Immunogenicity and efficacy of Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children. Phase II/III. - ISCANI

Biomolecular Chemistry Center (CQB)0 个研究点目标入组 1,140 人开始时间: 2014年8月6日最近更新: 2024年8月19日

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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

年龄范围: 1st Stage: 2 years, 2nd Stage: 12 months 至 1st Stage: 5 years, 2nd Stage: 23 months （—）
性别: All

•1. Children 2-5 years old in the first stage and 12 to 23 months in the second, residents in municipality Cienfuegos, whose health condition, established by medical criteria, by physical examination, medical history and personal and family history.
•2. Children whose parents or guardians sign the Informed Consent.
•3. Nutritional assessment greater than the 3rd percentile.

•1. Acute infectious disease at the time of application of the vaccine or within 7 days prior to administration of the vaccine. ( It may wait until 7 days after the date corresponding vaccination to apply the same to the case of the second dose).
•2. Major congenital malformations diseases.
•3. History of decompensated or chronic disease treatment as usual .
•4. History of immunosuppressive or immunostimulatory in the 30 days prior to administration of the VCN7-T.
•5. History of severe allergic reactions or illnesses or immune system diseases.
•6. Background of anaphylaxis after administration of a vaccine or as Thiomersal mercurial products.
•7. Children with a history of having been immunized with a vaccine against Streptococcus pneumoniae.
•8. Children with history of Febrile Seizure disease .
•9. Use of any investigational product within 30 days prior to immunization.
•10.History of treatment with blood as blood transfusion, plasma, whole blood or platelet concentrate at any time in their life.
•11. Children with a history of having been immunized with any vaccine in the vaccination scheme Cuban 30 days prior to the administration of the vaccine.

发起方

Biomolecular Chemistry Center (CQB)