Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier

To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation.

No vaccine will be administered in this study.

Study Type

Observational

Enrollment (Actual)

763

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Fountain Valley, California, United States, 92708
    • Georgia
      • Marietta, Georgia, United States, 30062
      • Martinez, Georgia, United States, 30907
      • Woodstock, Georgia, United States, 30189
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • Ohio
      • Austintown, Ohio, United States, 44515
      • Cleveland, Ohio, United States, 44121
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
      • Greenville, Pennsylvania, United States, 16125
      • Harleysville, Pennsylvania, United States, 19438
      • Latrobe, Pennsylvania, United States, 15650
      • Pittsburgh, Pennsylvania, United States, 15236
      • Pittsburgh, Pennsylvania, United States, 15241
      • Sellersville, Pennsylvania, United States, 18960
      • Wexford, Pennsylvania, United States, 15090
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Washington
      • Spokane, Washington, United States, 99202
      • Spokane, Washington, United States, 99218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 27 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects that previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257); or Menomune® in Study MTA04 and age-matched meningococcal vaccine-naive controls.

Description

Inclusion Criteria :

  • For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject
  • For subjects aged < 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian
  • Subject (and parent/legal guardian if subject is < 18 years of age) able to attend the scheduled visit and comply with all trial procedures
  • For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21)
  • For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04)
  • For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy > 2 weeks
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity
  • History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically)
  • For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21
  • Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Menactra® from Previous Studies
Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21.
Biological: Menactra®
0.5 mL, Intramuscular (from a previous study)
Group 2: Menomune® from Previous Study
Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04
Biological: Menomune®
0.5 mL, Intramuscular (from a previous study)
Group 3: Control
Meningococcal vaccine-naive age matched subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Time Frame: Day 0
Day 0
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (ESTIMATE)

March 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA64

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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