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

Primary Purpose

Meningitis, Meningococcemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Meningococcal polysaccharide diphtheria toxoid conjugate
Meningococcal polysaccharide diphtheria toxoid conjugate
Meningococcal polysaccharide diphtheria toxoid conjugate
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis focused on measuring Meningitis, Meningococcemia, Neisseria meningitidis, Menactra®

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

One-Dose Menactra Group

Two-Dose Menactra Group

Menactra vaccine-naïve Group

Arm Description

Participants received one dose of Menactra® in Study MTA26

Participants received two doses of Menactra® in Study MTA26

Participants had never received Menactra® vaccine.

Outcomes

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®
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.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2008
Last Updated
January 16, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00700713
Brief Title
Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcemia
Keywords
Meningitis, Meningococcemia, Neisseria meningitidis, Menactra®

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-Dose Menactra Group
Arm Type
Experimental
Arm Description
Participants received one dose of Menactra® in Study MTA26
Arm Title
Two-Dose Menactra Group
Arm Type
Experimental
Arm Description
Participants received two doses of Menactra® in Study MTA26
Arm Title
Menactra vaccine-naïve Group
Arm Type
Active Comparator
Arm Description
Participants had never received Menactra® vaccine.
Intervention Type
Biological
Intervention Name(s)
Meningococcal polysaccharide diphtheria toxoid conjugate
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL, IM
Intervention Type
Biological
Intervention Name(s)
Meningococcal polysaccharide diphtheria toxoid conjugate
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL, IM
Intervention Type
Biological
Intervention Name(s)
Meningococcal polysaccharide diphtheria toxoid conjugate
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL, IM
Primary Outcome Measure Information:
Title
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®
Description
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.
Time Frame
Day 0 (pre-vaccination) and Day 30 post-vaccination
Other Pre-specified Outcome Measures:
Title
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Description
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).
Time Frame
Day 0 (pre-vaccination) and Day 30 post-vaccination
Title
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Description
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.
Time Frame
Day 0 up to Day 7 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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

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