Yellow fever vaccine dose-response study on childre
- Conditions
- Yellow FeverInfections and InfestationsYellow fever
- Registration Number
- ISRCTN36905484
- Lead Sponsor
- Bio-Manguinhos/Fiocruz (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1800
1. Healthy children, aged 9 - 11 months old
2. Guardians agree to participate after reading and understanding free and informed consent form
1. Prior vaccination against yellow fever
2. Use of immunosuppressor drugs in the last 12 months
3. Personal history of autoimmune diseases
4. Personal history of thymus diseases
5. Personal history of anaphylactic reactions to foods, drugs or vaccines
6. Personal history of allergy to eggs, erythromycin, canamycin or gelatin
7. Persons who received immunoglobulin, blood transfusions or blood derivatives in the last 12 months
8. Persons who received live virus vaccines in the last 30 days or who plan to receive them in the following 30 days after yellow fever vaccination
9. Acute febrile disease with an impaired general condition on time of vaccination
10. Metabolic diseases or metabolism inborn errors
11. Personal history of primary acquired immunodeficiency
12. Personal history of neoplasia (on treatment)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the immunogenicity of yellow fever vaccine used in decreasing doses and with addition of a purification step in the process of vaccine producing in children 9-11 months of age in relation to the formulation currently used.<br><br>It will be measured by blood samples 30 days after vaccination and serum antibodies before and after vaccination
- Secondary Outcome Measures
Name Time Method 1. Reactogenicity<br>2. Frequency of viraemia measured 5 days after vaccination<br>3. Duration of immunity measured one year later (9 - 15 months is acceptable) after vaccination