Clinical trial NCT00700713: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis
Meningococcemia
Keywords: Meningitis
Meningococcemia
Neisseria meningitidis
Menactra®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 181
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
timeFrame: Day 0 (pre-vaccination) and Day 30 post-vaccination
measure: Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
timeFrame: Day 0 up to Day 7 post-vaccination
Locations:
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Annapolis
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Woburn
country: United States
state: Massachusetts
city: Greenville
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Layton
country: United States
state: Utah
city: Provo
country: United States
state: Utah
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: