Healthy or Stable Chronic IllnessPhase 3LAIVNCT01091246
A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children
A Phase 3 study testing Q/LAIV (MEDI3250), FluMist/B/Yamagata and FluMist/B/Victoria in people with Healthy or Stable Chronic Illness, run by MedImmune LLC at 110 sites in United States.
Trial summary
The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy or Stable Chronic Illness
- 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
- 2,312 participants
- Where
- 110 sitesUnited States
- Study dates
- Mar 2010to Dec 2010
- Phase
- Phase 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female
- Age 2 through 17 years at the time of randomization
- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU, and written informed assent if applicable) 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 hysterectomy), has sterile male partner, is premenarchal, or practices 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 with spermicide, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the final dose of investigational product
- A subject who is considered by the investigator to be at risk of pregnancy must also have a negative urine pregnancy test at screening and, if screening and Day 0 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess each subject's need for pregnancy testing
- Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year
Show all 9Show fewer
- Able to complete follow-up period of 180 days post last dose of vaccine as required by the protocol
- Subject/legal representative is available by telephone
- Child's legal representative is 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 (38.0°C) at randomization
- History of asthma, or in children < 5 years of age, history of recurrent wheezing
- Any drug therapy from 15 days prior to randomization or expected drug therapy through 28 days post last dose with the exception of the following classes/types of medications, which are allowed:
- Contraceptives (change in contraceptive type or method is acceptable as long as guidelines are followed for prevention of pregnancy during change);
- Topical corticosteroids, calcineurin inhibitors, or antifungals for uncomplicated dermatitis;
Show all 24Show fewer
- Chronic medications (including those taken on an as-needed basis) that have been well tolerated and were not initiated and/or did not have a dosage change within 90 days prior to randomization.
- Current or expected receipt of immunosuppressive medications within a 28 day window around any dose, including an immunosuppressive dose of corticosteroids, which is defined as ≥ 20 mg/day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days) (intranasal, intra-articular, and topical corticosteroids are permitted); Note: topical corticosteroids for uncomplicated dermatitis may be used throughout the study according to the judgment of the investigator; topical calcineurin inhibitors may be used in accordance with their package insert at entry and during study participation
- 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 within 28 days prior to Dose 1 or planned receipt of any investigational drug therapy through 90 days after final dosing of investigational product (use of licensed agents for indications not listed in the package insert is permitted)
- Receipt of any nonstudy vaccine within 28 days prior to randomization or planned receipt of nonstudy vaccine through 28 days after final dosing
- Receipt of any nonstudy seasonal influenza vaccine within 90 days of Dose 1 or planned receipt of nonstudy seasonal influenza vaccine prior to 35 days post last dose of investigational product
- 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
- Use of aspirin or salicylate-containing products within 28 days prior to randomization or expected receipt through 28 days after final vaccination;
- History of Guillain-Barré syndrome
- Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir, and zanamivir) within 28 days prior to first dose of investigational product or anticipated use of such agents within 28 days after last scheduled vaccination
- Known or suspected mitochondrial encephalomyopathy
- Pregnant or lactating female
- History of alcohol or drug abuse that, in the opinion of the investigator, would affect the subject's safety or compliance with study
- Any condition that, in the opinion of the investigator, might compromise the safety of the subject in the study or would interfere with evaluation of the safety or immunogenicity of the investigational products
- Subject, legal representative, or immediate family member of subject who is an employee of the clinical study site or who is otherwise involved with the conduct of the study
- A history of epilepsy, seizure, or an evolving neurological condition except that of a single febrile seizure that occurred 3 or more years prior to enrollment would not disqualify a subject
- Note: an individual who initially is excluded from study participation based on one or more of the above time-limited criteria may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria and the same SID number is used
Trial locations and contacts
110 sites in 1 country.
110 sites in 1 country
United States110 sites
Research Site
Akron, Ohio, 44308
Research Site
Albuquerque, New Mexico, 87108
Research Site
Altoona, Pennsylvania, 16602
Research Site
Anaheim, California, 92805
Research Site
Arlington, Texas, 76018
Research Site
Asheboro, North Carolina, 27203
Research Site
Bardstown, Kentucky, 40004
Research Site
Benton, Arkansas, 72019
Research Site
Bentonville, Arkansas, 72712
Research Site
Binghamton, New York, 13901
Research Site
Birmingham, Alabama, 35209
Research Site
Bismarck, North Dakota, 58501
Research Site
Boca Raton, Florida, 33432
Research Site
Boone, North Carolina, 28607
Research Site
Bristol, Tennessee, 37620
Research Site
Brooklyn, New York, 11201
Research Site
Burke, Virginia, 22015
Research Site
Charleston, South Carolina, 29406
Research Site
Charleston, South Carolina, 29425
Research Site
Charlottesville, Virginia, 22902
Research Site
Chicago, Illinois, 60614
Research Site
Cincinnati, Ohio, 45231
Research Site
Cincinnati, Ohio, 45245
Research Site
Cincinnati, Ohio, 45249
Research Site
Clarksville, Tennessee, 37043
Research Site
Clyde, North Carolina, 28721
Research Site
Dalton, Georgia, 30721
Research Site
Dayton, Ohio, 45415
Research Site
DeKalb, Illinois, 60115
Research Site
Draper, Utah, 84020
Research Site
Erie, Pennsylvania, 16505
Research Site
Fargo, North Dakota, 88104
Research Site
Fayetteville, Arkansas, 72703
Research Site
Fort Worth, Texas, 76107
Research Site
Fort Worth, Texas, 76135
Research Site
Fountain Valley, California, 92708
Research Site
Franklin, Wisconsin, 53123
Research Site
Fresno, California, 93720
Research Site
Greenville, Pennsylvania, 16125
Research Site
Harleysville, Pennsylvania, 19438
Research Site
Hermitage, Pennsylvania, 16148
Research Site
Huber Heights, Ohio, 45424
Research Site
Huntington, West Virginia, 25701
Research Site
Jacksonville, Florida, 32223
Research Site
Jonesboro, Arkansas, 72401
Research Site
Kalamazoo, Michigan, 49008
Research Site
Kansas City, Missouri, 64114
Research Site
Kingsport, Tennessee, 37660
Research Site
Las Vegas, Nevada, 89104
Research Site
Latrobe, Pennsylvania, 15650
Research Site
Layton, Utah, 84041
Research Site
Lebanon, New Hampshire, 03756
Research Site
Lexington, Kentucky, 40509
Research Site
Little Rock, Arkansas, 72205
Research Site
Long Beach, California, 90808
Research Site
Longview, Texas, 75605
Research Site
Marietta, Georgia, 30062
Research Site
Metairie, Louisiana, 70006
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33173
Research Site
Mineola, New York, 11501
Research Site
Mobile, Alabama, 36608
Research Site
Mt Pleasant, North Carolina, 29464
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Nashville, Tennessee, 37232
Research Site
New Branfels, Texas, 78130
Research Site
Newton, Kansas, 67005
Research Site
Niles, Michigan, 49120
Research Site
Norman, Oklahoma, 73071
Research Site
Omaha, Nebraska, 68134
Research Site
Omaha, Nebraska, 68198-2162
Research Site
Orem, Utah, 84057
Research Site
Overland Park, Kansas, 66210
Research Site
Papillion, Nebraska, 68046
Research Site
Paramount, California, 90723
Research Site
Pittsburgh, Pennsylvania, 15220
Research Site
Pittsburgh, Pennsylvania, 15227
Research Site
Pittsburgh, Pennsylvania, 15237
Research Site
Pittsburgh, Pennsylvania, 15241
Research Site
Plymouth, Minnesota, 55441
Research Site
Ponte Vedra, Florida, 32081
Research Site
Raleigh, North Carolina, 27607
Research Site
Raleigh, North Carolina, 27609
Research Site
Rochester, New York, 14609
Research Site
Rochester, New York, 14618
Research Site
Roy, Utah, 84067
Research Site
Sacramento, California, 95816
Research Site
Saint Paul, Minnesota, 55108
Research Site
Salt Lake City, Utah, 84124
Research Site
San Francisco, California, 94102
Research Site
Scotland, Pennsylvania, 17254
Research Site
Sellersville, Pennsylvania, 18960
Research Site
South Jordan, Utah, 84095
Research Site
South Miami, Florida, 33143
Research Site
St Louis, Missouri, 63104
Research Site
St Louis, Missouri, 63141
Research Site
St. Petersburg, Florida, 33710
Research Site
Stevensville, Michigan, 49127
Research Site
Sugarland, Texas, 77479
Research Site
Syracuse, Utah, 84075
Research Site
Tucson, Arizona, 85712
Research Site
Vienna, Virginia, 33180
Research Site
Virginia Beach, Virginia, 23454
Research Site
West Covina, California, 91790
Research Site
West Palm Beach, Florida, 33409
Research Site
Wichita, Kansas, 67207
Research Site
Wilmington, Delaware, 19899
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Woodstock, Georgia, 30189
Research Site
Yukon, Oklahoma, 73099
About this study
Official title: A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Children
The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age.
Read the detailed description
The randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared to FluMist in children 2-17 years by comparing the strain-specific post-dose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or one of two FluMist vaccines. Subjects 9-17 years of age received a single dose, and those 2-8 years of age received two doses one month apart. Serum was obtained 1 month after dose 1 except in influenza vaccine-naive subjects 2-8 years old, when it was obtained after dose 2. Safety and tolerability were also assessed.
- Conditions
- Healthy or Stable Chronic Illness
- Being tested
- Q/LAIV (MEDI3250), FluMist/B/Yamagata, FluMist/B/Victoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q/LAIV (MEDI3250)Biological
10 ^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria
FluMist/B/YamagataBiological
10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata
FluMist/B/VictoriaBiological
10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria
| Study group | Role | What they receive |
|---|---|---|
| Q/LAIV (MEDI3250) | Experimental | Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson 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 resassortant 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 | Experimental | FluMist/B/Yamagata (trivalent live attenuated 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 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]) Receives: Biological: FluMist/B/Yamagata |
| FluMist/B/Victoria | Experimental | FluMist/B/Victoria (trivalent live attenuated 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 stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]). 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 post immunogenicity dose
Secondary outcomes (33)
The Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose
Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose
Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose
Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose
Seroresponse was defined as a ≥ 4-fold rise from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Victoria Strain Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Measured: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Who Achieved an A/H1N1 or A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Measured: Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Measured: Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Measured: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8.
Measured: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8.
Measured: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8.
Measured: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Serosusceptible was defined as a baseline HAI titer ≤ 8.
Measured: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4.
Measured: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4.
Measured: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4.
Measured: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Seronegative was defined as a baseline HAI titer ≤ 4.
Measured: Day 28 post immunogenicity dose
Percent of All Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1
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 Post Dose 1
Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1
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 Post Dose 1
Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Dose 2 During Days 0-14 Post Dose 2
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 Post Dose 2
Percent of All Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1
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 Dose 1
Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1
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 Dose 1
Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Dose 2 Through 28 Days Post Dose 2
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 Dose 2
Percent of All Participants Reporting Any Serious Adverse Event (SAE) From Administration of Investigational Product Through Day 28 Post Dose 1
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.
Measured: Days 0-28 Post Dose 1
Percent of Two-dose Participants Reporting Any SAE From Administration of Dose 2 During Days 0-28 Post Dose 2
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.
Measured: Days 0-28 Post Dose 2
Percent of All Participants Reporting Any SAE From Administration of Investigational Product Through 180 Days Post Last Dose
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.
Measured: Days 0-180 Post Last Dose
Percent of All Participants Reporting Any New Onset Chronic Disease (NOCD) From Administration of Investigational Product Through 180 Days Post Last Dose
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 Last Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionDec 2010
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 Healthy or Stable Chronic IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,312 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
- NCT01091246
- Sponsor's protocol ID
- MI-CP208
- Acronym
- LAIV
- Status last verified
- Sep 2011
- First submitted
- 19 Mar 2010
- Last updated
- 26 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 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 Quadrivalent LAIV in Children
- ClinicalTrials.gov ID
- NCT01091246
- Acronym / sponsor ID
- LAIV / MI-CP208
- Conditions
- Healthy or Stable Chronic Illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,312 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Posted 22 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age.
Detailed description
The randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared to FluMist in children 2-17 years by comparing the strain-specific post-dose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or one of two FluMist vaccines. Subjects 9-17 years of age received a single dose, and those 2-8 years of age received two doses one month apart. Serum was obtained 1 month after dose 1 except in influenza vaccine-naive subjects 2-8 years old, when it was obtained after dose 2. Safety and tolerability were also assessed.
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 live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson 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 resassortant 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 | Experimental | Biological: FluMist/B/YamagataFluMist/B/Yamagata (trivalent live attenuated 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 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]) |
| FluMist/B/Victoria | Experimental | Biological: FluMist/B/VictoriaFluMist/B/Victoria (trivalent live attenuated 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 stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male or female
- Age 2 through 17 years at the time of randomization
- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU, and written informed assent if applicable) 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 hysterectomy), has sterile male partner, is premenarchal, or practices 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 with spermicide, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the final dose of investigational product
- A subject who is considered by the investigator to be at risk of pregnancy must also have a negative urine pregnancy test at screening and, if screening and Day 0 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess each subject's need for pregnancy testing
Key exclusion criteria (24 listed)
- Acute illness or evidence of significant active infection at randomization;
- Fever ≥ 100.4°F (38.0°C) at randomization
- History of asthma, or in children < 5 years of age, history of recurrent wheezing
- Any drug therapy from 15 days prior to randomization or expected drug therapy through 28 days post last dose with the exception of the following classes/types of medications, which are allowed:
- Contraceptives (change in contraceptive type or method is acceptable as long as guidelines are followed for prevention of pregnancy during change);
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)10 ^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria | Biological | Q/LAIV (MEDI3250) |
| FluMist/B/Yamagata10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata | Biological | FluMist/B/Yamagata |
| FluMist/B/Victoria10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria | 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 post immunogenicity dose
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. .
33 secondary outcomes
The Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Victoria Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose
Time frame: Day 0 and Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Who Achieved an A/H1N1 or A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of Seronegative Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose
Time frame: Day 28 post immunogenicity dose
Percent of All Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1
Time frame: Days 0-14 Post Dose 1
Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1
Time frame: Days 0-14 Post Dose 1
Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Dose 2 During Days 0-14 Post Dose 2
Time frame: Days 0-14 Post Dose 2
Percent of All Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1
Time frame: Days 0-28 Post Dose 1
Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1
Time frame: Days 0-28 Post Dose 1
Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Dose 2 Through 28 Days Post Dose 2
Time frame: Days 0-28 Post Dose 2
Percent of All Participants Reporting Any Serious Adverse Event (SAE) From Administration of Investigational Product Through Day 28 Post Dose 1
Time frame: Days 0-28 Post Dose 1
Percent of Two-dose Participants Reporting Any SAE From Administration of Dose 2 During Days 0-28 Post Dose 2
Time frame: Days 0-28 Post Dose 2
Percent of All Participants Reporting Any SAE From Administration of Investigational Product Through 180 Days Post Last Dose
Time frame: Days 0-180 Post Last Dose
Percent of All Participants Reporting Any New Onset Chronic Disease (NOCD) From Administration of Investigational Product Through 180 Days Post Last Dose
Time frame: Days 0-180 Post Last Dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
110 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Q/LAIV (MEDI3250), FluMist/B/Yamagata and FluMist/B/Victoria in people with Healthy or Stable Chronic Illness, run by MedImmune LLC at 110 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 24 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 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 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 post immunogenicity dose). 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 26 Sep 2011.