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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Meningitis; Meningococcemia

Treatments: Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700713

MTA62

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 3 patient groups

One-Dose Menactra Group

Experimental group

Description:

Participants received one dose of Menactra® in Study MTA26

Treatment:

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Two-Dose Menactra Group

Experimental group

Description:

Participants received two doses of Menactra® in Study MTA26

Treatment:

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Menactra vaccine-naïve Group

Active Comparator group

Description:

Participants had never received Menactra® vaccine.

Treatment:

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate