Clinical trial NCT00777257: Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningitis
Meningococcemia
Pertussis
Tetanus
Diphtheria
Keywords: Meningitis
Meningococcemia
Pertussis
Neisseria meningitidis
Tetanus
Diphtheria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 1345
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Day 0 to Day 28 post-vaccination
measure: Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
timeFrame: Day 0 and Day 28 post-vaccination
measure: Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
timeFrame: Day 0 and Day 28 Post-vaccination
Secondary outcomes:
measure: 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.
timeFrame: 0 to 7 days post-vaccination
Other outcomes:
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Boulder
country: United States
state: Colorado
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Woburn
country: United States
state: Massachusetts
city: Albuquerque
country: United States
state: New Mexico
city: Syracuse
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Sylva
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: