Influenza Vaccine
Conditions
Keywords
Live, attenuated influenza virus vaccine (LAIV), Trivalent inactivated influenza virus vaccine (TIV), FluMist
Brief summary
The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against influenza virus strains.
Detailed description
The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against antigenically matched and antigenically mismatched influenza virus strains. The secondary objective of this study is to describe the safety of FluMist and TIV in subjects 12 to \<36 months of age.
Interventions
BIOLOGICALTIV, Trivalent Inactivated Influenza Virus Vaccine
0.25 mL will be administered intramuscularly for each of two doses
BIOLOGICALFluMist, Influenza Virus Vaccine Live
0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 12 to \<36 months (reached their 1st year but not yet reached their 3rd year birthday) at the time of randomization * Written informed consent and HIPAA authorization obtained from the subject's legal representative * Ability of the subject's legal representative to understand and comply with the requirements of the study * Subject's legal representative available by telephone * Ability to complete follow-up period of 180 days after final study vaccination as required by the protocol
Exclusion criteria
* History of hypersensitivity to any component of FluMist or TIV, including egg or egg products * History of hypersensitivity to gentamicin * Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy * Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination) * History of Guillain-Barré syndrome * Any prior history of wheezing or asthma * Acute febrile (≥100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination * Use of aspirin or aspirin-containing products within the 30 days prior to randomization, or expected receipt through 180 days after final study vaccination * Receipt of any prior influenza vaccine * Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected receipt through 35 days after final study vaccination * Administration of any live virus vaccine, other than measles, mumps, rubella, and varicella-containing vaccine(s), within 30 days prior to randomization, or expected receipt through 30 days after final study vaccination * Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization, or expected receipt within 14 days before or 14 days after either study vaccination * Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after final study vaccination (use of licensed agents for indications not listed in the package insert is permitted) * Receipt of any blood product within 90 days prior to randomization, or expected receipt through 35 days after final study vaccination * Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study * Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| 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 | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| 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 | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| 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 | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| 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 | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| 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 | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Post Dose 1 (7 to 10 days post Dose 1) | 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 |
| 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 | Post Dose 1 (28 to 42 days post Dose 1) | 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 |
| Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay | Post Dose 2 (28 to 35 days post Dose 2) | 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 |
| Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Post Dose 1 (28 to 42 days post Dose 1) | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 101 subjects were entered and randomized into the study at 15 sites in the United States of America between 07 May 2007 and 28 Jun 2007.
Participants by arm
| Arm | Count |
|---|---|
| FluMist, Influenza Virus Vaccine Live FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses | 50 |
| 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 | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | FluMist, Influenza Virus Vaccine Live | TIV, Trivalent Inactivated Influenza Virus Vaccine | Total |
|---|---|---|---|
| Age, Continuous | 23.1 months STANDARD_DEVIATION 7 | 24.4 months STANDARD_DEVIATION 7 | 23.8 months STANDARD_DEVIATION 7 |
| Age, Customized 12 to < 24 months | 26 participants | 24 participants | 50 participants |
| Age, Customized 24 to < 36 months | 24 participants | 27 participants | 51 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 42 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 16 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 31 Participants | 57 Participants |
| Region of Enrollment United States | 50 participants | 51 participants | 101 participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 28 Participants | 30 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 50 | 31 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 |
Outcome results
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.
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -3 (%) | 0.00 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 1 (%) | 0.21 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -1 (%) | 0.07 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 2 (%) | 0.21 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -2 (%) | 0.02 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 3 (%) | 0.14 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 0 (%) | 0.23 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 4 (%) | 0.09 Units on a scale |
| FluMist, Influenza Virus Vaccine Live | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -4 (%) | 0.02 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 4 (%) | 0.00 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -4 (%) | 0.00 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -3 (%) | 0.00 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -2 (%) | 0.02 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of -1 (%) | 0.29 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 0 (%) | 0.57 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 1 (%) | 0.07 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 2 (%) | 0.05 Units on a scale |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects | Gene signature score of 3 (%) | 0.00 Units on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 9.8 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 4.1 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [1.48, 3.97]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 19.0 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 5.7 Titer |
Comparison: 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).95% CI: [1.54, 7.13]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 4.4 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 10.1 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.24, 0.87]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 4.2 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 2.9 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.8, 2.66]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 7.0 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 4.7 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.8, 2.69]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 12.5 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 11.8 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.56, 1.96]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 16.0 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 33.1 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.27, 0.87]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 37.6 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 11.5 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [1.44, 7.19]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 6.2 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 30.9 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.09, 0.48]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 8.0 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 4.6 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.88, 3.39]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 10.7 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 17.2 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.33, 1.16]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 27.4 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 47.0 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.31, 1.12]
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
Time frame: Post Dose 2 (7 to 10 days post Dose 2)
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU | 45.5 Counts of ASCs per 10^6 PBMCs |
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU/Anti-IgG Total | 0.161 Counts of ASCs per 10^6 PBMCs |
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU | 7.0 Counts of ASCs per 10^6 PBMCs |
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU/Anti-IgA Total | 0.015 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU/Anti-IgA Total | 0.018 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU | 45.0 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU | 7.0 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU/Anti-IgG Total | 0.076 Counts of ASCs per 10^6 PBMCs |
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
Time frame: Post Dose 1 (7 to 10 days post Dose 1)
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU | 6.5 Counts of ASCs per 10^6 PBMCs |
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU/Anti-IgG Total | 0.030 Counts of ASCs per 10^6 PBMCs |
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU | 4.8 Counts of ASCs per 10^6 PBMCs |
| FluMist, Influenza Virus Vaccine Live | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU/Anti-IgA Total | 0.011 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU/Anti-IgA Total | 0.043 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU | 57.0 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgA FLU | 22.0 Counts of ASCs per 10^6 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay | Anti-IgG FLU/Anti-IgG Total | 0.204 Counts of ASCs per 10^6 PBMCs |
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay | 3.6 SPC/2 x 10^5 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay | 3.2 SPC/2 x 10^5 PBMCs |
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | 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 | 3.3 SPC/2 x 10^5 PBMCs |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | 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 | 1.2 SPC/2 x 10^5 PBMCs |
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 21.9 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 8.9 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [1.26, 5.06]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 56.6 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 11.7 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [2.51, 9.22]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 10.7 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 47.5 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.15, 0.35]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 28.0 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 31.5 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.7, 1]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 22.4 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 28.2 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.22, 3.63]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 83.1 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 61.4 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.58, 3.04]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 34.0 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 67.1 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.23, 1.22]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 164.4 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 49.6 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [1.46, 7.54]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 24.5 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 226.2 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.05, 0.22]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 160.0 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 40.0 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [4, 4]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 56.3 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 85.8 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.25, 1.73]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 190.1 Titer |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 433.3 Titer |
Comparison: Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.95% CI: [0.16, 1.07]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 64.7 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 29.0 Percentage of Participants |
Comparison: 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).95% CI: [9.5, 57.1]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | 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 | 75.0 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | 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 | 30.8 Percentage of Participants |
Comparison: 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).95% CI: [12, 67.8]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | 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 | 20.8 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | 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 | 81.5 Percentage of Participants |
Comparison: 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).95% CI: [-79.7, -31.7]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 61.8 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 80.0 Percentage of Participants |
Comparison: 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).95% CI: [-40, 4.9]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 90.0 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 95.0 Percentage of Participants |
Comparison: 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).95% CI: [-27.7, 16]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | 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 | 84.6 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | 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 | 68.4 Percentage of Participants |
Comparison: 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).95% CI: [-17.6, 45.4]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | 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 | 28.6 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | 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 | 89.5 Percentage of Participants |
Comparison: 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).95% CI: [-83.8, -26]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 94.4 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 100 Percentage of Participants |
Comparison: 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).95% CI: [-27.4, 13.3]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 40.9 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 19.0 Percentage of Participants |
Comparison: 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).95% CI: [-6.7, 48.1]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 80.0 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 15.0 Percentage of Participants |
Comparison: 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).95% CI: [34.4, 85.3]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 26.3 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 72.2 Percentage of Participants |
Comparison: 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).95% CI: [-71.7, -11.6]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 63.0 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 100 Percentage of Participants |
Comparison: 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).95% CI: [-57.8, -17.5]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 69.2 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain | 91.7 Percentage of Participants |
Comparison: 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).95% CI: [-54.4, 12.2]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 91.7 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain | 92.3 Percentage of Participants |
Comparison: 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).95% CI: [-30.4, 30.3]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 75.0 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain | 100 Percentage of Participants |
Comparison: 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).95% CI: [-57.2, 4.8]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 91.7 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain | 100 Percentage of Participants |
Comparison: 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).95% CI: [-38.5, 14.5]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | 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 | 25.0 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | 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 | 10.3 Percentage of Participants |
Comparison: 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).95% CI: [-6.5, 38.4]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 47.2 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 35.5 Percentage of Participants |
Comparison: 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).95% CI: [-13, 34.9]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | 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 | 71.4 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | 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 | 33.3 Percentage of Participants |
Comparison: 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).95% CI: [0.9, 65.9]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 78.9 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 94.7 Percentage of Participants |
Comparison: 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).95% CI: [-40.7, 8]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 100 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 66.7 Percentage of Participants |
Comparison: 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).95% CI: [-81.1, 90.6]
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
Time frame: Post Dose 1 (28 to 42 days post Dose 1)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 33.3 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 42.9 Percentage of Participants |
Comparison: 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).95% CI: [-65.2, 58.8]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 100 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain | 100 Percentage of Participants |
Comparison: 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).95% CI: [-97.5, 84.2]
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
Time frame: Post Dose 2 (28 to 35 days post Dose 2)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist, Influenza Virus Vaccine Live | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 80.0 Percentage of Participants |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain | 100 Percentage of Participants |
Comparison: 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).95% CI: [-71.6, 33.9]