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

March 28, 2012 updated by: Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico

Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Pandemic Influenza A/H1N1 Produced by Sanofi

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62100
        • Instituto Nacional de Salud Publica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Vaccine Sanofi A(H1N1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reactogenicity and safety
Time Frame: day 28, day 56 and day 84
day 28, day 56 and day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

July 1, 2010

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (ESTIMATE)

October 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI:863, No. 777

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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