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

Community intervention trial to evaluate direct and indirect effect of pneumococcal vaccine VCN7-T in pediatric population of Cienfuegos, 2017-2021 - NeumoEfect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000255
Enrollment
Unknown
Registered
2017-10-13
Start date
2017-10-16
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal infections, invasive pneumococcal disease and related syndromes Pediatrics

Interventions

Intervention: Pneumococcal vaccination with VCN7-T addressing children between 1 and 5 y/o of Cienfuegos province through a massive campaign short time and high coverage (>=90%). Vaccine: Penumococca
Pneumococcal Vaccines
Injections, Intramuscular
VCN7-T

Sponsors

Finlay Vaccine Institute (IFV)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Months to 5 Years

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Global nasopharyngeal colonization (CNF) by pneumococcal serotypes (Proportion of subjects with CNF (# colonized / total population x 100)). Measurement time: every 6 months 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—

Secondary

MeasureTime frame
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. Global antimicrobial resistance by pneumococcus (Proportion of cases (# cases with antimicrobial resistance / total of cases sampled x 100)). Measurement time: annually 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.—

Countries

Cuba

Contacts

Public ContactBeatriz Paredes-Moreno

Clinical Research and Impact Evaluation Division at Finlay Vaccine Institute

bparedes@finlay.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026