Evaluation of the safety, immunogenicity and clinical effectiveness of the application of the Cuban anti-pneumococcal vaccine candidate PCV7-T, in patients from one to 18 years of age at risk of pneumococcal disease in the province of Havana. Phase III - NRH/24

Finlay Vaccine Institute (FVI)0 个研究点开始时间: 2023年10月4日最近更新: 2024年8月19日

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Prevention

•1. Patients from 1 to 18 years of age, of any sex, from the province of Havana, identified in risk groups for pneumococcal disease.
•2. Informed consent of parents and assent of adolescents for vaccination and follow-up.

•1. Previous pneumococcal vaccination.
•2. Children with a reported allergy to thiomersal or any biological product or vaccines causing a serious adverse reaction of the anaphylaxis type.
•3. Decompensation of the underlying disease at the time of evaluation.
•4. Subjects with febrile or acute infectious illness at the time of application of the vaccine candidate, or in the previous 7 days.
•5. Subjects vaccinated according to the Cuban immunization schedule, in a period of less than 15 days prior to the application of the investigational product.
•6. Adolescents who are pregnant or have amenorrhea greater than 4 weeks before the application of the vaccine candidate.

发起方

Finlay Vaccine Institute (FVI)