Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

This study has been completed.

Sponsor:

Collaborator:

Novartis Vaccines

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00310817

First received: April 3, 2006

Last updated: April 16, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2006

Last Updated Date

April 16, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Immune response as measured by serum bactericidal activity of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine at 28 days following immunization
Persistence of functional immune response at 6 or 12 months following administration as measured by GMTs and seroconversion

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00310817 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The booster effect 21 days after a second dose of either Men ACWY Ad+ or Men ACWY Ad- administered at 6 or 12 months after the first dose. Safety and tolerability.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Official Title ^ICMJE

A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Brief Summary

To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Meningococcal Meningitis

Intervention ^ICMJE

Biological: Men ACWY conjugate vaccine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

621

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy 12-<60 month old children;

Exclusion Criteria:

who have previously received any meningococcal vaccine
subjects with any serious acute or chronic progressive disease

Gender

Both

Ages

1 Year to 5 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland, Poland

Administrative Information

NCT Number ^ICMJE

NCT00310817

Other Study ID Numbers ^ICMJE

V59P7, EUDRACT NUMBER:2004-001896-21

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Chair:

Novartis Vaccines - Drug Information Services

Novartis

Information Provided By

Novartis

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top