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

Not Applicable

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

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

Primary Outcome Measures

Name	Time	Method
Global nasopharyngeal colonization (CNF) by pneumococcal serotypes (Proportion of subjects with CNF (# colonized / total population x 100)). Measurement time: every 6 months<br>Cumulative incidence of cases of disease-ENI, pneumonia and bacterial meningitis and Acute Otitis Media (Proportion of cases (# disease cases / total population x 1000)). Measurement time: annually<br><br><br>

Secondary Outcome Measures

Name	Time	Method
Adverse events attributable to vaccination (ESAVI) with VCN7-T (ESAVI rate (# of subjects with ESAVI / Total doses administered in the x 1000 campaign)). Measurement time: 30 days post vaccination. <br>Global antimicrobial resistance by pneumococcus (Proportion of cases (# cases with antimicrobial resistance / total of cases sampled x 100)). Measurement time: annually<br>Nasopharyngeal colonization by vaccine and non-vaccine pneumococcal serotypes (Proportion of subjects with CNF (colonized # total population surveyed x 100)). Measurement time: every 15 days in newborns and every 6 months in children aged 1-5 years.<br>