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Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier

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ClinicalTrials.gov Identifier: NCT02633787
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : November 6, 2016
Last Update Posted : November 6, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

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 a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77

Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Meningitis Meningococcal Infections Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Phase 4

Detailed Description:
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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately Four Years Earlier
Study Start Date : December 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Group
Participants received a booster dose of Menactra vaccine approximately four years earlier
 Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be administered in this trial
Other Name: Menactra®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. [ Time Frame: Pre-booster vaccination, 28 days, and 4 years post-booster vaccination ]
    Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.

  2. Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination [ Time Frame: Pre-booster vaccination, 28 days and 4 years post-booster vaccination ]
    Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.

  3. Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination [ Time Frame: Pre-booster, 28 Days and 4 years post-booster vaccination ]
    Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02633787


Locations
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United States, Kentucky
Bardstown, Kentucky, United States, 40004
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, Michigan
Niles, Michigan, United States, 49120
United States, Utah
Layton, Utah, United States, 84041
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02633787    
Other Study ID Numbers: MTA00093
U1111-1161-3151 ( Other Identifier: WHO )
First Posted: December 17, 2015    Key Record Dates
Results First Posted: November 6, 2016
Last Update Posted: November 6, 2016
Last Verified: September 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
Meningococcal Infections
Menactra®
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
 Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections