Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune® - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00269477

Purpose

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Persistence of Bactericidal Antibodies in Adolescents and Adults Aged 15 to 23 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 Meningococcal Infections

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. [ Time Frame: 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination) ] [ Designated as safety issue: No ]

Enrollment:	145
Study Start Date:	December 2005
Study Completion Date:	December 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Menactra® Vaccine Group 1 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 0.5 mL, Intramuscular Other Name: Menactra®
Experimental: Menactra® Vaccine Group 2 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 0.5 mL, Intramuscular Other Name: Menactra®
Active Comparator: Meningococcal Vaccine-naive Group 3 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 0.5 mL, Intramuscular Other Name: Menactra®
Active Comparator: Meningococcal Vaccine-naive Group 4 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 0.5 mL, Intramuscular Other Name: Menactra®

Eligibility

Ages Eligible for Study:	15 Years to 23 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 15 and 23 years (not yet 24 years).
For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study)
Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications
A negative urine pregnancy test is required for menstruating female subjects.

Exclusion Criteria:

History of documented invasive meningococcal disease.
Received any other meningococcal vaccine
Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment
Scheduled to receive any vaccination in the 28-day period after enrollment
Received systemic 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, hematologic, 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
Administration of immune globulin, other blood products, or corticosteroid within 3 months 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 or family history of Guillain-Barre 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: NCT00269477

Locations

United States, Georgia

Atlanta, Georgia, United States, 30322

Marietta, Georgia, United States, 30062
United States, Massachusetts

Woburn, Massachusetts, United States, 01801
United States, Ohio

Akron, Ohio, United States, 44308

Columbus, Ohio, United States, 43205
United States, Pennsylvania

Sellersville, Pennsylvania, United States, 18960
United States, Tennessee

Kingsport, Tennessee, United States, 37660
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:	Medical Monitor, Sanofi Pasteur Inc
ClinicalTrials.gov Identifier:	NCT00269477 History of Changes
Other Study ID Numbers:	MTA35
Study First Received:	December 22, 2005
Results First Received:	November 10, 2009
Last Updated:	December 14, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Meningitis
Meningococcal infection
Neisseria meningitidis
Menactra®
Menomune®

Additional relevant MeSH terms:

Meningitis
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases

Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012