Healthy or Stable Underlying Chronic Medical Condition
Conditions
Keywords
influenza, FluMist, adults, vaccine
Brief 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.
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.
Interventions
BIOLOGICALQ/LAIV (MEDI3250)
0.2 mL dose at Day 0
BIOLOGICALFluMist/B/Yamagata
0.2 mL dose at Day 0
BIOLOGICALFluMist/B/Victoria
0.2 mL dose at Day 0
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | 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. |
| The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 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. | Day 28-35 | Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain. |
| The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain. |
| The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
| The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
| The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Days 0-14 | 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. |
| The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination | Days 0-28 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 |
| Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination | Days 0-28 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. |
| Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination | Days 0-180 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. |
| Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination | Days 0-180 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. |
| The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain. |
Countries
United States
Participant flow
Recruitment details
A total of 1,924 participants provided written informed consent and were screened for the study. Of these, 1,800 participants were randomized into the study at 18 sites in the USA from 23Mar2009 and 26Mar2009.
Pre-assignment details
Participants who provided written informed consent and who met the eligibility criteria were randomized by site at a 4:1:1 ratio to receive Q/LAIV, FluMist/B/Yamagata, or FluMist/B/Victoria. The randomization incorporated a block design with a fixed block size of 6.
Participants by arm
| Arm | Count |
|---|---|
| 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 \[B/Florida/4/2006\]). | 1,200 |
| FluMist/B/Yamagata 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 temperate 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 \[B/Florida/4/2006\]). | 299 |
| FluMist/B/Victoria 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 \[B/Malaysia/2506/2004\]). | 301 |
| Total | 1,800 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 46 | 9 | 9 |
| Overall Study | Pregnancy | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Q/LAIV (MEDI3250) | Total | FluMist/B/Victoria | FluMist/B/Yamagata |
|---|---|---|---|---|
| Age Continuous Participants | 32.6 years STANDARD_DEVIATION 9.2 | 32.7 years STANDARD_DEVIATION 9.2 | 32.8 years STANDARD_DEVIATION 9.2 | 32.8 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 264 Participants | 409 Participants | 78 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 936 Participants | 1391 Participants | 223 Participants | 232 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 5 Participants | 10 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 15 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 249 Participants | 376 Participants | 61 Participants | 66 Participants |
| Race/Ethnicity, Customized Multiracial | 7 Participants | 8 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 4 Participants | 8 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 9 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 916 Participants | 1374 Participants | 230 Participants | 228 Participants |
| Region of Enrollment United States | 1200 participants | 1800 participants | 301 participants | 299 participants |
| Sex: Female, Male Female | 658 Participants | 994 Participants | 171 Participants | 165 Participants |
| Sex: Female, Male Male | 542 Participants | 806 Participants | 130 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 102 / 1,198 | 57 / 598 |
| serious Total, serious adverse events | 12 / 1,198 | 6 / 598 |
Outcome results
Primary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301;All FM=600), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=590), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=297; All FM=589).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Q/LAIV (MEDI3250) | 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. | A/H3N2 | 7.5 geometric mean titer |
| Q/LAIV (MEDI3250) | 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. | A/H1N1 | 5.9 geometric mean titer |
| Q/LAIV (MEDI3250) | 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. | B/Yamagata | 51.2 geometric mean titer |
| Q/LAIV (MEDI3250) | 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. | B/Victoria | 36.5 geometric mean titer |
| FluMist/B/Yamagata | 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. | A/H3N2 | NA geometric mean titer |
| FluMist/B/Yamagata | 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. | B/Yamagata | 56.4 geometric mean titer |
| FluMist/B/Yamagata | 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. | A/H1N1 | NA geometric mean titer |
| FluMist/B/Yamagata | 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. | B/Victoria | NA geometric mean titer |
| FluMist/B/Victoria | 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. | A/H1N1 | NA geometric mean titer |
| FluMist/B/Victoria | 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. | A/H3N2 | NA geometric mean titer |
| FluMist/B/Victoria | 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. | B/Victoria | 33.6 geometric mean titer |
| FluMist/B/Victoria | 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. | B/Yamagata | NA geometric mean titer |
| All FluMist | 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. | B/Victoria | NA geometric mean titer |
| All FluMist | 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. | B/Yamagata | NA geometric mean titer |
| All FluMist | 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. | A/H3N2 | 7.8 geometric mean titer |
| All FluMist | 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. | A/H1N1 | 6.5 geometric mean titer |
Comparison: A/H1N1: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.95% CI: [1.01, 1.18]Bootstrapping
Comparison: A/H3N2: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.95% CI: [0.96, 1.14]Bootstrapping
Comparison: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.95% CI: [0.97, 1.25]Bootstrapping
Comparison: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.95% CI: [0.82, 1.03]Bootstrapping
Secondary
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.
Time frame: Days 0-180 post vaccination
Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination | 12 participants |
| FluMist/B/Yamagata | Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination | 6 participants |
Secondary
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.
Time frame: Days 0-28 post vaccination
Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination | 2 participants |
| FluMist/B/Yamagata | Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination | 2 participants |
Secondary
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.
Time frame: Days 0-180 post vaccination
Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination | 11 participants |
| FluMist/B/Yamagata | Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination | 4 participants |
Secondary
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.
Time frame: Days 0-14
Population: The Evaluable Safety Population for solicited symptoms included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1197; All FM=597).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Any solicited symptom | 713 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 100.4°F | 16 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 101.3°F | 9 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 102.2°F | 4 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 103.1°F | 1 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 104.0°F | 0 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 104.9°F | 0 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Runny/stuffy nose | 522 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Sore throat | 227 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Cough | 163 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Headache | 338 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Generalized muscle aches | 121 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Decreased activity level (lethargy) or tiredness | 211 participants |
| Q/LAIV (MEDI3250) | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Decreased appetite | 77 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Headache | 164 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Any solicited symptom | 358 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Runny/stuffy nose | 236 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 100.4°F | 9 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Decreased activity level (lethargy) or tiredness | 106 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 101.3°F | 2 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Sore throat | 118 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 102.2°F | 1 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Generalized muscle aches | 59 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 103.1°F | 1 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Cough | 75 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 104.0°F | 0 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Decreased appetite | 32 participants |
| FluMist/B/Yamagata | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Fever ≥ 104.9°F | 0 participants |
Secondary
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
Population: Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301; All FM=600,), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=290), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=298; All FM=590).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H1N1 | 189 participants |
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H3N2 | 250 participants |
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Yamagata | 881 participants |
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Victoria | 771 participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Victoria | NA participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Yamagata | 226 participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H3N2 | NA participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H1N1 | NA participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Yamagata | NA participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Victoria | 191 participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H3N2 | NA participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H1N1 | NA participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Victoria | NA participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H1N1 | 100 participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | A/H3N2 | 133 participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | B/Yamagata | NA participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; FY=298; FV=300; All FM=598), had pre-dose and post-dose HAI measurement (Q=1181; FY=292; FV=298; All FM=599), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292; FV=297; All FM=589).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H1N1 | 61 participants |
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H3N2 | 59 participants |
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Yamagata | 118 participants |
| Q/LAIV (MEDI3250) | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Victoria | 145 participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H3N2 | NA participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Yamagata | 30 participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Victoria | NA participants |
| FluMist/B/Yamagata | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H1N1 | NA participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Yamagata | NA participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H3N2 | NA participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Victoria | 35 participants |
| FluMist/B/Victoria | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H1N1 | NA participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Victoria | NA participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H3N2 | 25 participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | A/H1N1 | 31 participants |
| All FluMist | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | B/Yamagata | NA participants |
Secondary
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
Time frame: Days 0-28 post vaccination
Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination | 210 participants |
| FluMist/B/Yamagata | The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination | 118 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590) and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=291; All FM=160).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 172 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 95 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1182; AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=373; All FM=196).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 232 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 122 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1182; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and were seropositive to the strain (Q=930; FV=231).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 714 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 175 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; FY=299), had post-dose HAI measurement (Q=1182; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were seropositive to the strain (Q=983; FY=249).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 837 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 215 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=291; All FM=160).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | 2 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | 1 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198, AFM=600), had pre-dose and post-dose HAI measurement (Q=1181, AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=373, All FM=196).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | 6 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | 0 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198, FV=301), had pre-dose and post-dose HAI measurement (Q=1181, FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were seropositive to the strain (Q=930, FV=231).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | 53 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | 7 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198, FY=299), had pre-dose and post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q1180; FY=292), and were seropositive to the strain (Q=983, FY=249).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | 52 participants |
| FluMist/B/Yamagata | The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | 13 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198, All FM=600), had post-dose HAI measurement (Q=1182; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181, All FM=589), and were serosusceptible to the strain(Q=889, All FM=429).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 17 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 5 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 18 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 11 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and serosusceptible (Q=250; FV=66).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 57 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 16 participants |
Secondary
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.
Time frame: Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198, FY=299), had post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were serosusceptible to the strain (Q=197, FY=43).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 44 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | 11 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=889; All FM=429).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | 59 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | 30 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | 53 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | 25 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; FV=301), had pre-dose and post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were serosusceptible to the strain (Q=250; FV=66).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | 92 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | 28 participants |
Secondary
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.
Time frame: Day 0 and Day 28-35
Population: Participants who received a full dose of investigational product (Q=1198; FY=299), had pre-dose and post-dose HAI measurement (Q=1181; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292), and were serosusceptible to the strain (Q=197; FY=43).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV (MEDI3250) | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | 66 participants |
| FluMist/B/Yamagata | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | 17 participants |