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

This study has been withdrawn prior to enrollment.
(Late approval by the Secretariat of Health, and expiration of vaccine)
Sponsor:
Collaborator:
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Information provided by (Responsible Party):
Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier:
NCT00989274
First received: October 2, 2009
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Influenza
Biological: Vaccine Sanofi A(H1N1) 15 ug & trivalent
Biological: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
Biological: Vaccine Sanofi A(H1N1) 7.5 ug
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • reactogenicity and safety [ Time Frame: day 28, day 56 and day 84 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaccine Sanofi A(H1N1) 15 ug & trivalent
120 participants selected by random
Biological: Vaccine Sanofi A(H1N1) 15 ug & trivalent
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);
Other Name: Vaccine Sanofi A(H1N1)
Active Comparator: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
120 participants selected in random form
Biological: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
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)
Other Name: Vaccine Sanofi A(H1N1)
Active Comparator: Vaccine Sanofi A(H1N1) 7.5 ug
120 participants selected in random form
Biological: Vaccine Sanofi A(H1N1) 7.5 ug
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).
Other Name: Vaccine Sanofi A(H1N1)

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989274

Locations
Mexico
Instituto Nacional de Salud Pública
Cuernavaca, Morelos, Mexico, 62100
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Investigators
Principal Investigator: Lourdes Garcia-Garcia, MD, PhD Instituto Nacional de Salud Publica, Mexico
  More Information

Additional Information:
Publications:
Responsible Party: Ma. de Lourdes Garcia Garcia, Director of the Center of Research in Infectious Diseases, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT00989274     History of Changes
Other Study ID Numbers: CI:863, No. 777
Study First Received: October 2, 2009
Last Updated: March 28, 2012
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Instituto Nacional de Salud Publica, Mexico:
Influenza
Vaccination
Immunology
Immunogenicity
Reactogenicity
Safety
Influenza vaccine
Immune response
Adverse effects

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014