Safety and immunogenicity of Heptavalent Conjugate Vaccine against Pneumococcal in healthy infants and children. Phase I.

Biomolecular Chemistry Center (CQB)0 个研究点开始时间: 2013年10月31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: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention

年龄范围: 1st Stage: 4 years 2nd Stage: 7 months 至 1st Stage: 5 years 2nd Stage: 8 months（—）
性别: All

•1. Children whose parents or guardians sign the Informed Consent.
•2. Children 4-5 years old.
•3. Healthy Children, established by medical criteria, by physical examination, medical history and personal and family history.
•4. Nutritional assessment greater than the 10th percentile and less than 90 on the weight and size.
•- 2nd Stage.
•1. Infants whose parents or guardians sign the Informed Consent.
•2. Infants 7-8 months old.
•3. Healthy infants, medically established by physical examination, medical history and personal and family history.
•4. Nutritional assessment greater than the 10th percentile and less than 90 on the weight and size.
•5. Birth weight greater than or equal to 2500 grams.
•6. Birth Apgar of 8-10 and 9-10 at five minutes after birth.
•7. Gestational age equal to or greater than 37 weeks at delivery.

•1. Acute infectious disease at the time of application of the vaccine or within 7 days prior to administration of the vaccine.
•2. Use of any investigational product within 30 days prior to immunization.
•3. Children at 7 months with incomplete immunization scheme.
•4. History of immunosuppressive or immunostimulatory in the 30 days prior to administration of the VCN7-T.
•5. History of treatment with blood as blood transfusion, plasma, whole blood or platelet concentrate at any time in their life.
•6. Background of anaphylaxis after administration of a vaccine or as Thiomersal mercurial products.
•7. A history of immunosuppressive disease, congenital or acquired.
•8. History of severe allergic reactions or illnesses.
•9. History of thrombocytopenia or coagulopathy.
•10. History of neurological diseases with febrile seizures or not.
•11. Major congenital malformations.
•12. Children with a history of chronic disease.
•13. Children with a history of having been immunized with a vaccine against Streptococcus pneumoniae.

发起方

Biomolecular Chemistry Center (CQB)