InfluenzaPhase 3NCT00192127
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 Influenza, run by MedImmune LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluMist
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Feb 2005
- 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
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
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
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- FluMist, Placebo
- 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
A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.
PlaceboOther
A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | FluMist Receives: Biological: FluMist |
| 2 | Placebo comparator | Placebo Receives: Other: Placebo |
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 (Day 0-7) defined as oral temperature ³101°F.
Measured: 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
Measured: Days 0-7; 0-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Walker, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192127
- Sponsor's protocol ID
- MI-CP113
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 18 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 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
- NCT00192127
- Acronym / sponsor ID
- MI-CP113
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Feb 2005 (actual)
- First posted
- 19 Sep 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: FluMistFluMist |
| 2 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
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 |
|---|---|---|
| FluMistA single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0. | Biological | 1 |
| PlaceboA single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0 | Other | 2 |
Primary outcome
The primary endpoint of this study is fever (Day 0-7) defined as oral temperature ³101°F.
Time frame: Day 0-7
1 secondary outcome
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
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 18 Dec 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 study director
Sponsor GmbH
1 site 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 Influenza, run by MedImmune LLC at 1 site 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 5 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 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 (Day 0-7) defined as oral temperature ³101°F. (time frame: Day 0-7). 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 18 Dec 2007.