Trial record 1 of 1 for:
MTA21
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
|
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: NCT00777257 |
|
Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : December 31, 2009
Last Update Posted : February 14, 2014
|
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:
The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.
Primary Objective:
To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.
Secondary Objective:
To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningitis Meningococcemia Pertussis Tetanus Diphtheria | Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1345 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine) |
| Study Start Date : | April 2005 |
| Actual Primary Completion Date : | March 2007 |
| Actual Study Completion Date : | September 2007 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Study Group A
Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
Other Names:
|
|
Experimental: Study Group B
Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later
|
Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
Other Names:
|
|
Experimental: Study Group C
Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later
|
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
Other Names:
|
Primary Outcome Measures :
- Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. [ Time Frame: Day 0 to Day 28 post-vaccination ]
- Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. [ Time Frame: Day 0 and Day 28 post-vaccination ]
- Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. [ Time Frame: Day 0 and Day 28 Post-vaccination ]
Secondary Outcome Measures :
- Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. [ Time Frame: 0 to 7 days post-vaccination ]Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.
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: | 11 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Healthy as determined by medical history and physical examination.
- Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
- Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
- Informed assent form that has been approved by the IRB signed by the subject.
- Subject (female) agrees to use measures to prevent pregnancy during the study.
Exclusion Criteria :
- Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
- Known or suspected impairment of immunologic function.
- Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
- History of documented invasive meningococcal disease or previous meningococcal vaccination.
- History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
- Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting <7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
- Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
- Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
- Suspected or known hypersensitivity to either of the two study vaccines or their components.
- Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
- Enrolled in another clinical trial.
- Diagnosed with 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.
- For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
- Nursing mothers.
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): NCT00777257
Locations
| United States, Arkansas | |
| Jonesboro, Arkansas, United States, 72401 | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Colorado | |
| Boulder, Colorado, United States, 80303 | |
| United States, Georgia | |
| Marietta, Georgia, United States, 30062 | |
| Woodstock, Georgia, United States, 30189 | |
| 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, New Mexico | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Raleigh, North Carolina, United States, 27609 | |
| Sylva, North Carolina, United States, 28779 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44308 | |
| Cleveland, Ohio, United States, 44118 | |
| Columbus, Ohio, United States, 43205 | |
| Dayton, Ohio, United States, 45404 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| Sellersville, Pennsylvania, United States, 18960 | |
| United States, Tennessee | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Washington | |
| Spokane, Washington, United States, 99202 | |
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: | NCT00777257 |
| Other Study ID Numbers: |
MTA21 |
| First Posted: | October 22, 2008 Key Record Dates |
| Results First Posted: | December 31, 2009 |
| Last Update Posted: | February 14, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
|
Meningitis Meningococcemia Pertussis |
Neisseria meningitidis Tetanus Diphtheria |
Additional relevant MeSH terms:
|
Whooping Cough Tetanus Diphtheria Meningitis Tetany Neuroinflammatory Diseases Nervous System Diseases Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Neuromuscular Manifestations Neurologic Manifestations Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Corynebacterium Infections Actinomycetales Infections |