Clinical trial NCT00422292: Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
Official title: An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) 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 vaccines
Haemophilus influenzae type b
Pneumococcal conjugate vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 1664
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.

Primary Objectives:

* To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.
* To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine.

Observational Objectives:

Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination\[s\]) in subjects in the study groups.

Immunogenicity:

- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.

Detailed description: No meningococcal vaccine is presently licensed for the population aged \< 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged \< 2 years would address this important, currently unmet public health need.

At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.

Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group

Eligibility criteria: Inclusion Criteria :

* Healthy, as determined by medical history and physical examination
* Aged 9 months (249 to 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment
* The parent or legal guardian has signed and dated the 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.
* 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 any blood draw. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.
* Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin.
* 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 planned 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 vaccines, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccines. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their fourth dose of Pneumococcal conjugate vaccine (PCV) or Haemophilus influenzae type b (Hib) vaccine or their first dose of Measles, mumps, rubella, varicella (MMRV) vaccine before enrollment or been scheduled to receive these vaccines outside of the study-specified visits.
* 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.

Primary outcomes:
measure: Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)
timeFrame: Day 30 after the 12-month vaccination
measure: Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4
timeFrame: Day 30 after the 12-month vaccination
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4
timeFrame: Day 30 after 12-month vaccination
measure: Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age
timeFrame: Days 0 to 7 after vaccination
measure: Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age
timeFrame: Days 0 to 7 after vaccination
Locations:
city: Tuscaloosa
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Atascadero
country: United States
state: California
city: Fresno
country: United States
state: California
city: Paramount
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Jose
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Viera
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Dalton
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Tifton
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Fishers
country: United States
state: Indiana
city: Dubuque
country: United States
state: Iowa
city: Dubuque
country: United States
state: Iowa
city: Owensboro
country: United States
state: Kentucky
city: Bossier City
country: United States
state: Louisiana
city: Perry Hall
country: United States
state: Maryland
city: Woburn
country: United States
state: Massachusetts
city: Niles
country: United States
state: Michigan
city: Stevensville
country: United States
state: Michigan
city: Bridgeton
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: St. Charles
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Bellevue
country: United States
state: Nebraska
city: La Vista
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Henderson
country: United States
state: Nevada
city: Whitehouse Station
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Fishkill
country: United States
state: New York
city: Hopewell Junction
country: United States
state: New York
city: Ithaca
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Boone
country: United States
state: North Carolina
city: Clyde
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Independence
country: United States
state: Ohio
city: Strongsville
country: United States
state: Ohio
city: Harleysville
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Clarksville
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Lehi
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Pleasant Grove
country: United States
state: Utah
city: Provo
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: Springville
country: United States
state: Utah
city: St. George
country: United States
state: Utah
city: Urem
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Huntington
country: United States
state: West Virginia
city: Morgantown
country: United States
state: West Virginia
city: Marshfield
country: United States
state: Wisconsin
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: