Trial record 1 of 1 for:
MTA62
Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00700713 |
|
Recruitment Status :
Completed
First Posted : June 19, 2008
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
|
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants.
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningitis Meningococcemia | Biological: Meningococcal polysaccharide diphtheria toxoid conjugate | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 181 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | February 2009 |
| Actual Study Completion Date : | March 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: One-Dose Menactra Group
Participants received one dose of Menactra® in Study MTA26
|
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra® |
|
Experimental: Two-Dose Menactra Group
Participants received two doses of Menactra® in Study MTA26
|
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra® |
|
Active Comparator: Menactra vaccine-naïve Group
Participants had never received Menactra® vaccine.
|
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra® |
Primary Outcome Measures :
- Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
Other Outcome Measures:
- Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).
- Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® [ Time Frame: Day 0 up to Day 7 post-vaccination ]Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Years to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700713
Locations
| United States, Georgia | |
| Marietta, Georgia, United States, 30062 | |
| Woodstock, Georgia, United States, 30189 | |
| United States, Kentucky | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Maryland | |
| Annapolis, Maryland, United States, 21401 | |
| Frederick, Maryland, United States, 21702 | |
| United States, Massachusetts | |
| Woburn, Massachusetts, United States, 01801 | |
| United States, Pennsylvania | |
| Greenville, Pennsylvania, United States, 16125 | |
| Harleysville, Pennsylvania, United States, 19438 | |
| Pittsburgh, Pennsylvania, United States, 15227 | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| United States, Tennessee | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Utah | |
| Layton, Utah, United States, 84041 | |
| Provo, Utah, United States, 84604 | |
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00700713 |
| Other Study ID Numbers: |
MTA62 |
| First Posted: | June 19, 2008 Key Record Dates |
| Results First Posted: | February 15, 2016 |
| Last Update Posted: | February 15, 2016 |
| Last Verified: | January 2016 |
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
|
Meningitis Meningococcemia Neisseria meningitidis Menactra® |
Additional relevant MeSH terms:
|
Meningitis Central Nervous System Diseases Nervous System Diseases |