InfluenzaPhase 4MI-MA182NCT00677820
A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine
A Phase 4 study testing Trivalent influenza virus vaccine in people with Influenza, run by MedImmune LLC at 3 sites in United States.
Trial summary
This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using a new strain recommended for the 2008-2009 influenza season not previously contained in the trivalent intranasal FluMist vaccine. 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?
- Trivalent influenza virus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female, 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, 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 subject 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
- Provide written informed consent (and HIPAA authorization, if applicable)
- 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 to 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 (eg, asthma), chronic metabolic diseases (eg, 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 (eg, cough or sore throat) within 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 13Show fewer
- A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid close contact with severely immunocompromised individuals for at least 21 days after study vaccination
- Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
- Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination Note: A daily dose of up to 81 mg of aspirin for prophylactic use 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 (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Covance, Austin
Austin, Texas, 78752
Covance, Daytona Beach
Daytona Beach, Florida, 32117
Covance, Portland
Portland, Oregon, 97239
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Trivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using a new strain recommended for the 2008-2009 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.
Read the detailed description
This was a prospective, randomized, double-blind, placebo-controlled release study. Eligible subjects were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site. Each subject received 1 dose of study vaccine on Study Day 0. The duration of study participation for each subject was the time from study vaccination through 180 days after study vaccination.
- Conditions
- Influenza
- Being tested
- Trivalent influenza virus vaccine, Placebo
- Keywords
- Influenza, FluMist, vaccine, prevention, trivalent
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent influenza virus vaccineBiological
Trivalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 ml of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10:7 FFU (fluorescent focus units) of each of three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.
PlaceboBiological
Placebo was supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.
| Study group | Role | What they receive |
|---|---|---|
| Trivalent influenza virus vaccine | Experimental | Frozen trivalent vaccine containing new strains Receives: Biological: Trivalent influenza virus vaccine |
| Placebo | Placebo comparator | treatment with placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Fever
Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.
Measured: Days 0-7
Secondary outcomes (6)
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Measured: Days 0-7
Number of Subjects Reporting Any Adverse Event (AE) Post-treatment
Measured: Days 0-7
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Measured: Days 0-14
Number of Subjects Reporting Any AEs Post Treatment
Measured: Days 0-14
Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)
SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Measured: Days 0-28
Number of Subjects Reporting SAEs and SNMCs
SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Measured: Days 0-180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raburn Mallory, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677820
- Sponsor's protocol ID
- MI-MA182
- Acronym
- MI-MA182
- Status last verified
- Oct 2010
- First submitted
- 13 May 2008
- Last updated
- 22 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. 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 Trivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
- ClinicalTrials.gov ID
- NCT00677820
- Acronym / sponsor ID
- MI-MA182 / MI-MA182
- Conditions
- Influenza
- Keywords
- Influenza, FluMist, vaccine, prevention, trivalent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 15 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using a new strain recommended for the 2008-2009 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.
Detailed description
This was a prospective, randomized, double-blind, placebo-controlled release study. Eligible subjects were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site. Each subject received 1 dose of study vaccine on Study Day 0. The duration of study participation for each subject was the time from study vaccination through 180 days after study vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trivalent influenza virus vaccine | Experimental | Biological: Trivalent influenza virus vaccineFrozen trivalent vaccine containing new strains |
| Placebo | Placebo comparator | Biological: Placebotreatment with placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female, 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, 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 subject 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 (13 listed)
- History of hypersensitivity to 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 (eg, asthma), chronic metabolic diseases (eg, 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 (eg, cough or sore throat) within 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 |
|---|---|---|
| Trivalent influenza virus vaccineTrivalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 ml of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10:7 FFU (fluorescent focus units) of each of three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. | Biological | Trivalent influenza virus vaccine |
| PlaceboPlacebo was supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer. | Biological | Placebo |
Primary outcome
Number of Subjects Reporting Fever
Time frame: Days 0-7
Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.
6 secondary outcomes
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Time frame: Days 0-7
Number of Subjects Reporting Any Adverse Event (AE) Post-treatment
Time frame: Days 0-7
Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Time frame: Days 0-14
Number of Subjects Reporting Any AEs Post Treatment
Time frame: Days 0-14
Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)
Time frame: Days 0-28
Number of Subjects Reporting SAEs and SNMCs
Time frame: Days 0-180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raburn Mallory, MD study director
MedImmune LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trivalent influenza virus vaccine in people with Influenza, run by MedImmune LLC at 3 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 13 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 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Reporting Fever (time frame: Days 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 22 Oct 2010.