| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| | | Title | Denominators | Categories |
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| | 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 |
|---|
| The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999). | | | | | Rate differences | -60.6 | | | | 95 | -79.7 | -31.7 | | | | | Superiority or Other (legacy) | | |
|
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2)for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29) | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7). | Posted | | Number | | Percentage of Participants | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5). | Posted | | Number | | Percentage of Participants | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
| |
| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain | The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5). | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 1 | Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=16; n=17). | Posted | | Median | Full Range | Counts of ASCs per 10^6 PBMCs | | Post Dose 1 (7 to 10 days post Dose 1) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 2 | Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=10; n=9). | Posted | | Median | Full Range | Counts of ASCs per 10^6 PBMCs | | Post Dose 2 (7 to 10 days post Dose 2) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay Following the First Dose | Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 42 days after Dose 1. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 42 days after Dose 1 | Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and post-Dose 1 T-cell Elispot results (n=12; n=15) | Posted | | Median | Full Range | SPC/2 x 10^5 PBMCs | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay | Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 35 days after Dose 2. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 35 days after Dose 2 | Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and any post-Dose T-cell Elispot results (n=3; n=6) | Posted | | Median | Full Range | SPC/2 x 10^5 PBMCs | | Post Dose 2 (28 to 35 days post Dose 2) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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| Primary | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Distribution of IFN-alpha/beta gene signature scores at 7 to 10 days after Dose 1. IFN alpha/beta gene signature scores were calculated as the average fold change in a panel of 21 type 1 IFN-inducible genes. The distribution of IFN alpha/beta gene signature scores ranged from -4 to 4, with -4 representing the lowest level of activity and 4 representing the highest level of activity. The percentage of subjects by IFN-alpha/beta gene signature score for each treatment group were compared. | | Posted | | Number | | Units on a scale | | Post Dose 1 (28 to 42 days post Dose 1) | | | | ID | Title | Description |
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| OG000 | FluMist, Influenza Virus Vaccine Live | FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | | OG001 | TIV, Trivalent Inactivated Influenza Virus Vaccine | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses |
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