Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy infants and children.

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1st Stage.
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.

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.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event (AE). Measuring time: 3 hours after each immunization and at 24, 48, 72 hours, 7, 21 and 30 days. <br>- Description of the expected AE (Nominal): Any sign or symptom that appears after the vaccination and 30 days before it is declared as AE expected. <br>- Description of the unexpected AE (Nominal): Any signs or symptoms that appear after the before vaccination and 30 days is not expected within the AE. <br>- Duration of AE (Ordinal): <= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours. <br>- Emergence of AE (Ordinal): <= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours. <br>- Intensity of AE (mild, moderate, severe). <br>- Severity of AE (Grave / Serious, not serious). <br>- Results of AE (recovered, recovered with sequelae, persistence, death or unknowns). <br>- Causality relationship (very likely or certain, probable, possible, unlikely, not related, not classifiable).

Secondary Outcome Measures

Name	Time	Method
Anti-PSC Concentration for each serotype: Undetectable (0 µg / mL) to the upper limit of quantification of the method. <br>Measurement time: -First Stage: before and 30 days post-vaccination. -Second Stage: 30 days after the prime dose and 30 days after booster<br>Opsonofagocitic Antibody titer anti-PsC for each serotype: From 1/4 to the highest dilution of serum that inhibits bacterial growth at 50%. <br>Measurement time: <br>-First Stage: before and 30 days post-vaccination.<br>-Second Stage: 30 days after the prime dose and 30 days after booster