A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
NCT ID: NCT00988884
Last Updated: 2018-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1241 participants
INTERVENTIONAL
2009-10-21
2011-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Concomitant Vaccination
V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
V503
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6
Comparator: Menactra™ (Concomitant)
Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
Comparator: Adacel™ (Concomitant)
Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
Non-concomitant Vaccination
V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
V503
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6
Comparator: Menactra™ (Non-Concomitant)
Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
Comparator: Adacel™ (Non-concomitant)
Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
Interventions
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V503
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6
Comparator: Menactra™ (Concomitant)
Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
Comparator: Adacel™ (Concomitant)
Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
Comparator: Menactra™ (Non-Concomitant)
Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
Comparator: Adacel™ (Non-concomitant)
Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
Eligibility Criteria
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Inclusion Criteria
* Subject's parent/legal guardian can read, understand, and complete the vaccine report card
* Subject is not sexually active and does not plan on becoming sexually active during the study
* Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)
Exclusion Criteria
* Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
* Subject has any coagulation disorder
* Female subject is pregnant
* Subject is immunocompromised or immunodeficient
* Subject has had a splenectomy
* Subject has received immunosuppressive therapies in the prior year
* Subject has received any immune globulin product or blood-derived product in the last 3 months
* Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination
* Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial
* Subject has received a meningococcal vaccine
* Subject has a fever \>= 100F within 24 hours of vaccination
* Subject has a history of HPV
11 Years
15 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Countries
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References
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Rodrigues S, Grenha A. Activation of Macrophages: Establishing a Role for Polysaccharides in Drug Delivery Strategies Envisaging Antibacterial Therapy. Curr Pharm Des. 2015;21(33):4869-87. doi: 10.2174/1381612821666150820103910.
Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, Engel E, Huicho L, Shew M, Maansson R, Caldwell N, Luxembourg A, Ter Meulen AS. Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines. Pediatrics. 2015 Sep;136(3):e563-72. doi: 10.1542/peds.2014-4199. Epub 2015 Aug 3.
Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
Study Documents
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Document Type: CSR Synopsis
View DocumentOther Identifiers
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V503-005
Identifier Type: -
Identifier Source: secondary_id
V503-005
Identifier Type: -
Identifier Source: org_study_id