Persistence of Antibody Response to N. Meningitidis Group C in Children

Phase 4CompletedNCT00316654

Novartis Vaccines489 enrolled

Overview

Persistence of Antibody Response to N. meningitidis Group C in Children

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

489

Conditions

Prevention of Meningococcal Infection

Interventions

Meningococcal C conjugate vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 7 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy children Exclusion Criteria: * previous ascertained or suspected disease caused by N. meningitidis * previous significant acute or chronic infections * any other serious disease

Locations (2)

Unnamed facility

Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland

Unnamed facility

Valencia, Spain

Outcomes

Primary Outcomes

Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

Secondary Outcomes

Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity

safety and tolerability

Data from ClinicalTrials.gov

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