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

NCT00384397 | Completed Phase 3 Results

• 1 other identifier: MTA44
• Study Type: interventional
• Target: 1,128
• Locations: 1 country
• Sites: 39

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.

Conditions

Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination

  0-7 days post-vaccination

Other Outcomes (2)

• 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®

Study Arms (3)

Group 1: Menactra® Vaccine

EXPERIMENTAL

Participants will receive Menactra® vaccine at age 9 months and 12 months, respectively.

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Group 2: Menactra® + MMRV

EXPERIMENTAL

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

Group 3: Menactra® + PCV

EXPERIMENTAL

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

Interventions

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Group 1: Menactra® Vaccine

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®, ProQuad®

Group 2: Menactra® + MMRV

Eligibility Criteria

• Age: 249 Days - 305 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (39)

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Montgomery, Alabama, 36106, United States

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Fayetteville, Arkansas, 72703, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72202-3591, United States

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Little Rock, Arkansas, 72205, United States

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Norwich, Connecticut, 06360, United States

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Cocoa Beach, Florida, 32931, United States

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Viera, Florida, 32955, United States

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Atlanta, Georgia, 30322, United States

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Marietta, Georgia, 30062, United States

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Bardstown, Kentucky, 40004, United States

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Woburn, Massachusetts, 01801, United States

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Bridgeton, Missouri, 63044, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89104, United States

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Rochester, New York, 14620, United States

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Syracuse, New York, 13210, United States

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Chapel Hill, North Carolina, 27514, United States

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Goldsboro, North Carolina, 27534, United States

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Laurinburg, North Carolina, 28352, United States

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Sylva, North Carolina, 28779, United States

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Cincinnati, Ohio, 45229-3039, United States

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Cleveland, Ohio, 44106, United States

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Columbus, Ohio, 43205, United States

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Tulsa, Oklahoma, 74127, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Sellersville, Pennsylvania, 18960, United States

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Kingsport, Tennessee, 37660, United States

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Fort Worth, Texas, 76107, United States

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Layton, Utah, 84041, United States

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Ogden, Utah, 84405, United States

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Pleasant Grove, Utah, 84062, United States

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Provo, Utah, 84604, United States

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Salt Lake City, Utah, 84123, United States

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Charlottesville, Virginia, 22911, United States

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Midlothian, Virginia, 23113, United States

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Norfolk, Virginia, 23510, United States

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Spokane, Washington, 99220, United States

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La Crosse, Wisconsin, 54601, United States

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Related Links

• Related Info

MeSH Terms

Conditions

Meningitis, Meningococcal; Measles; Mumps; Rubella; Chickenpox; Haemophilus Infections

Interventions

Meningococcal Vaccines; measles, mumps, rubella, varicella vaccine; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Pneumococcal Vaccines; Streptococcal Vaccines; Vaccines, Combined

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: February 1, 2009
• Last Updated: April 14, 2016
• Results First Posted: June 2, 2011

Record last verified: 2016-04

Locations

US (39)