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

February 5, 2018 updated by: Sanofi Pasteur, a Sanofi Company

Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
Experimental: Group 1
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 Names:
  • NeisVac-C® vaccine (Baxter Healthcare)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety and immunogenicity after administration of TetraMenT
Time Frame: 30 days after each injection
30 days after each injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MET32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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