Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
|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|
|Primary Completion Date :||April 2011|
|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.
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.|