Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age

A Phase 4 Double-blind Study to Evaluate the Shedding and Immunogenicity of Trivalent and Quadrivalent Formulations of FluMist in Children 24 to < 48 Months of Age

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03143101

Acronym

FluMist

Enrollment

200

Registered

2017-05-08

Start date

2017-05-08

Completion date

2017-09-29

Last updated

2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Influenza

Keywords

FluMist Quadrivalent, Trivalent, Influenza, Vaccine, Prevention

Brief summary

This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.

Detailed description

This randomized, double-blind, multi-center study will enroll approximately 200 children 24 to less than (\<) 48 months of age. Participants will be randomized in a 1:1:1 ratio to receive two doses of either FluMist quadrivalent 2017-2018, FluMist quadrivalent 2015-2016 formulation, or FluMist trivalent 2015-2016 formulation. Participants will be screened within 30 days prior to randomization. Randomization will be stratified according to whether the participant ever received prior influenza vaccination. Approximately 50% of the participants will not have been previously vaccinated. All participants will receive two doses of investigational product on Study Days 1 and 28, and followed for a 28-day follow-up period after each dose. Blood and nasal samples will be collected and safety evaluations perfomed. The duration of participants participation is approximately 2 to 3 months. The study will be conducted during the influenza off-season in the US. After completion of the study all participants will be offered and strongly encouraged to receive an inactivated influenza vaccine approved for use in the US for the 2017-2018 influenza season.

Interventions

BIOLOGICALFluMist trivalent (2015-2016)

0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10\^7±0.5 FFU of each vaccine strain.

BIOLOGICALFluMist Quadrivalent (2015-2016)

0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10\^7±0.5 FFU of each vaccine strain.

BIOLOGICALFluMist Quadrivalent (2017-2018)

0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10\^7±0.5 FFU of each vaccine strain.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Eligibility

Sex/Gender

ALL

Age

24 Months to 47 Months

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Age 24 months to \< 48 months of age * Healthy by medical history and physical examination or presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year Key

Exclusion criteria

* History of allergic disease or reactions likely to be exacerbated by any component of the investigational product * Acute illness or evidence of significant active infection (including fever \>= 100.4 degrees Fahrenheit (38.0 degrees Celsius) at randomization * History of asthma or history of recurrent wheezing * Any known immunosuppressive condition or immune deficiency disease * Current or expected receipt of immunosuppressive medications within a 28 day window around vaccination * Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt thru 28 days after vaccination * Use of antiviral agents with activity against influenza viruses within 48 hours prior to first dose of investigational product or anticipated use of such agents through the end of the study follow-up period * Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or planned receipt of non-study seasonal influenza vaccine prior to 28 days after last vaccination * Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation * Known or suspected mitochondrial encephalomyopathy * History of Guillian-Barre syndrome * Administration of intranasal medications within 10 days prior to randomization, for expected receipt through 10 days after administration of each dose of investigational product

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56	Day 56	Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Victoria HAI antibody titer at Day 56 is reported.
Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28	Day 28	Seroconversion rate is defined as at least (\>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28	Day 28	Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H3N2 HAI antibody titer at Day 28 is reported.
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28	Day 28	Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Yamagata HAI antibody titer at Day 28 is reported.
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28	Day 28	Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Victoria HAI antibody titer at Day 28 is reported.
Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56	Day 56	Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H1N1 HAI antibody titer at Day 56 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56	Day 56	Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H3N2 HAI antibody titer at Day 56 is reported.
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56	Day 56	Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Yamagata HAI antibody titer at Day 56 is reported.

Secondary

Measure	Time frame	Description
Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4, and 6 after Dose 2 (Day 28 dose)	Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Percentage of participants who shed virus are reported.
Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4 and 6 after Dose 2 (Day 28 dose)	Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Number of days of virus shedding are reported.
Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose)	Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral titer from the nasopharyngeal swabs. Viral titers are reported.
Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	Days 28 and 56	Seroconversion rate is defined as \>= 4-fold rise from baseline in strain specific microneutralizing antibody titer. Baseline microneutralization values of less than or equal to (\<=) 10 were considered as microneutralization status negative and values greater than (\>) 10 were considered microneutralization positive. Percentage of participants with \>= 4-fold rise in strain specific neutralizing antibody titer at Days 28 and 56 are reported.
Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	Days 28 and 56	Seroconversion rate is defined as \>= 2-fold rise from baseline in strain speciific nasal IgA antibody titer. Percentage of participants with \>= 2-fold rise in strain speciific nasal IgA antibody titer at Days 28 and 56 are reported for this outcome.
Percentage of Participants With Any Post Dose Strain-specific Antibody Response	Days 28 and 56	Strain specific antibody response defined as \>= 4-fold increase in HAI antibodies or \>= 4-fold increase in neutralizing antibodies or \>= 2-fold increase in IgA antibodies.
Percentage of Participants With Any Solicited Symptoms	Day 1 through Day 14 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)	Solicited symptoms included fever by any route (temperature \>= 100.4 degrees Fahrenheit), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, lethargy or tiredness/weakness, and decreased appetite.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)	An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug.

Countries

United States

Participant flow

Recruitment details

The study was conducted from 08 May 2017 through 29 Sep 2017 in the USA.

Pre-assignment details

A total of 200 participants were randomized and participated in the study.

Participants by arm

Arm	Count
FluMist Trivalent (2015-2016) Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10\^7±0.5 FFU of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).	67
FluMist Quadrivalent (2015-2016) Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10\^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).	66
FluMist Quadrivalent (2017-2018) Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10\^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).	67
Total	200

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	2	2	0
Overall Study	Withdrawal by Subject	0	1	0

Baseline characteristics

Characteristic	FluMist Trivalent (2015-2016)	FluMist Quadrivalent (2015-2016)	FluMist Quadrivalent (2017-2018)	Total
Age, Continuous	35.96 months STANDARD_DEVIATION 6.41	34.96 months STANDARD_DEVIATION 6.78	34.94 months STANDARD_DEVIATION 6.8	35.29 months STANDARD_DEVIATION 6.65
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	9 Participants	14 Participants	34 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants	57 Participants	53 Participants	166 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	9 Participants	9 Participants	13 Participants	31 Participants
Race (NIH/OMB) More than one race	3 Participants	1 Participants	3 Participants	7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants	0 Participants	1 Participants	3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) White	52 Participants	55 Participants	49 Participants	156 Participants
Sex: Female, Male Female	27 Participants	32 Participants	35 Participants	94 Participants
Sex: Female, Male Male	40 Participants	34 Participants	32 Participants	106 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 67	0 / 66	0 / 67
other Total, other adverse events	29 / 67	31 / 66	34 / 67
serious Total, serious adverse events	0 / 67	0 / 66	0 / 67

Outcome results

Primary

Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56

Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H1N1 HAI antibody titer at Day 56 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.

Time frame: Day 56

Population: Immunogenicity population included all participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure.

Arm	Measure	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56	23.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56	12.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56	45.2 Percentage of participants

p-value: <0.00195% CI: [14.4, 47.8]Cochran-Mantel-Haenszel

Primary

Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28

Seroconversion rate is defined as at least (\>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.

Time frame: Day 28

Population: Immunogenicity population included all participants in the as-treated population (ATP) who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure.

Arm	Measure	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28	10.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28	5.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28	23.4 Percentage of participants

p-value: 0.00695% CI: [4.8, 30.9]Cochran-Mantel-Haenszel

Primary

Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28

Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H3N2 HAI antibody titer at Day 28 is reported.

Time frame: Day 28

Arm	Measure	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28	51.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28	64.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28	31.3 Percentage of participants

Primary

Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56

Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H3N2 HAI antibody titer at Day 56 is reported.

Time frame: Day 56

Arm	Measure	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56	54.2 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56	66.1 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56	40.3 Percentage of participants

Primary

Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28

Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Victoria HAI antibody titer at Day 28 is reported.

Time frame: Day 28

Population: Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, N signifies number of participants analyzed for this outcome measure.

Arm	Measure	Value (NUMBER)
FluMist Quadrivalent (2015-2016)	Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28	14.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28	35.9 Percentage of participants

Primary

Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56

Time frame: Day 56

Population: Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, N signifies number of participants analyzed for this outcome measure.

Arm	Measure	Value (NUMBER)
FluMist Quadrivalent (2015-2016)	Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56	25.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56	40.3 Percentage of participants

Primary

Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28

Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Yamagata HAI antibody titer at Day 28 is reported.

Time frame: Day 28

Arm	Measure	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28	50.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28	42.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28	57.8 Percentage of participants

Primary

Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56

Time frame: Day 56

Arm	Measure	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56	50.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56	53.6 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56	54.8 Percentage of participants

Secondary

Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR

Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Number of days of virus shedding are reported.

Time frame: Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4 and 6 after Dose 2 (Day 28 dose)

Population: Participants included in immunogenicity population and who shed vaccine virus were analyzed for this outcome measure. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.

Arm	Measure	Group	Value (MEAN)	Dispersion
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose 2	1.3 Days	Standard Deviation 0.6
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose 1	4.5 Days	Standard Deviation 1
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose 1	2.2 Days	Standard Deviation 1.2
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose 1	3.6 Days	Standard Deviation 1.3
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose 2	1.1 Days	Standard Deviation 0.4
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose 2	1.3 Days	Standard Deviation 0.6
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose 1	3.8 Days	Standard Deviation 1.5
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose 1	2.2 Days	Standard Deviation 1
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose 2	1.3 Days	Standard Deviation 0.6
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose 1	2.5 Days	Standard Deviation 1.2
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose 2	1.1 Days	Standard Deviation 0.4
FluMist Trivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose 2	1.2 Days	Standard Deviation 0.4
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose 2	1.4 Days	Standard Deviation 0.6
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose 1	2.2 Days	Standard Deviation 1
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose 2	1.4 Days	Standard Deviation 0.7
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose 1	1.9 Days	Standard Deviation 0.7
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose 2	1.0 Days	Standard Deviation 0
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose 1	4.5 Days	Standard Deviation 0.9
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose 2	1.1 Days	Standard Deviation 0.4
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose 1	3.4 Days	Standard Deviation 1.6
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose 2	1.5 Days	Standard Deviation 0.8
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose 1	3.6 Days	Standard Deviation 1.3
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose 2	1.3 Days	Standard Deviation 0.7
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose 1	3.3 Days	Standard Deviation 1
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose 2	1.0 Days	Standard Deviation 0
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose 1	3.9 Days	Standard Deviation 1.2
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose 1	2.0 Days	Standard Deviation 1
FluMist Quadrivalent (2015-2016)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose 2	1.0 Days	Standard Deviation 0
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose 1	2.8 Days	Standard Deviation 1.3
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose 2	1.1 Days	Standard Deviation 0.3
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose 1	2.0 Days	Standard Deviation 1.3
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose 2	1.4 Days	Standard Deviation 0.6
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose 1	3.1 Days	Standard Deviation 1.6
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose 2	1.3 Days	Standard Deviation 0.5
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose 2	1.1 Days	Standard Deviation 0.3
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose 2	1.3 Days	Standard Deviation 0.5
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose 1	2.5 Days	Standard Deviation 1.4
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose 2	1.7 Days	Standard Deviation 0.8
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose 1	3.5 Days	Standard Deviation 1.5
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose 2	1.4 Days	Standard Deviation 0.6
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose 1	3.9 Days	Standard Deviation 1.2
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose 1	4.6 Days	Standard Deviation 0.8
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose 1	4.0 Days	Standard Deviation 1.1
FluMist Quadrivalent (2017-2018)	Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose 2	1.1 Days	Standard Deviation 0.4

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug.

Time frame: Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)

Population: ATP included all participants who received any investigational drug.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
FluMist Trivalent (2015-2016)	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TESAEs	0 Participants
FluMist Trivalent (2015-2016)	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TEAEs	29 Participants
FluMist Quadrivalent (2015-2016)	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TEAEs	31 Participants
FluMist Quadrivalent (2015-2016)	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TESAEs	0 Participants
FluMist Quadrivalent (2017-2018)	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TEAEs	34 Participants
FluMist Quadrivalent (2017-2018)	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TESAEs	0 Participants

Secondary

Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)

Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Percentage of participants who shed virus are reported.

Time frame: Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4, and 6 after Dose 2 (Day 28 dose)

Population: Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.

Arm	Measure	Group	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seronegative/Dose 1	100.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seropositive/Dose 2	50.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seronegative/Dose 1	100.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seronegative/Dose 2	55.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seropositive/Dose 1	86.1 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seropositive/Dose 2	47.7 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seropositive/Dose 1	95.6 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seronegative/Dose 2	17.2 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seropositive/Dose 1	73.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seropositive/Dose 2	22.9 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seronegative/Dose 1	86.7 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seronegative/Dose 2	42.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seronegative/Dose 2	44.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seronegative/Dose 1	81.4 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seronegative/Dose 2	25.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seropositive/Dose 1	63.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seropositive/Dose 2	23.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seronegative/Dose 1	100.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seronegative/Dose 2	60.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seropositive/Dose 1	83.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seropositive/Dose 2	44.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seronegative/Dose 1	98.1 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seronegative/Dose 2	39.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seropositive/Dose 1	81.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seropositive/Dose 2	54.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seronegative/Dose 1	100.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seropositive/Dose 1	83.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seropositive/Dose 2	50.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seronegative/Dose 1	94.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seronegative/Dose 2	31.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seropositive/Dose 1	71.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seronegative/Dose 2	53.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seropositive/Dose 1	93.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seronegative/Dose 2	46.2 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seropositive/Dose 2	37.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seropositive/Dose 2	53.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seropositive/Dose 1	95.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seronegative/Dose 2	79.2 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seropositive/Dose 1	100.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seropositive/Dose 2	59.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H3N2/HAI seronegative/Dose 1	95.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Victoria/HAI seronegative/Dose 1	100.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	B/Yamagata/HAI seronegative/Dose 1	100.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)	A/H1N1/HAI seropositive/Dose 2	29.6 Percentage of participants

Secondary

Percentage of Participants With Any Post Dose Strain-specific Antibody Response

Strain specific antibody response defined as \>= 4-fold increase in HAI antibodies or \>= 4-fold increase in neutralizing antibodies or \>= 2-fold increase in IgA antibodies.

Time frame: Days 28 and 56

Population: Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.

Arm	Measure	Group	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Microneutralization response/Day 28	60.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Microneutralization response/Day 28	3.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/HAI response/Day 56	50.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Microneutralization response/Day 56	57.6 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Nasal IgA response/Day 28	46.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Nasal IgA response/Day 28	65.6 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Nasal IgA response/Day 56	76.6 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Microneutralization response/Day 56	15.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Microneutralization response/Day 28	48.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/HAI response/Day 28	50.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/HAI response/Day 56	54.2 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/HAI response/Day 28	10.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Nasal IgA response/Day 56	46.9 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Nasal IgA response/Day 28	81.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Nasal IgA response/Day 56	70.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/HAI response/Day 28	51.7 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/HAI response/Day 56	23.7 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Microneutralization response/Day 56	61.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Nasal IgA response/Day 28	76.2 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/HAI response/Day 28	5.4 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Microneutralization response/Day 28	5.4 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/HAI response/Day 56	12.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Microneutralization response/Day 56	10.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Nasal IgA response/Day 56	53.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/HAI response/Day 28	64.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/HAI response/Day 56	66.1 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Microneutralization response/Day 56	69.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Nasal IgA response/Day 56	82.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/HAI response/Day 28	42.9 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Microneutralization response/Day 28	37.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Nasal IgA response/Day 28	87.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/HAI response/Day 56	53.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Microneutralization response/Day 56	57.1 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Nasal IgA response/Day 56	83.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/HAI response/Day 28	14.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Microneutralization response/Day 28	19.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/HAI response/Day 56	25.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Microneutralization response/Day 56	16.1 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Nasal IgA response/Day 56	83.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Nasal IgA response/Day 28	52.4 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Microneutralization response/Day 28	66.1 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Nasal IgA response/Day 28	85.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Nasal IgA response/Day 56	61.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Nasal IgA response/Day 28	38.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Nasal IgA response/Day 56	77.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Nasal IgA response/Day 28	35.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/HAI response/Day 28	35.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/HAI response/Day 28	23.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Microneutralization response/Day 28	17.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Microneutralization response/Day 56	31.7 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Nasal IgA response/Day 28	55.2 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Microneutralization response/Day 28	30.2 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/HAI response/Day 56	40.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/HAI response/Day 28	57.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Nasal IgA response/Day 56	50.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/Microneutralization response/Day 28	15.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Microneutralization response/Day 28	48.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/Microneutralization response/Day 56	30.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Microneutralization response/Day 56	21.7 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Nasal IgA response/Day 28	61.2 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/HAI response/Day 56	40.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Victoria/Nasal IgA response/Day 56	78.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/HAI response/Day 56	54.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H3N2/HAI response/Day 28	31.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	A/H1N1/HAI response/Day 56	45.2 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Post Dose Strain-specific Antibody Response	B/Yamagata/Microneutralization response/Day 56	61.3 Percentage of participants

Secondary

Percentage of Participants With Any Solicited Symptoms

Solicited symptoms included fever by any route (temperature \>= 100.4 degrees Fahrenheit), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, lethargy or tiredness/weakness, and decreased appetite.

Time frame: Day 1 through Day 14 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)

Population: ATP included all participants who received any investigational drug.

Arm	Measure	Group	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Generalized Muscle Aches: Dose 1	4.5 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Lethargy/Tiredness/Weakness: Dose 1	13.4 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Sore Throat: Dose 1	6.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Generalized Muscle Aches: Dose 2	0.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Lethargy/Tiredness/Weakness: Dose 2	12.7 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Sore Throat: Dose 2	3.2 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Decreased Appetite: Dose 1	13.4 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Headache: Dose 2	3.2 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Decreased Appetite: Dose 2	9.5 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Fever: Dose 1	3.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Headache: Dose 1	1.5 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Runny/Stuffy Nose: Dose 2	33.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Fever: Dose 2	3.2 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Cough: Dose 1	19.4 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Runny/Stuffy Nose: Dose 1	34.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Cough: Dose 2	19.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Runny/Stuffy Nose: Dose 1	41.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Cough: Dose 1	15.4 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Cough: Dose 2	21.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Headache: Dose 1	4.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Generalized Muscle Aches: Dose 2	3.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Headache: Dose 2	5.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Lethargy/Tiredness/Weakness: Dose 2	11.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Decreased Appetite: Dose 2	8.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Fever: Dose 2	8.2 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Generalized Muscle Aches: Dose 1	4.6 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Runny/Stuffy Nose: Dose 2	36.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Lethargy/Tiredness/Weakness: Dose 1	13.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Decreased Appetite: Dose 1	12.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Sore Throat: Dose 2	3.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Fever: Dose 1	1.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Any Solicited Symptoms	Sore Throat: Dose 1	1.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Decreased Appetite: Dose 2	7.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Runny/Stuffy Nose: Dose 1	43.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Runny/Stuffy Nose: Dose 2	34.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Sore Throat: Dose 1	4.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Sore Throat: Dose 2	4.7 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Headache: Dose 2	3.1 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Generalized Muscle Aches: Dose 1	1.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Lethargy/Tiredness/Weakness: Dose 2	7.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Decreased Appetite: Dose 1	11.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Fever: Dose 1	10.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Fever: Dose 2	6.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Cough: Dose 1	10.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Cough: Dose 2	10.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Headache: Dose 1	6.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Generalized Muscle Aches: Dose 2	0.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Any Solicited Symptoms	Lethargy/Tiredness/Weakness: Dose 1	16.4 Percentage of participants

Secondary

Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56

Seroconversion rate is defined as \>= 2-fold rise from baseline in strain speciific nasal IgA antibody titer. Percentage of participants with \>= 2-fold rise in strain speciific nasal IgA antibody titer at Days 28 and 56 are reported for this outcome.

Time frame: Days 28 and 56

Population: Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.

Arm	Measure	Group	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H3N2//Day 28	79.4 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H1N1//Day 56	40.6 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H3N2/Day 56	89.1 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Yamagata//Day 56	81.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H1N1/Day 28	33.9 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Yamagata//Day 28	69.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Victoria//Day 56	91.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Yamagata//Day 56	88.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H1N1/Day 28	31.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H1N1//Day 56	46.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H3N2//Day 28	79.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Yamagata//Day 28	79.4 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Victoria//Day 28	73.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H3N2/Day 56	88.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Victoria//Day 56	84.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H3N2/Day 56	55.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Yamagata//Day 28	77.6 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Yamagata//Day 56	86.4 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	B/Victoria//Day 28	79.1 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H3N2//Day 28	44.8 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H1N1/Day 28	40.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56	A/H1N1//Day 56	67.7 Percentage of participants

Secondary

Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus

Seroconversion rate is defined as \>= 4-fold rise from baseline in strain specific microneutralizing antibody titer. Baseline microneutralization values of less than or equal to (\<=) 10 were considered as microneutralization status negative and values greater than (\>) 10 were considered microneutralization positive. Percentage of participants with \>= 4-fold rise in strain specific neutralizing antibody titer at Days 28 and 56 are reported.

Time frame: Days 28 and 56

Population: Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.

Arm	Measure	Group	Value (NUMBER)
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:negative/Day 56	93.8 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:positive/Day 56	11.8 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:negative/Day 56	77.3 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:negative/Day 28	100.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:negative/Day 56	37.5 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:positive/Day 28	18.8 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:negative/Day 28	59.1 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:negative/Day 28	0.0 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:positive/Day 28	47.8 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:positive/Day 56	18.8 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:positive/Day 28	3.8 Percentage of participants
FluMist Trivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:positive/Day 56	44.2 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:negative/Day 56	25.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:positive/Day 56	2.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:negative/Day 28	100.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:negative/Day 56	100.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:positive/Day 28	34.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:negative/Day 28	45.7 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:negative/Day 56	68.1 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:positive/Day 28	0.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:negative/Day 28	20.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:negative/Day 56	16.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:positive/Day 28	12.5 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:positive/Day 56	14.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:negative/Day 28	10.0 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:positive/Day 28	2.8 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:positive/Day 56	43.3 Percentage of participants
FluMist Quadrivalent (2015-2016)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:positive/Day 56	0.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:positive/Day 28	14.3 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:negative/Day 56	84.6 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:negative/Day 56	75.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:negative/Day 28	58.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:positive/Day 28	25.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:positive/Day 56	31.7 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Yamagata/Baseline serostatus:positive/Day 56	7.7 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H1N1/Baseline serostatus:positive/Day 28	15.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:negative/Day 28	18.9 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:negative/Day 28	46.7 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:negative/Day 56	23.5 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:positive/Day 56	11.1 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	B/Victoria/Baseline serostatus:positive/Day 28	10.0 Percentage of participants
FluMist Quadrivalent (2017-2018)	Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus	A/H3N2/Baseline serostatus:positive/Day 56	14.9 Percentage of participants

Secondary

Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR

Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral titer from the nasopharyngeal swabs. Viral titers are reported.

Time frame: Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose)

Arm	Measure	Group	Value (MEAN)	Dispersion
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D4	4.86 log10 viral particles/mL	Standard Deviation 0.99
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D4	3.46 log10 viral particles/mL	Standard Deviation 0.04
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D6	3.82 log10 viral particles/mL	—
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D5	4.04 log10 viral particles/mL	Standard Deviation 1.09
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose2D2	3.68 log10 viral particles/mL	Standard Deviation 0.88
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D4	2.71 log10 viral particles/mL	Standard Deviation 0.62
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D7	4.10 log10 viral particles/mL	Standard Deviation 0.97
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose2D6	3.92 log10 viral particles/mL	—
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D2	3.30 log10 viral particles/mL	Standard Deviation 0.89
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose2D2	3.67 log10 viral particles/mL	Standard Deviation 1.03
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D3	3.93 log10 viral particles/mL	Standard Deviation 0.58
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D7	3.92 log10 viral particles/mL	Standard Deviation 1.06
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D4	3.63 log10 viral particles/mL	Standard Deviation 0.34
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D5	3.99 log10 viral particles/mL	Standard Deviation 1.05
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D2	3.79 log10 viral particles/mL	Standard Deviation 0.56
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D4	4.34 log10 viral particles/mL	Standard Deviation 1.03
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D2	3.80 log10 viral particles/mL	Standard Deviation 1.07
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D2	3.93 log10 viral particles/mL	Standard Deviation 0.2
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D3	4.79 log10 viral particles/mL	Standard Deviation 1.29
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D2	3.66 log10 viral particles/mL	Standard Deviation 0.46
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D3	3.66 log10 viral particles/mL	Standard Deviation 0.55
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose2D6	3.83 log10 viral particles/mL	Standard Deviation 0.35
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D3	3.39 log10 viral particles/mL	Standard Deviation 0.57
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D7	5.46 log10 viral particles/mL	—
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose2D4	3.74 log10 viral particles/mL	Standard Deviation 0.6
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D5	3.12 log10 viral particles/mL	Standard Deviation 0.16
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose2D2	3.92 log10 viral particles/mL	Standard Deviation 0.31
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D5	3.35 log10 viral particles/mL	Standard Deviation 0.64
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D7	4.37 log10 viral particles/mL	Standard Deviation 0.86
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D7	3.10 log10 viral particles/mL	—
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose2D2	3.38 log10 viral particles/mL	Standard Deviation 0.78
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D4	3.09 log10 viral particles/mL	Standard Deviation 0.62
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D5	4.56 log10 viral particles/mL	Standard Deviation 0.53
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D4	4.04 log10 viral particles/mL	Standard Deviation 0.61
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D2	4.20 log10 viral particles/mL	Standard Deviation 0.99
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D5	3.84 log10 viral particles/mL	—
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D3	4.10 log10 viral particles/mL	Standard Deviation 0.6
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D3	5.20 log10 viral particles/mL	Standard Deviation 1.12
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D7	3.17 log10 viral particles/mL	Standard Deviation 0.4
FluMist Trivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D2	3.93 log10 viral particles/mL	Standard Deviation 0.4
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose2D6	2.72 log10 viral particles/mL	—
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D2	3.76 log10 viral particles/mL	Standard Deviation 0.71
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D3	3.81 log10 viral particles/mL	Standard Deviation 0.83
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D4	3.34 log10 viral particles/mL	Standard Deviation 0.56
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D5	3.17 log10 viral particles/mL	Standard Deviation 0.1
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose2D2	3.29 log10 viral particles/mL	Standard Deviation 0.3
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose2D4	3.49 log10 viral particles/mL	Standard Deviation 0.37
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D2	3.48 log10 viral particles/mL	Standard Deviation 0.62
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D3	4.03 log10 viral particles/mL	Standard Deviation 0.91
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D4	3.39 log10 viral particles/mL	Standard Deviation 0.25
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose2D2	2.86 log10 viral particles/mL	—
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D2	4.15 log10 viral particles/mL	Standard Deviation 0.93
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D3	5.39 log10 viral particles/mL	Standard Deviation 1.19
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D4	4.51 log10 viral particles/mL	Standard Deviation 1.14
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D5	4.16 log10 viral particles/mL	Standard Deviation 1.2
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D7	4.12 log10 viral particles/mL	Standard Deviation 0.88
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose2D2	3.33 log10 viral particles/mL	Standard Deviation 0.67
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose2D4	3.41 log10 viral particles/mL	Standard Deviation 0.26
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D2	3.98 log10 viral particles/mL	Standard Deviation 1.02
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D3	5.06 log10 viral particles/mL	Standard Deviation 1.2
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D4	4.45 log10 viral particles/mL	Standard Deviation 1.14
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D5	4.01 log10 viral particles/mL	Standard Deviation 0.98
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D7	4.10 log10 viral particles/mL	Standard Deviation 1.36
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D2	3.55 log10 viral particles/mL	Standard Deviation 0.93
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D4	3.38 log10 viral particles/mL	Standard Deviation 0.9
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D6	2.32 log10 viral particles/mL	—
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D2	4.09 log10 viral particles/mL	Standard Deviation 0.53
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D3	4.60 log10 viral particles/mL	Standard Deviation 0.77
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D4	4.60 log10 viral particles/mL	Standard Deviation 0.83
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D5	4.42 log10 viral particles/mL	Standard Deviation 0.72
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D7	3.93 log10 viral particles/mL	Standard Deviation 0.5
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose2D2	4.10 log10 viral particles/mL	Standard Deviation 0.55
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose2D4	3.85 log10 viral particles/mL	Standard Deviation 0.52
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D2	3.57 log10 viral particles/mL	Standard Deviation 0.19
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D5	5.01 log10 viral particles/mL	—
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose2D2	3.38 log10 viral particles/mL	—
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D2	3.41 log10 viral particles/mL	Standard Deviation 0.58
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D3	4.12 log10 viral particles/mL	Standard Deviation 1.02
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D5	3.98 log10 viral particles/mL	Standard Deviation 1.05
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose2D2	3.43 log10 viral particles/mL	Standard Deviation 1.01
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose2D4	3.48 log10 viral particles/mL	Standard Deviation 0.88
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D2	2.73 log10 viral particles/mL	Standard Deviation 0.01
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D3	3.09 log10 viral particles/mL	Standard Deviation 0.42
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D4	2.73 log10 viral particles/mL	—
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D3	3.92 log10 viral particles/mL	Standard Deviation 0.51
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D4	4.60 log10 viral particles/mL	Standard Deviation 1.44
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D4	4.02 log10 viral particles/mL	Standard Deviation 1.13
FluMist Quadrivalent (2015-2016)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D7	3.57 log10 viral particles/mL	Standard Deviation 0.79
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D4	4.72 log10 viral particles/mL	Standard Deviation 0.88
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose2D2	3.36 log10 viral particles/mL	Standard Deviation 0.56
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D5	4.09 log10 viral particles/mL	Standard Deviation 1.02
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D5	4.59 log10 viral particles/mL	Standard Deviation 0.8
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D5	3.73 log10 viral particles/mL	Standard Deviation 0.62
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose2D4	2.67 log10 viral particles/mL	Standard Deviation 0.29
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D7	3.98 log10 viral particles/mL	Standard Deviation 0.62
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D4	3.97 log10 viral particles/mL	Standard Deviation 0.73
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D3	4.67 log10 viral particles/mL	Standard Deviation 0.79
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose2D2	3.80 log10 viral particles/mL	Standard Deviation 0.35
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D3	3.99 log10 viral particles/mL	Standard Deviation 0.84
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D2	3.10 log10 viral particles/mL	Standard Deviation 0.53
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose1D2	3.14 log10 viral particles/mL	Standard Deviation 0.45
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose2D4	4.02 log10 viral particles/mL	Standard Deviation 1.24
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose2D2	3.41 log10 viral particles/mL	Standard Deviation 0.51
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose2D2	3.90 log10 viral particles/mL	Standard Deviation 1.04
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D7	2.93 log10 viral particles/mL	Standard Deviation 0.23
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D4	4.94 log10 viral particles/mL	Standard Deviation 1.28
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D5	3.85 log10 viral particles/mL	Standard Deviation 0.48
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D3	3.96 log10 viral particles/mL	Standard Deviation 1.08
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D5	4.82 log10 viral particles/mL	Standard Deviation 0.65
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D4	3.81 log10 viral particles/mL	Standard Deviation 0.94
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D7	3.91 log10 viral particles/mL	Standard Deviation 0.63
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D7	4.00 log10 viral particles/mL	Standard Deviation 0.96
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose2D2	3.70 log10 viral particles/mL	Standard Deviation 0.11
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D2	3.19 log10 viral particles/mL	Standard Deviation 0.67
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D3	4.21 log10 viral particles/mL	Standard Deviation 0.97
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D3	3.54 log10 viral particles/mL	Standard Deviation 0.98
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose2D6	3.05 log10 viral particles/mL	Standard Deviation 0.61
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D4	4.40 log10 viral particles/mL	Standard Deviation 0.98
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D4	4.00 log10 viral particles/mL	Standard Deviation 1.24
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose2D4	3.68 log10 viral particles/mL	Standard Deviation 0.7
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D2	3.49 log10 viral particles/mL	Standard Deviation 0.72
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D5	3.98 log10 viral particles/mL	Standard Deviation 0.72
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose2D2	3.01 log10 viral particles/mL	Standard Deviation 0.49
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seropositive/Dose1D5	4.26 log10 viral particles/mL	Standard Deviation 0.9
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose1D7	3.30 log10 viral particles/mL	Standard Deviation 0.55
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D7	3.58 log10 viral particles/mL	Standard Deviation 1.26
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D3	4.39 log10 viral particles/mL	Standard Deviation 0.98
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D2	3.54 log10 viral particles/mL	Standard Deviation 0.78
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D5	3.67 log10 viral particles/mL	Standard Deviation 1.06
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D4	4.58 log10 viral particles/mL	Standard Deviation 1.24
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D4	3.26 log10 viral particles/mL	Standard Deviation 0.6
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D4	4.51 log10 viral particles/mL	Standard Deviation 1.05
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seronegative/Dose1D2	3.70 log10 viral particles/mL	Standard Deviation 0.49
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seropositive/Dose2D6	3.17 log10 viral particles/mL	—
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D3	4.34 log10 viral particles/mL	Standard Deviation 0.86
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose1D7	4.14 log10 viral particles/mL	Standard Deviation 0.84
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D2	4.16 log10 viral particles/mL	Standard Deviation 0.58
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H3N2/HAI seronegative/Dose1D2	3.52 log10 viral particles/mL	Standard Deviation 0.77
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seropositive/Dose1D2	4.15 log10 viral particles/mL	Standard Deviation 0.78
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Yamagata/HAI seronegative/Dose1D3	4.72 log10 viral particles/mL	Standard Deviation 0.92
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	A/H1N1/HAI seropositive/Dose2D4	3.65 log10 viral particles/mL	—
FluMist Quadrivalent (2017-2018)	Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR	B/Victoria/HAI seronegative/Dose2D2	2.94 log10 viral particles/mL	Standard Deviation 0.36

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026

Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56

Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28

Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28

Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56

Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28

Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56

Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28

Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56

Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)

Percentage of Participants With Any Post Dose Strain-specific Antibody Response

Percentage of Participants With Any Solicited Symptoms

Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56

Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus

Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR