Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00777257

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 IV

MedlinePlus related topics: Diphtheria Meningitis Tetanus Whooping Cough

Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine Tetanus Vaccine Meningococcal Vaccines Sodium chloride Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
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)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning immune response of Menactra® after concomitant vaccination with Tdap. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To provide information concerning the safety after concomitant administration of Menactra® with Tdap. [ Time Frame: 28 days post-vaccination and entire study period ] [ Designated as safety issue: Yes ]

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
A: Experimental Tdap vaccine + placebo concomitantly and 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
B: Experimental Tdap vaccine + Menactra vaccine concomitantly and 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
C: Experimental Menactra vaccine + placebo concomitantly and 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

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Healthy as determined by medical history and physical examination.
Aged >=11 to <18 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777257

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72205

Jonesboro, Arkansas, United States, 72401
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

Dayton, Ohio, United States, 45404

Akron, Ohio, United States, 44308

Columbus, Ohio, United States, 43205

Cleveland, Ohio, United States, 44118
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-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	MTA21
Study First Received:	October 21, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00777257
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Meningitis
Meningococcemia
Pertussis

Neisseria meningitidis
Tetanus
Diphtheria

Study placed in the following topic categories:

Bacterial Infections
Whooping Cough
Cough
Central Nervous System Diseases
Neisseria meningitidis
Diphtheria
Tetanus
Whooping cough

Meningitis
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Meningococcemia
Respiratory Tract Infections
Respiratory Tract Diseases
Central Nervous System Infections
Clostridium Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Nervous System Diseases
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009