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

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Brief Title

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)

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 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.

Condition

Meningitis

Intervention

T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.

Study Arms / Comparison Groups

 Study Group A
Description:  Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

1345

Start Date

April 2005

Completion Date

September 2007

Primary Completion Date

March 2007

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.
      

Gender

All

Ages

11 Years - 17 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Monitor, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00777257

Organization ID

MTA21


Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Monitor, Study Director, Sanofi Pasteur Inc.


Verification Date

January 2014