Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2015 |
End Date: | March 2016 |
Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately Four Years Earlier
The aim of this study is to provide information on the persistence of bactericidal
antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).
Objective:
- To evaluate the persistence of antibody responses (determined by serum bactericidal
assay using human complement [SBA-HC]) approximately 4 years after the administration
of a booster dose of Menactra vaccine in trial MTA77
antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).
Objective:
- To evaluate the persistence of antibody responses (determined by serum bactericidal
assay using human complement [SBA-HC]) approximately 4 years after the administration
of a booster dose of Menactra vaccine in trial MTA77
All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's
participation in the trial will be the duration of 1 visit (for enrollment and blood draw)
participation in the trial will be the duration of 1 visit (for enrollment and blood draw)
Inclusion Criteria:
- Aged ≥ 18 years on the day of inclusion
- Received booster dose of Menactra vaccine in trial MTA77
- Informed consent form has been signed and dated
- Able to attend the scheduled visit and to comply with all trial procedures.
Exclusion Criteria:
- Participation at the time of trial enrollment (or in the 4 weeks preceding trial
enrollment) in another clinical trial investigating a vaccine, drug, medical device,
or medical procedure
- Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine,
after receipt of the booster dose of Menactra vaccine administered in trial MTA77
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- 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)
- History of meningococcal infection, confirmed either clinically, serologically, or
microbiologically
- Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating
venipuncture at the discretion of the Investigator
- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily
- Current alcohol abuse or drug addiction
- Any illness that, in the opinion of the Investigator, might interfere with trial
conduct or trial results
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood
draw. (A prospective subject should not be included in the trial until 72 hours has
passed.)
- Identified as an Investigator or employee of the Investigator or trial center with
direct involvement in the proposed trial, or identified as an immediate family member
(i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
direct involvement in the proposed trial.
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