Healthy or Stable Underlying Chronic Medical ConditionPhase 2/3MI-CP185NCT00860067
A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
A Phase 2/3 study testing Q/LAIV (MEDI3250), FluMist/B/Yamagata and FluMist/B/Victoria in people with Healthy or Stable Underlying Chronic Medical Condition, run by MedImmune LLC at 18 sites in United States.
Trial summary
The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy or Stable Underlying Chronic Medical Condition
- What is being tested?
- Q/LAIV (MEDI3250), FluMist/B/Yamagata and FluMist/B/Victoria
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2009to Oct 2009
- Phase
- Phase 2/3
- 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 age 18 to 49 years, inclusive, on the day of randomization (reached his or her eighteenth year birthday but not yet reached his or her 50th year birthday) at the time of the dose of blinded investigational product
- Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], had a sterile male partner, was at least 1 year post-menopausal, or practiced abstinence) must have used an effective method 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 30 days prior to the first dose of investigational product, and must have agreed to continue using such precautions for 60 days after the dose of investigational product. In addition, the subject must also have had a negative urine or blood pregnancy test at screening and, if screening and Day 0 did not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment was required to assess a female subject's capability of pregnancy.
- Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization was not required in the previous year
- Able to complete follow-up period of 180 days post dose of vaccine as required by the protocol
- Subject available by telephone
- Able to understand and comply with the requirements of the protocol, as judged by the investigator
Who cannot join
- Acute illness or evidence of significant active infection at randomization
- Fever ≥ 100.4°F (38°C) at randomization
- History of asthma
- Any drug therapy from 15 days prior to randomization or expected drug therapy through 30 days post dose with the exception of contraceptives or chronic medications that were well tolerated and were not initiated and/or did not have a dosage change within 90 days of randomization.
- Previous medical history or evidence of an intercurrent illness that might have compromised the safety of the subject in the study
- Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids were permitted) including corticosteroids (≥ 20 mg/day of prednisone equivalent given daily or on alternate days for ≥ 14 days) within a 30-day window around dose of investigational product Note: topical corticosteroids for uncomplicated dermatitis were permitted according to the judgment of the investigator; topical calcineurin inhibitors were permitted in accordance with their package insert at entry and during study participation.
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- Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
- Receipt of any investigational drug therapy or standard vaccine within 30 days before the dose of investigational product in this study through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the package insert was permitted)
- Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV)
- History of allergic disease or reactions likely to be exacerbated by any component of the investigational product including allergy to eggs, egg proteins, gentamicin, or gelatin; or serious, life threatening, or severe reactions to previous influenza vaccinations
- History of Guillain-Barré syndrome
- Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir and zanamivir) within 30 days prior to dose of investigational product or anticipated use within 30 days after vaccination
- Known or suspected mitochondrial encephalomyopathy
- Lactating woman
- History of alcohol or drug abuse that, in the opinion of the investigator, would have affected the subject's safety or compliance with study
- Any condition 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
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Benchmark Research
Austin, Texas, 78705
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, 40004
University Clinical Research-Deland, LLC
DeLand, Florida, 32720
Benchmark Research
Fort Worth, Texas, 76135
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114
Pharmax Research Clinic, Inc
Miami, Florida, 33126
Clinical Research Associates, Inc
Nashville, Tennessee, 37201
Meridian Clinical Research, LLC
Omaha, Nebraska, 68314
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
University Clinical Research, Inc
Pembroke Pines, Florida, 33024
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Benchmark Research
Sacramento, California, 95816
California Research Foundation
San Diego, California, 92103-6204
Benchmark Research
San Francisco, California, 94102
Miami Research Associates
South Miami, Florida, 33143
Sundance Clinical Research
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 32801
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age
The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.
Read the detailed description
This randomized, double-blind, active controlled, multicenter study enrolled 1,800 subjects who were 18 to 49 years of age. Subjects were randomized by site in a 4:1:1 fashion to receive a single dose of Q/LAIV, trivalent FluMist containing an influenza B strain from the Yamagata lineage (FluMist/B/Yamagata), or trivalent FluMist containing an influenza B strain from the Victoria lineage (FluMist/B/Victoria). The study was conducted at multiple sites in the USA in the influenza off-season.
- Being tested
- Q/LAIV (MEDI3250), FluMist/B/Yamagata, FluMist/B/Victoria
- Keywords
- influenza, FluMist, adults, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q/LAIV (MEDI3250)Biological
Also called MEDI3250
0.2 mL dose at Day 0
FluMist/B/YamagataBiological
Also called FluMist
0.2 mL dose at Day 0
FluMist/B/VictoriaBiological
Also called FluMist
0.2 mL dose at Day 0
| Study group | Role | What they receive |
|---|---|---|
| Q/LAIV (MEDI3250) | Experimental | Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature-sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]). Receives: Biological: Q/LAIV (MEDI3250) |
| FluMist/B/Yamagata | Active comparator | FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature-sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006])a B strain of the Yamagata lineage. Receives: Biological: FluMist/B/Yamagata |
| FluMist/B/Victoria | Active comparator | FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature-sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004])a B strain of the Victoria lineage. Receives: Biological: FluMist/B/Victoria |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.
Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.
Measured: Day 28-35
Secondary outcomes (23)
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
Measured: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
Measured: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
Measured: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
Measured: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 0 and Day 28-35
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Measured: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
Measured: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
Measured: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
Measured: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
Measured: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
Measured: Day 28-35
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination
Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.
Measured: Days 0-14
The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: Days 0-28 post vaccination
Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
Serious adverse events 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 birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Days 0-28 post vaccination
Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination
Serious adverse events 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 birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Days 0-180 post vaccination
Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination
An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.
Measured: Days 0-180 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionOct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy or Stable Underlying Chronic Medical ConditionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Falloon, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860067
- Sponsor's protocol ID
- MI-CP185
- Acronym
- MI-CP185
- Status last verified
- Nov 2011
- First submitted
- 9 Mar 2009
- Last updated
- 5 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine. 2011 Nov 21;29(50):9391-7. doi: 10.1016/j.vaccine.2011.09.109. Epub 2011 Oct 6.
PubMed 21983154
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age
- ClinicalTrials.gov ID
- NCT00860067
- Acronym / sponsor ID
- MI-CP185 / MI-CP185
- Keywords
- influenza, FluMist, adults, vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 12 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.
Detailed description
This randomized, double-blind, active controlled, multicenter study enrolled 1,800 subjects who were 18 to 49 years of age. Subjects were randomized by site in a 4:1:1 fashion to receive a single dose of Q/LAIV, trivalent FluMist containing an influenza B strain from the Yamagata lineage (FluMist/B/Yamagata), or trivalent FluMist containing an influenza B strain from the Victoria lineage (FluMist/B/Victoria). The study was conducted at multiple sites in the USA in the influenza off-season.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Q/LAIV (MEDI3250) | Experimental | Biological: Q/LAIV (MEDI3250)Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature-sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]). |
| FluMist/B/Yamagata | Active comparator | Biological: FluMist/B/YamagataFluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature-sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006])a B strain of the Yamagata lineage. |
| FluMist/B/Victoria | Active comparator | Biological: FluMist/B/VictoriaFluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature-sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004])a B strain of the Victoria lineage. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female age 18 to 49 years, inclusive, on the day of randomization (reached his or her eighteenth year birthday but not yet reached his or her 50th year birthday) at the time of the dose of blinded investigational product
- Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], had a sterile male partner, was at least 1 year post-menopausal, or practiced abstinence) must have used an effective method 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 30 days prior to the first dose of investigational product, and must have agreed to continue using such precautions for 60 days after the dose of investigational product. In addition, the subject must also have had a negative urine or blood pregnancy test at screening and, if screening and Day 0 did not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment was required to assess a female subject's capability of pregnancy.
- Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization was not required in the previous year
- Able to complete follow-up period of 180 days post dose of vaccine as required by the protocol
Key exclusion criteria (17 listed)
- Acute illness or evidence of significant active infection at randomization
- Fever ≥ 100.4°F (38°C) at randomization
- History of asthma
- Any drug therapy from 15 days prior to randomization or expected drug therapy through 30 days post dose with the exception of contraceptives or chronic medications that were well tolerated and were not initiated and/or did not have a dosage change within 90 days of randomization.
- Previous medical history or evidence of an intercurrent illness that might have compromised the safety of the subject in the study
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 |
|---|---|---|
| Q/LAIV (MEDI3250)Also: MEDI32500.2 mL dose at Day 0 | Biological | Q/LAIV (MEDI3250) |
| FluMist/B/YamagataAlso: FluMist0.2 mL dose at Day 0 | Biological | FluMist/B/Yamagata |
| FluMist/B/VictoriaAlso: FluMist0.2 mL dose at Day 0 | Biological | FluMist/B/Victoria |
Primary outcome
The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.
Time frame: Day 28-35
Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.
23 secondary outcomes
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.
Time frame: Day 0 and Day 28-35
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Time frame: Day 28-35
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination
Time frame: Days 0-14
The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
Time frame: Days 0-28 post vaccination
Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
Time frame: Days 0-28 post vaccination
Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination
Time frame: Days 0-180 post vaccination
Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination
Time frame: Days 0-180 post vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21983154Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine. 2011 Nov 21;29(50):9391-7. doi: 10.1016/j.vaccine.2011.09.109. Epub 2011 Oct 6.
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.
Judith Falloon, M.D. study director
MedImmune LLC
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Q/LAIV (MEDI3250), FluMist/B/Yamagata and FluMist/B/Victoria in people with Healthy or Stable Underlying Chronic Medical Condition, run by MedImmune LLC at 18 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 7 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 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 12 Aug 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?
The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. (time frame: Day 28-35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860067, which also lists 1 linked publication.
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 5 Dec 2011.