Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00700713
First received: May 7, 2008
Last updated: September 2, 2010
Last verified: September 2010
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Purpose
Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers.
Objectives:
- To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26.
- To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects.
- To describe the safety profile of a single dose of Menactra® vaccine in subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis Meningococcemia |
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate |
Phase 2 |
| 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: | Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® (Meningococcal [Groups A, C, Y, and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Three Years Earlier in Study MTA26 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the immune response to Menactra® after booster vaccination. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 181 |
| Study Start Date: | June 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Participants received one dose of Menactra® in MTA26
|
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra®
|
|
Experimental: Group 2
Participants received two doses of Menactra® in MTA26
|
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra®
|
|
Active Comparator: Group 3
Menactra® vaccine-naïve participants
|
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra®
|
Eligibility| Ages Eligible for Study: | 3 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received
- At 3 to < 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine).
- Informed consent form signed and dated by the parent(s) or another legally acceptable representative.
- Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures.
Exclusion Criteria :
- Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first study vaccination
- Planned participation in another clinical trial during the present trial period.
- 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.
- Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or to a product containing any of the substances present in the study vaccine.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- Received blood or blood-derived products in the past 3 months.
- Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first study vaccination.
- Planned receipt of any vaccine within the 4 weeks following the study vaccination.
- Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
- History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
- Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
- Personal or family history of Guillain-Barré Syndrome (GBS).
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700713
Locations
| United States, Georgia | |
| Marietta, Georgia, United States, 30062 | |
| United States, Kentucky | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Woburn, Massachusetts, United States, 01801 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| Sellersville, Pennsylvania, United States, 18960 | |
| United States, Tennessee | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Utah | |
| Bountiful, Utah, United States, 84010 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
More Information
Additional Information:
Related Info 
Related Info 
No publications provided
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00700713 History of Changes |
| Other Study ID Numbers: | MTA62 |
| Study First Received: | May 7, 2008 |
| Last Updated: | September 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Meningitis Meningococcemia Neisseria meningitidis Menactra® |
Additional relevant MeSH terms:
|
Meningitis Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases |
Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013