Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation Aof Safety and Immunogenicity of Non-adjuvanted Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants, Produced by Butantan Institute

Conditions
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Immunocompromised Patients, Safety of Pandemic Influenza A (H1N1)Vaccine, Immunogenicity of Pandemic Influenza A (H1N1)Vaccine

Intervention / Treatment
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* Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers able to understand and agree to participate in the study. Exclusion Criteria: Have egg allergy Have past history of allergy to seasonal influenza vaccine Have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study Acute infectious disease during seven days prior vaccination Confirmed prior infection by pandemic influenza A (H1N1) Have participated in another clinical trial in the last 6 months Any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health adults<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| Health children<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| Pregnants<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| Elderly over 65 years old<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| HIV patients<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| Kidney transplant<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| Oncologic patients<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| Rheumatologic adult patients<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|
| Rheumatologic children patients<br> | Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunocompromised patients, Safety of pandemic influenza A (H1N1)vaccine, Immunogenicity of pandemic influenza A (H1N1)vaccine