Clinical trial to evaluate the reactogenicity profile of the Cuban trivalent vaccine against diphtheria, tetanus and pertussis infections in infants, during its application in the National Program of Immunizations.

Finlay Institute0 个研究点目标入组 57 人开始时间: 2008年7月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Placebo. Assignment: Single group. Purpose: Treatment

•1-A male or female infant of 2, 4, and 6 months of age that requires the first, second or third doses of DTP vaccine according to the planned schedule of 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-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. 2-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 3-Axillary temperature of >=37.5°C before vaccination. 4-History of any neurological disorders, seizures or hypotonic hyporesponsiveness episode. 5-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 6-Premature infant. 7-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 8-A family history of congenital immunodeficiency. 9-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.

发起方