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H1N1 Influenza VirusPhase 3NCT01031719

Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors

A Phase 3 study testing adjuvanted A(H1N1) influenza vaccine and non-adjuvanted A(H1N1) influenza vaccine in people with H1N1 Influenza Virus and Invasive Solid Tumors, run by Chiltern Pesquisa Clinica Ltda at 3 sites in Brazil.

Completed

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

Official record
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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 Solid Invasive Tumors and to… Read more about this study

Who is it for?
Ages 2 to 70 yearsHealthy volunteers can take part
Conditions the study is for
H1N1 Influenza Virus, Invasive Solid Tumors
What is being tested?
adjuvanted A(H1N1) influenza vaccine and non-adjuvanted A(H1N1) influenza vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
3 sitesBrazil
Study dates
Aug 2010to Jul 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 2 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • For Invasive Solid Tumor Subjects:
  • Subjects between 2 and 70 years of age (inclusive)
  • Any sex or ethnicity
  • Confirmed diagnosis of Invasive Solid Tumor or hematological malignancies in complete remission for at least 3 months and not more than 18 months after the last neo-adjuvant and/or adjuvant chemotherapy cycle according to investigators assessment and the subjects medical records
  • Previous use of neo-adjuvant and/or adjuvant chemotherapy for the treatment on an invasive solid tumor
  • Life expectancy of at least 12 months
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  • Karnofsky Performance Scale > 40%
  • 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 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
  • In case of children and adolescents (below 18 years of age): Subjects capable of understanding the nature of the study and whose legal guardian understands the nature and risk of the study proposed and signs the consent form
  • The study subjects may have other underlying chronic diseases that do not involve immunosuppression (e.g. osteoarticular diseases, cardiorespiratory diseases, metabolic diseases, stable, non progressive, non-severe neurologic disorders without cognitive impairment, ophthalmologic diseases, etc.), but their symptoms/signs must be under control through medical follow-ups and drug therapy
  • For Healthy Subjects:
  • Subjects between 2 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
  • In case of children and adolescents (below 18 years of age): Subjects capable of understanding the nature of the study and whose legal guardian understands the nature and risk of the study proposed and signs the consent form

Who cannot join

  • For Invasive Solid Tumor Subjects:
  • 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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  • Presence of other diseases, not related to cancer with confirmed immunosuppression
  • Chemotherapy, biologic therapy or radiation within 3 months prior to inclusion in the study
  • 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
  • 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

3 sites in 1 country.

Brazil3 sites

  • BIOCANCER Clinical Research

    Belo Horizonte, Minas Gerais

  • Centro de Estudos e Pesquisas de Oncologia e Hematologia da Faculdade de Medicina da Fundação do ABC

    Santo André, São Paulo

  • Universidade Federal de São Paulo

    São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors

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 Solid Invasive Tumors 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
adjuvanted A(H1N1) influenza vaccine, non-adjuvanted A(H1N1) influenza vaccine
Keywords
Influenza A Virus, Virus Diseases, Influenza, Human, H1N1, Immunogenicity, safety, tolerability, tumors, oncology
Medical subject headings
Virus Diseases, Influenza, Human, Neoplasms

What participants receive

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

  • adjuvanted A(H1N1) influenza vaccineBiological

    7.5 ug of HA antigen; adjuvanted; monovalent

  • non-adjuvanted A(H1N1) influenza vaccineBiological

    15ug of HA antigen, non-adjuvanted; trivalent

  • non-adjuvanted A(H1N1) influenza vaccineBiological

    15 mcg of antigen; non-adjuvanted; trivalent

Study groups in NCT01031719
Study groupRoleWhat they receive
Group A: High Risk PopulationExperimentalEach subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Receives: Biological: adjuvanted A(H1N1) influenza vaccine
Group B: High Risk SubjectsExperimentalEach subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Receives: Biological: non-adjuvanted A(H1N1) influenza vaccine
Group C: Healthy SubjectsExperimentalEach subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Receives: Biological: adjuvanted A(H1N1) influenza vaccine
Group D: Healthy SubjectsExperimentalEach subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Receives: Biological: non-adjuvanted A(H1N1) influenza vaccine

What is being measured

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

  1. The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors

    Measured: 3 months

Secondary outcomes (4)

  1. Assess whether the adjuvanted vaccine offers a meaningful benefit in relation to the non-adjuvanted vaccine in this at-risk population

    Measured: 3 months

  2. Assess whether two doses of either study vaccine will provide meaningful benefit in comparison to one dose

    Measured: 3 months

  3. Assess the persistence of antibody levels in the two vaccine groups

    Measured: 3 months

  4. Gain further insight into the safety of the adjuvanted and non-adjuvanted H1N1 vaccines in this high-risk patient population

    Measured: 3 months

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 startAug 2010
  3. Primary completionSep 2011
  4. Study completionJul 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
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01031719
Sponsor's protocol ID
V111_15TP
Status last verified
Sep 2012
First submitted
14 Dec 2009
Last updated
13 Sep 2012
Results posted
No

Publications

  • 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

  • Gross PA, Gould AL, Brown AE. Effect of cancer chemotherapy on the immune response to influenza virus vaccine: review of published studies. Rev Infect Dis. 1985 Sep-Oct;7(5):613-8. doi: 10.1093/clinids/7.5.613.

    PubMed 3903940

  • Kunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis. 2009 Aug;9(8):493-504. doi: 10.1016/S1473-3099(09)70175-6.

    PubMed 19628174

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adjuvanted A(H1N1) influenza vaccine and non-adjuvanted A(H1N1) influenza vaccine in people with H1N1 Influenza Virus and Invasive Solid Tumors, run by Chiltern Pesquisa Clinica Ltda at 3 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 28 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 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors (time frame: 3 months). 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 NCT01031719, which also lists 4 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 13 Sep 2012.

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