| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00010.0(3.8 to 20.5)
- OG0015.4(1.1 to 14.9)
- OG00223.4(13.8 to 35.7)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | | 0.006 | p-value is calculated from the Cochran-Mantel-Haenszel (CMH) test adjusting for the prior influenza vaccination status. | Mean Difference (Net) | 18.1 | | | 2-Sided | 95 | 4.8 | 30.9 | | | | | Superiority | | |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
|
| Primary | Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
|
| Primary | Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | |
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| 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. | Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. | Posted | | Number | | Percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Days | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| 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. | 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. | Posted | | Mean | Standard Deviation | log10 viral particles/mL | | Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
|
| 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. | Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 28 and 56 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
|
| 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. | Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 28 and 56 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| 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. | Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. | Posted | | Number | | Percentage of participants | | Days 28 and 56 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | FluMist Quadrivalent (2017-2018) |
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| 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. | ATP included all participants who received any investigational drug. | Posted | | Number | | Percentage of participants | | Day 1 through Day 14 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | FluMist Quadrivalent (2017-2018) |
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| 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. | ATP included all participants who received any investigational drug. | Posted | | Count of Participants | | Participants | | Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
|