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Trial record 1 of 1 for:    MTA43
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Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

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.
 
ClinicalTrials.gov Identifier: NCT00355121
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : August 23, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.

The main objectives are:

Immunogenicity:

To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.

Safety:

To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.


Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Tetanus Diphtheria Pertussis Poliomyelitis Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.
Study Start Date : October 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
DAPTACEL® + IPOL on Day 0 and Menactra on Day 30
 Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Other Names:
  • Menactra®
  • DAPTACEL®
  • IPOL
Experimental: Group 2
DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
 Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Other Names:
  • Menactra®
  • DAPTACEL®
  • IPOL
Experimental: Group 3
Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30
 Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Other Names:
  • Menactra®
  • DAPTACEL®
  • IPOL


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination [ Time Frame: Day 30 post-vaccination (Visit 1) ]
    Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.

  2. Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. [ Time Frame: Day 30 post-vaccination (Visit 1) ]
    Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)


Secondary Outcome Measures :
  1. Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 [ Time Frame: Day 30 post-vaccination 1 ]
    Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).

  2. Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination [ Time Frame: Day 30 post-vaccination ]
    Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

  3. Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine [ Time Frame: Day 0 through Day 7 post-vaccination at Visit 1 ]
    Fever was defined as a maximum oral temperature of ≥ 100.4ºF.


Other Outcome Measures:
  1. Geometric Mean Titers Against Poliovirus After IPOL Vaccination. [ Time Frame: Day 30 post-vaccination ]
    Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.

  2. Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 [ Time Frame: Day 0 through Day 7 post-vaccination ]
    Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

  3. Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 [ Time Frame: Day 0 through Day 7 post-vaccination ]
    Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, as determined by medical history and physical examination.
  • Aged 4 to < 7 years at the time of study vaccination on Day 0.
  • Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
  • Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

Exclusion Criteria:

  • Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
  • Known or suspected impairment of immunologic function
  • Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
  • History of documented invasive meningococcal disease or previous meningococcal vaccination
  • Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
  • 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 enrollment.
  • Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
  • Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
  • Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
  • 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 physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
  • Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
  • Personal or family history of Guillain-Barré Syndrome (GBS).
Contacts and Locations
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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): NCT00355121


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, Colorado
Boulder, Colorado, United States, 80304
United States, Georgia
Atlanta, Georgia, United States, 30322
Layton, UT 84041, Georgia, United States, 30062
United States, Kentucky
Bardstown, Kentucky, United States, 40004
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, Missouri
Bridgeton, Missouri, United States, 63044
St. Louis, Missouri, United States, 63141
United States, New Mexico
Albuquerque, New Mexico, United States, 87108
United States, New York
Rochester, New York, United States, 14620
Syracuse, New York, United States, 13210
United States, Ohio
Akron, Ohio, United States, 44308
Cincinnati, Ohio, United States, 45229
Columbus, Ohio, United States, 43205
University Heights, 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, Utah
Layton, Utah, United States, 84041
Ogden, Utah, United States, 84405
Pleasant Grove, Utah, United States, 84062
Provo, Utah, United States, 84604
Salt Lake City, Utah, United States, 84123
South Jordan, Utah, United States, 84095
United States, Virginia
Norfolk, Virginia, United States, 23510
United States, Washington
Spokane, Washington, United States, 99220
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00355121    
Other Study ID Numbers: MTA43
First Posted: July 21, 2006    Key Record Dates
Results First Posted: August 23, 2011
Last Update Posted: August 24, 2011
Last Verified: August 2011
Keywords provided by Sanofi:
Meningococcal meningitis
Tetanus
Diphtheria
 Pertussis
Poliomyelitis
Neisseria meningitidis
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
Meningitis, Meningococcal
Meningitis
Tetany
Neuroinflammatory Diseases
Nervous System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
 Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections