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

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ClinicalTrials.gov Identifier: NCT00862277
Recruitment Status : Completed
First Posted : March 16, 2009
Results First Posted : January 13, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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

Condition or disease Intervention/treatment
Meningococcal Infections Meningitis Biological: Menactra® Biological: Menomune®

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.


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Study Type : Observational
Actual Enrollment : 763 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier
Study Start Date : December 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : December 2009


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



Primary Outcome Measures :
  1. 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 ]
  2. Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment [ Time Frame: Day 0 ]


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Ages Eligible for Study:   14 Years to 27 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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)

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): NCT00862277


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Fountain Valley, California, United States, 92708
United States, Georgia
Marietta, Georgia, United States, 30062
Martinez, Georgia, United States, 30907
Woodstock, Georgia, United States, 30189
United States, Kentucky
Bardstown, Kentucky, United States, 40004
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Ohio
Austintown, Ohio, United States, 44515
Cleveland, Ohio, United States, 44121
United States, 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
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Washington
Spokane, Washington, United States, 99202
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00862277     History of Changes
Other Study ID Numbers: MTA64
First Posted: March 16, 2009    Key Record Dates
Results First Posted: January 13, 2011
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Menactra®
Menomune®
Meningitis
Meningococcal Infections
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs