Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
2 other identifiers
interventional
139
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2010
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
June 19, 2012
CompletedJune 25, 2012
June 1, 2012
5 months
November 8, 2010
May 14, 2012
June 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
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.
Day 0 to Day 7 post-vaccination
Other Outcomes (6)
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Day 0 (pre-vaccination) and Day 28 post-vaccination
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.
Day 0 (pre-vaccination) and Day 28 post-vaccination
- +3 more other outcomes
Study Arms (2)
Menomune® vaccine group
EXPERIMENTALParticipants received Menomune® vaccine in MTA29 (NCT00874549)
Menactra® vaccine group
EXPERIMENTALParticipants received Menactra® vaccine in trial MTA29 (NCT00874549)
Interventions
0.5 mL, Subcutaneous
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Received the appropriate Menactra or Menomune vaccine as assigned by randomization in Trial MTA29.
- Ambulatory and healthy, as determined by medical history.
- Informed consent form has been signed and dated.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
You may not qualify if:
- Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
- Known pregnancy, or a positive pregnancy test.
- Currently breastfeeding a child.
- History of documented invasive meningococcal disease.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Receipt of any meningococcal vaccine since participation in trial MTA29.
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.
- Previous personal history of Guillain-Barré Syndrome (GBS).
- Known systemic hypersensitivity to any of the vaccine components, latex, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
- Laboratory-confirmed thrombocytopenia, contraindicating intramuscular (IM) vaccination.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (6)
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Albuquerque, New Mexico, 87108, United States
Unknown Facility
West Jordan, Utah, 84088, United States
Unknown Facility
Seattle, Washington, 98101, United States
Unknown Facility
Spokane, Washington, 99202, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2010
First Posted
November 11, 2010
Study Start
November 1, 2010
Primary Completion
April 1, 2011
Study Completion
February 1, 2012
Last Updated
June 25, 2012
Results First Posted
June 19, 2012
Record last verified: 2012-06