Pneumococcal conjugate vaccination among Warao children

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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:

Pneumococcal conjugate vaccination among Warao children in the Delta Amacuro, Venezuela: impact on bacterial colonization.

Secondary indentifying numbers:

Not applicable

Source(s) of monetary or material support:

Pfizer CA Venezuela

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:

Jacobus H.de Waard, Microbiologist Berenice del Nogal, Pediatric

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

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

Research ethics committees:

Servicio Autonomo Instituto de Biomedicina, 22-03-2011

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

08/06/2012

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 infections

Intervention(s):

Study group (PCV13 vaccine); intramuscular 0.5 ml of the 113-valent pneumococcal conjugate vaccine according to the following schedule: three doses (at 2, 4 and 6 months of age), and a booster between 12 and 15 months of life.

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):

Streptococcus pneumoniae in the nasopharynx (Presence, Absence). Measuring time: Before the first dose of vaccine and 8 weeks after the last dose.

Key secondary outcomes:

Carrier in the nasopharynx of S. aureus (Presence, Absence). Measuring time: before the first dose and 8 weeks after the last dose. Carrier in the nasopharynx of M. catarhalis (Presence, Absence). Measuring time: before the first dose and 8 weeks after the last dose. Carrier in the nasopharynx of H. influenzae (Presence, Absence). Measuring time: before the first dose and 8 weeks after the last 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:

6 weeks

Maximum age:

59 months

Inclusion criteria:

All children aged between 6 weeks and 59 months from 10 communities in the State of Delta Amacuro Informed consent obtained from parents or legal guardian

Exclusion criteria:

Children younger than 6 weeks of age or older than 59 months. Children previously vaccinated against S. pneumoniae. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C). Acute disease at the time of enrolment. Chronic disease that might preclude participation to the whole study. Moving out the village within the study period

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

0

Target sample size:

500

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:

Henri

Last Name:

de Waard

Affiliation:

Servicio Autonomo Instituto de Biomedicina

Postal Address:

al Lado de Hospital Vargas, San Jose

City:

Caracas

Country:

Venezuela

Zip Code:

1010A

Telephone:

00-212-58-8306670

Email :

jacobusdeward@gmail.com

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:

jacobus

Middle Name:

Henri

Last Name:

de Waard

Affiliation:

Servicio Autonomo Instituto de Biomedicna

Postal Address:

al lado de Hospital Vargas, San Jose

City:

Caracas

Country:

Venezuela

Zip Code:

1010A

Telephone:

00-58-212-8306670

Email :

jacobusdeward@gmail.com

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:

RPCEC00000158

Date of Registration in Primary Registry:

2013-06-14

Record Verification Date:

2013-06-11

Next update date:

2014-06-11

Link to the spanish version:

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Registered Trials

Registration process

Pneumococcal conjugate vaccination among Warao children

About the RPCEC

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