Clinical trial NCT00989274: Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Influenza A/H1N1
Official title: Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Pandemic Influenza A/H1N1 Produced by Sanofi
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Vaccination
Immunology
Immunogenicity
Reactogenicity
Safety
Influenza vaccine
Immune response
Adverse effects
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
First posted: 2009-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: reactogenicity and safety
timeFrame: day 28, day 56 and day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: Instituto Nacional de Salud Pública
state: Morelos
Study officials:
affiliation: Instituto Nacional de Salud Publica, Mexico
name: Lourdes Garcia-Garcia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu B, Huang C, Garcia L, Ponce de Leon A, Osornio JS, Bobadilla-del-Valle M, Ferreira L, Canizales S, Small P, Kato-Maeda M, Krensky AM, Clayberger C. Unique gene expression profiles in infants vaccinated with different strains of Mycobacterium bovis bacille Calmette-Guerin. Infect Immun. 2007 Jul;75(7):3658-64. doi: 10.1128/IAI.00244-07. Epub 2007 May 14.
citation: Wong-Chew RM, Islas-Romero R, Garcia-Garcia Mde L, Beeler JA, Audet S, Santos-Preciado JI, Gans H, Lew-Yasukawa L, Maldonado YA, Arvin AM, Valdespino-Gomez JL. Immunogenicity of aerosol measles vaccine given as the primary measles immunization to nine-month-old Mexican children. Vaccine. 2006 Jan 30;24(5):683-90. doi: 10.1016/j.vaccine.2005.08.045. Epub 2005 Aug 24.
citation: Wong-Chew RM, Islas-Romero R, Garcia-Garcia Mde L, Beeler JA, Audet S, Santos-Preciado JI, Gans H, Lew-Yasukawa L, Maldonado YA, Arvin AM, Valdespino-Gomez JL. Induction of cellular and humoral immunity after aerosol or subcutaneous administration of Edmonston-Zagreb measles vaccine as a primary dose to 12-month-old children. J Infect Dis. 2004 Jan 15;189(2):254-7. doi: 10.1086/380565. Epub 2004 Jan 5.