Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

Summary

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start

2007-06-05

Primary completion

2008-02-26

Completion

2008-03-26

Publications

• Background Vesikari T, Karvonen A, Bianco V, Van der Wielen M, Miller J. Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial. Vaccine. 2011 Jun 6;29(25):4274-84. doi: 10.1016/j.vaccine.2011.03.043. Epub 2011 Apr 6.
• Background Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.

Drugs

Indications