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Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FluMist
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-49 years of age (not yet reached their 50th birthday); In good health; Available by telephone; Ability to understand and comply with the requirements of the protocol; and Signed informed consent and HIPAA authorization. Exclusion Criteria: Any condition for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the preceding year; Acute febrile (>100.0°F oral) and/or respiratory illness, including cough or sore throat, within the 14 days prior to enrollment; Hypersensitivity to egg or egg protein; Hypersensitivity to gentamicin; Any known immunosuppressive condition or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; History of Guillan-Barré Syndrome; Household contact who is immunocompromised (participant should also avoid close contact with immunocompromised individuals for at least 21 days); Participation in another investigational trial within 30 days prior to enrollment or expected enrollment in another investigational trial during this study; Chronic or regular use of antipyretic or analgesic medication on a daily or every other day basis; Notes: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of antipyretic or analgesic medications at the time of enrollment and for fourteen days following vaccination is not considered a contraindication to enrollment. Pregnancy or, in biologically capable women (e.g., menses within the last year) participant does not agree to use acceptable birth control measures as determined by the investigator continuously for three months after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result); Breastfeeding or lactating women; Administration of intranasal medications within two weeks prior to enrollment or expected receipt during this study; Employees of the investigational site or their family member or any individuals involved with the conduct of the study; and Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.

Sites / Locations

  • SFBC International, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

FluMist

Placebo

Outcomes

Primary Outcome Measures

The primary endpoint of this study is fever (Day 0-7) defined as oral temperature ³101°F.

Secondary Outcome Measures

Secondary endpoints of the study include other reported reactogenicity events and other adverse events that occur within seven days (Day 0-7) and fourteen days (Day 0-14) following vaccination

Full Information

First Posted
September 12, 2005
Last Updated
December 12, 2007
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00192127
Brief Title
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
Official Title
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

Brief Summary
This study is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.
Detailed Description
The primary study objective is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them. Safety will be demonstrated by similar fever rates (oral temperature ≥101°F Days 0-7) in vaccine and placebo recipients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
FluMist
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
FluMist
Intervention Description
A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0
Primary Outcome Measure Information:
Title
The primary endpoint of this study is fever (Day 0-7) defined as oral temperature ³101°F.
Time Frame
Day 0-7
Secondary Outcome Measure Information:
Title
Secondary endpoints of the study include other reported reactogenicity events and other adverse events that occur within seven days (Day 0-7) and fourteen days (Day 0-14) following vaccination
Time Frame
Days 0-7; 0-14

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: 18-49 years of age (not yet reached their 50th birthday); In good health; Available by telephone; Ability to understand and comply with the requirements of the protocol; and Signed informed consent and HIPAA authorization. Exclusion Criteria: Any condition for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the preceding year; Acute febrile (>100.0°F oral) and/or respiratory illness, including cough or sore throat, within the 14 days prior to enrollment; Hypersensitivity to egg or egg protein; Hypersensitivity to gentamicin; Any known immunosuppressive condition or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; History of Guillan-Barré Syndrome; Household contact who is immunocompromised (participant should also avoid close contact with immunocompromised individuals for at least 21 days); Participation in another investigational trial within 30 days prior to enrollment or expected enrollment in another investigational trial during this study; Chronic or regular use of antipyretic or analgesic medication on a daily or every other day basis; Notes: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of antipyretic or analgesic medications at the time of enrollment and for fourteen days following vaccination is not considered a contraindication to enrollment. Pregnancy or, in biologically capable women (e.g., menses within the last year) participant does not agree to use acceptable birth control measures as determined by the investigator continuously for three months after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result); Breastfeeding or lactating women; Administration of intranasal medications within two weeks prior to enrollment or expected receipt during this study; Employees of the investigational site or their family member or any individuals involved with the conduct of the study; and Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Walker, MD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
SFBC International, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33181
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults

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