Pneumococcal conjugate vaccination among Warao childre
Phase 1
Recruiting
- Conditions
- Pneumococcal infections
- Registration Number
- RPCEC00000158
- Lead Sponsor
- Servicio Autonomo Instituto de Biomedicina
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Streptococcus pneumoniae in the nasopharynx (Presence, Absence). Measuring time: Before the first dose of vaccine and 8 weeks after the last dose.
- Secondary Outcome Measures
Name Time Method 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.