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Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers

This study is ongoing, but not recruiting participants.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00631995
  Purpose

This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.

Primary Objectives: Safety and Immunogenicity:

To describe the safety and immunogenicity profiles of:

  • A single dose of each formulation of TetraMen-T vaccine
  • A single dose of NeisVac-C® vaccine.

Condition Intervention Phase
Meningitis
Meningococcal Infection
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
Dietary Supplement: Meningococcal polysaccharide group C conjugated
Phase I

MedlinePlus related topics:   Meningitis    Tetanus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the safety and immunogenicity after administration of TetraMenT [ Time Frame: 30 days after each injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   360
Study Start Date:   April 2008
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
2: Experimental Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
3: Experimental Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
4: Experimental Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
5: Experimental Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
6: Active Comparator Dietary Supplement: Meningococcal polysaccharide group C conjugated
0.5 mL, Intramuscular

Detailed Description:

The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.

  Eligibility
Ages Eligible for Study:   12 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria :

  • Subject is healthy, as determined by medical history and physical assessment.
  • Aged 12 months (± 21 days) on the day of inclusion.
  • Institutional Review Board (IRB)-approved informed consent form signed by the subject's parent/legal guardian.
  • Able to attend all scheduled visits and to comply with all trial procedures.

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 >= 37.5oC (axillary) at the time of enrollment (temporary contraindication).
  • 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.
  • Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
  • Parent or legal guardian unable or unwilling to comply with the stu dy 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 14 days before or 14 days after receiving the study vaccines.
  • History of seizures, including febrile seizures, or any other neurologic disorder.
  • Personal or family history of Guillain-Barré Syndrome (GBS).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631995

Locations
Australia
      Melbourne, Australia
      Westmead, Australia
      North Adelaide, Australia
      Herston, Australia
      Perth, Australia

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:   MET32
First Received:   February 29, 2008
Last Updated:   October 1, 2008
ClinicalTrials.gov Identifier:   NCT00631995
Health Authority:   Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi-Aventis:
Neisseria meningitidis  

Study placed in the following topic categories:
Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Central Nervous System Diseases
Neisseria meningitidis
Tetanus
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:
Nervous System Diseases
Infection

ClinicalTrials.gov processed this record on October 31, 2008




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