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H1N1 Influenza VirusPhase 3NCT01032395

Immunogenicity, Safety, and Tolerability of an MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus

A Phase 3 study testing Focetria®, Fluad® and Begrivac® in people with H1N1 Influenza Virus and Chronic Pulmonary Disease, run by Chiltern Pesquisa Clinica Ltda at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Chronic Pulmonary Disease… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Focetria®, Fluad® and Begrivac®
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
2 sitesBrazil
Study dates
Mar 2010to Aug 2012
Phase
Phase 3
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For Subjects with Chronic Diseases:
  • Subjects between 18 and 70 years of age (inclusive)
  • Any sex or ethnicity
  • Outpatient or hospitalized subjects
  • Confirmed diagnosis of chronic pulmonary and/or cardiac, and/or diabetes mellitus based on the investigator's assessment (subjects may present one or more of such conditions)
  • Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
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  • Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
  • Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
  • Intra-uterine device (IUD)
  • Monogamous relation with vasectomized partner (must have been vasectomized at least six months before the volunteer entered the study)
  • Subjects capable of following all the study procedures and available for all visits scheduled to the investigation site
  • Subjects capable of understanding the nature and risk of the study proposed and sign the consent form
  • The study subjects may have other underlying chronic diseases that do not involve immunosuppression (e.g. osteoarticular diseases, stable, non-progressive, non-severe neurologic disorders without cognitive impairment, ophthalmologic diseases, hypothyroidism, etc.), but their symptoms/signs must be under control through medical follow-ups and drug therapy
  • For Healthy Subjects:
  • Subjects between 18 and 70 years of age (inclusive)
  • Any sex and ethnicity
  • Subjects with good health as determined by medical history, physical evaluation, and investigator's clinical opinion
  • Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
  • Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
  • Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole sexual intercourse
  • Intra-uterine device (IUD)
  • Monogamous relation with vasectomized partner (must have been vasectomized for at least six months before the volunteer entered the study)
  • Subjects capable of respecting all the study procedures and available for all the visits scheduled at the investigation site
  • Subjects capable of understanding the nature and risk of the study proposed and sign the consent form

Who cannot join

  • For Subjects with Chronic Diseases
  • Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
  • Administration of other vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
  • Any recent vaccine given within the last 21 days (inclusive)
  • History of allergic reaction to an influenza vaccine in the past, or a current or previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate
  • Acute febrile disease (vaccination may be delayed up to 3 days after the resolution of the symptoms)
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  • History of cancer, except for skin cancer, including Kaposi's Sarcoma, basal cell carcinoma, and non-invasive malignancy related to HPV
  • History of chronic hepatic or renal disease
  • History of cognitive disorders
  • History of progressive or severe neurological disorders, including Guillain-Barré Syndrome
  • Pregnancy or breast-feeding
  • Use of immunomodulatory therapy, including cyclosporin,interleukins, and interferons, within 3 months prior to inclusion in the study
  • Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study
  • Life expectancy of at least 12 months
  • Receipt of any investigational product within 12 months prior to inclusion in the study
  • For Healthy Subjects:
  • Previous laboratory confirmed diagnosis of an infection by the new virus H1N1
  • Receipt of another vaccine against the new virus H1N1 within 3 months prior to inclusion in the study
  • Any recent vaccine given within the last 21 days (inclusive)
  • History of allergic reaction to influenza vaccine in the past, or a current or previous allergy to egg or egg protein, kanamycin, and neomycin sulfate
  • Acute febrile disease (the vaccination may be delayed up to 3 days after symptoms resolution)
  • Pregnancy or breast-feeding
  • Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study
  • Receipt of any investigational product within 12 months prior to inclusion in the study

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC

    Santo André, São Paulo

  • Instituto de Ensino e Pesquisa em Geriatria e Gerontologia

    São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.

Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

Being tested
Focetria®, Fluad®, Begrivac®
Keywords
H1N1, Pulmonary Disease, Heart Disease, Diabetes, Influenza, immunogenicity, safety, tolerability
Medical subject headings
Diabetes Mellitus, Lung Diseases, Heart Diseases, Influenza, Human

What participants receive

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

  • Focetria®Biological

    7.5 ug of HA antigen; adjuvanted; monovalent

  • Fluad®Biological

    15 ug of HA antigen; adjuvanted; trivalent

  • Begrivac®Biological

    15 ug of antigen; non-adjuvanted; trivalent

Study groups in NCT01032395
Study groupRoleWhat they receive
Chronic Disease Subjects Receiving Vaccine with AdjuvantExperimentalEach subject received two doses of vaccine with adjuvant (Focetria® or Fluad®), the first on Study Day 1, and the second on Study Day 22.
Receives: Biological: Focetria®; Biological: Fluad®
Chronic Disease Subjects Receiving Vaccine without AdjuvantExperimentalEach subject received two doses of vaccine without adjuvant (Begrivac®), the first on Study Day 1, and the second on Study Day 22.
Receives: Biological: Begrivac®
Healthy Subjects Receiving Vaccine with AdjuvantExperimentalEach subject received two doses of vaccine with adjuvant (Focetria® or Flaud®), the first on Study Day 1, and the second on Study Day 22.
Receives: Biological: Focetria®; Biological: Fluad®
Healthy Subjects Receiving Vaccine without AdjuvantExperimentalEach subject received two doses of vaccine without adjuvant (Begrivac®), the first on Study Day 1, and the second on Study Day 22.
Receives: Biological: Begrivac®

What is being measured

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

  1. Geometric Mean HI Titer by Visit

    Geometric mean hemagglutinin inhibition (HI) titer = GMT

    Measured: 13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)

  2. Geometric Mean Ratio by Visit

    The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus).

    Measured: 13 months after vaccination (Day 22/Day1, Day 43/Day 1, Day 43/Day 22, Day 133/Day 43, Day 223/Day 43 and Day 403/Day 223)

  3. Ratio of Immunogenicity Data by Visit (Vaccine With Adjuvant : Vaccine Without Adjuvant)

    The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using ratios of immunogenicity data and were presented with 95% confidence intervals.

    Measured: 13 months after vaccination (Day 1, Day 22, Day 22/Day1, Day 43, Day 43/Day 1, Day 43/Day 22, Day 133, Day 133/Day 43, Day 223, Day 223/Day 43 and Day 403, Day 403/Day 223)

  4. Percentage of Subjects Who Reached Seroprotection by Visit

    The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). The percentage of subjects that reached seroprotection in comparison to the pre-vaccination result are presented by visit. Seroprotection was defined as HI titer ≥40.

    Measured: 13 months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)

  5. Percent of Subjects Who Seroconverted or Had a Significant Increase in Geometric Mean Titer by Visit

    The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). The percentage of subjects that reached seroconversion or had a significant increase in comparison to the pre-vaccination result were presented by visit. Seroconversion or a significant increase was defined as HI titer ≥40 in subjects with negative results at pre-vaccination (HI titer <10) or an increase of at least 4 times in HI titer for individuals with positive results at pre-vaccination (HI titer >10) at Day 22 and Day 43 in comparison to the pre-vaccination result.

    Measured: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)

  6. Difference in the Seroprotection Rates by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)

    The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using differences in the percentage of subjects with seroprotection and were presented with 95% confidence intervals.

    Measured: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)

  7. Differences in the Seroconversion Rates or Significant Increase by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)

    The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using differences in the percentage of subjects with seroconversion/significant increase and were presented with 95% confidence intervals.

    Measured: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)

Timeline

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

  1. First posted15 Dec 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2011
  4. Study completionAug 2012

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01032395
Sponsor's protocol ID
V111_16TP
Status last verified
Jun 2013
First submitted
14 Dec 2009
Last updated
14 Jun 2013
Results posted
No

Publications

  • ANZIC Influenza Investigators; Webb SA, Pettila V, Seppelt I, Bellomo R, Bailey M, Cooper DJ, Cretikos M, Davies AR, Finfer S, Harrigan PW, Hart GK, Howe B, Iredell JR, McArthur C, Mitchell I, Morrison S, Nichol AD, Paterson DL, Peake S, Richards B, Stephens D, Turner A, Yung M. Critical care services and 2009 H1N1 influenza in Australia and New Zealand. N Engl J Med. 2009 Nov 12;361(20):1925-34. doi: 10.1056/NEJMoa0908481. Epub 2009 Oct 8.

    PubMed 19815860

  • Bridges CB, Katz JM, Levandowski RA, Cox NJ. Inactivated influenza vaccines. In. Plotkin SA, Orenstein WA, Offit PA. Vaccines 5th ed. WB Saunders. Phila PA 2008; 291-309

  • Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.

    PubMed 19745215

  • Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.

    PubMed 19423869

  • Dominguez-Cherit G, Lapinsky SE, Macias AE, Pinto R, Espinosa-Perez L, de la Torre A, Poblano-Morales M, Baltazar-Torres JA, Bautista E, Martinez A, Martinez MA, Rivero E, Valdez R, Ruiz-Palacios G, Hernandez M, Stewart TE, Fowler RA. Critically Ill patients with 2009 influenza A(H1N1) in Mexico. JAMA. 2009 Nov 4;302(17):1880-7. doi: 10.1001/jama.2009.1536. Epub 2009 Oct 12.

    PubMed 19822626

  • Jain S, Kamimoto L, Bramley AM, Schmitz AM, Benoit SR, Louie J, Sugerman DE, Druckenmiller JK, Ritger KA, Chugh R, Jasuja S, Deutscher M, Chen S, Walker JD, Duchin JS, Lett S, Soliva S, Wells EV, Swerdlow D, Uyeki TM, Fiore AE, Olsen SJ, Fry AM, Bridges CB, Finelli L; 2009 Pandemic Influenza A (H1N1) Virus Hospitalizations Investigation Team. Hospitalized patients with 2009 H1N1 influenza in the United States, April-June 2009. N Engl J Med. 2009 Nov 12;361(20):1935-44. doi: 10.1056/NEJMoa0906695. Epub 2009 Oct 8.

    PubMed 19815859

  • Kumar A, Zarychanski R, Pinto R, Cook DJ, Marshall J, Lacroix J, Stelfox T, Bagshaw S, Choong K, Lamontagne F, Turgeon AF, Lapinsky S, Ahern SP, Smith O, Siddiqui F, Jouvet P, Khwaja K, McIntyre L, Menon K, Hutchison J, Hornstein D, Joffe A, Lauzier F, Singh J, Karachi T, Wiebe K, Olafson K, Ramsey C, Sharma S, Dodek P, Meade M, Hall R, Fowler RA; Canadian Critical Care Trials Group H1N1 Collaborative. Critically ill patients with 2009 influenza A(H1N1) infection in Canada. JAMA. 2009 Nov 4;302(17):1872-9. doi: 10.1001/jama.2009.1496. Epub 2009 Oct 12.

    PubMed 19822627

  • Vaillant L, La Ruche G, Tarantola A, Barboza P; epidemic intelligence team at InVS. Epidemiology of fatal cases associated with pandemic H1N1 influenza 2009. Euro Surveill. 2009 Aug 20;14(33):19309. doi: 10.2807/ese.14.33.19309-en.

    PubMed 19712643

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Focetria®, Fluad® and Begrivac® in people with H1N1 Influenza Virus and Chronic Pulmonary Disease, run by Chiltern Pesquisa Clinica Ltda at 2 sites in Brazil.

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 24 inclusion and 24 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: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Geometric Mean HI Titer by Visit (time frame: 13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)). The study lists 7 primary outcomes in all. 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 NCT01032395, which also lists 8 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 14 Jun 2013.

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