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

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

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.

Study Overview

• Status: Completed
• Conditions: Measles; Rubella; Mumps; Varicella; Meningococcal Meningitis
• Intervention / Treatment: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1128
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36106
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
    • Jonesboro, Arkansas, United States, 72401
    • Little Rock, Arkansas, United States, 72205
    • Little Rock, Arkansas, United States, 72202-3591
  • Connecticut
    • Norwich, Connecticut, United States, 06360
  • Florida
    • Cocoa Beach, Florida, United States, 32931
    • Viera, Florida, United States, 32955
  • Georgia
    • Atlanta, Georgia, United States, 30322
    • Marietta, Georgia, United States, 30062
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
  • Missouri
    • Bridgeton, Missouri, United States, 63044
    • St. Louis, Missouri, United States, 63141
  • Nevada
    • Las Vegas, Nevada, United States, 89104
  • New York
    • Rochester, New York, United States, 14620
    • Syracuse, New York, United States, 13210
  • 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
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
    • Cleveland, Ohio, United States, 44106
    • Columbus, Ohio, United States, 43205
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
    • Sellersville, Pennsylvania, United States, 18960
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
  • Texas
    • Ft. Worth, Texas, United States, 76107
  • 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
  • Virginia
    • Charlottesville, Virginia, United States, 22911
    • Midlothian, Virginia, United States, 23113
    • Norfolk, Virginia, United States, 23510
  • Washington
    • Spokane, Washington, United States, 99220
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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®; Prevnar®
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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)	30 days post-visit 2 Menactra®

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction 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.	0-7 days post-vaccination

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)	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.	30 days post-Visit 2 Menactra®

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: October 5, 2006
• First Submitted That Met QC Criteria: October 5, 2006
• First Posted (Estimate): October 6, 2006

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Pneumococcal conjugate vaccine; Meningococcal meningitis; Measles; Haemophilus influenzae type b; Mumps; Rubella; Menactra vaccine; Varicella virus
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Central Nervous System Infections; DNA Virus Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Togaviridae Infections; Rubivirus Infections; Measles; Herpes Zoster; Meningitis, Meningococcal; Meningitis; Chickenpox; Rubella; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: MTA44