Dose Comparison Study of Menactra® in US Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00700635
First received: May 7, 2008
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Meningitis
Meningococcal Infection
Neisseria Meningitidis
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: No ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)


Secondary Outcome Measures:
  • Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: No ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)

  • Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: No ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)

  • Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination [ Time Frame: 7 days post-vaccination 1 ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

  • Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination [ Time Frame: 7 days post-vaccination 2 ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.


Enrollment: 333
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menactra® Group 1
Participants aged 2 to < 4 years
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Other Name: Menactra®
Experimental: Menactra® Group 2
Participants aged 4 to < 6 years
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Other Name: Menactra®
Active Comparator: Menactra® Group 3
Participants aged 6 to < 11 years
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 1 dose Intramuscular
Other Name: Menactra®

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.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700635

Locations
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, Florida
Boca Raton, Florida, United States, 33433
Viera, Florida, United States, 32940
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, Ohio
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Fort Worth, Texas, United States, 76135
San Antonio, Texas, United States, 78205
United States, Utah
Orem, Utah, United States, 84057
United States, Virginia
Midlothian, Virginia, United States, 23113
United States, Washington
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00700635     History of Changes
Other Study ID Numbers: MTA61
Study First Received: May 7, 2008
Results First Received: December 11, 2010
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis; Meningococcal infection, Neisseria meningitidis

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014