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 sites880 target enrollmentApril 28, 2017

Overview

No summary available.

Registry

who.int

Start Date

April 28, 2017

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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.