Evaluation of the safety and immunogenicity of the pentavalent vaccine candidate against pneumococcus (VCN7-T) in different administration regimens to infants. Phase I/II”. - SILAC

Finlay Institute Vaccine0 个研究点目标入组 880 人开始时间: 2017年4月28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

•1. Infants whose parents or legal guardians sign the Informed Consent.
•2. Infant of 2 and 3 months of age after questioning and physical examination practiced by the Clinical Investigator.
•3. Weight-height nutritional assessment above the 10th percentile.
•4. Birth weight greater than or equal to 2500 grams.
•5. Apgar equal or greater than 7 at birth and equal or greater than 8 at five minutes of birth.
•6. Maternal gestational age equal to or greater than 37 weeks at the time of delivery.

•1. Infectious diseases at moment of vaccination or 7 days before vaccination.
•2. Previous use of any investigation product or any product 30 days before vaccination.
•3. History of immune suppressor or immune stimulant treatment 30 days before vaccination.
•4. History of use of blood products like blood transfusions, plasma, whole blood, platelet concentrate, gamma globulins and transfer factor at any time of lives.
•5. History of anaphylaxis reactions related with the use Thiomersal or other pharmaceutical products.
•6. History of severe allergic diseases or reactions.
•7. History of immunosuppressive, congenital or acquired disease.
•8. Infants with febrile convulsions history.
•9. Diseases or mayor genetic defects.
•10. History of chronic diseases as Asthma Bronquial, Diabetes Mellitus, Epilepsy, Allergic Dermatitis, encephalopathy and others.
•11. Immunization with any Streptococcus pneumoniae vaccine.
•12. History of vaccination with any vaccine 15 days before the administration of research product.
•13. Mother less than 18 years old or mental disability.

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