HealthyPhase 3NCT00125944
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
A Phase 3 study testing FluMist in people with Healthy and Influenza, run by MedImmune LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- What is being tested?
- FluMist
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2005to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Radiant Research, Daytona Beach
Daytona Beach, Florida, 32114
Radiant Research
Portland, Oregon, 97239
Healthcare Discoveries, Inc.
San Antonio, Texas, 78229
Radiant Research, San Diego
San Diego, California, 92123
About this study
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
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.
- Being tested
- FluMist
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least ³101°F.
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startJul 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Walker, MD, Principal investigator, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125944
- Sponsor's protocol ID
- MI-CP125
- Status last verified
- May 2007
- First submitted
- 1 Aug 2005
- Last updated
- 9 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00125944
- Acronym / sponsor ID
- MI-CP125
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jan 2006
- First posted
- 2 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluMist | Biological | – |
Primary outcome
The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least ³101°F.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Walker, MD principal investigator
MedImmune LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FluMist in people with Healthy and Influenza, run by MedImmune LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least ³101°F.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2007.