%)	55/485 (11.34%)
Injection Site Erythema ADACEL™ + Menactra™ * ^A # participants affected / at risk	121/514 (23.54%)	107/401 (26.68%)
Injection Site Pain ADACEL™ + Menactra™ * ^A # participants affected / at risk	421/514 (81.91%)	303/401 (75.56%)
Injection Site Swelling ADACEL™ + Menactra™ * ^A # participants affected / at risk	145/514 (28.21%)	113/401 (28.18%)
Injection Site Erythema qHPV Vaccine (post-vaccination 1) * ^A # participants affected / at risk	37/514 (7.20%)	26/406 (6.40%)
Injection Site Swelling qHPV Vaccine (post-vaccination 2) * ^A # participants affected / at risk	42/506 (8.30%)	48/492 (9.76%)
Injection Site Bruising ADACEL™ + Menactra™ * ^A # participants affected / at risk	30/514 (5.84%)	9/401 (2.24%)
Pyrexia * ^A # participants affected / at risk	45/520 (8.65%)	50/498 (10.04%)
Nervous system disorders
Headache Systemic Clinical * ^A # participants affected / at risk	113/520 (21.73%)	114/498 (22.89%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain * ^A # participants affected / at risk	26/520 (5.00%)	35/498 (7.03%)

*	Indicates events were collected by non-systematic assessment.
^A	Term from vocabulary, MedDRA 11.0

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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 & Co., Inc.
phone: 1-800-672-6372

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_092, V501-025
Study First Received:	May 11, 2006
Results First Received:	May 19, 2009
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00325130 History of Changes
Health Authority:	United States: Food and Drug Administration