Inmunogenicity-PCV-Carriage-Venezuelan High Risk Childre
Not Applicable
- Conditions
- Infection Prophylaxis of Streptococcus pneumoniae
- Registration Number
- RPCEC00000150
- Lead Sponsor
- Servicio Autónomo Instituto de Biomedicina
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 110
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 for this study included; acute disease at enrollment and antibiotic treatment in the last 7 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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