Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects

Summary

The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start

2007-09-18

Primary completion

2008-09-03

Completion

2009-01-06

Outcome

Mixed primary results

registry analysis (non-inferiority test); Nimenrix Group vs Mencevax ACWY Group; Difference in percentage 14.77 (95% CI 10.26 to 20.23) NCT00514904 ↗

registry analysis (non-inferiority test); Nimenrix Group vs Mencevax ACWY Group; p = 0.2202; Risk Ratio (RR) 3.34 (95% CI 0.56 to 20.25); Chi-squared NCT00514904 ↗

Publications

• Background Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Mencevax	Vaccine	—	Subcutaneous
Subject	Nimenrix	Vaccine	—	Intramuscular

Indications