Pneumococcal infections
Conditions
Interventions
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.
Sponsors
Servicio Autonomo Instituto de Biomedicina
Eligibility
Sex/Gender
All
Age
6 Weeks to 59 Months
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Streptococcus pneumoniae in the nasopharynx (Presence, Absence). Measuring time: Before the first dose of vaccine and 8 weeks after the last dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Venezuela
Contacts
Public ContactJacobus de Waard
Servicio Autonomo Instituto de Biomedicina
Outcome results
None listed