Safety Study to Evaluate FluMist in Immunocompromised Children

Study identifier:MI-CP114

ClinicalTrials.gov identifier:NCT00112112

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

cancer

Phase

Phase 1

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

5 Years - 17 Years

Date

Study Start Date: 01 Aug 2005

Primary Completion Date: 01 Mar 2008

Study Completion Date: 01 May 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Jun 2017 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- 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).

Exclusion Criteria

- 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;
- 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

Location

St. Jude's Children's Research Hospital

Memphis, TN, United States, 38105

Location

University of Rochester School of Medicine & Dentistry

Rochester, NY, United States, 14642

Location

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794

Location

Children's Hospital Regional Medical Center

Seattle, Washington, United States, 98105

Location

Vanderbilt University

Nashville, TN, United States, 37232

Arms	Assigned Interventions
Active Comparator: FluMist 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.	Biological/Vaccine: FluMist 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.
Placebo Comparator: Placebo 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).	Biological/Vaccine: Placebo 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).

Arms

Assigned Interventions

Active Comparator: FluMist
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.

Biological/Vaccine: FluMist
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.

Placebo Comparator: Placebo
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).

Biological/Vaccine: Placebo
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).

Documents available

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Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
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Trial Results Summaries
Available here

Contacts

Contact

Helene Mortimer

301-398-0000

mortimerh@medimmune.com

Investigators

Principal Investigator

Raburn Mallory

MedImmune, Inc.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

St. Jude's Children's Research Hospital

University of Rochester School of Medicine & Dentistry

Stony Brook University Medical Center

Children's Hospital Regional Medical Center

Vanderbilt University

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Trial Results Summaries