Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

Summary

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Timeline

Start

2007-05-02

Primary completion

2008-04-16

Completion

2008-09-10

Outcome

Mixed primary results

paper The pre-specified immunogenicity criterion for non-inferiority to Men-PS was met. PMID 21343698 ↗

paper the statistical criterion for non-inferiority between pooled treatment groups in terms of the ratio of incidences of grade 3 general symptoms was not demonstrated. PMID 21343698 ↗

Publications

• Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK134612	Vaccine	—	Intramuscular
Comparator	Mencevax™ ACWY	Vaccine	—	Subcutaneous

Indications