Safety and immunogenicity of VCN7-T in infants of 2 and 3 months. Phase I/II.

Phase 1

• Conditions: Pneumococcal disease; Healthy Volunteers; Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections

• Registration Number: RPCEC00000243
• Lead Sponsor: Finlay Institute Vaccine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified