A Phase 2 Study to Evaluate Immune Responses of FluMist®

NCT00461981 | Completed Phase 2 Results DMC

• 1 other identifier: MI-CP128
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 19

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.

Conditions

Influenza Vaccine

Keywords

Live, attenuated influenza virus vaccine (LAIV); Trivalent inactivated influenza virus vaccine (TIV); FluMist

Outcome Measures

Primary Outcomes (53)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post Dose 1)

• 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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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

  Post Dose 1 (7 to 10 days post Dose 1)

• 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

  Post Dose 2 (7 to 10 days post Dose 2)

• 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

  Post Dose 1 (28 to 42 days post 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

  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

  Post Dose 2 (28 to 35 days post Dose 2)

• 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.

  Post Dose 1 (28 to 42 days post Dose 1)

Study Arms (2)

FluMist, Influenza Virus Vaccine Live

EXPERIMENTAL

FluMist, Influenza Virus Vaccine Live, Intranasal

Biological: FluMist, Influenza Virus Vaccine Live

TIV, Trivalent Inactivated Influenza Virus Vaccine

ACTIVE COMPARATOR

TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular

Biological: TIV, Trivalent Inactivated Influenza Virus Vaccine

Interventions

TIV, Trivalent Inactivated Influenza Virus Vaccine BIOLOGICAL

0.25 mL will be administered intramuscularly for each of two doses

TIV, Trivalent Inactivated Influenza Virus Vaccine

FluMist, Influenza Virus Vaccine Live BIOLOGICAL

0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses

FluMist, Influenza Virus Vaccine Live

Eligibility Criteria

• Age: 12 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (19)

Harvey Pediatrics

Jonesboro, Arkansas, 73401, United States

Location

Arkansas Pediatric Clinic

Little Rock, Arkansas, 72205, United States

Location

NuLife Clinical Research

Anaheim, California, 92805, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Peak Medical Research, LLC

Owensboro, Kentucky, 42303, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Henderson Pediatrics

Henderson, Nevada, 89015, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Northeast Cincinnati Pediatric Asso., Inc.

Mason, Ohio, 45040, United States

Location

Celia Reyes-Acuna, M.D.

Corpus Christi, Texas, 78414, United States

Location

Allergy Immunology Research Center of North Texas

Dallas, Texas, 75230, United States

Location

Healthcare Discoveries, Inc.

San Antonio, Texas, 78209, United States

Location

Wee Care Pediatrics

Layton, Utah, 84041, United States

Location

Bear Care Pediatrics

Ogden, Utah, 84405, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

Pediatrics at the Beach

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Christopher Ambrose, MD
• Organization: MedImmune, LLC

ambrosec@medimmune.com

301-398-0000

Study Officials

• Maria Allende, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2008
• Last Updated: October 6, 2021
• Results First Posted: February 2, 2010

Record last verified: 2010-01

Locations

US (19)