NCT01345721

Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C 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 or Meningococcal C Conjugate Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 22 Months – 45 Months
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-05-02
• Last updated: 2018-06-18
• Results posted: 2013-10-18

Locations

11 sites across 1 country: Germany