Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.

Safety Objective:

To describe the safety profile of two doses of Menactra® Vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1378

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
      • Santiago de Chile, Chile
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
      • Birmingham, Alabama, United States, 35244
      • Dothan, Alabama, United States, 36305
      • Pinson, Alabama, United States, 35126
      • Tuscaloosa, Alabama, United States, 35406
    • Arizona
      • Chandler, Arizona, United States, 85234
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
      • Conway, Arkansas, United States, 72034
      • Hardy, Arkansas, United States, 72542
      • Jonesboro, Arkansas, United States, 72401
    • California
      • Downy, California, United States, 90241
      • Fountain Valley, California, United States, 92708
      • Huntington Beach, California, United States, 92647
      • Huntington Park, California, United States, 90255
      • LaCosta, California, United States, 92009
      • LaJolla, California, United States, 92037
      • Pico Rivera, California, United States, 90660
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Longmont, Colorado, United States, 80501
      • Thornton, Colorado, United States, 80233
    • Florida
      • Lake Mary, Florida, United States, 32746
      • Tampa, Florida, United States, 33614
    • Georgia
      • Stone Mountain, Georgia, United States, 30087
    • Idaho
      • Boise, Idaho, United States, 83704
    • Indiana
      • Evansville, Indiana, United States, 47710
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Wichita, Kansas, United States, 67207
    • Kentucky
      • Lexington, Kentucky, United States, 40503
      • Louisville, Kentucky, United States, 40202
      • Louisville, Kentucky, United States, 40207
      • Louisville, Kentucky, United States, 40272
    • Massachusetts
      • Fall River, Massachusetts, United States, 02724
    • New Jersey
      • Clifton, New Jersey, United States, 07013
    • New York
      • Endwell, New York, United States, 13760
      • Liverpool, New York, United States, 13088
      • Utica, New York, United States, 13502
    • North Carolina
      • Garner, North Carolina, United States, 27529
      • Raleigh, North Carolina, United States, 27615
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58104
      • Minot, North Dakota, United States, 58701
    • Ohio
      • Cincinnati, Ohio, United States, 45245
      • Fairfield, Ohio, United States, 45014
      • Huber Heights, Ohio, United States, 45424
      • Kettering, Ohio, United States, 45429
      • Mason, Ohio, United States, 45040
      • Poland, Ohio, United States, 44514
      • Youngstown, Ohio, United States, 44505
    • Pennsylvania
      • Meadowbrook, Pennsylvania, United States, 19046
      • Philadelphia, Pennsylvania, United States, 19114
      • Philadelphia, Pennsylvania, United States, 19116
      • Pittsburgh, Pennsylvania, United States, 15217
    • Rhode Island
      • Barrington, Rhode Island, United States, 02806
      • Providence, Rhode Island, United States, 02903
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Barnwell, South Carolina, United States, 29812
      • Mount Pleasant, South Carolina, United States, 29464
    • South Dakota
      • Watertown, South Dakota, United States, 57201
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Jackson, Tennessee, United States, 38305
      • Tullahoma, Tennessee, United States, 37388
    • Texas
      • Amarillo, Texas, United States, 79106
      • Amarillo, Texas, United States, 79124
      • Carrollton, Texas, United States, 75007
      • Fort Worth, Texas, United States, 76012
      • Grapevine, Texas, United States, 76057
      • Houston, Texas, United States, 77065
      • Houston, Texas, United States, 77084
      • San Antonio, Texas, United States, 78229
      • Sugar Land, Texas, United States, 77479
      • Tomball, Texas, United States, 77375
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
      • West Valley City, Utah, United States, 84120
    • Virginia
      • Newport News, Virginia, United States, 23606
      • Norfolk, Virginia, United States, 23507
      • Vienna, Virginia, United States, 22180
    • Washington
      • Bellingham, Washington, United States, 98226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (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 305 days) or 12 months (365 to 400 days) at the time of enrollment
  • The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/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.
  • Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine.
  • 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.
  • Suspected or known hypersensitivity to any of the vaccine components.
  • 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 the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).
  • 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.

For the subjects scheduled to provide blood samples:

- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Menactra® and Routine Pediatric Vaccines
Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months.
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM at age 9 and 12 months
Other Names:
  • Menactra®
Biological: Measles-mumps-rubella-varicella vaccine
0.5 mL, intramuscular at 12 months of age
Other Names:
  • MMRV: ProQuad
Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV)
0.5 mL, Intramuscular at age 12 months
Other Names:
  • Pneumococcal conjugate (PCV),
Biological: Routine paediatric vaccine - Hepatitis A
0.5 mL, Intramuscular at age 12 months
Other Names:
  • Hepatitis A
Other: Group 2: Routine Pediatric Vaccines
Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
Biological: Measles-mumps-rubella-varicella vaccine
0.5 mL, intramuscular at 12 months of age
Other Names:
  • MMRV: ProQuad
Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV)
0.5 mL, Intramuscular at age 12 months
Other Names:
  • Pneumococcal conjugate (PCV),
Biological: Routine paediatric vaccine - Hepatitis A
0.5 mL, Intramuscular at age 12 months
Other Names:
  • Hepatitis A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Time Frame: Day 0 to 7 Post-vaccination

Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.

Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
Day 0 to 7 Post-vaccination

Other Outcome Measures

Outcome Measure
Time Frame
Safety Overview After Any Vaccination in Participants Who Received MMR+V
Time Frame: Day 0 to 7 Post-vaccination
Day 0 to 7 Post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 6, 2007

First Posted (Estimate)

June 7, 2007

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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