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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00862277

Purpose

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	Phase
Meningococcal Infections Meningitis	Phase IV

Study Type:	Observational
Study Design:	Case Control, 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

Resource links provided by NLM:

MedlinePlus related topics: Meningitis

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of Menactra® [ Time Frame: Clinic Visit Day 1 (4-8 years post-vaccination) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Group 1 (Case) Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21.
Group 2 (Case Comparison) Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04
Group 3 (Control) Meningococcal vaccine-naive age matched subjects

Detailed Description:

Subjects who received one dose of Menactra or Menomune in study MTA04, MTA19, MTA12, or MTA21 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.

Eligibility

Ages Eligible for Study:	14 Years to 27 Years
Genders Eligible for Study:	Both
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, or MTA21; 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862277

Locations

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

Woodstock, Georgia, United States, 30189

Martinez, Georgia, United States, 30907
United States, Kentucky

Bardstown, Kentucky, United States, 40004
United States, Nebraska

Omaha, Nebraska, United States, 68131
United States, North Carolina

Sylva, North Carolina, United States, 28779
United States, Ohio

Austintown, Ohio, United States, 44515

Cleveland, Ohio, United States, 44121
United States, Pennsylvania

Sellersville, Pennsylvania, United States, 18960

Pittsburgh, Pennsylvania, United States, 15241

Wexford, Pennsylvania, United States, 15090

Erie, Pennsylvania, United States, 16505

Uniontown, Pennsylvania, United States, 15401

Latrobe, Pennsylvania, United States, 15650

Pittsburgh, Pennsylvania, United States, 15236

Pittsburgh, Pennsylvania, United States, 15217

Pittsburgh, Pennsylvania, United States, 15227

Greenville, Pennsylvania, United States, 16125

Harleysville, Pennsylvania, United States, 19438
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-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:	MTA64
Study First Received:	March 13, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00862277 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Menactra®
Menomune®
Meningitis
Meningococcal Infections

Study placed in the following topic categories:

Bacterial Infections
Antibodies
Central Nervous System Infections
Meningococcal Infections
Central Nervous System Diseases

Meningococcal Infection
Immunoglobulins
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Nervous System Diseases
Central Nervous System Diseases

Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

ClinicalTrials.gov processed this record on September 11, 2009