Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children.

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:

ISCANI

Scientific title:

Immunogenicity and efficacy of Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children. Phase II/III.

Acronym of Scientific Title:

ISCANI

Secondary indentifying numbers:

CQB/NEU/14/EC-II-III/03

Issuing authority of the secondary identifying numbers:

Biomolecular Chemistry Center (CQB)

Source(s) of monetary or material support:

Biomolecular Chemistry Center (CQB)

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 :

03/06/2014

Reference number:

05-008-14-BB

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 :

1st Degree Specialist in Integral General Medicine

Affiliation:

Tropical Medicine Institute "Pedro Kourí"

Postal address:

Autopista Novia del Mediodía Km 6 1/2. La Lisa

City:

Havana City

Country:

Cuba

Zip Code:

17100

Telephone:

+53-72553204

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, Municipality Cienfuegos, Area I, Mercedes Seivane Alfonso, MD. First degree specialist in Pediatrics.

Cienfuegos, Municipality Cienfuegos, Area II, Trina Maria Gonzalez Esquivel, MD. First degree specialist in Pediatrics.

Cienfuegos, Municipality Cienfuegos, Area III, Caridad Hernandez Gutierrez, MD. First degree specialist in Pediatrics, Second Degree Specialist in Integral General Medicine.

Cienfuegos, Municipality Cienfuegos, Area IV, Jose Ariel Trujillo, MD. First Degree Specialist in Pediatrics.

Cienfuegos, Municipality Cienfuegos, Area V, Odalys Garcia, MD. First Degree Specialist in Pediatrics.

Cienfuegos, Municipality Cienfuegos, Area VI, Bladimir Arteaga Valdes, MD. First Degree Specialist in Pediatrics

Cienfuegos, Municipality Cienfuegos, Area VII, Enrique de Jesus Fuentes Fernandez, MD. First Degree Specialist in Pediatrics

Cienfuegos, Municipality Cienfuegos, Area VIII, Deisy Celia Hernandez Mora, MD. First degree Specialist in Pediatrics.

Research ethics committees:

Institute of Tropical Medicine "Pedro Kouri", 23/06/2014

Faculty of Medical Sciences Cienfuegos, 16/05/2014

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

09/06/2014

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 infection

Intervention(s):

First Stage: Children 2 to 5 years. Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7-T)): 1 dose of VCN7-T, intramuscularly in the deltoid. Control Group (Pneumococcal 10-valent protein D conjugate Haemophilus influenzae nontypable, Synflorix ®, GlaxoSmithKline): 1 dose of Synflorix, intramuscularly in the left deltoid. Second stage: Children 12 to 23 months. Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7-T)): 2 doses of VCN7-T with interval of 8 weeks intramuscularly in the deltoid. Control Group (Pneumococcal 10-valent protein D conjugate Haemophilus influenzae nontypable, Synflorix ®, GlaxoSmithKline): 2 doses of Synflorix with interval of 8 weeks intramuscularly in the deltoid.

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):

- Geometric mean concentration of anti-PsC antibodies for each serotype included in VCN7-T and additional serotypes 6A and 19A (continuous). Measurement time: First stage: Before and 30 days post-vaccination, Second Stage: Before the first dose and 30 days after the second dose. - Seroprotection (dichotomous): Proportion of subjects reaching anti-PsC concentration of antibodies for each serotype included in VCN7-T and additional serotypes 6A and 19A of ≥ 0.20 mg / mL. Measurement time: First stage: Before and 30 days post-vaccination, Second Stage: Before the first dose and 30 days after the second dose. - Seroconversion (dichotomous): proportion of subjects who seroconverted. Measurement time: First stage: Before and 30 days post-vaccination, Second Stage: Before the first dose and 30 days after the second dose.

Key secondary outcomes:

Adverse event (AE). Measuring time: 3 hours after each immunization and at 24, 48, 72 hours, 7, 21 and 30 days. -Description of the expected AE (Fever, pain injection site, erythema, induration, local temperature increase, functional impotence, infiltration, abscess, necrosis, headache, malaise, nausea, vomiting, weakness, anaphylactic shock. -Description of the unexpected AE (Any signs or symptoms that appear after the before vaccination and 30 days is not expected within the AE. -Duration of AE (<= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours). -Emergence of AE (<= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours). -Intensity of AE (mild, moderate, severe). -Severity of AE (Grave / Serious, not serious). -Results of AE (recovered, recovered with sequelae, persistence, death or unknowns). -Causality relationship (very likely or certain, probable, possible, unlikely, not related, not classifiable).

Selection criterias

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

Gender:

Male/Female

Minimum age:

1st Stage: 2 years, 2nd Stage: 12 months

Maximum age:

1st Stage: 5 years, 2nd Stage: 23 months

Inclusion criteria:

1. Children 2-5 years old in the first stage and 12 to 23 months in the second, residents in municipality Cienfuegos, whose health condition, established by medical criteria, by physical examination, medical history and personal and family history. 2. Children whose parents or guardians sign the Informed Consent. 3. Nutritional assessment greater than the 3rd percentile.

Exclusion criteria:

1. Acute infectious disease at the time of application of the vaccine or within 7 days prior to administration of the vaccine. ( It may wait until 7 days after the date corresponding vaccination to apply the same to the case of the second dose). 2. Major congenital malformations diseases. 3. History of decompensated or chronic disease treatment as usual . 4. History of immunosuppressive or immunostimulatory in the 30 days prior to administration of the VCN7-T. 5. History of severe allergic reactions or illnesses or immune system diseases. 6. Background of anaphylaxis after administration of a vaccine or as Thiomersal mercurial products. 7. Children with a history of having been immunized with a vaccine against Streptococcus pneumoniae. 8. Children with history of Febrile Seizure disease . 9. Use of any investigational product within 30 days prior to immunization. 10.History of treatment with blood as blood transfusion, plasma, whole blood or platelet concentrate at any time in their life. 11. Children with a history of having been immunized with any vaccine in the vaccination scheme Cuban 30 days prior to the administration of the vaccine.

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:

1140

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:

Nadezhda

Last Name:

Gonzalez Garcia

Specialty:

1st Degree Specialist in Microbiology and Integral General Medicine

Affiliation:

Biomolecular Chemistry Center (CQB)

Postal Address:

Ave. 21 No. 19802 e/ 198 y 200, Atabey, Playa.

City:

Havana City

Country:

Cuba

Zip Code:

11600

Telephone:

537 2717822 Ext.170

Email :

nadezhda.glez@cqb.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:

Nadezhda

Last Name:

Gonzalez Garcia

Specialty:

1st Degree Specialist in Microbiology and Integral General Medicine

Affiliation:

Biomolecular Chemistry Center (CQB)

Postal Address:

Ave. 21 No. 19802 e/ 198 y 200, Atabey, Playa.

City:

Havana City

Country:

Cuba

Zip Code:

11600

Telephone:

537 2717822 Ext.170

Email :

nadezhda.glez@cqb.cu

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:

RPCEC00000182

Date of Registration in Primary Registry:

06/08/2014

Record Verification Date:

2015/07/17

Next update date:

2016/07/17

Link to the spanish version:

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Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children.

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