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Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00483574
  Purpose

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects aged 9 months and at 12 months when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.

Safety Objective:

To describe the safety profile of two doses of Menactra® Vaccine.


Condition Intervention Phase
Meningococcal Meningitis
Measles
Mumps
Rubella
Varicella
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Biological: Routine pediatric vaccines
Phase III

MedlinePlus related topics: Chickenpox Measles Meningitis Mumps Rubella Shingles
Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Meningococcal Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the safety of Menactra after vaccination. [ Time Frame: 6 months post-vaccinnation 2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1820
Study Start Date: May 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM at age 9 and 12 months
2: No Intervention Biological: Routine pediatric vaccines
At 12 months of age

  Eligibility

Ages Eligible for Study:   9 Months to 12 Months
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 305 days) or 12 months (365 to 400 days) at the time of enrollment
  • The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board (IRB)-approved informed consent form.

Exclusion Criteria :

  • Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, 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 a temperature >= 100.4 oF (>= 38.0oC) at the time of enrollment.
  • History of documented invasive meningococcal disease or previous meningococcal vaccination.
  • Has received the fourth dose of Prevnar, or the first dose of MMR, varicella, or HepA vaccine.
  • 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.
  • Suspected or known hypersensitivity to any of the vaccine components.
  • 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 the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).
  • 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.

For the subjects scheduled to provide blood samples:

- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483574

Locations
United States, New York
Liverpool, New York, United States, 13088
United States, Texas
Galveston, Texas, United States, 77555
Amarillo, Texas, United States, 79124
Chile
Santiago de Chile, Chile
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Director 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: MTA48
Study First Received: June 6, 2007
Last Updated: October 7, 2008
ClinicalTrials.gov Identifier: NCT00483574  
Health Authority: United States: Food and Drug Administration;   Chile: Instituto de Salud Publica de Chile

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