NCT01823536

Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose

A Phase IV, Open-label, Controlled, Multi-center Study to Evaluate the 5-year Antibody Persistence Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine at 2 to 10 Years of Age and to Assess the Immune Response to a Single Dose of Novartis MenACWY Conjugate Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Accepted

Summary

In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine	Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-10-01
• Completion: 2014-06-01
• First posted: 2013-04-04
• Last updated: 2014-08-15
• Results posted: 2014-08-15

Locations

16 sites across 2 countries: United States, Ukraine