A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine (MI-MA182)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Trivalent influenza virus vaccine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, FluMist, vaccine, prevention, trivalent
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination
- Healthy by medical history and health assessment
- Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, injectable, or transdermal contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to study vaccination, and must agree to continue using such precautions for at least 90 days after study vaccination; the subject must also have a negative serum or urine pregnancy test within 14 days prior to study vaccination (if screening and study vaccination do not occur on the same day) and on the day of study vaccination prior to randomization
- Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after study vaccination
- Available by telephone
- Provide written informed consent (and HIPAA authorization, if applicable)
- 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 study vaccination as required by the protocol
Exclusion Criteria:
- History of hypersensitivity to any component of the vaccine, including egg or egg protein
- History of hypersensitivity to gentamicin
- Any condition for which the inactivated influenza vaccine is 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 HIV infection, or ongoing immunosuppressive therapy
- History of Guillain-Barré syndrome
- A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid close contact with severely immunocompromised individuals for at least 21 days after study vaccination
- Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
- Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a contraindication to enrollment.
- Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
- Nursing mother
- Employee of the research center, any individual involved with the conduct of the study, or any family member of such individuals
- Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results
Sites / Locations
- Covance, Daytona Beach
- Covance, Portland
- Covance, Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Trivalent influenza virus vaccine
Placebo
Arm Description
Frozen trivalent vaccine containing new strains
treatment with placebo
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Fever
Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.
Secondary Outcome Measures
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Number of Subjects Reporting Any Adverse Event (AE) Post-treatment
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Number of Subjects Reporting Any AEs Post Treatment
Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)
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 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 SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Number of Subjects Reporting SAEs and SNMCs
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 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 SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00677820
Brief Title
A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine
Acronym
MI-MA182
Official Title
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Trivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MedImmune LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using a new strain recommended for the 2008-2009 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 was a prospective, randomized, double-blind, placebo-controlled release study. Eligible subjects were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site. Each subject received 1 dose of study vaccine on Study Day 0. The duration of study participation for each subject was the time from study vaccination through 180 days after study vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, FluMist, vaccine, prevention, trivalent
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trivalent influenza virus vaccine
Arm Type
Experimental
Arm Description
Frozen trivalent vaccine containing new strains
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
treatment with placebo
Intervention Type
Biological
Intervention Name(s)
Trivalent influenza virus vaccine
Intervention Description
Trivalent 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 each of three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Fever
Description
Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.
Time Frame
Days 0-7
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Time Frame
Days 0-7
Title
Number of Subjects Reporting Any Adverse Event (AE) Post-treatment
Time Frame
Days 0-7
Title
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Time Frame
Days 0-14
Title
Number of Subjects Reporting Any AEs Post Treatment
Time Frame
Days 0-14
Title
Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)
Description
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 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 SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Time Frame
Days 0-28
Title
Number of Subjects Reporting SAEs and SNMCs
Description
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 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 SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Time Frame
Days 0-180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination
Healthy by medical history and health assessment
Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, injectable, or transdermal contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to study vaccination, and must agree to continue using such precautions for at least 90 days after study vaccination; the subject must also have a negative serum or urine pregnancy test within 14 days prior to study vaccination (if screening and study vaccination do not occur on the same day) and on the day of study vaccination prior to randomization
Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after study vaccination
Available by telephone
Provide written informed consent (and HIPAA authorization, if applicable)
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 study vaccination as required by the protocol
Exclusion Criteria:
History of hypersensitivity to any component of the vaccine, including egg or egg protein
History of hypersensitivity to gentamicin
Any condition for which the inactivated influenza vaccine is 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 HIV infection, or ongoing immunosuppressive therapy
History of Guillain-Barré syndrome
A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid close contact with severely immunocompromised individuals for at least 21 days after study vaccination
Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a contraindication to enrollment.
Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
Nursing mother
Employee of the research center, any individual involved with the conduct of the study, or any family member of such individuals
Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raburn Mallory, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Covance, Daytona Beach
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Covance, Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Covance, Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine
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