Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

• Conditions: ovartis Meningococcal ACWY conjugate vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis serogroups A, C, W and Y.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004903-63-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-25
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 825

Inclusion Criteria

Healthy naive male and female individuals were recruited from the local communities and
were age-matched with those who previously participated in V59P13 study.
Healthy follow-on male and female subjects who previously completed the V59P13 study
protocol and were 11 through 18 years of age inclusive at the time of the enrollment into
the V59P13 study were recruited into this extension study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 825
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

Naive individuals not eligible to be enrolled in the study were those:
? Who were unwilling or unable to give written informed assent or consent to participate in the study;
? Who had a previous or suspected disease caused by N meningitidis;
? Who had household contact with and/or intimate exposure to an individual with
culture-proven N meningitidis infection within 60 days prior to enrollment;
? Who had previously been immunized with a meningococcal vaccine or
vaccine containing meningococcal antigen(s) (licensed or investigational)
(Exception: Receipt of Outer Membrane Particle (OMP)-containing Hemophilus influenza B (Hib) vaccines was permitted);
? Who had prior military service;
? Who had received any investigational agents or vaccines within 90 days prior to
enrollment or who expected to receive an investigational agent or vaccine prior to the
completion of the study;
? Who had received any licensed vaccines within one month prior to enrollment
(Exception: Influenza vaccine may have been administered up to 15 days prior to
enrollment);
? Who had received a live viral vaccine within 60 days prior to enrollment;

Study & Design

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