Influenza Clinical Trial
Official title:
Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Pandemic Influenza A/H1N1 Produced by Sanofi
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).
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:
1. 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.
2. 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).
3. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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