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

Phase 2

Withdrawn

• Conditions: Influenza
• Interventions: Biological: Vaccine Sanofi A(H1N1) 7.5 ug; Biological: Vaccine Sanofi A(H1N1) 15 ug & trivalent; Biological: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante

• Registration Number: NCT00989274
• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico

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.

Study Timeline

• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Study Start: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccine Sanofi A(H1N1) 7.5 ug	Vaccine Sanofi A(H1N1) 7.5 ug	120 participants selected in random form
Vaccine Sanofi A(H1N1) 15 ug & trivalent	Vaccine Sanofi A(H1N1) 15 ug & trivalent	120 participants selected by random
Vaccine Sanofi (H1N1) 15 ug.nonadyuvante	Vaccine Sanofi (H1N1) 15 ug.nonadyuvante	120 participants selected in random form

Primary Outcome Measures

Name	Time	Method
reactogenicity and safety	day 28, day 56 and day 84

Trial Locations

Locations (1)

Instituto Nacional de Salud Pública; 🇲🇽 Cuernavaca, Morelos, Mexico