NCT01148017

Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 37 Months – 63 Months
• Healthy volunteers: Accepted

Summary

The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-06-22
• Last updated: 2017-08-14
• Results posted: 2014-05-14

Locations

19 sites across 1 country: United States