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A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

Meningococcal Disease Clinical Trial

Official title:
A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

Clinical Trial Summary

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Clinical Trial Description

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01018732
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date January 2010
Completion date July 2010
View Details
See also
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