Inmunogenicity-PCV-Carriage-Venezuelan High Risk 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:

Immunogenicity of a pneumococcal conjugate vaccine and impact on carriage in Venezuelan children at risk of invasive pneumococcal infection

Secondary indentifying numbers:

Not applicable

Source(s) of monetary or material support:

Servicio Autónomo Instituto de Biomedicina

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Hospital de Niños “JM de los Ríos”, Dra.Berenice del Nogal. Especialista en Puericultura y Pediatría Hospital de Niños “JM de los Ríos”, Dra. Mariana Fuentes. Especialista en Puericultura y Pediatría. Hospital de Niños “JM de los Ríos”, Dra. Rossana Cortez. Especialista en Puericultura y Pediatría.

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:

Venezuela

Clinical sites:

Servicio Autónomo Instituto de Biomedicina (For processing samples), Lcda. Ismar Rivera-Olivero. Especialista en Microbiología Clínica.

Research ethics committees:

Hospital de Niños “JM de los Rios”, May 8th,2007

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

24/06/2007

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:

Infection Prophylaxis of Streptococcus pneumoniae

Intervention(s):

Study Group (PCV7V). Doses of 0.5mL of pneumococcal conjugate vaccine PCV7 by intramuscular route according to schedule of CDC's Advisory Committee on Immunization Practices (ACIP) depending on age and previous immunization with a pneumococcal vaccine: AGE (months) --PREVIOUS DOSES(PCV7V) -- INDICATIONS 2-6 -- None -- 3 doses every to 2 months (minimum 4 weeks between doses) and 1 dose at 12-15 months 7-11 -- None -- 2 doses every to 2 months (minimum 4 weeks between doses) and 1 dose at 12-15 months 12-23 -- None -- 2 doses every to 2 months 24-59 -- None -- 2 doses of PCV7 every 8 weeks PPSV23 indicated 24-59 -- 1 -- 2 doses of PCV7 every 8 weeks PPSV23 indicated 24-59 -- 2-3 -- 1 dose PCV7 PPSV23 indicated 24-59 -- 4 -- None PCV7 PPSV23 indicated

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):

Antibody titers (Serum IgG concentrations to each 7 pneumococcal serotype expressed in ug/mL with a cut-off =0.35 ug/mL was used to define minimun protective specific IgG antibody concentration). Measuring time: Previous first vaccine dose and 8 weeks after last dose. Pneumococcal carriage ( Presence or absence of Streptococcus pneumoniae in nasopharynx). Measuring time: Each immunization dose and 8 weeks after last dose.

Key secondary outcomes:

Adverse reactions (local reaction (tenderness, redness, swelling),systemic events ( fever, decreased appetite, irritability, increased sleep and decreased sleep).Measuring time: 30 minutes after vaccination and during 4 days after the vaccinations

Selection criterias

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

Gender:

Male/Female

Minimum age:

2 months

Maximum age:

60 months

Inclusion criteria:

The study included male and female subjects aged 2 to 60 months of age with at least one of the following immunosuppressive conditions that define as a child at high risk for pneumococcal invasive disease: HIV infection Sickle cell disease Asplenia Congenital immunodeficiency Chronic heart disease Chronic pulmonary disease Cerebrospinal fluid leak Chronic renal failure Patients with immunosuppressive therapy (Neoplasms, leukemia, etc) Diabetes mellitus

Exclusion criteria:

Exclusion criteria for this study included; acute disease at enrollment and antibiotic treatment in the last 7 days

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

110

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:

Jacobus

Middle Name:

Henry

Last Name:

de Waard

Affiliation:

Servicio Autónomo Instituto de Biomedicina

Postal Address:

Esquina de San Nicola a San Jose Providencia. San Jose. Caracas, Venezuela

City:

Caracas

Country:

Venezuela

Zip Code:

1010

Telephone:

00582128306670

Email :

jacobusdeward@gmail.com [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:

Ismar

Middle Name:

Last Name:

Rivera-Olivero

Affiliation:

Servicio Autónomo Instituto de Biomedicina

Postal Address:

Esquina de San Nicola a San Jose Providencia. San Jose. Caracas, Venezuela

City:

Caracas

Country:

Venezuela

Zip Code:

1010

Telephone:

00582126400993

Email :

ismaralejandra@gmail.com [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:

RPCEC00000150

Date of Registration in Primary Registry:

2013-03-06

Record Verification Date:

2013-02-19 19:00

Link to the spanish version:

Click here [4]