Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune® - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00258856

Purpose

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.

Condition	Intervention	Phase
Meningitis Meningococcal Infection	Biological: Polysaccharide Diphtheria Conjugate Vaccine	Phase II

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Meningitis

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. [ Time Frame: 7 or 14 days post-vaccination ] [ Designated as safety issue: No ]

Enrollment:	487
Study Start Date:	January 2006
Study Completion Date:	November 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Menactra® Group 1: Experimental	Biological: Polysaccharide Diphtheria Conjugate Vaccine 0.5 mL, Intramuscular
Menactra® Group 2: Experimental	Biological: Polysaccharide Diphtheria Conjugate Vaccine 0.5 mL, Intramuscular
Meningococcal Vaccine-naïve Group 3: Experimental	Biological: Polysaccharide Diphtheria Conjugate Vaccine 0.5 mL, Intramuscular
Meningococcal Vaccine-naïve Group 4: Experimental	Biological: Polysaccharide Diphtheria Conjugate Vaccine 0.5 mL, Intramuscular

Eligibility

Ages Eligible for Study:	7 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject is healthy, as determined by medical history.
Subject is between the ages of 7 and 15 years (not yet 16 years).
For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
A negative urine pregnancy test is required for menstruating female subjects.
Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.

Exclusion Criteria:

Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
History of documented invasive meningococcal disease
Received any other meningococcal vaccine
Received any vaccine in the 28-day period prior to enrollment
Received antibiotic therapy within the 72 hours prior to collection of a blood sample
Actively enrolled or scheduled to be enrolled in another clinical study
Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment
Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Personal of family history of Guillain-Barres Syndrome
Suspected or known hypersensitivity to any of the vaccine components
Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
Any condition which, in the opinion of the investigator, would pose a health risk to the participant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258856

Locations

United States, Arkansas

Jonesboro, Arkansas, United States, 72401

Little Rock, Arkansas, United States, 72205
United States, Georgia

Marietta, Georgia, United States, 30062
United States, Maryland

Baltimore, Maryland, United States, 21201-1559
United States, Massachusetts

Woburn, Massachusetts, United States, 01801
United States, Missouri

Bridgeton, Missouri, United States, 63044
United States, New York

Rochester, New York, United States, 14620
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15241

Sellersville, Pennsylvania, United States, 18960
United States, Utah

Salt Lake City, Utah, United States, 84123
United States, Virginia

Norfolk, Virginia, United States, 23510

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

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 Monitor )
Study ID Numbers:	MTA23
Study First Received:	November 24, 2005
Results First Received:	October 19, 2009
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00258856 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Meningitis
Meningococcal infection
Neisseria meningitidis
Menactra®
Menomune®

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
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 November 27, 2009