Safety Study to Evaluate FluMist in Immunocompromised Children

NCT00112112 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: MI-CP114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cancer

Keywords

cancer, pediatric, influenza, vaccine

Outcome Measures

Primary Outcomes (4)

• 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.

  0-42 days after study vaccination

• 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.

  0-180 days after study vaccination

• 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.

  0-42 days after study vaccination

• 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.

  43-180 days after study vaccination

Secondary Outcomes (64)

• Number of Participants Shedding Vaccine-like Virus

  3-5 days after study vaccination

• Number of Participants Shedding Vaccine-like Virus

  7-10 days after study vaccination

• Number of Participants Shedding Vaccine-like Virus

  14-28 days after study vaccination

• Number of Participants Shedding Vaccine-like Virus

  35-42 days after study vaccination

• Number of Participants Shedding Vaccine-like Virus

  Unscheduled visits occurring during 0-42 days after study vaccination

Study Arms (2)

FluMist

ACTIVE COMPARATOR

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: FluMist

Placebo

PLACEBO COMPARATOR

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: Placebo

Interventions

FluMist BIOLOGICAL

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.

FluMist

Placebo BIOLOGICAL

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).

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (5)

University of Rochester School of Medicine & Dentistry

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

St. Jude's Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Children's Hospital Regional Medical Center

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 21496468 RESULT

MeSH Terms

Conditions

Neoplasms; Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Raburn Mallory
• Organization: MedImmune, LLC

malloryr@medimmune.com

301-398-0000

Study Officials

• Raburn Mallory, MD

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2005
• First Posted: May 30, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 14, 2017
• Results First Posted: September 3, 2012

Record last verified: 2017-06

Locations

US (5)