Community intrevention trial with VCN7-T in pediatric population, 2017-2021 (NeumoEfect)

Not Applicable

Not yet recruiting

• Conditions: Pneumococcal infections, invasive pneumococcal disease and related syndromes; Pediatrics; Bacterial Infection; Gram-Positive Bacterial Infections; Streptococcal Infections; Pneumococcal Infections

• Registration Number: RPCEC00000255
• Lead Sponsor: Finlay Vaccine Institute (IFV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-13
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

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

Inclusion Criteria

Eligibility criteria for clusters selection (health áreas)
•Availability of research product (VCN7-T vaccine candidate) to reach a coverage =95% of eligible population
•Prevalence of NP colonization global and by serotype
•Included on Pneumococci sentinel surveillance network

Inclusion criteria for vaccination
•Children 1-5 y/o living in Cienfuegos province
•Informed consent for vaccination and follow up

Inclusion criteria for follow up
•Children 0-5 y/o with parent consent

Exclusion Criteria

Exclusion criteria for vaccination
•Previous pneumococcal vaccination
•Children with chronic disease, according clinical criteria.
•Allergy to thiomersal

Study & Design

• Study Type: Interventional
• Study Design: Not specified