Clinical trial NCT00483574: Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
Official title: Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Meningitis
Measles
Mumps
Rubella
Varicella
Keywords: Menactra® vaccine
Meningococcal meningitis
Measles
Mumps
Rubella
Varicella virus
Haemophilus influenzae type b
Pneumococcal conjugate vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 1378
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.

Safety Objective:

To describe the safety profile of two doses of Menactra® Vaccine.


Eligibility criteria: Inclusion Criteria :

* Healthy, as determined by medical history and physical examination
* Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment
* The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board (IRB)-approved informed consent form.

Exclusion Criteria :

* Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, 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 a temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of enrollment.
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine.
* 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.
* 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 study 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 the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).
* Personal or family history of Guillain-Barré Syndrome (GBS).
* History of seizures, including febrile seizures, or any other neurologic disorder.
* Known hypersensitivity to dry natural rubber latex.

For the subjects scheduled to provide blood samples:

- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.

Primary outcomes:
measure: Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
timeFrame: Day 0 to 7 Post-vaccination
Secondary outcomes:
Other outcomes:
measure: Safety Overview After Any Vaccination in Participants Who Received MMR+V
timeFrame: Day 0 to 7 Post-vaccination
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Dothan
country: United States
state: Alabama
city: Pinson
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Bentonville
country: United States
state: Arkansas
city: Conway
country: United States
state: Arkansas
city: Hardy
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Downy
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: LaCosta
country: United States
state: California
city: LaJolla
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Thornton
country: United States
state: Colorado
city: Lake Mary
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Stone Mountain
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Arkansas City
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Fall River
country: United States
state: Massachusetts
city: Clifton
country: United States
state: New Jersey
city: Endwell
country: United States
state: New York
city: Liverpool
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Garner
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Minot
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Huber Heights
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Poland
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Meadowbrook
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Barrington
country: United States
state: Rhode Island
city: Providence
country: United States
state: Rhode Island
city: Warwick
country: United States
state: Rhode Island
city: Barnwell
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Watertown
country: United States
state: South Dakota
city: Bristol
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Tullahoma
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Amarillo
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Valley City
country: United States
state: Utah
city: Newport News
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Santiago de Chile
country: Chile
city: Santiago
country: Chile
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: