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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 6
Updated:4/21/2016
Start Date:June 2008
End Date:March 2009

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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 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.

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.

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.
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