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AzTrials

CancerPhase 1NCT00112112

Safety Study to Evaluate FluMist in Immunocompromised Children

A Phase 1 study testing FluMist in people with Cancer, run by MedImmune LLC at 5 sites in United States.

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

The main purpose of this study is to get information about the safety of a flu vaccine spray, called FluMist, in children with cancer. The study is also being done to find out how much and how long the vaccine spray can be found in the nose. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Cancer
What is being tested?
FluMist
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
5 sitesUnited States
Study dates
1 Aug 2005to 1 May 2008
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 5 through 17 years of age (not yet reached their 18th birthday) at the time of entry into the study;
  • Patient's parent or legal guardian available by telephone during the course of the study;
  • Written informed consent (assent if applicable) and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the patient's parent or legal guardian;
  • Ability of the patient or patient's parent/guardian to comply with the requirements of the protocol;
  • Currently receiving chemotherapy and/or radiation therapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;
  • If the subject's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the subject's underlying disease is a hematologic malignancy, current status must be in remission;
  • Estimated life expectancy of >1 year; and
  • Currently has no worse than mild to moderate immunosuppression (meets none of the exclusion criteria).

Who cannot join

  • History of hypersensitivity to any component of FluMist, including egg or egg products, or monosodium glutamate;
  • History of hypersensitivity to gentamicin;
  • Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment);
  • History of Guillain-Barré syndrome;
  • History of asthma;
  • Use of aspirin or salicylate-containing products in the 30 days prior to study vaccination or expected receipt within the study duration;
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  • Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt (unless medically indicated) during this study;
  • Currently receiving inhaled steroid therapy;
  • Receipt of immunoglobulin within the past 90 days;
  • Receipt of stem cell transplant;
  • Acute febrile [>100.0°F (37.8°C) oral] illness or acute respiratory illness, e.g., cough or sore throat, within three days prior to enrollment;
  • Administration of any live vaccine within 30 days prior to enrollment or if receipt of another live vaccine is expected within 30 days after the vaccination in this study;
  • Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks after the vaccination in this study;
  • Receipt of an investigational product studied under an investigational new drug (IND) within 10 days prior to study entry or expected receipt of such an investigational product within 10 days after study vaccination (Note: an investigational product not studied under an IND is allowed at the investigator's discretion);
  • Pregnancy or, in biologically capable females (e.g., menses within the last year), not willing to agree to acceptable birth control for three months after study vaccination (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
  • Female who is breastfeeding or lactating;
  • Any condition or receipt of other medication that, in the opinion of the investigator, might interfere with the evaluation of the vaccine or interpretation of study results;
  • At the study screening visit (within 16 days before study vaccination) a CD4+ T cell percentage of <15%;
  • At study entry, an absolute neutrophil count less than or equal to 500 cells/mm3;
  • Receipt of high-dose systemic corticosteroids (≥ 2 mg/kg total of prednisone or equivalent given daily or on alternating days) for ≥ 14 consecutive days within 30 days prior to or following study vaccination

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • St. Jude's Children's Research Hospital

    Memphis, Tennessee, 38105

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • University of Rochester School of Medicine & Dentistry

    Rochester, New York, 14642

  • Children's Hospital Regional Medical Center

    Seattle, Washington, 98105

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: A Phase I Randomized, Double-Blind Trial of the Safety and Immunogenicity of FluMist® A Live, Intranasal Influenza Virus Vaccine vs. Placebo in Immunocompromised Children Ages 5 Through 17 Years of Age

The main purpose of this study is to get information about the safety of a flu vaccine spray, called FluMist, in children with cancer. The study is also being done to find out how much and how long the vaccine spray can be found in the nose.

Read the detailed description

This study is a randomized, double-blind Phase 1 study of FluMist vs. placebo in mild to moderately immunocompromised children 5 to 17 years of age with cancer. The primary objective of this study is to describe the safety of FluMist compared with placebo in mild to moderately immunocompromised children with cancer. The secondary objectives of this study are to describe the immune responses following vaccination with FluMist and to determine the incidence and duration of viral replication following vaccination with FluMist.

The standard 0.5 mL dose of vaccine or placebo was administered intranasally. Patients were evaluated at four visits scheduled between days 3-5, days 7-10, days 14-28, and days 35-42 for viral shedding via nasal swabs. Safety outcomes were collected at study clinic visits or by telephone contact through 42 days post dose. Serious adverse events and significant new medical conditions were collected through 180 days after receipt of investigational product.

Immune responses were measured by detection of influenza-specific antibodies as measured by the standard hemagglutination inhibition (HAI) assay. Influenza-specific serum antibody isotype levels were determined and nasal swab specimens were analyzed for the expression of influenza-specific immunoglobulin A (IgA). Serum was analyzed for its ability to neutralize viral particles from infecting Madin-Darby canine kidney cells (microneutralization). Baseline immunosuppression as measured by expression of T- and B-lymphocyte subsets was compared to immunosuppression at time points after vaccination. The duration of viral replication and the titers of live-attenuated influenza virus shed was evaluated from nasal swab specimens collected at scheduled time points after administration of FluMist.

Conditions
Cancer
Being tested
FluMist, Placebo
Keywords
cancer, pediatric, influenza, vaccine
Medical subject headings
Neoplasms, Influenza, Human

What participants receive

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

  • FluMistBiological

    The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like.

    brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm.

  • PlaceboBiological

    Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

Study groups in NCT00112112
Study groupRoleWhat they receive
FluMistActive comparatorThe total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like.
Receives: Biological: FluMist
PlaceboPlacebo comparatorPlacebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Receives: Biological: Placebo

What is being measured

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

  1. Number of Participants Who Had Reactogenicity Events (REs)

    Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.

    Measured: 0-42 days after study vaccination

  2. Number of Participants Who Had Serious Adverse Events (SAEs)

    An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.

    Measured: 0-180 days after study vaccination

  3. Number of Participants Who Had Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: 0-42 days after study vaccination

  4. Number of Significant New Medical Conditions (SNMCs)

    A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.

    Measured: 43-180 days after study vaccination

Secondary outcomes (64)

  1. Number of Participants Shedding Vaccine-like Virus

    Number of participants with nasal swab samples that contained vaccine-like virus are reported.

    Measured: 3-5 days after study vaccination

  2. Number of Participants Shedding Vaccine-like Virus

    Number of participants with nasal swab samples that contained vaccine-like virus are reported.

    Measured: 7-10 days after study vaccination

  3. Number of Participants Shedding Vaccine-like Virus

    Number of participants with nasal swab samples that contained vaccine-like virus are reported.

    Measured: 14-28 days after study vaccination

  4. Number of Participants Shedding Vaccine-like Virus

    Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.

    Measured: 35-42 days after study vaccination

  5. Number of Participants Shedding Vaccine-like Virus

    Number of participants with nasal swab samples that contained vaccine-like virus are reported.

    Measured: Unscheduled visits occurring during 0-42 days after study vaccination

  6. T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19

    Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: pre-dosing (Day 0)

  7. T- and B-lymphocyte Subsets by Flow Cytometry - CD3

    Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: pre-dosing (Day 0)

  8. T- and B-lymphocyte Subsets by Flow Cytometry - CD4

    Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: pre-dosing (Day 0)

  9. T- and B-lymphocyte Subsets by Flow Cytometry - CD8

    Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: pre-dosing (Day 0)

  10. T- and B-lymphocyte Subsets by Flow Cytometry - CD19

    Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: 7-10 days after study vaccination

  11. T- and B-lymphocyte Subsets by Flow Cytometry - CD3

    Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: 7-10 days after study vaccination

  12. T- and B-lymphocyte Subsets by Flow Cytometry - CD4

    Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: 7-10 days after study vaccination

  13. T- and B-lymphocyte Subsets by Flow Cytometry - CD8

    Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.

    Measured: 7-10 days after study vaccination

  14. Interferon (INF)-Gamma

    Mean and standard deviation spots-forming cells per 10^5 T cells is reported.

    Measured: pre-dosing (Day 0)

  15. INF-Gamma

    Mean and standard deviation spots-forming cells per 10^5 T cells is reported.

    Measured: 7-10 days after study vaccination

  16. INF-Gamma

    Mean and standard deviation spots-forming cells per 10^5 T cells is reported.

    Measured: 35-42 days after study vaccination

  17. Interleukin (IL)-4

    Mean and standard deviation spots-forming cells per 10^5 T cells is reported.

    Measured: pre-dosing (Day 0)

  18. IL-4

    Mean and standard deviation spots-forming cells per 10^5 T cells is reported.

    Measured: 7-10 days after study vaccination

  19. IL-4

    Mean and standard deviation spots-forming cells per 10^5 T cells is reported.

    Measured: 35-42 days after study vaccination

  20. Human Leukocyte Antigen (HLA) Matched Tetramers CD8+

    The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.

    Measured: pre-dosing (Day 0)

  21. HLA Matched Tetramers CD8+

    The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.

    Measured: 7-10 days after study vaccination

  22. HLA Matched Tetramers CD8+

    The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.

    Measured: 35-42 days after study vaccination

  23. Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42

    Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.

    Measured: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination

  24. Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42

    Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.

    Measured: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination

  25. Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42

    Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.

    Measured: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination

  26. Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42

    Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.

    Measured: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination

  27. Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42

    Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.

    Measured: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination

  28. Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42

    Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.

    Measured: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination

  29. Influenza A/H1N1 Immunoglobulin A (IgA)

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  30. Influenza A/H1N1 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 3-5 days after study vaccination

  31. Influenza A/H1N1 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 7-10 days after study vaccination

  32. Influenza A/H1N1 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 14-28 days after study vaccination

  33. Influenza A/H1N1 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  34. Influenza A/H3N2 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  35. Influenza A/H3N2 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 3-5 days after study vaccination

  36. Influenza A/H3N2 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 7-10 days after study vaccination

  37. Influenza A/H3N2 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 14-28 days after study vaccination

  38. Influenza A/H3N2 IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  39. Influenza B IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  40. Influenza B IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 3-5 days after study vaccination

  41. Influenza B IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 7-10 days after study vaccination

  42. Influenza B IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 14-28 days after study vaccination

  43. Influenza B IgA

    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  44. T- and B-lymphocyte Subsets by Flow Cytometry - CD56

    Mean and standard deviation results of CD56 lymphocyte subsets is reported.

    Measured: pre-dosing (Day 0)

  45. T- and B-lymphocyte Subsets by Flow Cytometry - CD56

    Mean and standard deviation results of CD56 lymphocyte subsets is reported.

    Measured: 7-10 days after study vaccination

  46. T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells

    Mean and standard deviation results of white blood cells subsets is reported.

    Measured: pre-dosing (Day 0)

  47. T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells

    Mean and standard deviation results of white blood cells subsets is reported.

    Measured: 7-10 days after study vaccination

  48. T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes

    Mean and standard deviation results of lymphocytes subsets is reported.

    Measured: pre-dosing (Day 0)

  49. T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes

    Mean and standard deviation results of lymphocytes subsets is reported.

    Measured: 7-10 days after study vaccination

  50. T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes

    Mean and standard deviation results of absolute lymphocytes subsets is reported.

    Measured: pre-dosing (Day 0)

  51. T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes

    Mean and standard deviation results of absolute lymphocytes subsets is reported.

    Measured: 7-10 days after study vaccination

  52. T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils

    Mean and standard deviation results of absolute neutrophils subsets is reported.

    Measured: pre-dosing (Day 0)

  53. Influenza A/H1N1 Immunoglobulin G (IgG)

    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  54. Influenza A/H1N1 IgG

    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  55. Influenza A/H3N2 IgG

    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  56. Influenza A/H3N2 IgG

    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  57. Influenza B IgG

    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  58. Influenza B IgG

    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  59. Influenza A/H1N1 Immunoglobulin M (IgM)

    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  60. Influenza A/H1N1 IgM

    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  61. Influenza A/H3N2 IgM

    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  62. Influenza A/H3N2 IgM

    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

  63. Influenza B IgM

    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: pre-dosing (Day 0)

  64. Influenza B IgM

    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.

    Measured: 35-42 days after study vaccination

Timeline

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

  1. First posted30 May 2005 (estimated)
  2. Study start1 Aug 2005
  3. Primary completion1 Mar 2008
  4. Study completion1 May 2008

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112112
Sponsor's protocol ID
MI-CP114
Status last verified
Jun 2017
First submitted
27 May 2005
Last updated
14 Aug 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Halasa N, Englund JA, Nachman S, Weinberg GA, Huber VC, Allison K, Dubovsky F, Yi T, McCullers JA, Flynn PM. Safety of live attenuated influenza vaccine in mild to moderately immunocompromised children with cancer. Vaccine. 2011 May 31;29(24):4110-5. doi: 10.1016/j.vaccine.2011.03.097. Epub 2011 Apr 13.

    PubMed 21496468

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FluMist in people with Cancer, run by MedImmune LLC at 5 sites in United States.

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 8 inclusion and 20 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Had Reactogenicity Events (REs) (time frame: 0-42 days after study vaccination). The study lists 4 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 NCT00112112, which also lists 1 linked publication.

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 Aug 2017.

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