Infection Prophylaxis of Streptococcus pneumoniae
Conditions
Interventions
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 a
Sponsors
Servicio Autónomo Instituto de Biomedicina
Eligibility
Sex/Gender
All
Age
2 Months to 60 Months
Inclusion criteria
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: Exclusion criteria for this study included; acute disease at enrollment and antibiotic treatment in the last 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Venezuela
Contacts
Public ContactJacobus de Waard
Servicio Autónomo Instituto de Biomedicina
Outcome results
None listed