Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00269477
First received: December 22, 2005
Last updated: December 14, 2009
Last verified: December 2009
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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 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: | 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:
Further study details as provided by Sanofi:
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
Investigators
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
More Information
Additional Information:
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:
|
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 May 16, 2013