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A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00384397
  Purpose

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 Intervention Phase
Meningococcal Meningitis
Measles
Mumps
Rubella
Varicella
Biological: Polysaccharide Diphtheria Conjugate Vaccine
Biological: Meningococcal Polysaccharide Diphtheria Conjugate
Phase III

MedlinePlus related topics: Chickenpox Diphtheria Measles Meningitis Mumps Rubella Shingles
Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Meningococcal Vaccines Meningococcal Conjugate Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Menactra® [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of Menactra® [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 1128
Study Start Date: September 2006
Estimated Study Completion Date: November 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Menactra vaccine at age 12 months
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
2: Experimental
Menactra + MMRV vaccines at age 12 month
Biological: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, Intramuscular
3: Experimental
Menactra + PCV vaccines at age 12 months
Biological: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, Intramuscular

  Eligibility

Ages Eligible for Study:   249 Days to 291 Days
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384397

  Show 39 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: MTA44
Study First Received: October 5, 2006
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00384397  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Menactra vaccine
Meningococcal meningitis
Measles
Mumps
Rubella
Varicella virus
Haemophilus influenzae type b
Pneumococcal conjugate vaccine

Study placed in the following topic categories:
Bacterial Infections
Herpes Zoster
Haemophilus influenzae
Paramyxoviridae Infections
Measles
Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases
Chickenpox
Healthy
Rubella
Togaviridae Infections
Meningococcal infection
Gram-Negative Bacterial Infections
Meningitis
Herpesviridae Infections
Virus Diseases
Central Nervous System Infections
Meningococcal Infections
Influenza, Human
DNA Virus Infections
Chicken pox
Mumps
Neisseriaceae Infections

Additional relevant MeSH terms:
Rubivirus Infections
RNA Virus Infections
Morbillivirus Infections
Nervous System Diseases
Central Nervous System Bacterial Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009