Phase II-III clinical trial to evaluate the vaccine candidate against pneumococcal diseases VCN11 in infants

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:

NEUMO11

Scientific title:

Phase II-III, controlled, randomized, double-blind, non-inferiority, adaptive and multicenter clinical trial to evaluate the immunogenicity, safety and efficacy of the 11-valent conjugate vaccine candidate against pneumococci (VCN11) in infants

Acronym of Scientific Title:

NEUMO11/25

Secondary indentifying numbers:

IFV/NEU/06

Issuing authority of the secondary identifying numbers:

Finlay Vaccine Institute (FVI)

Source(s) of monetary or material support:

Cuban Fund for Science and Innovation (CFSI), of the Ministry of Science, Technology and Environment; Finlay Vaccine Institute (FVI)

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 :

PhD. First degree specialist in Comprehensive General Medicine

Affiliation:

Pedro Kouri Tropical Medicine Institute

Postal address:

Autopista Novia del Mediodia. No. Km 6 y ½. Arroyo Arenas. La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

+53-72553205

Email address:

mariaeugenia@ipk.sld.cu

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, Pediatric Hospital "Paquito Gonzalez Cueto", MD. Maria F. Casanova González, PhD. Second Degree Specialist in Neurophysiology

Cienfuegos, Area 1, MD. Geisy Quintana Leon, First Degree Specialist in Comprehensive General Medicine

Cienfuegos, Area 2, MD. Isabel Diaz Alfonso, First Degree Specialist in Comprehensive General Medicine

Cienfuegos, Area 3, MD. Anabel Fernandez Garcia, First Degree Specialist in Comprehensive General Medicine

Cienfuegos, Area 4, MD. Yaima Montalvo Hernandez, First Degree Specialist in Comprehensive General Medicine

Cienfuegos, Area 5, MD. Yolanda Maricela Rodriguez Alvarez, First Degree Specialist in Comprehensive General Medicine

Cienfuegos, Area 6, MD. Miladys Santana Iznaga, First Degree Specialist in Comprehensive General Medicine

Cienfuegos, Area 7, MD. Dianeisis Rodriguez Cortes, First Degree Specialist in Comprehensive General Medicine

Cienfuegos, Area 8, MD. Yutmila Castro Perez, First Degree Specialist in Comprehensive General Medicine

Santiago de Cuba, Polyclinic "30 de noviembre", MD. Dayan Alvarez Dupuy, First Degree Specialist in Comprehensive General Medicine

Santiago de Cuba, Polyclinic "Jose Marti", MD. Odalis Alfaro, First Degree Specialist in Comprehensive General Medicine

Santiago de Cuba, Polyclinic "Josue Pais, MD. Yilenia Mora Sanchez, First Degree Specialist in Comprehensive General Medicine

Santiago de Cuba, Polyclinic "28 de septiembre", MD. Yaima Fernandez, First Degree Specialist in Comprehensive General Medicine

Santiago de Cuba, Polyclinic "Ramon Lopez Penna", MD. Sejaila Cata Navarro, First Degree Specialist in Comprehensive General Medicine

Santiago de Cuba, Northen pediatric hospital “Juan de la Cruz Martinez Maceira”, Neyda Gonzalez Fernandez, MD. First Degree Specialist in Pediatrics

Santiago de Cuba, South pediatric hospital “Antonio Maria Beguez Cesar”, Yaima Palay Justiz, MD. First Degree Specialist in Pediatrics

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

09/09/2024

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 diseases

Intervention(s):

Elevenvalent Conjugate Vaccine against Pneumococci (PCV11) (Experimental group): The vaccine will be administered by intramuscular route on the anterolateral aspect of the left thigh. Primary vaccination - Two doses with an interval of 8 weeks (First dose at 2 months of age and second dose at 4 months of age). Single booster dose, at 11 months of age Prevnar13® vaccine, from Pfizer (Control group): The vaccine will be administered by intramuscular route on the anterolateral aspect of the left thigh. Primary vaccination - Two doses with an interval of 8 weeks (First dose at 2 months of age and second dose at 4 months of age). Single booster dose, at 11 months of age

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):

1. Seroprotection (It is defined as concentration of anti-PsC IgG antibodies ≥ 0.35 µg/mL [≥ 0.35 /< 0.35]). Measurement time: Four weeks after second dose and, four weeks after booster dose. 2. Adverse Events-AE (Type of AE (Description of the AE), Severity of the AE (Grievous/Serious; Not grievous/Not serious), Intensity of the AE (Mild, Moderate, Severe), Causality of the AE (A. Causal association consistent with immunization [A1. Event related to the vaccine product; A2. Event related to a vaccine quality defect; A3. Event related to immunization errors; A4. Event related with immunization anxiety]; B. Undetermined [B1. The temporal relationship is consistent, but there is insufficient definitive evidence that the vaccine caused the event; B2. Review of factors results in conflicting trends of consistency - inconsistency of causal association with immunization]; C. Inconsistent causal association with immunization; D. Not classifiable)). Measurement time: until four weeks after booster dose.

Key secondary outcomes:

1. Antibody concentration (Concentration of anti-Psc IgG antibodies [ug/ml]). Measurement time: Four weeks after second dose and, four weeks after booster dose. 2. Opsonophagocytic titers (Functionality of the antibodies determined through opsonophagocytic titers in a subsample of 20% of the included participants; titers ≥ 1:8 will be considered protection according to the correlation of protection established by the WHO). Measurement time: Four weeks after booster dose. 3. Opsonophagocytic titers ≥ 1:8 (Opsonophagocytic titers ≥ 1:8/Opsonophagocytic titers < 1:8). Measurement time: Four weeks after booster dose.

Selection criterias

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

Gender:

Male/Female

Minimum age:

Two months old

Maximum age:

Two months old

Inclusion criteria:

1. Infants two months of age, of both sexes, whose parents or legal guardians sign the informed consent. 2. Weight-height nutritional assessment above the 10th percentile. 3. Birth weight greater than or equal to 2500 grams. 4. Apgar equal to or greater than 7 at birth and equal to or greater than 8 at five minutes after birth. 5. Maternal gestational age equal to or greater than 37 weeks at the time of delivery.

Exclusion criteria:

1. Acute infectious disease at the time or within 7 days before the application of each dose. (You can wait up to 14 days after the date on which the second dose and booster dose vaccination is due). 2. Use of any investigational product. 3. Present a history of immunosuppressive or immunostimulant treatment in the 30 days prior to the administration of the vaccine. 4. History of treatment with blood products such as transfusions of blood cells, plasma, whole blood, platelet concentrate, gamma globulins and transfer factor at some point in their life. 5. History of anaphylaxis after the administration of a vaccine, mercurial products such as Thiomersal or other drugs. 6. History of severe allergic reactions or diseases. 7. History of immunosuppressive disease, congenital or acquired. 8. Infants with a history of febrile seizure illness. 9. Major congenital diseases or malformations. 10 Infants with a history of recurrent or chronic diseases such as bronchial asthma, diabetes mellitus, epilepsy, atopic or allergic dermatitis or eczema, immunosuppressed, encephalopathies). 11. History of application of any vaccine against Streptococcus pneumoniae. 12. Infants with a history of receiving any vaccine from the Cuban vaccination scheme in a period of less than 15 days, prior to the administration of the investigational product.

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:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

752

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:

Narciso

Middle Name:

Argelio

Last Name:

Jimenez Perez

Specialty:

Second degree specialist in Internal Medicine. Master in Epidemiology

Affiliation:

Finlay Vaccine Institute (FVI)

Postal Address:

Calle 21, entre 198 y 200, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72718331

Email :

njimenez@finlay.edu.cu

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:

Meiby

Middle Name:

de la Caridad

Last Name:

Rodriguez Gonzalez

Specialty:

First Degree Specialist in Comprehensive General Medicine. Master in Epidemiology

Affiliation:

Finlay Vaccine Institute (FVI)

Postal Address:

Calle 21 entre 198 y 200, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717389

Email :

mcrodriguez@finlay.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Pediatric Hospital "Paquito Gonzalez Cueto" (centralized for Cienfuegos)

Medical Science University of Santiago de Cuba (centralized for Santiago de Cuba)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

07/05/2024

27/05/2024

Postal address of Ethic Committee :

Calle 39 # 3602 e/ ave. 36 y ave. 38. Cienfuegos. ZC: 55100. Cuba

Avenida de las Americas y Calle J, Rpto. Suenno. Santiago de Cuba. ZC: 90100. Cuba

Telephone:

+53-53770678

+53-54299435

Email:

vddoc@hosped.cfg.sld.cu

fidel.durand93@ gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

06/10/2025

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:

RPCEC00000448

Date of Registration in Primary Registry:

21/08/2024

Record Verification Date:

2024/08/21

Next update date:

2025/08/21

Link to the spanish version:

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Phase II-III clinical trial to evaluate the vaccine candidate against pneumococcal diseases VCN11 in infants

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