Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
Biological0.5 mL, Subcutaneous
Other names: Menomune®
NCT Number: NCT01239043
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).
Objectives:
* 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.
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Notify Me56 year and older
All sexes
Interventional
Phase 2
Scottsdale, Arizona, United States
Participants who were randomized and received either Menactra® or Menomune® vaccine in trial MTA29 will receive 1 dose of either Menactra® or Menomune®, respectively on Day 0 and will be followed-up for 28 days post-vaccination.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5 mL, Subcutaneous
Other names: Menomune®
0.5 mL, Intramuscular
Other names: Menactra®
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.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Sanofi
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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