Dose Comparison Study of Menactra® in US Children

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

Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.

Primary Objective:

To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Study Type

Interventional

Enrollment (Actual)

333

Phase

  • Phase 2

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

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
    • Florida
      • Boca Raton, Florida, United States, 33433
      • Viera, Florida, United States, 32940
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • Ohio
      • Cleveland, Ohio, United States, 44121
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Fort Worth, Texas, United States, 76135
      • San Antonio, Texas, United States, 78205
    • Utah
      • Orem, Utah, United States, 84057
    • Virginia
      • Midlothian, Virginia, United States, 23113
    • Washington
      • Spokane, Washington, United States, 99202

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

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Aged 2 to < 11 years on the day of inclusion.
  • Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
  • Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
  • Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
  • Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Receipt of blood or blood-derived products in the past 3 months.
  • Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
  • Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
  • History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
  • Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
  • Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
  • Personal or family history of Guillain-Barré Syndrome (GBS).
  • 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.

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: Menactra® Group 1
Participants aged 2 to < 4 years
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Other Names:
  • Menactra®
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 1 dose Intramuscular
Other Names:
  • Menactra®
Experimental: Menactra® Group 2
Participants aged 4 to < 6 years
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Other Names:
  • Menactra®
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 1 dose Intramuscular
Other Names:
  • Menactra®
Active Comparator: Menactra® Group 3
Participants aged 6 to < 11 years
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Other Names:
  • Menactra®
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 1 dose Intramuscular
Other Names:
  • Menactra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Time Frame: 30 days post-vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
30 days post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Time Frame: 30 days post-vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
30 days post-vaccination
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Time Frame: 30 days post-vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
30 days post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Time Frame: 7 days post-vaccination 1
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
7 days post-vaccination 1
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Time Frame: 7 days post-vaccination 2
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
7 days post-vaccination 2

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

June 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA61

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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