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A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine (MI-MA205)

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ClinicalTrials.gov Identifier: NCT00873912
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : July 13, 2011
Last Update Posted : July 14, 2011
Sponsor:
Information provided by:
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 2, 2009
Results First Submitted Date  ICMJE October 8, 2010
Results First Posted Date  ICMJE July 13, 2011
Last Update Posted Date July 14, 2011
Study Start Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F [ Time Frame: Days 1-8 after vaccination ]
The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Fever (Study Days 1-8), defined as oral temperature ≥ 101°F [ Time Frame: Study Days 1-8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
  • Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE) [ Time Frame: Days 1-8 after vaccination ]
    Solicited symptoms were collected from administration of investigational product through Study Day 15. For this study, solicited symptoms included: fever (> 100°F oral), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), headache.
  • Number of Participants Reporting Any Solicited Symptom or at Least One AE [ Time Frame: Days 1-15 after vaccination ]
  • Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD) [ Time Frame: Days 1-29 after vaccination ]
    SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
  • Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD) [ Time Frame: Days 1-181 after vaccination ]
    SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Other reported solicited symptoms and AEs that occur within 7 days after vaccination (Study Days 1-8), and all solicited symptoms and AEs that occur within 14 days after vaccination (Study Days 1-15). [ Time Frame: 7 days after vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a New 6:2 Influenza Virus Reassortant in Healthy Adults
Brief Summary This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.
Detailed Description

This prospective, randomized, double-blind, placebo-controlled release study enrolled 300 healthy adults 18 to 49 years of age. Eligible participants were randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. This study was conducted at multiple sites in the United States. Randomization was stratified by site.

Each participant received one dose of investigational product on Day 1. The duration of study participation for each participant was the time from receipt of investigational product through 180 days after receipt of investigational product.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Monovalent influenza virus vaccine
    Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).
  • Biological: Placebo
    Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.
Study Arms  ICMJE
  • Experimental: Monovalent influenza virus vaccine
    Frozen monovalent vaccine containing new strain
    Intervention: Biological: Monovalent influenza virus vaccine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2009)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of investigational product administration
  • Healthy by medical history and physical exam
  • Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
  • Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), had sterile male partner, were premenarchal or at least 2 years postmenopausal, or practiced abstinence, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for at least 30 days prior to dosing with investigational product, and must have agreed to continue using such precautions for at least 90 days after dosing with investigational product; cessation of birth control after this point was to be discussed with a responsible physician. The subject must also have had a negative serum or urine pregnancy test within 14 days prior to investigational product administration (if screening and administration of investigational product did not occur on the same day) and on the day of investigational product administration prior to randomization
  • Males, unless surgically sterile, must have used 2 effective methods of birth control with a female partner and must have agreed to continue using such contraceptive precautions for at least 30 days after dosing with investigational product (from Day 1 through Day 31 of the study)
  • Subject available by telephone
  • Ability to understand and comply with the requirements of the protocol, as judged by the investigator
  • Ability to complete follow-up period of 180 days after dosing as required by the protocol

Exclusion Criteria:

  • History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life-threatening, or severe reactions to previous influenza vaccinations
  • History of hypersensitivity to gentamicin
  • Any condition for which the inactivated influenza vaccine was indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
  • Acute febrile (> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
  • Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus [HIV] infection, or ongoing immunosuppressive therapy
  • History of Guillain-Barré syndrome
  • A household contact who was severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual required care in a protective environment); subject should additionally have avoided close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product
  • Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the package insert was permitted)
  • Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product
  • Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product
  • Known or suspected mitochondrial encephalomyopathy
  • Nursing mother
  • Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would have interfered with evaluation of the investigational product or interpretation of subject safety or study results
  • Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00873912
Other Study ID Numbers  ICMJE MI-MA205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elissa Malkin, DO/Dir Clinical Development, MedImmune, LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elissa Malkin, D.O. MedImmune LLC
PRS Account MedImmune LLC
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP