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

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:

NeumoEfect

Scientific title:

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

Acronym of Scientific Title:

NeumoEfect

Secondary indentifying numbers:

IFV/NEU/17/ECI/01

Issuing authority of the secondary identifying numbers:

Finlay Vaccine Institute (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)

Authorization date :

28/08/2017

Reference number:

37.00117BF4

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 :

Family Medicine

Affiliation:

Tropical Medicine Institute "Pedro Kouri"

Postal address:

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

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-72553204

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)

Santiago de Cuba, Municipal Directorate of Public Health of Santiago de Cuba, Primary Health Care of Camilo Torres, Yaquelin Rigal (Specialist on Familiar Medicine)

Santiago de Cuba, Municipal Directorate of Public Health of Santiago de Cuba, Primary Health Care of López Peña, Pablo Fernández (Specialist on Familiar Medicine)

Santiago de Cuba, Municipal Directorate of Public Health of Santiago de Cuba, Primary Health Care of 28 de septiembre, Antonio Martínez (Specialist on Familiar Medicine)

Santiago de Cuba, Municipal Directorate of Public Health of Santiago de Cuba, Primary Health Care of Distrito José Martí, Niurka Trava Delis (Specialist on Familiar Medicine)

Santiago de Cuba, Municipal Directorate of Public Health of Santiago de Cuba, Primary Health Care of Grimau, Rebeca Fernández (Specialist on Familiar Medicine)

Santiago de Cuba, Municipal Directorate of Public Health of Santiago de Cuba, Primary Health Care of Armando García, Lourma Infantes (Specialist on Familiar Medicine)

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

Cienfuegos, Provintial Center of Hygiene, Epidemiology and Microbiology Cienfuegos, Sadis Suárez (Epidemiologíst)

Santiago de Cuba, Universitary Pediatric Hospital of Santiago de Cuba, “Juan de la Cruz Martínez Maceira” (Pediatric Hospital North), Josefina Herrera López (Pediatrician)

Santiago de Cuba, Universitary Pediatric Hospital of Santiago de Cuba “Antonio María Beguez Cesar” (Pediatric Hospital South), Caridad Tamayo (Pediatrician)

Santiago de Cuba, Provintial Center of Hygiene, Epidemiology and Microbiology Santiago, Mariela Sedeños (Epidemiologíst)

Research ethics committees:

University of Medical Science of Cienfuegos, March 20 and April 26, 2017. Scope: centralized for follow-up in the study field in Cienfuegos

Tropical Medicine Institute “Pedro Kouri”-IPK, Revision date: Pending result. Scope: centralized for initial approval and annual follow-up of study results

Provintial Center of Hygiene, Epidemiology and Microbiology Santiago, Revision date: pending result, centralized for . Scope: centralized for follow-up in the study field in Santiago de Cuba

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

16/10/2017

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:

Pneumococcal Infections

Streptococcal Infections; ;

Gram-Positive Bacterial Infections

Bacterial Infection

Health condition keyword:

Pediatrics

Intervention(s):

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: Penumococcal heptavalente vaccine candidate (VCN7-T) Dose and Schedule: 1 dose (children 2-5 years) 2 dose (children12-23 months), interval 8 weeks. Administration route: intramuscular Duration of intervention: 6 -8 months (2 steps) Groups Intervention clusters (Cienfuegos province): 20. First step: 4 cluster Second step 16 clusters. Control clusters: First step: Internal control: 16 clusters (Cienfuegos province) and, external Control: 6 clusters (Santiago de Cuba municipality) Second step: External Control: 6 clusters (Santiago de Cuba municipality)

Intervention code:

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):

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

Key secondary outcomes:

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.

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:

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

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:

Quasi-experimental study combining: a) Non randomized cluster community intervention trial (intervention site) and b) multiple time series study of pneumococcal disease-related (intervention and control sites)

Phase:

N/A

Target sample size:

22,714 children (For vaccination) and 2,400 (for follow up)

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:

Clinical Research and Impact Evaluation Division at Finlay Vaccine Institute

Postal Address:

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

City:

Havana

País:

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:

Nivaldo

Last Name:

Linares-Perez

Specialty:

Epidemiology

Affiliation:

Clinical Research and Impact Evaluation Division at Finlay Vaccine Institute

Postal Address:

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

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72717389

Email :

nlinares@finlay.edu.cu [3]

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:

RPCEC00000255

Date of Registration in Primary Registry:

13/10/2017

Record Verification Date:

2017/10/13

Next update date:

2018/10/13

Link to the spanish version:

Click here [4]