A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

Summary

This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.

Timeline

Start

2009-10-21

Primary completion

2011-02-22

Completion

2011-02-22

Outcome

Mixed primary results

paper were all noninferior in the concomitant group compared with the nonconcomitant group. PMID 26240207 ↗

registry analysis (superiority or other test); Concomitant Vaccination vs Non-concomitant Vaccination; p = 0.806; Difference in percentage -0.4 (95% CI -3.5 to 2.7) NCT00988884 ↗

Publications

• Results 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.
• Results 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.
• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adacel	Vaccine	0.5 ml	Intramuscular
Subject	Menactra	Vaccine	0.5 ml	Intramuscular
Subject	V503	Vaccine	0.5 ml	Intramuscular

Indications