Clinical trial NCT00125944: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-08-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.


Eligibility criteria: Inclusion Criteria:

* Males or females, 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, intrauterine device \[IUD\], 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 volunteer 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
* Written informed consent (and Health Insurance Portability and Accountability Act \[HIPAA\] authorization if applicable) obtained from the participant
* 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 of 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 (e.g., asthma); chronic metabolic diseases (e.g., 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 (e.g., cough or sore throat) within the 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
* Household contact who is immunocompromised (participant should also avoid close contact with immunocompromised individuals for at least 21 days post study vaccination)
* Receipt of any investigational agent within 30 days prior to enrollment, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
* Chronic or regular use of anti-pyretic or analgesic medication on a daily or every other day basis.

Note: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of anti-pyretic or analgesic medications at the time of enrollment and for 14 days following vaccination 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 that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results

Primary outcomes:
measure: The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least ³101°F.
Secondary outcomes:
measure: Reported Reactogenocity Events (REs) and Adverse Events (AEs) that occur within 7 days after vaccination and that occur within 14 days after vaccination. SAEs and SNMCs that occur within 28 days after vaccination and within 180 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Radiant Research, San Diego
state: California
city: Daytona Beach
country: United States
facility: Radiant Research, Daytona Beach
state: Florida
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: San Antonio
country: United States
facility: Healthcare Discoveries, Inc.
state: Texas
Study officials:
affiliation: MedImmune LLC
name: Robert Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: