Study Stopped
Late approval by the Secretariat of Health, and expiration of vaccine
Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Influenza A/H1N1
Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Pandemic Influenza A/H1N1 Produced by Sanofi
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedApril 2, 2012
March 1, 2012
Same day
October 2, 2009
March 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reactogenicity and safety
day 28, day 56 and day 84
Study Arms (3)
Vaccine Sanofi A(H1N1) 15 ug & trivalent
ACTIVE COMPARATOR120 participants selected by random
Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
ACTIVE COMPARATOR120 participants selected in random form
Vaccine Sanofi A(H1N1) 7.5 ug
ACTIVE COMPARATOR120 participants selected in random form
Interventions
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);
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)
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).
Eligibility Criteria
You may qualify if:
- Informed Consent
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Salud Pública
Cuernavaca, Morelos, 62100, Mexico
Related Publications (3)
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.
PMID: 17502394BACKGROUNDWong-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.
PMID: 16154241BACKGROUNDWong-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.
PMID: 14722890BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lourdes Garcia-Garcia, MD, PhD
Instituto Nacional de Salud Publica, Mexico
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Center of Research in Infectious Diseases
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 5, 2009
Study Start
June 1, 2010
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
April 2, 2012
Record last verified: 2012-03