Immunogenicity and Safety of Men ACWY in Infants (6 & 12 Months)

This study has been completed.

First Received: April 3, 2006 Last Updated: April 16, 2008 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310856

Purpose

To assess the immunogenicity of Chiron Men ACWY conjugate vaccine (Men ACWY) when administered as a two-dose schedule at 6 and 12 months of age.

Condition	Intervention	Phase
Meningococcal Meningitis	Biological: Meningococcal ACWY conjugate vaccine	Phase II

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of a Commercially Available Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children

Further study details as provided by Novartis:

Primary Outcome Measures:

immunogenicity as measured by serum bactericidal activity and GMTs when administered at 6 and 12 months of age.

Secondary Outcome Measures:

booster response of C component of the vaccine when administered at 18 months of age, after second immunization at 12 months, as measured serum bactericidal activity and GMTs. Safety and tolerability.

Estimated Enrollment:	175
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	6 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy infants 6 months of age who previously received two doses of both heptavalent conjugate pneumococcal and DTaP-Hib-IPV vaccines
healthy subjects 12 months of age who previously received 3 doses of DTaP-Hib-IPV vaccine

Exclusion Criteria:

Subjects who previously received any meningococcal vaccine
Subjects with any serious, acute or chronic progressive disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310856

Locations

Canada
Clinical Trials Research Center, Department of Pediatrics, Dalhousie University IWK Health Center
Halifax, Canada, B3K 6R8
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Canada
Canada, Ontario
Herridge Community Health Clinic
Ottawa, Ontario, Canada

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	V59P9
Study First Received:	April 3, 2006
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00310856 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Novartis:

meningitis
children
vaccine

Study placed in the following topic categories:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases

Meningococcal Infection
Healthy
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Nervous System Diseases
Central Nervous System Bacterial Infections

Meningitis, Meningococcal
Central Nervous System Diseases
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

ClinicalTrials.gov processed this record on May 07, 2009