Study on pneunococcal vaccination in the pediatric population from 1 year to 5 years

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

NeumoEfect1

Scientific title:

COMMUNITY INTERVENTION TRIAL TO EVALUATE THE DIRECT AND INDIRECT EFFECTS OF PNEUMOCOCCAL VACCINATION WITH VCN7-T IN PEDIATRIC POPULATION.

Acronym of Scientific Title:

NeumoEfect1

Secondary indentifying numbers:

IFV/NEU/23/EC/01

Issuing authority of the secondary identifying numbers:

Instituto Finlay de Vacunas (IFV)

Source(s) of monetary or material support:

Finlay Vaccine Institute (IFV) Cuban Found for reserach and innovation (FONCI) of Ministry of Science, Technology and Environment (CITMA)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria

Midle name:

Eugenia

Last name:

Toledo-Romani

Medical Specialty :

First degree specialist in Integral General Medicine. Doctor of Medical Science

Affiliation:

Institute of Tropical Medicine "Pedro Kouri"

Postal address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

Email address:

mariaeugenia@ipk.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Cienfuegos, Municipal Directorate of Public Health Cienfuegos, Area I of Primary Health Care, Mercedes Seivane Alfonso (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cienfuegos, Area II of Primary Health Care, Trina María González Esquivel (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cienfuegos, Area III of Primary Health Care, Caridad Hernández Gutiérrez (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cienfuegos, Area IV of Primary Health Care, José Ariel Trujillo (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cienfuegos, Area V of Primary Health Care, Odalys de la Caridad Quintero Rodríguez (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cienfuegos, Area VI of Primary Health Care, Bladimir Arteaga Valdés (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cienfuegos, Area VII of Primary Health Care, Enrique de Jesús Fuentes Fernández (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cienfuegos, Area VIII of Primary Health Care, Deisy Celia Hernández Mora (Pediatrician)

Cienfuegos, Municipal Directorate of Public Health of Cumanayagua, Primary Health Care of Cumanayagua, Dayalieski Mesa Pérez (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Cumanayagua, Primary Health Care of San Blas, María Ocquendo (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Abreus, Primary Health Care of Abreus, Israel González Herrera (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Abreus, Primary Health Care of Yaguaramas, Talena Vázquez (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Aguada de Pasajeros, Primary Health Care of Aguada de Pasajeros, Midalis Otero Hernández (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Aguada de Pasajeros, Primary Health Care of Antonio Sánchez, Arturo Menéndez (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Rodas, Primary Health Care of Rodas, Osvaldo Castellano Robaina (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Rodas, Primary Health Care of Cartagenas, Diaspora García (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Palmira, Primary Health Care of Palmira, Idaymis Molina del Sol (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Palmira, Primary Health Care of Camarones, Luis García (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Cruces, Primary Health Care of Cruces, Zakia Matía Santana (Specialist on Familiar Medicine)

Cienfuegos, Municipal Directorate of Public Health of Lajas, Primary Health Care of Lajas, Owel Pérez Arbolay (Specialist on Familiar Medicine)

Cienfuegos, Universitary Pediatric Hospital of Cieenfuegos“Paquito González Cueto”, Mercedes Fonseca Hernández (Pediatrician)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

18/09/2023

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Pneumococcal infections, invasive pneumococcal disease and related syndromes

Health condition(s) code:

Healthy Volunteers

Pneumococcal Infections

Streptococcal Infections

Gram-Positive Bacterial Infections

Bacterial Infection

Intervention(s):

Group I (Intervention): First moment: application of the seven-valent anti-pneumococcal vaccine candidate (VCN7-T); 2 doses (0.5 ml) for all children in the Cienfuegos province from 12 months to 23 months with 29 days; with an interval of 8 weeks, intramuscular route of administration. One dose (0.5 ml) for all children in the Cienfuegos province from 2 years to 5 years, intramuscular route of administration. Second moment: hospital surveillance, for the entire pediatric population in the Cienfuegos province, of invasive pneumococcal diseases (IPD), pneumococcal pneumonia and acute otitis media (AOM) from the year after the vaccination campaign ended. Group II (No intervention): First moment: No intervention. Second moment: hospital surveillance, for the entire pediatric population in the Santiago de Cuba municipality, in the Santiago de Cuba province, of invasive pneumococcal diseases (IPD), pneumococcal pneumonia and acute otitis media (AOM) from the year after the conclusion of the vaccination campaign.

Intervention code:

Heptavalent Pneumococcal Conjugate Vaccine

Pneumococcal Vaccines

Injections, Intramuscular

Intervention keyword:

VCN7-T

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Cumulative incidence of disease cases (ENI, pneumonia and bacterial meningitis and Acute Otitis Media). operationalization: proportion of cases (# cases of disease / total population x 1000). Measurement time: one year and 3 years

Key secondary outcomes:

Adverse events supposedly attributable to vaccination (ESAVI) with VCN7-T (ESAVI rate (# of subjects with ESAVI / Total doses administered in the campaign x 1000)). Measurement time: 30 days after each administered dose of VCN7-T. Global antimicrobial resistance due to pneumococcus (Proportion of cases (# cases with antimicrobial resistance / total cases sampled x 100)). Measurement time: one year and 3 years

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

12 months

Maximum age:

5 years

Inclusion criteria:

1. Children 1-5 years old residing in the health areas of the Province. 2. Children whose parents sign the informed consent for vaccination and follow-up

Exclusion criteria:

1. Children previously vaccinated with any pneumococcal vaccine or participants in previous studies with the VCN7-T vaccine candidate. 2. Children with decompensated chronic diseases according to clinical criteria. 3. Children with a known allergy to thiomersal

Type of population:

Children

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Other

Other design:

Non-randomized community intervention trial of non-equivalent groups

Phase:

N/A

Target sample size:

18771

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Beatriz

Last Name:

Paredes-Moreno

Specialty:

Pharmaceutical

Affiliation:

Finlay Institute of Vaccines

Postal Address:

Ave. 21 No. 19810 e/ 198 y 200, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717389

Email :

bparedes@finlay.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maria

Middle Name:

Eugenia

Last Name:

Toledo Romani

Specialty:

First degree specialist in Integral General Medicine. Doctor of Medical Science

Affiliation:

Instituto de Medicina Tropical “Pedro Kouri”

Postal Address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

Email :

mariaeugenia@ipk.sld.cu [1]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Pediatric Hospital "Paquito González Cueto"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

19/05/2023

Postal address of Ethic Committee :

39 street 3602 b/ 36 and 38. ZC55100. Cienfuegos, Cuba

Telephone:

+53-43516170

Email:

director@hosped.cfg.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

14/12/2026

Date of available results:

28/01/2027

Date of first publication:

17/05/2027

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000428

Date of Registration in Primary Registry:

03/08/2023

Record Verification Date:

2023/08/03

Next update date:

2024/08/03

Link to the spanish version:

Click here [3]