Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
1 other identifier
interventional
360
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFebruary 6, 2018
February 1, 2018
10 months
February 29, 2008
February 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the safety and immunogenicity after administration of TetraMenT
30 days after each injection
Study Arms (6)
Group 1
EXPERIMENTALGroup 2
EXPERIMENTALGroup 3
EXPERIMENTALGroup 4
EXPERIMENTALGroup 5
EXPERIMENTALGroup 6
ACTIVE COMPARATORInterventions
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Subject is healthy, as determined by medical history and physical assessment.
- 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.
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Herston, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
North Adelaide, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Westmead, Australia
Related Publications (1)
McVernon J, Nolan T, Richmond P, Reynolds G, Nissen M, Lambert SB, Marshall H, Papa T, Rehm C. A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers. Pediatr Infect Dis J. 2012 Jan;31(1):e15-23. doi: 10.1097/INF.0b013e31823e1e34.
PMID: 22094636RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2008
First Posted
March 10, 2008
Study Start
April 1, 2008
Primary Completion
February 1, 2009
Study Completion
April 1, 2009
Last Updated
February 6, 2018
Record last verified: 2018-02