Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

This study has been completed.

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00262002

Purpose

The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Chiron Meningococcal ACWY Conjugate Vaccine administered to healthy infants.

Condition	Intervention	Phase
Prevention of Meningococcal Disease	Biological: Meningococcal Conjugate ACWY Vaccine	Phase II

MedlinePlus related topics: Memory

Drug Information available for: Meningococcal Vaccines

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, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity at one month following 3rd vaccination

Secondary Outcome Measures:

Immune response following 2nd immunization and memory response at 12 months of age; Safety and tolerability

Estimated Enrollment:	600
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	55 Days to 89 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy 2-month old infants born after full-term pregnancy

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: NCT00262002

Locations

Canada, British Columbia

Vancouver, British Columbia, Canada
Canada, Nova Scotia

Halifax, Nova Scotia, Canada
United Kingdom

Oxford, United Kingdom

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Director:

Novartis Vaccines

Novartis Vaccines & Diagnostics

More Information

Publications indexed to this study:

Snape MD, Perrett KP, Ford KJ, John TM, Pace D, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):173-84.

Study ID Numbers:	V59P5, 2004-000195-13
Study First Received:	December 2, 2005
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00262002
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Healthy

Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on January 16, 2009