Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Influenza A/H1N1

Study Overview
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Brief Summary
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In agreement with the World Organization of the Health (WHO), during the annual epidemics of influenza they become infected between 10-20 % of the total population, appearing from a feverish disease up to leading to the hospitalization and in some cases to the death. To unpredictable intervals and due to the nature of the virus, this one can acquire new genes of others virus of the influenza that they concern birds or porks, of it it turns out to be a new virus with a completely new subtype of IT (HE,SHE) HAS and NA, and if this one is transmitted efficiently of person-to-person can cause a pandemic. This phenomenon has been the one that has given place to the appearance of a new causative virus of the outbreak of influenza humanizes in Mexico (A/México/2009 (H1N1)), and in agreement to official Mexican numbers(figures), until August 13 there have been brought(reported) a whole of 18,861 cases and 163 deaths. The measure of the most effective control against the influenza constitutes it the vaccine, by what study becomes imperative to possess (to rely on) a vaccine against the new virus To (H1N1) East is relevant, due to the level of response of alert to a level 6 (pandemic) that has passed the World Organization of the Health (WHO).

Detailed Description
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The originality of the study is based the fact that the study will be a clinical test(essay) phase the IInd for this new vaccine. Additional it will allow to obtain information in relation to the immunity crossed between(among) pandemic vaccines and seasonal vaccines. Equally it will allow to obtain evidence on the impact of the possible protection of the seasonal vaccine that is in use in the routine programs of vaccination in opposition to the virus of the influenza To (H1N1sw). Finally this type of study is only(unique) in his design since adult population will be evaluated in Mexico. This study will allow: To evaluate and to compare the experimental vaccine against the virus of the pandemic influenza To (H1N1) produced by Sanofi with the seasonal trivalent vaccine against the influenza. To determine the possibility of predicting the level of immunological response in level terms(ends) of antibodies that the Vaccine pandemic Sanofi produces To (H1N1). To determine the possibility of predicting the frequency of adverse reactions attributed to the Vaccine pandemic Sanofi To (H1N1) evaluated in adult Mexican population. The response will be evaluated of seroconversión (I increase in the titles in four times with regard to the level basal), seropositividad (titles(degrees) overhead of 1:40) and titles(degrees) to geometric averages. The patients will be analyzed in the group in which they were randomized (intention of treatment). The information will be tried using the statistical package SPSS, version 10.1.

Official Title
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Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Pandemic Influenza A/H1N1 Produced by Sanofi

Conditions
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Influenza

Intervention / Treatment
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* Biological: Vaccine Sanofi A(H1N1) 15 ug & trivalent
* Biological: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
* Biological: Vaccine Sanofi A(H1N1) 7.5 ug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent 18 to 60 years old Resident in study area Available during the time of follow-up In good state of health Laboratory examinations normal in 28 days before the recruitment Negative test(proof) to VIH Negative test(proof) to surface antigen of hepatitis B (HBsAg) Negative test(proof) to virus of hepatitis C Exclusion Criteria: In women, suckling or plans of pregnancy(embarrassment) Ingestion of Medicines immunosuppressants Receipt of blood products, 120 days before the screening for VIH Receipt of immunoglobulin 60 days before the tamizaje for VIH Have received alive(vivacious) attenuated vaccines 30 days to the vaccination To have received vaccines unactivated (influenza, pneumococcus or treatment for allergy) in 14 days before the vaccination Treatment of latent or active tuberculosis History of autoimmune disease or immunodeficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaccine Sanofi A(H1N1) 15 ug & trivalent<br>120 participants selected by random | Biological: Vaccine Sanofi A(H1N1) 15 ug & trivalent<br>* Grup 1: day 0: Vaccine trivalent (A/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/10/2007 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) Vaccine Sanofi A(H1N1) administrated 15 ug. (nonadjuvant); day 28 Vaccine Sanofi A(H1N1) administrated a 15 ug. (nonadjuvant);<br>* Other names: Vaccine Sanofi A(H1N1);|
| Active Comparator: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante<br>120 participants selected in random form | Biological: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante<br>* Grup 2: Day 0: Vaccine trivalent(A/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/10/2007 (H3N2)-like virus, y B/Brisbane/60/2008-like virus); Day 28 Vaccine Sanofi A(H1N1) administrated a 15 ug. (nonadjuvant); day 56; Vaccine Sanofi A(H1N1) administrated a 15 ug. (nonadjuvant)<br>* Other names: Vaccine Sanofi A(H1N1);|
| Active Comparator: Vaccine Sanofi A(H1N1) 7.5 ug<br>120 participants selected in random form | Biological: Vaccine Sanofi A(H1N1) 7.5 ug<br>* Grup 3: day 0: day 28 Vaccine Sanofi A(H1N1) administrated a 7.5 ug (non adjuvant); day 56; Vaccine Sanofi A(H1N1) administrated a 7.5 ug (nonadjuvant).<br>* Other names: Vaccine Sanofi A(H1N1);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reactogenicity and safety |  | day 28, day 56 and day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccination, Immunology, Immunogenicity, Reactogenicity, Safety, Influenza vaccine, Immune response, Adverse effects