Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Information source: Novartis
Information obtained from ClinicalTrials.gov on 2006-11-30
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningococcal Disease; Meningococcal Meningitis
Intervention: Meningococcal ACWY conjugate vaccine (Vaccine)
Phase: Phase 3
Status: Recruiting. Expecting to enroll 1000 people.
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Vaccines - Information Services, Study Chair, Affiliation: Novartis Vaccines & Diagnostics
Overall contact:
Novartis Vaccines - Information Services, Phone: +1 800 2447668, Ext: press 2
Summary
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Clinical Details
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
Study design: Interventional, Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome:
Secondary outcome:
Eligibility
Minimum age: 11 Years.
Maximum age: 25 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Vaccines - Information Services, Phone: +1 800 2447668, Ext: press 2
Genova-Pieve di Soligo-Massafra-, Ferrara- Chieti-Lanciano-Modena, Italy; Recruiting
Additional Information
Starting date:
April 2006
Last updated: September 13, 2006
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