Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
NCT ID: NCT00422292
Last Updated: 2016-04-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1664 participants
INTERVENTIONAL
2006-12-31
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
NCT00483574
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
NCT00384397
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
NCT00643916
Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
NCT01659996
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
NCT03537508
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Menactra® at 9 and 12 Months
Participants will received Menactra® vaccination at 9 and 12 months of age.
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, intramuscular (IM)
Menactra® at 9 Months and Menactra® + MMRV at 12 Months
Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
Menactra® at 9 Months and Menactra® + PCV at 12 Months
Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 Ml dose, IM
MMRV + PCV at 12 Months
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Measles, Mumps, Rubella and Varicella
0.5 mL dose, SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, intramuscular (IM)
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 Ml dose, IM
Measles, Mumps, Rubella and Varicella
0.5 mL dose, SC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
9 Months
12 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tuscaloosa, Alabama, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Atascadero, California, United States
Fresno, California, United States
Paramount, California, United States
Roseville, California, United States
Sacramento, California, United States
San Jose, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Norwich, Connecticut, United States
Viera, Florida, United States
West Palm Beach, Florida, United States
Dalton, Georgia, United States
Marietta, Georgia, United States
Tifton, Georgia, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Fishers, Indiana, United States
Dubuque, Iowa, United States
Dubuque, Iowa, United States
Owensboro, Kentucky, United States
Bossier City, Louisiana, United States
Perry Hall, Maryland, United States
Woburn, Massachusetts, United States
Niles, Michigan, United States
Stevensville, Michigan, United States
Bridgeton, Missouri, United States
Kansas City, Missouri, United States
Saint Charles, Missouri, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
La Vista, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Whitehouse Station, New Jersey, United States
Brooklyn, New York, United States
Fishkill, New York, United States
Hopewell Junction, New York, United States
Ithaca, New York, United States
Lake Success, New York, United States
Mineola, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
Boone, North Carolina, United States
Clyde, North Carolina, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Beachwood, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Independence, Ohio, United States
Strongsville, Ohio, United States
Harleysville, Pennsylvania, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Wexford, Pennsylvania, United States
Clarksville, Tennessee, United States
Kingsport, Tennessee, United States
Houston, Texas, United States
Longview, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Lehi, Utah, United States
Ogden, Utah, United States
Pleasant Grove, Utah, United States
Provo, Utah, United States
South Jordan, Utah, United States
Springville, Utah, United States
St. George, Utah, United States
Urem, Utah, United States
Charlottesville, Virginia, United States
Charlottesville, Virginia, United States
Charlottesville, Virginia, United States
Midlothian, Virginia, United States
Richmond, Virginia, United States
Huntington, West Virginia, United States
Morgantown, West Virginia, United States
Marshfield, Wisconsin, United States
San Juan, PR, Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MTA37
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.