A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
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|ClinicalTrials.gov Identifier: NCT00384397|
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : June 2, 2011
Last Update Posted : April 14, 2016
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This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age.
To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.
- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.
- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine.
- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.
|Condition or disease||Intervention/treatment||Phase|
|Meningococcal Meningitis Measles Mumps Rubella Varicella||Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Immunogenicity and Safety Evaluation of Two Doses of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Given to Healthy Subjects at 9 and 12 Months of Age|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||February 2009|
Experimental: Group 1: Menactra® Vaccine
Participants will receive Menactra® vaccine at age 9 months and 12 months, respectively.
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Group 2: Menactra® + MMRV
Participants will receive Menactra® at age 9 months followed by Menactra® and Measles-Mumps-Rubella-Varicella (MMRV) vaccines at Age 12 Months
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Experimental: Group 3: Menactra® + PCV
Participants will receive Menactra® at age 9 months followed by Menactra® and Pneumococcal Conjugate (PCV) vaccines at Age 12 Months
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
- Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) [ Time Frame: 30 days post-visit 2 Menactra® ]
- Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination [ Time Frame: 0-7 days post-vaccination ]Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.
- Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) [ Time Frame: 30 days post-Visit 2 Menactra® ]
- Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. [ Time Frame: 30 days post-Visit 2 Menactra® ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||249 Days to 305 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Healthy, as determined by medical history and physical examination.
- Aged 9 months (249 to 291 days) at the time of enrollment.
- The parent or legal guardian has signed and dated the Institutional Review Board-approved informed consent form
- 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 ≥ 100.4 ºF (≥ 38.0 ºC) 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 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, 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 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 two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their 4th dose of Pneumococcal Conjugate (PCV) or Hib vaccine or their first dose of Measles-Mumps-Rubella-Varicella (MMRV) vaccine before enrollment.
- 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 (pertinent to the Menactra® vaccine needle shield)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384397
|United States, Alabama|
|Montgomery, Alabama, United States, 36106|
|United States, Arkansas|
|Fayetteville, Arkansas, United States, 72703|
|Jonesboro, Arkansas, United States, 72401|
|Little Rock, Arkansas, United States, 72202-3591|
|Little Rock, Arkansas, United States, 72205|
|United States, Connecticut|
|Norwich, Connecticut, United States, 06360|
|United States, Florida|
|Cocoa Beach, Florida, United States, 32931|
|Viera, Florida, United States, 32955|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Marietta, Georgia, United States, 30062|
|United States, Kentucky|
|Bardstown, Kentucky, United States, 40004|
|United States, Massachusetts|
|Woburn, Massachusetts, United States, 01801|
|United States, Missouri|
|Bridgeton, Missouri, United States, 63044|
|St. Louis, Missouri, United States, 63141|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89104|
|United States, New York|
|Rochester, New York, United States, 14620|
|Syracuse, New York, United States, 13210|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|Goldsboro, North Carolina, United States, 27534|
|Laurinburg, North Carolina, United States, 28352|
|Sylva, North Carolina, United States, 28779|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45229-3039|
|Cleveland, Ohio, United States, 44106|
|Columbus, Ohio, United States, 43205|
|United States, Oklahoma|
|Tulsa, Oklahoma, United States, 74127|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15241|
|Sellersville, Pennsylvania, United States, 18960|
|United States, Tennessee|
|Kingsport, Tennessee, United States, 37660|
|United States, Texas|
|Ft. Worth, Texas, United States, 76107|
|United States, Utah|
|Layton, Utah, United States, 84041|
|Ogden, Utah, United States, 84405|
|Pleasant Grove, Utah, United States, 84062|
|Provo, Utah, United States, 84604|
|Salt Lake City, Utah, United States, 84123|
|United States, Virginia|
|Charlottesville, Virginia, United States, 22911|
|Midlothian, Virginia, United States, 23113|
|Norfolk, Virginia, United States, 23510|
|United States, Washington|
|Spokane, Washington, United States, 99220|
|United States, Wisconsin|
|La Crosse, Wisconsin, United States, 54601|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|
|Responsible Party:||Sanofi Pasteur, a Sanofi Company|
|Other Study ID Numbers:||
|First Posted:||October 6, 2006 Key Record Dates|
|Results First Posted:||June 2, 2011|
|Last Update Posted:||April 14, 2016|
|Last Verified:||April 2016|
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