InfluenzaPhase 4NCT01579916
A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
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 two new strains recommended for the 2012-2013 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
- 303 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to Nov 2012
- 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
- Age 18 through 49 years at the time of investigational product administration
- Written informed consent and any locally required authorization (ie, HIPAA in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use effective contraception for 30 days prior to study vaccination, and must agree to continue using such precautions for 60 days after study vaccination
- Nonsterilized males who are sexually active with a female partner of child-bearing potential must use an effective method of contraception from prior to study vaccination amd must agree to continue using such precautions for at least 30 days after receipt study vaccination
- Healthy by medical history and physical examination
- Female subjects of child-bearing potential must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization.
Show all 9Show fewer
- 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
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- 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 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
Show all 17Show fewer
- 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 infection, or ongoing immunosuppressive therapy
- History of Guillain-Barré syndrome
- 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); additionally, subject should 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 30 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
- Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after study vaccination
- Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination
- Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
- Receipt of influenza antiviral therapy or antiviral agents within 48 hours prior to study vaccination or expected receipt of influenza antiviral therapy or antiviral agents through 14 days after study vaccination
- Known or suspected mitochondrial encephalomyopathy
- Nursing mother
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Miami, Florida, 33143
Research Site
Portland, Oregon, 97239
Research Site
Stockbridge, Georgia, 30281
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine.
Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.
Read the detailed description
This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site.
This study will be conducted at 3 sites in the United States of America. Each subject will receive one dose of investigational product on Study Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.
- Conditions
- Influenza
- Being tested
- Trivalent Influenza Virus Vaccine, Placebo
- Keywords
- Trivalent, Influenza, FluMist, Vaccine, Prevention
- 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 is 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 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
PlaceboOther
Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Experimental | Trivalent vaccine is 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 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1. Receives: Biological: Trivalent Influenza Virus Vaccine |
| Placebo | Placebo comparator | Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting Fever Within 7 Days Post Vaccination
A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.
Measured: Study Days 1 - 8
Secondary outcomes (10)
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Measured: Study Days 1- 8
Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination
Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.
Measured: Study Days 1 - 8
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Measured: Study Days 1 - 15
Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination
Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.
Measured: Study Days 1 - 15
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination
Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.
Measured: Study Days 1 - 29
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination
Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.
Measured: Study Days 1 - 181
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.
Measured: Study Days 1 - 29
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.
Measured: Study Days 1 - 181
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.
Measured: Study Days 1 - 8
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.
Measured: Study Days 1 - 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionNov 2012
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Raburn Mallory, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579916
- Sponsor's protocol ID
- CD-VA-FluMist-1114
- Status last verified
- Dec 2013
- First submitted
- 16 Apr 2012
- Last updated
- 3 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
- ClinicalTrials.gov ID
- NCT01579916
- Acronym / sponsor ID
- CD-VA-FluMist-1114
- Conditions
- Influenza
- Keywords
- Trivalent, Influenza, FluMist, Vaccine, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Posted 3 Feb 2014
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 two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine.
Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.
Detailed description
This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site.
This study will be conducted at 3 sites in the United States of America. Each subject will receive one dose of investigational product on Study Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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 VaccineTrivalent vaccine is 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 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 through 49 years at the time of investigational product administration
- Written informed consent and any locally required authorization (ie, HIPAA in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use effective contraception for 30 days prior to study vaccination, and must agree to continue using such precautions for 60 days after study vaccination
- Nonsterilized males who are sexually active with a female partner of child-bearing potential must use an effective method of contraception from prior to study vaccination amd must agree to continue using such precautions for at least 30 days after receipt study vaccination
- Healthy by medical history and physical examination
Key exclusion criteria (17 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- 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
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 is 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 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1. | Biological | Trivalent Influenza Virus Vaccine |
| PlaceboPlacebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1. | Other | Placebo |
Primary outcome
Percentage of Participants Reporting Fever Within 7 Days Post Vaccination
Time frame: Study Days 1 - 8
A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.
10 secondary outcomes
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Time frame: Study Days 1- 8
Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination
Time frame: Study Days 1 - 8
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Time frame: Study Days 1 - 15
Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination
Time frame: Study Days 1 - 15
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination
Time frame: Study Days 1 - 29
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination
Time frame: Study Days 1 - 181
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination
Time frame: Study Days 1 - 29
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination
Time frame: Study Days 1 - 181
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination
Time frame: Study Days 1 - 8
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination
Time frame: Study Days 1 - 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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 9 inclusion and 17 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 3 Feb 2014. 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 3 Feb 2014). 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?
Percentage of Participants Reporting Fever Within 7 Days Post Vaccination (time frame: Study Days 1 - 8). 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 3 Feb 2014.