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

• Conditions: The primary objective of this phase 3b study is to evaluate the persistence ofbactericidal antibodies in children of approximately 22 to 45 months of age previouslyenrolled in the V59P22 study who received Novartis MenACWY Conjugate Vaccine orMeningococcal C Conjugate Vaccine.; MedDRA version: 12.1Level: LLTClassification code 10027202Term: Meningitis bacterial

• Registration Number: EUCTR2010-023858-37-DE
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children eligible to be enrolled in the study are those whose parents provide written
informed consent, and are in generally good health based on the clinical judgment of the investigators. Subjects must be 22-45 months of age at the time of enrollment into V59P22E1 and have participated in the original V59P22 study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serious, acute, or chronic illnesses are reasons for exclusion. Non-standard exclusion
criteria include the following:
? Subjects who have received any vaccine (excluding influenza vaccines) 28 days
preceding enrollment visit. Influenza vaccines are excluded for the 14 days prior to
the enrollment visit.
? Subjects who have received any Meningococcal vaccine since the study dose of
MenACWY or Men C at 12 months of age in V59P22 trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified