Phase III study of the Cuban vaccine candidate VCN7-T in patients from 1 to 18 years of age at risk of pneumococcal disease in Havana

Phase 3

Not yet recruiting

• Conditions: Pneumococcal diseases; VCN7-T; Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections

• Registration Number: RPCEC00000432
• Lead Sponsor: Finlay Vaccine Institute (FVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-04
• Last Update Posted: 2024-08-19
• Study Completion: 2027-03-11
• Results First Posted: 2027-11-17

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients from 1 to 18 years of age, of any sex, from the province of Havana, identified in risk groups for pneumococcal disease.
2. Informed consent of parents and assent of adolescents for vaccination and follow-up.

Exclusion Criteria

1. Previous pneumococcal vaccination.
2. Children with a reported allergy to thiomersal or any biological product or vaccines causing a serious adverse reaction of the anaphylaxis type.
3. Decompensation of the underlying disease at the time of evaluation.
4. Subjects with febrile or acute infectious illness at the time of application of the vaccine candidate, or in the previous 7 days.
5. Subjects vaccinated according to the Cuban immunization schedule, in a period of less than 15 days prior to the application of the investigational product.
6. Adolescents who are pregnant or have amenorrhea greater than 4 weeks before the application of the vaccine candidate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified