A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

• ClinicalTrials.gov Identifier: NCT00384397
• Recruitment Status: Completed
• First Posted: October 6, 2006
• Results First Posted: June 2, 2011
• Last Update Posted: April 14, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief Summary:

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.

Primary Objective:

To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.

Secondary Objectives:

Immunogenicity

• 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.

Safety

- 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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

Arms and Interventions

Arm	Intervention/treatment
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; Other Names: Menactra®; ProQuad®
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; Other Names: Menactra®; Prevnar®

Outcome Measures

Primary Outcome Measures :

1. 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® ]

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. 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® ]
2. 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® ]

Eligibility Criteria

• Ages Eligible for Study: 249 Days to 305 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Monitor; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00384397
• Other Study ID Numbers: MTA44
• First Posted: October 6, 2006
• Results First Posted: June 2, 2011
• Last Update Posted: April 14, 2016
• Last Verified: April 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Menactra vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella virus; Haemophilus influenzae type b; Pneumococcal conjugate vaccine

Additional relevant MeSH terms:

Measles; Chickenpox; Herpes Zoster; Rubella; Meningitis, Meningococcal; Meningitis; Neuroinflammatory Diseases; Nervous System Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Rubivirus Infections; Togaviridae Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors