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 (V501-025)(COMPLETED) - Full Text View

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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: Boostrix Adacel Meningococcal Vaccines Human Papillomaviruses

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:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 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. Other Name: Gardasil 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
Experimental: Group 2 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. Other Name: Gardasil 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

Experimental: Group 1

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.

Other Name: Gardasil

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

Experimental: Group 2

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.

Other Name: Gardasil

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:	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:	March 27, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Diphtheria
Meningitis
Neoplasms, Glandular and Epithelial
Tetanus
Tetany
Whooping Cough
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

Neoplasms by Histologic Type
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013