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

• Conditions: Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Prophylaxis for Neisseria meningitidis serogroup A, C,W-135, and Y.

• Registration Number: EUCTR2014-005133-30-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines & Diagnostics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-05
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 500

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.
•Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study.
•Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.

Are the trial subjects under 18? yes
Number of subjects for this age range: 500
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.
•Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
•Subjects who have received any meningococcal vaccine since birth (Groups 3 & 4 -naive) or last study dose in V59P14 trial (Groups 1 & 2 - follow on).

Study & Design

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