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Trial record 1 of 1 for:    MTA44
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A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

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: NCT00384397
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : June 2, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age.

Primary Objective:

To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.

Secondary Objectives:

Immunogenicity

  • To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.
  • To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine.

Safety

- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.


Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Measles Mumps Rubella Varicella Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Immunogenicity and Safety Evaluation of Two Doses of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Given to Healthy Subjects at 9 and 12 Months of Age
Study Start Date : September 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : February 2009


Arm Intervention/treatment
Experimental: Group 1: Menactra® Vaccine
Participants will receive Menactra® vaccine at age 9 months and 12 months, respectively.
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®

Experimental: Group 2: Menactra® + MMRV
Participants will receive Menactra® at age 9 months followed by Menactra® and Measles-Mumps-Rubella-Varicella (MMRV) vaccines at Age 12 Months
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
  • Menactra®
  • ProQuad®

Experimental: Group 3: Menactra® + PCV
Participants will receive Menactra® at age 9 months followed by Menactra® and Pneumococcal Conjugate (PCV) vaccines at Age 12 Months
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
  • Menactra®
  • Prevnar®




Primary Outcome Measures :
  1. Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) [ Time Frame: 30 days post-visit 2 Menactra® ]

Secondary Outcome Measures :
  1. Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination [ Time Frame: 0-7 days post-vaccination ]
    Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.


Other Outcome Measures:
  1. Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) [ Time Frame: 30 days post-Visit 2 Menactra® ]
  2. Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. [ Time Frame: 30 days post-Visit 2 Menactra® ]


Information from the National Library of Medicine

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Ages Eligible for Study:   249 Days to 305 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, as determined by medical history and physical examination.
  • Aged 9 months (249 to 291 days) at the time of enrollment.
  • The parent or legal guardian has signed and dated the Institutional Review Board-approved informed consent form

Exclusion Criteria:

  • Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
  • Known or suspected impairment of immunologic function.
  • Acute medical illness within the last 72 hours, or temperature ≥ 100.4 ºF (≥ 38.0 ºC) at the time of enrollment.
  • History of documented invasive meningococcal disease or previous meningococcal vaccination.
  • Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian
  • 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 two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.
  • Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion.
  • Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin.
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
  • Parent or legal guardian unable or unwilling to comply with the study procedures.
  • Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
  • 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.
  • Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their 4th dose of Pneumococcal Conjugate (PCV) or Hib vaccine or their first dose of Measles-Mumps-Rubella-Varicella (MMRV) vaccine before enrollment.
  • Personal or family history of Guillain-Barré Syndrome (GBS).
  • History of seizures, including febrile seizures, or any other neurologic disorder.
  • Known hypersensitivity to dry natural rubber latex (pertinent to the Menactra® vaccine needle shield)

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): NCT00384397


Locations
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United States, Alabama
Montgomery, Alabama, United States, 36106
United States, Arkansas
Fayetteville, Arkansas, United States, 72703
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72202-3591
Little Rock, Arkansas, United States, 72205
United States, Connecticut
Norwich, Connecticut, United States, 06360
United States, Florida
Cocoa Beach, Florida, United States, 32931
Viera, Florida, United States, 32955
United States, Georgia
Atlanta, Georgia, United States, 30322
Marietta, 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, Nevada
Las Vegas, Nevada, United States, 89104
United States, New York
Rochester, New York, United States, 14620
Syracuse, New York, United States, 13210
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Goldsboro, North Carolina, United States, 27534
Laurinburg, North Carolina, United States, 28352
Sylva, North Carolina, United States, 28779
United States, Ohio
Cincinnati, Ohio, United States, 45229-3039
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43205
United States, Oklahoma
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
Sellersville, Pennsylvania, United States, 18960
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Ft. Worth, Texas, United States, 76107
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
United States, Virginia
Charlottesville, Virginia, United States, 22911
Midlothian, Virginia, United States, 23113
Norfolk, Virginia, United States, 23510
United States, Washington
Spokane, Washington, United States, 99220
United States, Wisconsin
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur Inc.
Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00384397    
Other Study ID Numbers: MTA44
First Posted: October 6, 2006    Key Record Dates
Results First Posted: June 2, 2011
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Menactra vaccine
Meningococcal meningitis
Measles
Mumps
Rubella
Varicella virus
Haemophilus influenzae type b
Pneumococcal conjugate vaccine
Additional relevant MeSH terms:
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Measles
Chickenpox
Herpes Zoster
Rubella
Meningitis, Meningococcal
Meningitis
Neuroinflammatory Diseases
Nervous System Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Infections
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Central Nervous System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors