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

NCT00192127 | Completed Phase 3

• 1 other identifier: MI-CP113
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

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

  Day 0-7

Secondary Outcomes (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

  Days 0-7; 0-14

Study Arms (2)

1

ACTIVE COMPARATOR

FluMist

Biological: FluMist

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

FluMist BIOLOGICAL

A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.

1

Placebo OTHER

A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0

2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

SFBC International, Inc

Miami, Florida, 33181, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Walker, MD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2004
• Study Completion: February 1, 2005
• Last Updated: December 18, 2007

Record last verified: 2007-12

Locations

US (1)