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AzTrials

InfluenzaPhase 2NCT00989274

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

A Phase 2 study testing Vaccine Sanofi A(H1N1) 15 ug & trivalent, Vaccine Sanofi (H1N1) 15 ug.nonadyuvante and Vaccine Sanofi A(H1N1) 7.5 ug in people with Influenza, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Influenza
What is being tested?
Vaccine Sanofi A(H1N1) 15 ug & trivalent, Vaccine Sanofi (H1N1) 15 ug.nonadyuvante and Vaccine Sanofi A(H1N1) 7.5 ug
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteMexico
Study dates
Jun 2010to Jul 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Negative test(proof) to VIH
  • Negative test(proof) to surface antigen of hepatitis B (HBsAg)
  • Negative test(proof) to virus of hepatitis C

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Salud Pública

    Cuernavaca, Morelos, 62100

Other trials in Mexico

About this study

Official title: 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).

Read the 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.
Conditions
Influenza
Being tested
Vaccine Sanofi A(H1N1) 15 ug & trivalent, Vaccine Sanofi (H1N1) 15 ug.nonadyuvante, Vaccine Sanofi A(H1N1) 7.5 ug
Keywords
Influenza, Vaccination, Immunology, Immunogenicity, Reactogenicity, Safety, Influenza vaccine, Immune response, Adverse effects
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaccine Sanofi A(H1N1) 15 ug & trivalentBiological

    Also called Vaccine Sanofi A(H1N1)

    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);

  • Vaccine Sanofi (H1N1) 15 ug.nonadyuvanteBiological

    Also called Vaccine Sanofi A(H1N1)

    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)

  • Vaccine Sanofi A(H1N1) 7.5 ugBiological

    Also called Vaccine Sanofi A(H1N1)

    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).

Study groups in NCT00989274
Study groupRoleWhat they receive
Vaccine Sanofi A(H1N1) 15 ug & trivalentActive comparator120 participants selected by random
Receives: Biological: Vaccine Sanofi A(H1N1) 15 ug & trivalent
Vaccine Sanofi (H1N1) 15 ug.nonadyuvanteActive comparator120 participants selected in random form
Receives: Biological: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
Vaccine Sanofi A(H1N1) 7.5 ugActive comparator120 participants selected in random form
Receives: Biological: Vaccine Sanofi A(H1N1) 7.5 ug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. reactogenicity and safety

    Measured: day 28, day 56 and day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2009 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2010 (estimated)
  4. Study completionJul 2010 (estimated)

Why it stopped: Late approval by the Secretariat of Health, and expiration of vaccine

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00989274
Sponsor's protocol ID
CI:863, No. 777
Status last verified
Mar 2012
First submitted
2 Oct 2009
Last updated
2 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17502394

  • Wong-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.

    PubMed 16154241

  • Wong-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.

    PubMed 14722890

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vaccine Sanofi A(H1N1) 15 ug & trivalent, Vaccine Sanofi (H1N1) 15 ug.nonadyuvante and Vaccine Sanofi A(H1N1) 7.5 ug in people with Influenza, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reactogenicity and safety (time frame: day 28, day 56 and day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00989274, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.

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