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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00874549 |
Safety:
To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine.
Immunogenicity:
To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.
Condition | Intervention | Phase |
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Meningococcal Infections Meningococcal Meningitis |
Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Safety and Immunogenicity Evaluation of a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) and a Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in Subjects 56 Years of Age or Older |
Enrollment: | 216 |
Study Start Date: | October 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator
Participants received a single dose of Menomune® vaccine on Day 0.
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Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide
0.5 mL, Subcutaneous
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Group 2: Experimental
Participants received two single-dose injections of Menactra® vaccine on Day 0
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Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
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Group 3: Experimental
Participants received a single dose of Menactra® vaccine on Day 0 and on Day 14
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Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL. Intramuscular
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Group 4: Experimental
Participants received a single dose of Menactra® vaccine on Day 0 and on Day 28.
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Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
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Ages Eligible for Study: | 56 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Scottsdale, Arizona, United States, 85251 | |
United States, Kentucky | |
Bardstown, Kentucky, United States, 40004 | |
United States, New Mexico | |
Albuquerque, New Mexico, United States, 87108 | |
United States, Utah | |
West Jordon, Utah, United States, 84088 | |
United States, Washington | |
Seattle, Washington, United States, 98101 | |
Spokane, Washington, United States, 99202 |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Director ) |
Study ID Numbers: | MTA29 |
Study First Received: | March 31, 2009 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00874549 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Meningococcal Vaccine Menactra® Menomune® |
Bacterial Infections Central Nervous System Infections Meningococcal Infections Meningitis, Bacterial Meningitis, Meningococcal Central Nervous System Diseases |
Meningococcal Infection Diphtheria Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Bacterial Infections Central Nervous System Infections Meningococcal Infections Meningitis, Bacterial Nervous System Diseases Central Nervous System Bacterial Infections |
Meningitis, Meningococcal Central Nervous System Diseases Infection Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |