HealthyPhase 4MI-MA205NCT00873912
A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine
A Phase 4 study testing Monovalent influenza virus vaccine in people with Healthy, 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 monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 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
- Healthy
- What is being tested?
- Monovalent 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
- May 2009to Dec 2009
- 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 investigational product administration
- Healthy by medical history and physical exam
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), had sterile male partner, were premenarchal or at least 2 years postmenopausal, or practiced abstinence, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for at least 30 days prior to dosing with investigational product, and must have agreed to continue using such precautions for at least 90 days after dosing with investigational product; cessation of birth control after this point was to be discussed with a responsible physician. The subject must also have had a negative serum or urine pregnancy test within 14 days prior to investigational product administration (if screening and administration of investigational product did not occur on the same day) and on the day of investigational product administration prior to randomization
- Males, unless surgically sterile, must have used 2 effective methods of birth control with a female partner and must have agreed to continue using such contraceptive precautions for at least 30 days after dosing with investigational product (from Day 1 through Day 31 of the study)
- Subject available by telephone
- 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 dosing as required by the protocol
Who cannot join
- History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life-threatening, or severe reactions to previous influenza vaccinations
- History of hypersensitivity to gentamicin
- Any condition for which the inactivated influenza vaccine was 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 human immunodeficiency virus [HIV] infection, or ongoing immunosuppressive therapy
- History of Guillain-Barré syndrome
Show all 14Show fewer
- A household contact who was severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual required care in a protective environment); subject should additionally have avoided close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product
- Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the package insert was permitted)
- Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product
- Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product
- Known or suspected mitochondrial encephalomyopathy
- Nursing mother
- Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would have interfered with evaluation of the investigational product or interpretation of subject safety or study results
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Covance CRU, Inc
Austin, Texas, 78757
Covance CRU, Inc.
Daytona Beach, Florida, 32117
Covance CRU, Inc
Portland, Oregon, 97239
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a New 6:2 Influenza Virus Reassortant in Healthy Adults
This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 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 prospective, randomized, double-blind, placebo-controlled release study enrolled 300 healthy adults 18 to 49 years of age. Eligible participants were randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. This study was conducted at multiple sites in the United States. Randomization was stratified by site.
Each participant received one dose of investigational product on Day 1. The duration of study participation for each participant was the time from receipt of investigational product through 180 days after receipt of investigational product.
- Conditions
- Healthy
- Being tested
- Monovalent influenza virus vaccine, Placebo
- Keywords
- influenza, 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.
Monovalent influenza virus vaccineBiological
Monovalent 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 the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).
PlaceboBiological
Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.
| Study group | Role | What they receive |
|---|---|---|
| Monovalent influenza virus vaccine | Experimental | Frozen monovalent vaccine containing new strain Receives: Biological: Monovalent influenza virus vaccine |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F
The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.
Measured: Days 1-8 after vaccination
Secondary outcomes (4)
Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)
Solicited symptoms were collected from administration of investigational product through Study Day 15. For this study, solicited symptoms included: fever (> 100°F oral), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), headache.
Measured: Days 1-8 after vaccination
Number of Participants Reporting Any Solicited Symptom or at Least One AE
Measured: Days 1-15 after vaccination
Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)
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 important 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 NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Measured: Days 1-29 after vaccination
Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)
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 important 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 NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Measured: Days 1-181 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2009
- Study completionDec 2009
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 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 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
- Elissa Malkin, D.O., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873912
- Sponsor's protocol ID
- MI-MA205
- Acronym
- MI-MA205
- Status last verified
- Jul 2011
- First submitted
- 1 Apr 2009
- Last updated
- 14 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. 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 New 6:2 Influenza Virus Reassortant in Healthy Adults
- ClinicalTrials.gov ID
- NCT00873912
- Acronym / sponsor ID
- MI-MA205 / MI-MA205
- Conditions
- Healthy
- Keywords
- influenza, FluMist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Posted 13 Jul 2011
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 monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 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 prospective, randomized, double-blind, placebo-controlled release study enrolled 300 healthy adults 18 to 49 years of age. Eligible participants were randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. This study was conducted at multiple sites in the United States. Randomization was stratified by site.
Each participant received one dose of investigational product on Day 1. The duration of study participation for each participant was the time from receipt of investigational product through 180 days after receipt of investigational product.
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 |
|---|---|---|
| Monovalent influenza virus vaccine | Experimental | Biological: Monovalent influenza virus vaccineFrozen monovalent vaccine containing new strain |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo |
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 investigational product administration
- Healthy by medical history and physical exam
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), had sterile male partner, were premenarchal or at least 2 years postmenopausal, or practiced abstinence, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for at least 30 days prior to dosing with investigational product, and must have agreed to continue using such precautions for at least 90 days after dosing with investigational product; cessation of birth control after this point was to be discussed with a responsible physician. The subject must also have had a negative serum or urine pregnancy test within 14 days prior to investigational product administration (if screening and administration of investigational product did not occur on the same day) and on the day of investigational product administration prior to randomization
- Males, unless surgically sterile, must have used 2 effective methods of birth control with a female partner and must have agreed to continue using such contraceptive precautions for at least 30 days after dosing with investigational product (from Day 1 through Day 31 of the study)
Key exclusion criteria (14 listed)
- History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life-threatening, or severe reactions to previous influenza vaccinations
- History of hypersensitivity to gentamicin
- Any condition for which the inactivated influenza vaccine was 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 human immunodeficiency virus [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 |
|---|---|---|
| Monovalent influenza virus vaccineMonovalent 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 the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage). | Biological | Monovalent influenza virus vaccine |
| PlaceboPlacebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. | Biological | Placebo |
Primary outcome
Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F
Time frame: Days 1-8 after vaccination
The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.
4 secondary outcomes
Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)
Time frame: Days 1-8 after vaccination
Number of Participants Reporting Any Solicited Symptom or at Least One AE
Time frame: Days 1-15 after vaccination
Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)
Time frame: Days 1-29 after vaccination
Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)
Time frame: Days 1-181 after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- 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.
Elissa Malkin, D.O. 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 Monovalent influenza virus vaccine in people with Healthy, 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 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 14 Jul 2011. 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 13 Jul 2011). 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 Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F (time frame: Days 1-8 after vaccination). 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 14 Jul 2011.