Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
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|ClinicalTrials.gov Identifier: NCT00777257|
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : December 31, 2009
Last Update Posted : February 14, 2014
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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.
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.
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|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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
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
- 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 ]
- 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.
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|Ages Eligible for Study:||11 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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.
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
|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|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|
|Responsible Party:||Sanofi Pasteur, a Sanofi Company|
|Other Study ID Numbers:||
|First Posted:||October 22, 2008 Key Record Dates|
|Results First Posted:||December 31, 2009|
|Last Update Posted:||February 14, 2014|
|Last Verified:||January 2014|
Nervous System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections and Mycoses
Respiratory Tract Infections
Respiratory Tract Diseases
Gram-Positive Bacterial Infections
Calcium Metabolism Disorders