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

July 21, 2017 updated by: Novartis Vaccines

A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

489

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland
  • Spain
      • Valencia, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Novartis Vaccines Drug Information Services, Novartis Vaccines & Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

April 19, 2006

First Submitted That Met QC Criteria

April 19, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V14P38E1
  • 2004-001522-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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