Heptavalent Conjugate Vaccine against Pneumococcal in healthy adults (VCN7-T).

Phase 1

• Conditions: Pneumococcal infection.

• Registration Number: RPCEC00000133
• Lead Sponsor: Biomolecular Chemistry Center (CQB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Subjects aged between 18 and 35 (including the limit ages) 2. General, regional and specific physical examination without any alteration. 3. Vital signs within the following limits: - Sistolic Blood Pressure < 140 mmHg - Diastolic Blood Pressure < 90 mmHg - Heart rate80 ± 20 per minute - Respiratory rate16 ± 4 per minute - Temperature< 37 0C 4. Subject with hemoglobin rate above 12.5 g/L and other laboratory findings within the range of reference values. 5. Body Mass Index (BMI) between 18.5 and 29.9 (including the limits). 6. Subjects who express their consent to participate in the study written.

Exclusion Criteria

1. Chronic diseases such as Asthma, Chronic Obstructive Pulmonary Disease (COPD), Ischemic Heart Disease, High Blood Pressure (hypertension), Diabetes mellitus (DM), thyroid disease, Epilepsy, neuropathies or diseases of the haemolymphopoietic system. 2. Immunosuppresive diseases, either congenital or acquired. 3. Fever or acute infection within ten (10) days prior to vaccination or upon the shot. 4. Severe allergic disease or immune system diseases. 5. Renal and / or hepatic failure. 6. Hypersensitivity to thimerosal or any of the other components of the formulation. 7. Mentally handicapped 8. Convulsive encephalopathies 9. Immunostimulatory or immunosuppressive therapy, blood products or other vaccinations in a period of 2 months 10. Subject with a history of previous vaccination against Streptococcus pneumoniae 11. Alcoholism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified