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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00631995
First received: February 29, 2008
Last updated: June 11, 2013
Last verified: June 2013
  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 1

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Enrollment: 373
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
Experimental: Group 2 Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
Experimental: Group 3 Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
Experimental: Group 4 Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
Experimental: Group 5 Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
Active Comparator: Group 6 Dietary Supplement: Meningococcal polysaccharide group C conjugated
0.5 mL, Intramuscular
Other Name: NeisVac-C® vaccine (Baxter Healthcare)

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 intramuscular (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia
Herston, Australia
Melbourne, Australia
North Adelaide, Australia
Perth, Australia
Westmead, Australia
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00631995     History of Changes
Other Study ID Numbers: MET32
Study First Received: February 29, 2008
Last Updated: June 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi:
Neisseria meningitidis

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Tetanus
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Clostridium Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on August 26, 2014