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 - Tabular View

Tracking Information

First Received Date ^ICMJE

May 11, 2006

Last Updated Date

October 1, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Comparable (non-inferior) immunogenicity for all vaccine components

Change History

Complete list of historical versions of study NCT00325130 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Acceptable safety profile

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Neoplasms, Glandular and Epithelial
Diphtheria
Tetanus
Whooping Cough
Meningitis

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Experimental: Concomitant Administration
Experimental: Non-concomitant administration

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1042

Completion Date

May 2008

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

11 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00325130

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_092, V501-025

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP