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

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 adults. Phase I.

Secondary indentifying numbers:

CQB/NEU/11/EC-I/01

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 the Quality of Drugs(CECMED)

Authorization date :

27/05/2012

Reference number:

05.002.12B

Principal investigator

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

First name:

Sonia Pérez Rodríguez, MD. 1st Degree Specialist in Internal Medicine

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [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:

Ethics Committees of National Toxicology Center, 25/05/2012

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

17/06/2012

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):

Both groups received the vaccine by intramuscular route. Study group: Single dose (0.5ml) of VCN7-T Heptavalent Pneumococcal Conjugate Vaccine. Control group: Single dose (0.5ml) PNEUMO 23 ® Polyvalent Pneumococcal vaccine. Sanofi Pasteur

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 (EA). Measurement time: Measurement time: 3 hours, 24 hours, 48 hours, 72 hours and 30 days after immunization • Description of EA: report of adverse event • Duration of EA: Date of beginning and end of the event reported • Intensity of EA: mild, moderate and severe • Severity of EA: serious or not serious • Results of the EA: recovered, recovered with sequelae, persistence when the subject concludes the study, death and unknown • Relationship Causality: related and unrelated.

Key secondary outcomes:

Seroprotection (Concentrations of antibodies for each serotype PsC greater than or equal to 0.20 mg / mL and titles opsonophagocytic greater or equal to 1:8). Measurement time: 30 days after immunization

Selection criterias

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

Gender:

Male

Minimum age:

18 years

Maximum age:

35 years

Inclusion criteria:

1. Subjects aged between 18 and 35 (including the limit ages) 2. General, regional and specific physical examination without any alteration. 3. Vital signs within the following limits: - Sistolic Blood Pressure < 140 mmHg - Diastolic Blood Pressure < 90 mmHg - Heart rate80 ± 20 per minute - Respiratory rate16 ± 4 per minute - Temperature< 37 0C 4. Subject with hemoglobin rate above 12.5 g/L and other laboratory findings within the range of reference values. 5. Body Mass Index (BMI) between 18.5 and 29.9 (including the limits). 6. Subjects who express their consent to participate in the study written.

Exclusion criteria:

1. Chronic diseases such as Asthma, Chronic Obstructive Pulmonary Disease (COPD), Ischemic Heart Disease, High Blood Pressure (hypertension), Diabetes mellitus (DM), thyroid disease, Epilepsy, neuropathies or diseases of the haemolymphopoietic system. 2. Immunosuppresive diseases, either congenital or acquired. 3. Fever or acute infection within ten (10) days prior to vaccination or upon the shot. 4. Severe allergic disease or immune system diseases. 5. Renal and / or hepatic failure. 6. Hypersensitivity to thimerosal or any of the other components of the formulation. 7. Mentally handicapped 8. Convulsive encephalopathies 9. Immunostimulatory or immunosuppressive therapy, blood products or other vaccinations in a period of 2 months 10. Subject with a history of previous vaccination against Streptococcus pneumoniae 11. Alcoholism.

Type of population:

Adults

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:

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

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

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:

RPCEC00000133

Date of Registration in Primary Registry:

2012-07-20

Record Verification Date:

2012-07-13 20:00

Link to the spanish version:

Click here [3]