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Pneumococcal conjugate vaccination among Warao 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:
Pneumococcal conjugate vaccination among Warao children in the Delta Amacuro, Venezuela: impact on bacterial colonization.
Secondary indentifying numbers:
Not applicable
Primary sponsor:
Servicio Autonomo Instituto de Biomedicina
Secondary sponsor:
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
País:
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
País:
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
País:
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:
Click here
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