Controlled, randomized and double-blind study to assess the immunogenicity and reactogenicity of a supporting dose of the TETANUS vaccines vax-TET®-5 under study and vax-TET® used as a control, administered in adolescents.

Finlay Institute, Center of Research and Production of Vaccines.0 个研究点目标入组 472 人开始时间: 2013年6月10日最近更新: 2024年8月19日

适应症

试验速览

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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

•Healthy adolescents of both sexes from 13 years to 15 years. - Signature of the informed consent. - Antecedent of vaccination according to National Vaccination program of the MINSAP. - Good health condition, established for the practitioner criterion, via physical examination.

•- Be under processing immunosuppressive (more than 14 days) or another type of medication such as steroids for inhalation that it modifies the immunological state, excluding topical steroids. - Administration of a vaccination not considered in the protocol, 30 days sooner or later of the application of the vaccination in study. - Any suspected or confirmed condition of immunosuppression or immunodeficiency, including a positive examination to the human immunodeficiency virus (1 HIV-1 and 2). - Allergy or exacerbated reaction history to any component of the vaccination of the study. - History of some neurological or convulsions illness. - Acute illness presence severe or moderate (with or without fever) at the time of its incorporation to the study. - Use of some experimental drug 30 days before the study initiated or during its development. - Axillary temperature ³ 37,5 0C before vaccination. - Pregnancy.

发起方

Finlay Institute, Center of Research and Production of Vaccines.