WithdrawnNCT00989274Updated Apr 2, 2012

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

A Phase 2 interventional study of Vaccine Sanofi A(H1N1) 15 ug & trivalent and Vaccine Sanofi (H1N1) 15 ug.nonadyuvante in Influenza, sponsored by Instituto Nacional de Salud Publica, Mexico. Withdrawn at 1 site in Mexico. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-04-02.

Sponsored by Instituto Nacional de Salud Publica, Mexico · Phase 2, Interventional, and Prevention

Why this study was withdrawn

Late approval by the Secretariat of Health, and expiration of vaccine

Phase: Phase 2
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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).

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:

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.
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).
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 studied

Influenza

Browse trials for

Influenza, Human 2,214

Keywords

Influenza
Vaccination
Immunology
Immunogenicity
Reactogenicity
Safety
Influenza vaccine
Immune response
Adverse effects

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

Browse Influenza, Human studies →

Lead sponsor

Instituto Nacional de Salud Publica, Mexico is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Active comparator
Vaccine Sanofi A(H1N1) 15 ug & trivalent
120 participants selected by random
Biological: Vaccine Sanofi A(H1N1) 15 ug & trivalent
Active comparator
Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
120 participants selected in random form
Biological: Vaccine Sanofi (H1N1) 15 ug.nonadyuvante
Active comparator
Vaccine Sanofi A(H1N1) 7.5 ug
120 participants selected in random form
Biological: Vaccine Sanofi A(H1N1) 7.5 ug

Interventions

BiologicalVaccine 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);
Also known as: Vaccine Sanofi A(H1N1)
BiologicalVaccine 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)
Also known as: Vaccine Sanofi A(H1N1)
BiologicalVaccine 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).
Also known as: Vaccine Sanofi A(H1N1)

What researchers measure

Primary outcomes

reactogenicity and safety
Time frame: day 28, day 56 and day 84

Study locations

1 site

Instituto Nacional de Salud Pública
Cuernavaca, Morelos 62100, Mexico

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00989274
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Collaborators: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Responsible party: Ma. de Lourdes Garcia Garcia (Director of the Center of Research in Infectious Diseases, Instituto Nacional de Salud Publica, Mexico) — Principal investigator
First posted: Oct 5, 2009
Start date: Jun 2010
Primary completion: Jun 2010 (estimated)
Completion: Jul 2010 (estimated)
Last update: Apr 2, 2012

Study contacts

Lourdes Garcia-Garcia, MD, PhD

principal investigator · Instituto Nacional de Salud Publica, Mexico

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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