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

NCT ID: NCT00700713

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-03-31

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.

Conditions

Meningitis; Meningococcemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

One-Dose Menactra Group

Participants received one dose of Menactra® in Study MTA26

Group Type: EXPERIMENTAL

Meningococcal polysaccharide diphtheria toxoid conjugate

Intervention Type: BIOLOGICAL

0.5 mL, IM

Two-Dose Menactra Group

Participants received two doses of Menactra® in Study MTA26

Group Type: EXPERIMENTAL

Meningococcal polysaccharide diphtheria toxoid conjugate

Intervention Type: BIOLOGICAL

0.5 mL, IM

Menactra vaccine-naïve Group

Participants had never received Menactra® vaccine.

Group Type: ACTIVE_COMPARATOR

Meningococcal polysaccharide diphtheria toxoid conjugate

Intervention Type: BIOLOGICAL

0.5 mL, IM

Interventions

Meningococcal polysaccharide diphtheria toxoid conjugate

0.5 mL, IM

Intervention Type: BIOLOGICAL

Meningococcal polysaccharide diphtheria toxoid conjugate

0.5 mL, IM

Intervention Type: BIOLOGICAL

Meningococcal polysaccharide diphtheria toxoid conjugate

0.5 mL, IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Menactra®; Menactra®; Menactra®

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Marietta, Georgia, United States

Woodstock, Georgia, United States

Bardstown, Kentucky, United States

Annapolis, Maryland, United States

Frederick, Maryland, United States

Woburn, Massachusetts, United States

Greenville, Pennsylvania, United States

Harleysville, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Kingsport, Tennessee, United States

Layton, Utah, United States

Provo, Utah, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

MTA62

Identifier Type: -

Identifier Source: org_study_id