Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00777257
First received: October 21, 2008
Last updated: December 1, 2009
Last verified: December 2009
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Purpose
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 | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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) |
Resource links provided by NLM:
Drug Information available for:
Sodium chloride
Chlorine
Diphtheria vaccine
Boostrix
Adacel
Meningococcal Vaccines
U.S. FDA Resources
Further study details as provided by Sanofi:
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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 1345 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 11 Years to 17 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
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: | NCT00777257 History of Changes |
| Other Study ID Numbers: | MTA21 |
| Study First Received: | October 21, 2008 |
| Results First Received: | September 24, 2009 |
| Last Updated: | December 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Meningitis Meningococcemia Pertussis |
Neisseria meningitidis Tetanus Diphtheria |
Additional relevant MeSH terms:
|
Diphtheria Meningitis Whooping Cough Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases |
Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013