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

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ClinicalTrials.gov Identifier: NCT00192127
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 18, 2007
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: FluMist Other: Placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : August 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
FluMist
Biological: FluMist
A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.
Placebo Comparator: 2
Placebo
Other: Placebo
A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0


Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint of this study is fever (Day 0-7) defined as oral temperature ³101°F. [ Time Frame: Day 0-7 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192127


Locations
United States, Florida
SFBC International, Inc
Miami, Florida, United States, 33181
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Walker, MD Sponsor GmbH
More Information

Responsible Party: Robert Walker, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00192127     History of Changes
Other Study ID Numbers: MI-CP113
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs