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

Tracking Information

First Received Date ^ICMJE

May 23, 2006

Last Updated Date

January 31, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00329901 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Meningococcal Disease
Meningococcal Meningitis

Intervention ^ICMJE

Biological: Meningococcal ACWY conjugate vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

11 Years to 25 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00329901

Responsible Party

Study ID Numbers ^ICMJE

V59P11, Eudract Number: 2005-005519-12

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Chair:

Novartis Vaccines - Information Services

Novartis Vaccines & Diagnostics

Information Provided By

Novartis

Verification Date

January 2007

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