Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
NCT ID: NCT00337428
Last Updated: 2016-11-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
843 participants
INTERVENTIONAL
2006-05-31
2007-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Concomitant/CMF
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: REPEVAX™ (Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
Group 2
Non-Concomitant/CMF
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: REPEVAX™ (Non-Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
Group 3
Concomitant/FMF
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: REPEVAX™ (Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
Group 4
Non-Concomitant/FMF
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: REPEVAX™ (Non-Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
GARDASIL™ (quadrivalent human papillomavirus \[types 6, 11, 16, 18\] virus-like particle \[VLP\] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: REPEVAX™ (Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
Comparator: REPEVAX™ (Non-Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis \[acellular, component\] and poliomyelitis \[inactivated\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be a virgin with no intention of becoming sexually active during the study period
* Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio
Exclusion Criteria
* Must not have received any prior human papillomavirus (HPV) vaccine
11 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Vesikari T, Van Damme P, Lindblad N, Pfletschinger U, Radley D, Ryan D, Vuocolo S, Haupt RM, Guris D. An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age. Pediatr Infect Dis J. 2010 Apr;29(4):314-8. doi: 10.1097/INF.0b013e3181c177fb.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005_093
Identifier Type: -
Identifier Source: secondary_id
V501-024
Identifier Type: -
Identifier Source: org_study_id