Clinical trial NCT00643916: Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
Official title: Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis
Meningococcal Infection
Keywords: Meningitis; Meningococcal Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 378
Sex: ALL
Minimum age (years): 9
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.

Detailed description: This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Eligibility criteria: Inclusion Criteria :

* Aged either 9, 12, 15 or 18 months of age or 3 to \< 6 years of age on the day of inclusion.
* Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
* Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

* History of a serious chronic disease that could interfere with trial conduct or completion.
* Known or suspected impairment of immunologic function.
* Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
* History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
* Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 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.
* Antibiotic therapy within the 72 hours prior to having any blood sample drawn.
* Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
* Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* Unable to attend one or more of the scheduled visits or to comply with the study procedures.
* Participation in another clinical trial in the 4 weeks preceding enrollment.
* Planned participation in another clinical trial during the present trial period.
* 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.

Primary outcomes:
measure: Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
timeFrame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
timeFrame: Day 0 up to 7 post-vaccination
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Norwich
country: United States
state: Connecticut
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Woburn
country: United States
state: Massachusetts
city: Akron
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Drexel Hill
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: