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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
| Insituto Adolfo Lutz | UNKNOWN |
| Centro de Referencia e Treinamento em DST/AIDS | UNKNOWN |
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The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health adults |
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| Health children |
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| Pregnants |
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| Elderly over 65 years old |
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| HIV patients |
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| Kidney transplant |
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| Oncologic patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | Biological | 1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titers of 1:40 or more for influenza A pandemic (H1N1) | the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the vaccine | Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination | 21 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteers with chronic and or immunocompromised disease, elderly and pregnant in follow - up at the institutions participants in the study will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Roberto Precioso, MD, PhD | Butantan Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avenida Vital Brasil 1500 | São Paulo | São Paulo | 05503-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22087267 | Derived | Miraglia JL, Abdala E, Hoff PM, Luiz AM, Oliveira DS, Saad CG, Laurindo IM, Viso AT, Tayra A, Pierrotti LC, Azevedo LS, Campos LM, Aikawa NE, Timenetsky Mdo C, Luna E, Cardoso MR, Guedes Jda S, Raw I, Kalil J, Precioso AR. Immunogenicity and reactogenicity of 2009 influenza A (H1N1) inactivated monovalent non-adjuvanted vaccine in elderly and immunocompromised patients. PLoS One. 2011;6(11):e27214. doi: 10.1371/journal.pone.0027214. Epub 2011 Nov 8. |
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| Rheumatologic adult patients |
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| Rheumatologic children patients |
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