Status:
WITHDRAWN
Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Influenza A/H1N1
Lead Sponsor:
Instituto Nacional de Salud Publica, Mexico
Collaborating Sponsors:
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 u...
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 immu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00989274
Start Date
June 1 2010
End Date
July 1 2010
Last Update
April 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Nacional de Salud Pública
Cuernavaca, Morelos, Mexico, 62100