RPCEC00000173
Completed
Phase 1
Safety and immunogenicity of Heptavalent Conjugate Vaccine against Pneumococcal in healthy infants and children. Phase I.
Biomolecular Chemistry Center (CQB)0 sitesOctober 31, 2013
ConditionsPneumococcal infection
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pneumococcal infection
- Sponsor
- Biomolecular Chemistry Center (CQB)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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