Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
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|ClinicalTrials.gov Identifier: NCT01239043|
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : June 19, 2012
Last Update Posted : June 25, 2012
The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549).
- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination.
- To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago.
- To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.
|Condition or disease||Intervention/treatment||Phase|
|Meningitis Meningococcal Meningitis Meningococcal Infections||Biological: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide Biological: Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® Vaccine Approximately Three Years Following Initial Vaccination in Adults Who Participated in Trial MTA29|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||February 2012|
Experimental: Menomune® vaccine group
Participants received Menomune® vaccine in MTA29 (NCT00874549)
Biological: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
0.5 mL, Subcutaneous
Other Name: Menomune®
Experimental: Menactra® vaccine group
Participants received Menactra® vaccine in trial MTA29 (NCT00874549)
Biological: Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
- Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine [ Time Frame: Day 0 to Day 7 post-vaccination ]
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.
Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - > 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239043
|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 Jordan, Utah, United States, 84088|
|United States, Washington|
|Seattle, Washington, United States, 98101|
|Spokane, Washington, United States, 99202|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|