Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

NCT00422292 | Completed Phase 3 Results DMC

• 1 other identifier: MTA37
• Study Type: interventional
• Target: 1,664
• Locations: 2 countries
• Sites: 88

Brief Summary

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. 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.

Conditions

Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)

  Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.

  Day 30 after the 12-month vaccination

• Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4

  Day 30 after the 12-month vaccination

Other Outcomes (3)

• Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4

  Day 30 after 12-month vaccination

• Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age

  Days 0 to 7 after vaccination

• Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age

  Days 0 to 7 after vaccination

Study Arms (4)

Menactra® at 9 and 12 Months

EXPERIMENTAL

Participants will received Menactra® vaccination at 9 and 12 months of age.

Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine

Menactra® at 9 Months and Menactra® + MMRV at 12 Months

EXPERIMENTAL

Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age

Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine

Menactra® at 9 Months and Menactra® + PCV at 12 Months

EXPERIMENTAL

Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age

Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine

MMRV + PCV at 12 Months

ACTIVE COMPARATOR

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

Biological: Measles, Mumps, Rubella and Varicella

Interventions

Meningococcal Polysaccharide Diphtheria Conjugate Vaccine BIOLOGICAL

0.5 mL dose, intramuscular (IM)

Also known as: Menactra®

Menactra® at 9 and 12 Months

Measles, Mumps, Rubella and Varicella BIOLOGICAL

0.5 mL dose, SC

Also known as: ProQuad®, M-M-R®II

MMRV + PCV at 12 Months

Eligibility Criteria

• Age: 9 Months - 12 Months
• 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) 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.

You may not qualify if:

• Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, 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 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (88)

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Tuscaloosa, Alabama, 35401, United States

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Tucson, Arizona, 85741, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Atascadero, California, 93422, United States

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Fresno, California, 93726, United States

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Paramount, California, 90723, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95823, United States

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San Jose, California, 95119, United States

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Torrance, California, 90502, United States

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Aurora, Colorado, 80012, United States

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Norwich, Connecticut, 06360, United States

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Viera, Florida, 32940, United States

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West Palm Beach, Florida, 33409, United States

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Dalton, Georgia, 30721, United States

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Marietta, Georgia, 30062, United States

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Tifton, Georgia, 31794, United States

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Woodstock, Georgia, 30189, United States

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Chicago, Illinois, 60614, United States

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Chicago, Illinois, 60647, United States

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Fishers, Indiana, 46038, United States

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Dubuque, Iowa, 52001, United States

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Dubuque, Iowa, 52002, United States

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Owensboro, Kentucky, 42303, United States

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Bossier City, Louisiana, 71111, United States

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Perry Hall, Maryland, 21128, United States

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Woburn, Massachusetts, 01801, United States

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Niles, Michigan, 49120, United States

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Stevensville, Michigan, 49127, United States

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Bridgeton, Missouri, 63044, United States

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Kansas City, Missouri, 64108, United States

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Saint Charles, Missouri, 63303, United States

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St Louis, Missouri, 63104, United States

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Bellevue, Nebraska, 68123, United States

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La Vista, Nebraska, 68128, United States

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Omaha, Nebraska, 68117, United States

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Omaha, Nebraska, 68124, United States

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Omaha, Nebraska, 68131, United States

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Omaha, Nebraska, 68132, United States

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Henderson, Nevada, 89105, United States

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Whitehouse Station, New Jersey, 08889, United States

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Brooklyn, New York, 11201, United States

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Fishkill, New York, 12524, United States

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Hopewell Junction, New York, 12533, United States

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Ithaca, New York, 14850, United States

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Lake Success, New York, 11021, United States

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Mineola, New York, 11501, United States

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New York, New York, 10016, United States

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Poughkeepsie, New York, 12603, United States

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Syracuse, New York, 13210, United States

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Boone, North Carolina, 28607, United States

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Clyde, North Carolina, 28721, United States

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Durham, North Carolina, 27704, United States

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Durham, North Carolina, 27705, United States

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Beachwood, Ohio, 44122, United States

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Cleveland, Ohio, 44121, United States

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Cleveland, Ohio, 44195, United States

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Independence, Ohio, 44131, United States

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Strongsville, Ohio, 44136, United States

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Harleysville, Pennsylvania, 19438, United States

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Hershey, Pennsylvania, 17033, United States

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Pittsburgh, Pennsylvania, 15220, United States

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Sellersville, Pennsylvania, 18960, United States

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Wexford, Pennsylvania, 15090, United States

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Clarksville, Tennessee, 37043, United States

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Kingsport, Tennessee, 37660, United States

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Houston, Texas, 77004, United States

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Longview, Texas, 75605, United States

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San Antonio, Texas, 78205, United States

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San Antonio, Texas, 78229, United States

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Lehi, Utah, 84043, 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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South Jordan, Utah, 84095, United States

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Springville, Utah, 84663, United States

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St. George, Utah, 84790, United States

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Urem, Utah, 84057, United States

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Charlottesville, Virginia, 22902, United States

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Charlottesville, Virginia, 22903, United States

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Charlottesville, Virginia, 22911, United States

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Midlothian, Virginia, 23113, United States

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Richmond, Virginia, 23219, United States

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Huntington, West Virginia, 25701, United States

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Morgantown, West Virginia, 26506, United States

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Marshfield, Wisconsin, 54449, United States

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San Juan, PR, 00918, Puerto Rico

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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

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

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  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: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 15, 2007
• Study Start: December 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 14, 2016
• Results First Posted: June 2, 2011

Record last verified: 2016-04

Locations

US (87); PR (1)