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Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
This study has been completed.
First Received: January 12, 2007   Last Updated: April 30, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00422292
  Purpose

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.

Primary Objectives:

  • To evaluate the antibody responses induced by MMRV vaccine when administered alone or concomitantly with Menactra vaccine.
  • To evaluate the antibody responses induced by PCV when administered alone or concomitantly with Menactra vaccine.

Observational Objectives:

Safety

  • To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups.

Immunogenicity:

  • To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.

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

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immune response of MMRV, Hib, and PCV after vaccination. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Enrollment: 1664
Study Start Date: December 2006
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
2: Experimental Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
3: Experimental Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 Ml dose, IM
4: Active Comparator Biological: Measles, Mumps, Rubella and Varicella
0.5 mL dose, SC

Detailed Description:

No meningococcal vaccine is presently licensed for the population aged < 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged < 2 years would address this important, currently unmet public health need.

At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial. Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group

  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 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment
  • The parent or legal guardian has signed and dated the 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 >= 100.4oF (>=38.0oC) 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 any blood draw. Topical antibiotics and 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 planned 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 vaccines, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccines. 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 fourth dose of PCV or Hib vaccine or their first dose of MMRV vaccine before enrollment or been scheduled to receive these vaccines outside of the study-specified visits.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422292

Locations
United States, California
Paramount, California, United States, 90723
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New York
Poughkeepsie, New York, United States, 12603
United States, North Carolina
Sylva, North Carolina, United States, 28779
United States, Ohio
Cincinnati, Ohio, United States, 45245
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
Hershey, Pennsylvania, United States, 17033
United States, Texas
San Antonio, Texas, United States, 78229
Dallas, Texas, United States, 75234
United States, Utah
Ogden, Utah, United States, 84405
Salt Lake City, Utah, United States, 84123
St. George, Utah, United States, 84790
United States, Wisconsin
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur, Inc ( Medical Monitor )
Study ID Numbers: MTA37
Study First Received: January 12, 2007
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00422292     History of Changes
Health Authority: United States: Food and Drug Administration

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

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

Additional relevant MeSH terms:
Bacterial Infections
Herpes Zoster
RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Measles
Meningitis, Bacterial
Nervous System Diseases
Meningitis, Meningococcal
Central Nervous System Diseases
Chickenpox
Rubella
Togaviridae Infections
Gram-Negative Bacterial Infections
Meningitis
Herpesviridae Infections
Virus Diseases
Rubivirus Infections
Central Nervous System Infections
Meningococcal Infections
Central Nervous System Bacterial Infections
DNA Virus Infections
Neisseriaceae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on July 02, 2009