Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

Summary

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Timeline

Start

2007-04-23

Primary completion

2007-10-31

Completion

2008-04-11

Outcome

Mixed primary results

registry analysis (superiority test); Nimenrix 11-25Y Group vs Menactra Group; Difference in percentage 11.2 (95% CI 3.87 to 19.18) NCT00454909 ↗

registry analysis (superiority test); Nimenrix 11-25Y Group vs Menactra Group; Difference in percentage -2.77 (95% CI -5.08 to 0.40) NCT00454909 ↗

Publications

• Background Baxter R, Baine Y, Ensor K, Bianco V, Friedland LR, Miller JM. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age. Pediatr Infect Dis J. 2011 Mar;30(3):e41-8. doi: 10.1097/INF.0b013e3182054ab9.
• Background Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Menactra	Vaccine	—	Intramuscular
Subject	Meningococcal vaccine 134612	Vaccine	—	Intramuscular

Indications