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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00777257
First Posted: October 22, 2008
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 1345
Study Start Date: April 2005
Study Completion Date: September 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • ADACEL®
  • Menactra®
  • 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00777257     History of Changes
Other Study ID Numbers: MTA21
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: September 24, 2009
Results First Posted: December 31, 2009
Last Update Posted: February 14, 2014
Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcemia
Pertussis
Neisseria meningitidis
Tetanus
Diphtheria

Additional relevant MeSH terms:
Meningitis
Whooping Cough
Tetanus
Tetany
Diphtheria
Central Nervous System Diseases
Nervous System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs