A phase II, double-blind, randomized, controlled study to evaluate the reactogenicity and immunogenicity of a booster dose of the Cuban adult formulation tetanus and diphtheria vaccine (adult d.T.) and the control vaccine, IMOVAX d.T. adult, in adolescents.

Finlay Institute0 个研究点目标入组 225 人开始时间: 2008年7月29日最近更新: 2024年8月19日

研究概览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention

•1-A male or female over, and including, 13 years of age at the time of the vaccination. 2-Written informed consent obtained from the parents or guardians. 3-Free from obvious health problems as established by medical history and clinical examination before entering into the study.

•1-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the vaccination. Inhaled and topical steroids are allowed. 2-Administration of a vaccine not foreseen by the study protocol during the period starting one month before the application of the study vaccine and ending one month after that application. 3-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 4-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 5-History of any neurological disorders or seizures. 6-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 7-Use of any investigational or non-registered drug other than the study vaccine within 30 days preceding the single dose of the study vaccine, or planned use during the study period. 8-Pregnancy or breastfeeding. 8-Axillary temperature of >=37.5°C before vaccination.

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