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

January 21, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1345

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
    • Colorado
      • Boulder, Colorado, United States, 80303
    • Georgia
      • Marietta, Georgia, United States, 30062
      • Woodstock, Georgia, United States, 30189
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
    • New York
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
      • Sylva, North Carolina, United States, 28779
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cleveland, Ohio, United States, 44118
      • Columbus, Ohio, United States, 43205
      • Dayton, Ohio, United States, 45404
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
      • Sellersville, Pennsylvania, United States, 18960
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Washington
      • Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Menactra®
  • ADACEL®
  • Sterile Buffered 0.9% Sodium Chloride
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:
  • Menactra®
  • Adacel®
  • Sterile Buffered 0.9% Sodium Chloride
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:
  • Menactra®
  • Adacel®
  • Sterile Buffered 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Day 0 to Day 28 post-vaccination
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
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
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.
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.
0 to 7 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 21, 2008

First Submitted That Met QC Criteria

October 21, 2008

First Posted (Estimate)

October 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

January 21, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pertussis

Clinical Trials on T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe