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

Scientific title:

Safety and immunogenicity of Heptavalent Conjugate Vaccine against Pneumococcal in healthy infants and children. Phase I.

Secondary indentifying numbers:

CQB/NEU/12/EC-I/02

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 :

10/04/2013

Reference number:

05.00213.B

Principal investigator

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

First name:

Carlos

Midle name:

Pablo

Last name:

Dotres Martínez

Medical Specialty :

2nd Degree Specialist in Pediatrics.

Affiliation:

Juan Manuel Marquez Pediatric Hospital.

Postal address:

Avenue 31 e/. 76 y 100, Marianao

City:

La Habana

Country:

Cuba

Zip Code:

11500

Telephone:

+53-72609651

Email address:

cpablo@infomed.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:

Not applicable

Research ethics committees:

Juan Manuel Marquez Pediatric Hospital´s Ethics Committees, 26/02/2013.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

01/05/2013

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 4 to 5 years. Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7-T)): 1 dose of VCN7-T, intramuscularly in the left 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: Infants 7-8 months. Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7-T)): 2 doses of VCN7-T with interval of 4 weeks + reinforcement 3 months after second dose intramuscularly in the anterolateral left thigh. Control Group (Pneumococcal 10-valent protein D conjugate Haemophilus influenzae nontypable, Synflorix ®, GlaxoSmithKline): 2 doses of Synflorix with interval of 4 weeks + reinforcement 3 months after second dose intramuscularly in the anterolateral left thigh.

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):

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 (Nominal): Any sign or symptom that appears after the vaccination and 30 days before it is declared as AE expected. - Description of the unexpected AE (Nominal): Any signs or symptoms that appear after the before vaccination and 30 days is not expected within the AE. - Duration of AE (Ordinal): <= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours. - Emergence of AE (Ordinal): <= 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).

Key secondary outcomes:

Anti-PSC Concentration for each serotype: Undetectable (0 μg / mL) to the upper limit of quantification of the method. Measurement time: -First Stage: before and 30 days post-vaccination. -Second Stage: 30 days after the prime dose and 30 days after booster Opsonofagocitic Antibody titer anti-PsC for each serotype: From 1/4 to the highest dilution of serum that inhibits bacterial growth at 50%. Measurement time: -First Stage: before and 30 days post-vaccination. -Second Stage: 30 days after the prime dose and 30 days after booster

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: 4 years 2nd Stage: 7 months

Maximum age:

1st Stage: 5 years 2nd Stage: 8 months

Inclusion criteria:

- 1st Stage. 1. Children whose parents or guardians sign the Informed Consent. 2. Children 4-5 years old. 3. Healthy Children, established by medical criteria, by physical examination, medical history and personal and family history. 4. Nutritional assessment greater than the 10th percentile and less than 90 on the weight and size. - 2nd Stage. 1. Infants whose parents or guardians sign the Informed Consent. 2. Infants 7-8 months old. 3. Healthy infants, medically established by physical examination, medical history and personal and family history. 4. Nutritional assessment greater than the 10th percentile and less than 90 on the weight and size. 5. Birth weight greater than or equal to 2500 grams. 6. Birth Apgar of 8-10 and 9-10 at five minutes after birth. 7. Gestational age equal to or greater than 37 weeks at delivery.

Exclusion criteria:

1. Acute infectious disease at the time of application of the vaccine or within 7 days prior to administration of the vaccine. 2. Use of any investigational product within 30 days prior to immunization. 3. Children at 7 months with incomplete immunization scheme. 4. History of immunosuppressive or immunostimulatory in the 30 days prior to administration of the VCN7-T. 5. History of treatment with blood as blood transfusion, plasma, whole blood or platelet concentrate at any time in their life. 6. Background of anaphylaxis after administration of a vaccine or as Thiomersal mercurial products. 7. A history of immunosuppressive disease, congenital or acquired. 8. History of severe allergic reactions or illnesses. 9. History of thrombocytopenia or coagulopathy. 10. History of neurological diseases with febrile seizures or not. 11. Major congenital malformations. 12. Children with a history of chronic disease. 13. Children with a history of having been immunized with a vaccine against Streptococcus pneumoniae.

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:

Target sample size:

1st Stage: 15 2nd Stage: 30

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:

Degree in pharmaceutical sciences

Affiliation:

Biomolecular Chemistry Center (CQB)

Postal Address:

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

City:

Havana City

Country:

Cuba

Zip Code:

CP 11600, Box 16042.

Telephone:

537 2717822 Ext.170

Email :

beatriz.paredes@cqb.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:

Beatriz

Last Name:

Paredes Moreno

Specialty:

Degree in pharmaceutical sciences

Affiliation:

Biomolecular Chemistry Center (CQB)

Postal Address:

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

City:

Havana City

Country:

Cuba

Zip Code:

CP 11600, Box 16042.

Telephone:

537 2717822 Ext.170

Email :

beatriz.paredes@cqb.cu [2]

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:

RPCEC00000173

Date of Registration in Primary Registry:

31/10/2013

Record Verification Date:

2013/10/31

Next update date:

2014/10/31

Link to the spanish version:

Click here [3]