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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00772629 |
This study was designed to generate data for the assessment of Menactra vaccine when given to adults aged 18 to 55 years.
Primary Objective:
To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the administration of one dose of the investigational Menactra vaccine, as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups.
Condition | Intervention | Phase |
---|---|---|
Meningitis Meningococcemia |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults Who Were Either Previously Vaccinated With Unconjugated Meningococcal Polysaccharide (Serogroups A, C or Serogroups A, C, Y, and W-135) Vaccine or Not Vaccinated With Meningococcal Vaccine |
Enrollment: | 18 |
Study Start Date: | January 2004 |
Study Completion Date: | April 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Subjects naïve to any meningococcal vaccination
|
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
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2: Experimental
Subjects who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135)
|
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | MTA16 |
Study First Received: | October 13, 2008 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00772629 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Meningitis Meningococcemia Neisseria meningitidis |
Antibodies Meningococcemia Central Nervous System Infections Central Nervous System Diseases |
Neisseria meningitidis Healthy Immunoglobulins Meningitis |
Nervous System Diseases |