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Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00700713
First received: May 7, 2008
Last updated: January 16, 2016
Last verified: January 2016
  Purpose

Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants.

Objectives:

  • To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26.
  • To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects.
  • To describe the safety profile of a single dose of Menactra® vaccine in subjects.

Condition Intervention Phase
Meningitis
Meningococcemia
Biological: Meningococcal polysaccharide diphtheria toxoid 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: Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Three Years Earlier in Study MTA26

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ] [ Designated as safety issue: No ]
    Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.


Other Outcome Measures:
  • Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ] [ Designated as safety issue: No ]
    Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).

  • Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.


Enrollment: 181
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One-Dose Menactra Group
Participants received one dose of Menactra® in Study MTA26
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra®
Experimental: Two-Dose Menactra Group
Participants received two doses of Menactra® in Study MTA26
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra®
Active Comparator: Menactra vaccine-naïve Group
Participants had never received Menactra® vaccine.
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra®

Detailed Description:
Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.
  Eligibility

Ages Eligible for Study:   3 Years to 6 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received
  • At 3 to < 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine).
  • Informed consent form signed and dated by the parent(s) or another legally acceptable representative.
  • Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria :

  • 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 study 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.
  • Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or 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.
  • Received 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 study vaccination.
  • Planned receipt of any vaccine within the 4 weeks following the study vaccination.
  • 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: NCT00700713

Locations
United States, Georgia
Marietta, Georgia, United States, 30062
Woodstock, Georgia, United States, 30189
United States, Kentucky
Bardstown, Kentucky, United States, 40004
United States, Maryland
Annapolis, Maryland, United States, 21401
Frederick, Maryland, United States, 21702
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, Pennsylvania
Greenville, Pennsylvania, United States, 16125
Harleysville, Pennsylvania, United States, 19438
Pittsburgh, Pennsylvania, United States, 15227
Pittsburgh, Pennsylvania, United States, 15236
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Utah
Layton, Utah, United States, 84041
Provo, Utah, United States, 84604
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00700713     History of Changes
Other Study ID Numbers: MTA62 
Study First Received: May 7, 2008
Results First Received: January 16, 2016
Last Updated: January 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcemia
Neisseria meningitidis
Menactra®

Additional relevant MeSH terms:
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016