Healthy or Stable Underlying Chronic Medical Condition
Conditions
Brief summary
The purpose of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.
Detailed description
The primary objective of this study was to determine the immunologic noninferiority of MEDI8662, a quadrivalent live attenuated influenza vaccine (Q/LAIV) (delivered intranasally using the blow-fill-seal \[BFS\] delivery system) (Q/LAIV-BFS) to two trivalent formulations of licensed FluMist (delivered intranasally using the Becton Dickinson \[BD\] Accuspray™ device) by comparing the strain-specific geometric mean titers (GMTs) post dosing.
Interventions
BIOLOGICALQ/LAIV-BFS (MEDI8662)
A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.
BIOLOGICALFluMist/B/Yamagata
FluMist/B/Yamagata - 0.2 mL dose at Day 0
BIOLOGICALFluMist/B/Victoria
FluMist/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 through 49 years, inclusive (reached their 18th year birthday but not yet reached their 50th year birthday) at the time of randomization * Females of child-bearing potential, must have used an effective method of avoiding pregnancy 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 participant must also have had a negative urine or blood 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. * Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization had not been required in the previous year
Exclusion criteria
* Acute illness or evidence of significant active infection at randomization * Fever greater than or equal to 100.4 degrees 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; topical corticosteroids or antifungals for uncomplicated dermatitis; chronic medications (including those taken on an as-needed basis) 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 may have compromised the safety of the participant in the study * Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids and topical calcineurin inhibitors were permitted) within a 30-day window around the dose * 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 30 days prior to randomization or planned receipt of any investigational drug therapy through 30 days after dosing of investigational product (use of licensed agents for indications not listed in the package insert were permitted) * Receipt of any nonstudy vaccine within 30 days prior to randomization or planned receipt of nonstudy vaccine through 30 days after dosing * Receipt of any influenza vaccine (investigational or licensed) in 2009 prior to randomization or anticipated receipt prior to the collection of the post-dose immunogenicity blood sample for this study * 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 Q/LAIV-BFS 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 receipt of investigational product or anticipated use within 30 days after receipt of investigational product * Known or suspected mitochondrial encephalomyopathy * Pregnant or lactating female * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of participant safety or study results * Participant, legal guardian, or immediate family member of participant who was an employee of the clinical study site or who was otherwise involved with the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | Day 28 to 35 | Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. | Day 0 and Day 28-35 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm. |
| The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. | Day 0 and Day 28-35 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm. |
| The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. | 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 comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. | 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 comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. | 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 comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm. |
| The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. | 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 comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm. |
| The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. | 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 comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. | 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 comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. | 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 comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm. |
| The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. | 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 comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm. |
| The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | Day 28-35 | The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. | Day 28-35 | The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm. |
| The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. | Day 28-35 | The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm. |
| The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | Day 0 and Day 28-35 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. | Day 28-35 | Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. | Day 28-35 | Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm. |
| The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. | Day 28-35 | Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm. |
| The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms). |
| The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm. |
| The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. | Day 28-35 | Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm. |
| The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Days 0-14 post dose | — |
| The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose | Days 0-28 post dose | — |
| The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose | Days 0-28 post dose | — |
| The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose | Days 0-180 post dose | — |
| The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose | Days 0-180 post dose | — |
| The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. | Day 28-35 | Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms). |
Countries
United States
Participant flow
Recruitment details
Participants were screened for the study within 30 days prior to randomization at investigator clinic sites in the USA. The first and last dates of informed consent were 14Aug2009 and 26Aug2009, respectively.
Pre-assignment details
Of 1,888 participants who provided written informed consent and were screened for the study, 88 were screened but were not randomized into the study due to one or more of the following reasons: not meeting the eligibility criteria; study was full; withdrawal of consent; lost to follow-up; unable to obtain a blood sample for immunogenicity testing.
Participants by arm
| Arm | Count |
|---|---|
| Q/LAIV-BFS (MEDI8662) Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus 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). | 1,202 |
| FluMist/B/Yamagata FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10\^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006). | 300 |
| FluMist/B/Victoria FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10\^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004). | 298 |
| Total | 1,800 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 0 |
| Overall Study | Exclusion criteria not met pre dose | 0 | 1 | 0 |
| Overall Study | Incarcerated post dose | 5 | 0 | 0 |
| Overall Study | Lost to Follow-up | 24 | 8 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Q/LAIV-BFS (MEDI8662) | FluMist/B/Yamagata | FluMist/B/Victoria | Total |
|---|---|---|---|---|
| Age, Continuous | 33.9 Years STANDARD_DEVIATION 9.5 | 34.0 Years STANDARD_DEVIATION 9.1 | 33.8 Years STANDARD_DEVIATION 8.8 | 33.9 Years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 701 Participants | 169 Participants | 167 Participants | 1037 Participants |
| Sex: Female, Male Male | 501 Participants | 131 Participants | 131 Participants | 763 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 100 / 1,198 | 45 / 596 |
| serious Total, serious adverse events | 15 / 1,198 | 2 / 596 |
Outcome results
Primary
The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).
Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.
Time frame: Day 28 to 35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had a post-dose HAI measurement, and had no protocol violation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H3N2 | 8.3 Geometric Mean Titer |
| Q/LAIV-BFS (MEDI8662) | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Victoria | 27.4 Geometric Mean Titer |
| Q/LAIV-BFS (MEDI8662) | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Yamagata | 60.3 Geometric Mean Titer |
| Q/LAIV-BFS (MEDI8662) | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H1N1 | 8.1 Geometric Mean Titer |
| FluMist/B/Yamagata | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Yamagata | 54.1 Geometric Mean Titer |
| FluMist/B/Yamagata | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H1N1 | 7.1 Geometric Mean Titer |
| FluMist/B/Yamagata | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H3N2 | 8.0 Geometric Mean Titer |
| FluMist/B/Yamagata | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Victoria | 19.9 Geometric Mean Titer |
| FluMist/B/Victoria | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Yamagata | 49.8 Geometric Mean Titer |
| FluMist/B/Victoria | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Victoria | 26.7 Geometric Mean Titer |
| FluMist/B/Victoria | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H1N1 | 8.3 Geometric Mean Titer |
| FluMist/B/Victoria | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H3N2 | 7.4 Geometric Mean Titer |
| All FluMist | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H3N2 | 7.7 Geometric Mean Titer |
| All FluMist | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Yamagata | 51.9 Geometric Mean Titer |
| All FluMist | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | A/H1N1 | 7.7 Geometric Mean Titer |
| All FluMist | The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). | B/Victoria | 23.0 Geometric Mean Titer |
Comparison: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.95% CI: [0.87, 1.03]Bootstrapping method
Comparison: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.95% CI: [0.85, 1]Bootstrapping method
Comparison: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.95% CI: [0.79, 1.02]Bootstrapping method
Comparison: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.95% CI: [0.87, 1.1]Bootstrapping method
Secondary
The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.
The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586, respectively, received a full dose of investigational product, had post-dose HAI measurement for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H1N1 | 25.3 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H3N2 | 25.8 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H1N1 | 22.5 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H3N2 | 23.4 Percentage of Participants |
Secondary
The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.
The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. | 55.5 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. | 52.7 Percentage of Participants |
Secondary
The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.
The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1176 and 294, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. | 78.7 Percentage of subjects |
| FluMist/B/Yamagata | The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. | 75.2 Percentage of subjects |
Secondary
The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose
Time frame: Days 0-14 post dose
Population: The Evaluable Safety Population for solicited symptoms included all participants who received any investigational product and had any solicited symptom data available during the reporting period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Decreased activity level (lethargy) or tiredness | 16.2 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 103.1°F | 0.1 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 100.4°F | 1.6 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 104.0°F | 0.0 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Generalized muscle aches | 8.4 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 104.9°F | 0.0 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 101.3°F | 0.7 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Runny/stuffy nose | 31.3 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Headache | 23.8 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Sore throat | 17.3 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 102.2°F | 0.3 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Cough | 9.6 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Decreased appetite | 5.3 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Any solicited symptom | 50.6 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Decreased appetite | 5.7 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Any solicited symptom | 54.3 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Cough | 7.9 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Headache | 24.4 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Generalized muscle aches | 11.1 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Decreased activity level (lethargy) or tiredness | 17.5 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 100.4°F | 2.0 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 101.3°F | 0.7 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 102.2°F | 0.2 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 103.1°F | 0.0 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 104.0°F | 0.0 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Fever ≥ 104.9°F | 0.0 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Runny/stuffy nose | 37.6 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose | Sore throat | 15.0 Percentage of Participants |
Secondary
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H1N1 | 5.4 Percentage of Participants |
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H3N2 | 4.7 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H1N1 | 6.5 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. | A/H3N2 | 4.8 Percentage of Participants |
Secondary
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. | 7.5 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. | 10.3 Percentage of Participants |
Secondary
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1175 and 294 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. | 8.2 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. | 9.5 Percentage of Participants |
Secondary
The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose
Time frame: Days 0-28 post dose
Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose | 15.6 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose | 14.9 Percentage of Participants |
Secondary
The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose
Time frame: Days 0-180 post dose
Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose | 1.3 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose | 0.3 Percentage of Participants |
Secondary
The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose
Time frame: Days 0-28 post dose
Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose | 0.3 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose | 0.0 Percentage of Participants |
Secondary
The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose
Time frame: Days 0-180 post dose
Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose | 0.5 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose | 0.5 Percentage of Participants |
Secondary
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.
Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. | 70.2 Percentage of participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. | 71.8 Percentage of participants |
Secondary
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.
Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. | 67.9 Percentage of participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. | 65.0 Percentage of participants |
Secondary
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.
Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. | 75.8 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. | 74.5 Percentage of Participants |
Secondary
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.
Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. | 89.7 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. | 86.8 Percentage of Participants |
Secondary
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.
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 comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. | 0.5 Percentage of participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. | 0.6 Percentage of participants |
Secondary
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.
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 comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. | 1.9 Percentage of participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. | 0.5 Percentage of participants |
Secondary
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.
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 comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. | 2.8 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. | 4.1 Percentage of Participants |
Secondary
The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.
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 comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. | 1.6 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. | 1.6 Percentage of Participants |
Secondary
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.
Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. | 2.7 Percentage of participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. | 1.7 Percentage of participants |
Secondary
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.
Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. | 1.5 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. | 1.8 Percentage of Participants |
Secondary
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.
Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. | 9.7 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. | 13.5 Percentage of Participants |
Secondary
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.
Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time frame: Day 28-35
Population: Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. | 21.7 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. | 19.6 Percentage of Participants |
Secondary
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.
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 comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. | 7.9 Percentage of participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. | 9.0 Percentage of participants |
Secondary
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.
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 comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. | 6.3 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. | 7.0 Percentage of Participants |
Secondary
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.
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 comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. | 20.8 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. | 26.0 Percentage of Participants |
Secondary
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.
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 comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time frame: Day 0 and Day 28-35
Population: Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q/LAIV-BFS (MEDI8662) | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. | 36.0 Percentage of Participants |
| FluMist/B/Yamagata | The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. | 35.3 Percentage of Participants |