Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

Study Overview
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Brief Summary
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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. 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.

Official Title
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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)

Conditions
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Meningitis, Meningococcemia, Pertussis, Tetanus, Diphtheria

Intervention / Treatment
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* Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
* Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
* Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group A<br>Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later | Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.<br>* Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular<br>* Other names: Sterile Buffered 0.9% Sodium Chloride;|
| Experimental: Study Group B<br>Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later | Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.<br>* Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular<br>* Other names: Sterile Buffered 0.9% Sodium Chloride;|
| Experimental: Study Group C<br>Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later | Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap<br>* Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular<br>* Other names: Sterile Buffered 0.9% Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | 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. |  | Day 0 and Day 28 Post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia. | 0 to 7 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcemia, Pertussis, Neisseria meningitidis, Tetanus, Diphtheria