ClinicalTrials.gov

History of Changes for Study: NCT00384397
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Latest version (submitted April 12, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 5, 2006 None (earliest Version on record)
2 April 5, 2007 Study Status
3 October 16, 2007 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 September 24, 2008 Arms and Interventions, Study Status, Study Design, Contacts/Locations, Outcome Measures and Sponsor/Collaborators
5 September 25, 2008 Arms and Interventions and Study Status
6 April 30, 2009 Recruitment Status and Study Status
7 March 31, 2010 Arms and Interventions, Study Status, Eligibility, Contacts/Locations, Study Description, Oversight and Study Identification
8 May 10, 2011 Study Status, Outcome Measures, More Information, Adverse Events, Baseline Characteristics and Participant Flow
9 January 20, 2014 Sponsor/Collaborators, Outcome Measures, Baseline Characteristics, Study Status, Adverse Events, Participant Flow, References, Study Description and Study Identification
10 April 12, 2016 Study Status
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Study NCT00384397
Submitted Date:  October 5, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: MTA44
Brief Title: A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2006
Overall Status: Recruiting
Study Start: September 2006
Primary Completion:
Study Completion:
First Submitted: October 5, 2006
First Submitted that
Met QC Criteria:
October 5, 2006
First Posted: October 6, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 5, 2006
Last Update Posted: October 6, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Detailed Description:
Open or close this module Conditions
Conditions: Meningococcal Meningitis
Measles
Mumps
Rubella
Varicella
Keywords: Menactra vaccine
Meningococcal meningitis
Measles
Mumps
Rubella
Varicella virus
Haemophilus influenzae type b
Pneumococcal conjugate vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Single (masked role unspecified)
Allocation: Randomized
Enrollment: 1200
Open or close this module Arms and Interventions
Intervention Details:
Biological: Menactra®: Polysaccharide Diphtheria Conjugate Vaccine
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 249 Days
Maximum Age: 291 Days
Sex: All
Gender Based:
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 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 PCV or Hib vaccine or their first dose of 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)
Open or close this module Contacts/Locations
Central Contact Person: Public Registry
Email: RegistryContactUs@sanofipasteur.com
Study Officials: Clinical Trials
Study Director
Sanofi Pasteur, a Sanofi Company
Locations: United States, Alabama
[Recruiting]
Montgomery, Alabama, United States, 36106
United States, Arkansas
[Recruiting]
Fayetteville, Arkansas, United States, 72703
[Recruiting]
Jonesboro, Arkansas, United States, 72401
[Recruiting]
Little Rock, Arkansas, United States, 72202-3591
[Recruiting]
Little Rock, Arkansas, United States, 72205
United States, Connecticut
[Recruiting]
Norwich, Connecticut, United States, 06360
United States, Florida
[Recruiting]
Cocoa Beach, Florida, United States, 32931
[Recruiting]
Viera, Florida, United States, 32955
United States, Georgia
[Recruiting]
Atlanta, Georgia, United States, 30322
[Recruiting]
Marietta, Georgia, United States, 30062
United States, Kentucky
[Recruiting]
Bardstown, Kentucky, United States, 40004
United States, Massachusetts
[Recruiting]
Woburn, Massachusetts, United States, 01801
United States, Missouri
[Recruiting]
Bridgeton, Missouri, United States, 63044
[Recruiting]
St. Louis, Missouri, United States, 63141
United States, Nevada
[Recruiting]
Las Vegas, Nevada, United States, 89104
United States, New York
[Recruiting]
Rochester, New York, United States, 14620
[Recruiting]
Syracuse, New York, United States, 13210
United States, North Carolina
[Recruiting]
Chapel Hill, North Carolina, United States, 27514
[Recruiting]
Goldsboro, North Carolina, United States, 27534
[Recruiting]
Laurinburg, North Carolina, United States, 28352
[Recruiting]
Sylva, North Carolina, United States, 28779
United States, Ohio
[Recruiting]
Cincinnati, Ohio, United States, 45229-3039
[Recruiting]
Cleveland, Ohio, United States, 44106
[Recruiting]
Columbus, Ohio, United States, 43205
United States, Oklahoma
[Recruiting]
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15241
[Recruiting]
Sellersville, Pennsylvania, United States, 18960
United States, Tennessee
[Recruiting]
Kingsport, Tennessee, United States, 37660
United States, Texas
[Recruiting]
Ft. Worth, Texas, United States, 76107
United States, Utah
[Recruiting]
Layton, Utah, United States, 84041
[Recruiting]
Ogden, Utah, United States, 84405
[Recruiting]
Pleasant Grove, Utah, United States, 84062
[Recruiting]
Provo, Utah, United States, 84604
[Recruiting]
Salt Lake City, Utah, United States, 84123
United States, Virginia
[Recruiting]
Charlottesville, Virginia, United States, 22911
[Recruiting]
Midlothian, Virginia, United States, 23113
[Recruiting]
Norfolk, Virginia, United States, 23510
United States, Washington
[Recruiting]
Spokane, Washington, United States, 99202
United States, Wisconsin
[Recruiting]
La Crosse, Wisconsin, United States, 54601
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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