Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

This study has been completed.

First Received: May 23, 2006 Last Updated: January 31, 2008 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00329901

Purpose

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Condition	Intervention	Phase
Meningococcal Disease Meningococcal Meningitis	Biological: Meningococcal ACWY conjugate vaccine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, Or One Dose of Chiron Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years

Resource links provided by NLM:

MedlinePlus related topics: Childhood Immunization Meningitis Whooping Cough

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity as measured by ELISA at one month following immunization (Tdap vaccine)
Local and systemic reactions during period day 1-day 7 after vaccination
Adverse events day 1-day 29
medically significant AEs day 30-day 180

Secondary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity at one month following immunization. Safety and Tolerability.
Safety and tolerability.

Estimated Enrollment:	1000
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	11 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy subjects aged 11-25 years

Exclusion Criteria:

previous ascertained or suspected disease caused by N. meningitidis
previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
serious acute, chronic or progressive disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329901

Locations

Italy
Genova-Pieve di Soligo-Massafra-
Ferrara- Chieti-Lanciano-Modena, Italy

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines - Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	V59P11, Eudract Number: 2005-005519-12
Study First Received:	May 23, 2006
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00329901 History of Changes
Health Authority:	United States: Food and Drug Administration; Italy: Ministry of Health

Keywords provided by Novartis:

Meningitis
healthy subject
vaccine

Study placed in the following topic categories:

Bacterial Infections
Meningitis, Bacterial
Meningitis, Meningococcal
Whooping Cough
Central Nervous System Diseases
Healthy
Diphtheria

Meningococcal Infection
Tetanus
Meningitis
Gram-Negative Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Neisseriaceae Infections

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 July 02, 2009