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

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ClinicalTrials.gov Identifier: NCT00422292
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : June 2, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.


Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Measles Mumps Rubella Varicella Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine Biological: Measles, Mumps, Rubella and Varicella Phase 3

Detailed Description:

No meningococcal vaccine is presently licensed for the population aged < 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged < 2 years would address this important, currently unmet public health need.

At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.

Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) to Healthy Toddlers
Study Start Date : December 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009


Arm Intervention/treatment
Experimental: Menactra® at 9 and 12 Months
Participants will received Menactra® vaccination at 9 and 12 months of age.
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, intramuscular (IM)
Other Name: Menactra®

Experimental: Menactra® at 9 Months and Menactra® + MMRV at 12 Months
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
0.5 mL dose, IM
Other Name: Menactra®

Experimental: Menactra® at 9 Months and Menactra® + PCV at 12 Months
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
0.5 Ml dose, IM
Other Name: Menactra®

Active Comparator: MMRV + PCV at 12 Months
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
0.5 mL dose, SC
Other Names:
  • ProQuad®
  • M-M-R®II




Primary Outcome Measures :
  1. Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) [ Time Frame: Day 30 after the 12-month vaccination ]
    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.

  2. Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 [ Time Frame: Day 30 after the 12-month vaccination ]

Other Outcome Measures:
  1. Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 [ Time Frame: Day 30 after 12-month vaccination ]
  2. Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age [ Time Frame: Days 0 to 7 after vaccination ]

    Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.

    Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.


  3. Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age [ Time Frame: Days 0 to 7 after vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 12 Months   (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) 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.

Exclusion Criteria :

  • 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
  • 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 any blood draw. Topical antibiotics and 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 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.

Information from the National Library of Medicine

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): NCT00422292


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Locations
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United States, Alabama
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
Tucson, Arizona, United States, 85741
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Atascadero, California, United States, 93422
Fresno, California, United States, 93726
Paramount, California, United States, 90723
Roseville, California, United States, 95661
Sacramento, California, United States, 95823
San Jose, California, United States, 95119
Torrance, California, United States, 90502
United States, Colorado
Aurora, Colorado, United States, 80012
United States, Connecticut
Norwich, Connecticut, United States, 06360
United States, Florida
Viera, Florida, United States, 32940
West Palm Beach, Florida, United States, 33409
United States, Georgia
Dalton, Georgia, United States, 30721
Marietta, Georgia, United States, 30062
Tifton, Georgia, United States, 31794
Woodstock, Georgia, United States, 30189
United States, Illinois
Chicago, Illinois, United States, 60614
Chicago, Illinois, United States, 60647
United States, Indiana
Fishers, Indiana, United States, 46038
United States, Iowa
Dubuque, Iowa, United States, 52001
Dubuque, Iowa, United States, 52002
United States, Kentucky
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Bossier City, Louisiana, United States, 71111
United States, Maryland
Perry Hall, Maryland, United States, 21128
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, Michigan
Niles, Michigan, United States, 49120
Stevensville, Michigan, United States, 49127
United States, Missouri
Bridgeton, Missouri, United States, 63044
Kansas City, Missouri, United States, 64108
St. Charles, Missouri, United States, 63303
St. Louis, Missouri, United States, 63104
United States, Nebraska
Bellevue, Nebraska, United States, 68123
La Vista, Nebraska, United States, 68128
Omaha, Nebraska, United States, 68117
Omaha, Nebraska, United States, 68124
Omaha, Nebraska, United States, 68131
Omaha, Nebraska, United States, 68132
United States, Nevada
Henderson, Nevada, United States, 89105
United States, New Jersey
Whitehouse Station, New Jersey, United States, 08889
United States, New York
Brooklyn, New York, United States, 11201
Fishkill, New York, United States, 12524
Hopewell Junction, New York, United States, 12533
Ithaca, New York, United States, 14850
Lake Success, New York, United States, 11021
Mineola, New York, United States, 11501
New York, New York, United States, 10016
Poughkeepsie, New York, United States, 12603
Syracuse, New York, United States, 13210
United States, North Carolina
Boone, North Carolina, United States, 28607
Clyde, North Carolina, United States, 28721
Durham, North Carolina, United States, 27704
Durham, North Carolina, United States, 27705
United States, Ohio
Beachwood, Ohio, United States, 44122
Cleveland, Ohio, United States, 44121
Cleveland, Ohio, United States, 44195
Independence, Ohio, United States, 44131
Strongsville, Ohio, United States, 44136
United States, Pennsylvania
Harleysville, Pennsylvania, United States, 19438
Hershey, Pennsylvania, United States, 17033
Pittsburgh, Pennsylvania, United States, 15220
Sellersville, Pennsylvania, United States, 18960
Wexford, Pennsylvania, United States, 15090
United States, Tennessee
Clarksville, Tennessee, United States, 37043
Kingsport, Tennessee, United States, 37660
United States, Texas
Houston, Texas, United States, 77004
Longview, Texas, United States, 75605
San Antonio, Texas, United States, 78205
San Antonio, Texas, United States, 78229
United States, Utah
Lehi, Utah, United States, 84043
Ogden, Utah, United States, 84405
Pleasant Grove, Utah, United States, 84062
Provo, Utah, United States, 84604
South Jordan, Utah, United States, 84095
Springville, Utah, United States, 84663
St. George, Utah, United States, 84790
Urem, Utah, United States, 84057
United States, Virginia
Charlottesville, Virginia, United States, 22902
Charlottesville, Virginia, United States, 22903
Charlottesville, Virginia, United States, 22911
Midlothian, Virginia, United States, 23113
Richmond, Virginia, United States, 23219
United States, West Virginia
Huntington, West Virginia, United States, 25701
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Marshfield, Wisconsin, United States, 54449
Puerto Rico
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00422292     History of Changes
Other Study ID Numbers: MTA37
First Posted: January 15, 2007    Key Record Dates
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 vaccines
Haemophilus influenzae type b
Pneumococcal conjugate vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningitis, Meningococcal
Measles
Chickenpox
Herpes Zoster
Rubella
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs