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 - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00325130

Purpose

Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types 6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Condition	Intervention	Phase
Neoplasms, Glandular and Epithelial Diphtheria Tetanus Whooping Cough Meningitis	Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine Biological: Comparator: Menactra™ (Concomitant) Biological: Comparator: Adacel™ (Concomitant) Biological: Comparator: Menactra™ (Non-concomitant) Biological: Comparator: Adacel™	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V501 Given Concomitantly With Menactra™ and ADACEL™ in Healthy Adolescents 11-17 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cough Diphtheria Meningitis Tetanus Whooping Cough

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acceptable Safety Profile [ Time Frame: 15 days post injection ] [ Designated as safety issue: No ]

Enrollment:	1042
Study Start Date:	April 2006
Study Completion Date:	May 2008
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Concomitant Administration	Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6. Biological: Comparator: Menactra™ (Concomitant) A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1 Biological: Comparator: Adacel™ (Concomitant) a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
Group 2: Experimental Non-concomitant administration	Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6. Biological: Comparator: Menactra™ (Non-concomitant) A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1 Biological: Comparator: Adacel™ A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1

Arms

Assigned Interventions

Group 1: Experimental

Concomitant Administration

Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine

Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.

Biological: Comparator: Menactra™ (Concomitant)

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1

Biological: Comparator: Adacel™ (Concomitant)

a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1

Group 2: Experimental

Non-concomitant administration

Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine

Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.

Biological: Comparator: Menactra™ (Non-concomitant)

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1

Biological: Comparator: Adacel™

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Must be healthy boys or girls, 11-17 years of age
Must be a virgin with no intention of becoming sexually active during the study period
Must have been properly vaccinated against diphtheria, tetanus and pertussis

Exclusion Criteria:

Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years
Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325130

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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

Additional relevant MeSH terms:

Bacterial Infections
Neoplasms by Histologic Type
Nervous System Diseases
Whooping Cough
Central Nervous System Diseases
Diphtheria
Infection
Tetanus
Actinomycetales Infections
Gram-Negative Bacterial Infections

Meningitis
Bordetella Infections
Neoplasms
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Central Nervous System Infections
Corynebacterium Infections
Clostridium Infections
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009