Influenza
Conditions
Brief summary
This randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20 will receive IIV.
Detailed description
This Phase IV, randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed inactivated influenza vaccine (IIV) (2010-2011 season appropriate) or licensed live attenuated influenza vaccine (LAIV) (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive IIV, and 20 will receive LAIV. Subjects will receive 1 dose of IIV or LAIV in the Center for Vaccine Development on Day 0 and will return to the site on days 7 and 45 to assess immunogenicity. Subjects will be asked to report any serious adverse events. Blood samples and nasal washes for assessment of immune responses will be obtained at three time points: on Day 0 prior to dosing with IIV or LAIV, and at visits conducted 7 and 45-51 days post vaccination. The study will be conducted just prior to and during the influenza season. Subjects will receive a single dose of IIV or LAIV administered as instructed per package insert. Two contacts will be made with subjects, either telephone calls or e-mail, to collect serious adverse events only, one at Days 28-35, and one at approximately Days 180-190 to conclude the subject's participation. The duration of each subject's participation is approximately 6 months. The primary immune studies conducted with collected samples will include serum hemagglutinin inhibition (HAI) antibody titers, nasal wash influenza-specific secretory immunoglobulin A (IgA) responses, peripheral blood interferon gamma (IFN-γ) ELISPOT assays and peripheral blood carboxyfluorescein succinimidyl ester (CFSE) dilution/intracellular cytokine staining flow cytometric assays. In addition, frozen serum and peripheral blood mononuclear cells (PBMC) samples will be used in exploratory assays to determine the kinetics and nature of innate responses and the detailed molecular signatures of memory T cells induced by IIV and LAIV vaccinations. Investigators will be performing genome-wide expression studies, but will not perform DNA sequencing and will not send anything other than coded samples outside of Saint Louis University.
Interventions
BIOLOGICALInactivated Influenza Vaccine
BIOLOGICALLive Attenuated Influenza Vaccine
Sponsors
MedImmune LLC
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects will be randomized to one of two different groups to receive either licensed inactivated influenza vaccine (IIV) or licensed live attenuated influenza vaccine (LAIV) from the 2010-2011 season.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female age 18 to 49 years, inclusive, on the day of randomization (reached his or her 18th year birthday but not yet reached his or her 50th year birthday) at the time of the dose of study product * Written informed consent and a locally required authorization (eg, HIPAA in the USA, ) obtained from the subject prior to performing any protocol-related procedures. * Females of child-bearing potential, (ie, unless surgically sterile \[eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\], has sterile male partner, is at least 1 year post-menopausal, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of study product, and must agree to continue using such precautions for 60 days after the dose of vaccine due to a potential dose of live vaccine product. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 0 do not occur on the same day, a negative urine pregnancy test on the day of vaccination prior to randomization. Investigator judgment is required to assess a female subject's capability of pregnancy. * Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant by physician investigator, and targeted physical examination based on medical history. * Able to complete follow-up period of 180 days post dose of vaccine as required by the protocol * Subject available by telephone * Able to understand and comply with the requirements of the protocol, as judged by the investigator
Exclusion criteria
Any of the following would exclude the subject from participation in the study: * Have an acute illness, including an oral temperature ≥ 100.4°F, within 3 days prior to vaccination. * Participated in an investigational influenza vaccine study or had a known infection with flu since 2007 (confirmed by laboratory culture, including subtype of the influenza A virus (H1N1) investigational vaccines or illness). * Previous vaccination against influenza in 2007, 2008, 2009 or 2010 with seasonal trivalent live or inactivated influenza vaccine (including H1N1 vaccines). * Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids are permitted) including corticosteroids (≥ 20 mg/day of prednisone equivalent given daily or on alternate days for ≥ 14 days) within a 30 day window around dose of study vaccine product Note: topical corticosteroids for uncomplicated dermatitis may be used throughout the study according to the judgment of the investigator; topical calcineurin inhibitors may be used in accordance with their package insert at entry and during study participation. * Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation * Received an experimental agent within 1 month prior to vaccination in this study or expect to receive an experimental agent during the active study period (prior to Day 60 after vaccination (Experimental agent includes: vaccine, biologic, device, or medication). * Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 60 days following the vaccination. * Any known immunosuppressive condition or immune deficiency disease including known cancer illness or organ transplant * Have known active HIV, Hepatitis B or Hepatitis C infection. * Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, gentamycin and chicken protein) or severe reactions to previous influenza vaccinations. * History of Guillain-Barré syndrome * Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir and zanamivir) within 30 days prior to dose of study vaccine products or anticipated use within 30 days after vaccination * Breastfeeding woman * History of alcohol or drug abuse that, in the opinion of the investigator, would affect the subject's safety or compliance with study * Previous medical history, evidence of an intercurrent illness or any condition that, in the opinion of the investigator, would interfere with evaluation of the study vaccine products or interpretation of subject safety or that may compromise the safety of the subject in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Antibody Responses | Day 0, Day 7, and Day 45 | Geometric mean hemagglutination inhibition titers to three different influenza viruses |
| T-cell Responses | Day 0, Day 7, and Day 45 | Number of Interferon gamma ELISPOT spot forming cells (SFC) per million Peripheral Blood Mononuclear Cells (PBMCs) were calculated. |
| Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Day 0, Day 7, and Day 45 | Mean absolute numbers of CD4(+), Carboxyfluorescein succinimidyl ester \[CFSE(low)\] IFN-gamma(+), and T cells after activation with a specific antigen measured by flow cytometry |
| Secretory Immunoglobulin A (IgA) Responses | Day 0 and Day 45 | Influenza virus strain-specific nasal wash secretory immunoglobulin A (IgA) titers by ELISA was measured |
| Hemagglutinin Immunoglobulin A (IgA) Responses | Day 7 | Hemagglutinin (HA) specific nasal wash secretory immunoglobulin A (IgA) of serum reactivity with HA bound to ELISA plates. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inactivated Influenza Vaccine (IIV) Eighteen subjects received one dose 0.5 mL of Inactivated Influenza Vaccine intramuscularly on Day 0. | 19 |
| Live Attenuated Influenza Vaccine (IIV) Eighteen subjects received one dose 0.5 mL Live Attenuated Influenza Vaccine intranasally on Day 0. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missed Visit 02 and/or Visit 03 | 1 | 1 |
Baseline characteristics
| Characteristic | Inactivated Influenza Vaccine (IIV) | Live Attenuated Influenza Vaccine (IIV) | Total |
|---|---|---|---|
| Age | 33.5 years STANDARD_DEVIATION 10.8 | 30.4 years STANDARD_DEVIATION 9.8 | 31.2 years STANDARD_DEVIATION 10.3 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 19 Participants | 36 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 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 | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 1 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Mean absolute numbers of CD4(+), Carboxyfluorescein succinimidyl ester \[CFSE(low)\] IFN-gamma(+), and T cells after activation with a specific antigen measured by flow cytometry
Time frame: Day 0, Day 7, and Day 45
Population: For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.~For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Medium Day 7 | 1075.24 T Cells | Standard Error 711.71 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Live H3N2 Day 45 | 21320.85 T Cells | Standard Error 6054.77 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Live H3N2 Day 0 | 15939.07 T Cells | Standard Error 5984.03 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | FluMist Day 0 | 14009.94 T Cells | Standard Error 6259.1 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Medium Day 45 | 338.86 T Cells | Standard Error 224.16 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Flu Mist Day 7 | 26999.98 T Cells | Standard Error 9510.82 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Live H3N2 Day 7 | 32527.86 T Cells | Standard Error 11165.21 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Flu Mist Day 45 | 21704.19 T Cells | Standard Error 6455.24 |
| Inactivated Influenza Vaccine (IIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Medium Day 0 | 92.79 T Cells | Standard Error 38.19 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Flu Mist Day 45 | 14618.15 T Cells | Standard Error 4314.62 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Medium Day 0 | 83.80 T Cells | Standard Error 20.6 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Medium Day 7 | 65.45 T Cells | Standard Error 18.04 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Medium Day 45 | 144.58 T Cells | Standard Error 64.94 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Live H3N2 Day 0 | 22958.77 T Cells | Standard Error 8371.46 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Live H3N2 Day 7 | 28557.23 T Cells | Standard Error 8835.01 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Live H3N2 Day 45 | 15654.57 T Cells | Standard Error 4626.64 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | FluMist Day 0 | 12552.22 T Cells | Standard Error 3718.47 |
| Live Attenuated Influenza Vaccine (LAIV) | Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation | Flu Mist Day 7 | 24265.06 T Cells | Standard Error 5147.71 |
Comparison: Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.95Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.17Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.06Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.14Wilcoxon (Mann-Whitney)
Comparison: Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.09Wilcoxon (Mann-Whitney)
Comparison: Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.08Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.84Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.27Wilcoxon (Mann-Whitney)
Comparison: Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.46Wilcoxon (Mann-Whitney)
Comparison: Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7p-value: 0.006Wilcoxon (Mann-Whitney)
Comparison: Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45p-value: 0.41Wilcoxon (Mann-Whitney)
Primary
Hemagglutinin Immunoglobulin A (IgA) Responses
Hemagglutinin (HA) specific nasal wash secretory immunoglobulin A (IgA) of serum reactivity with HA bound to ELISA plates.
Time frame: Day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inactivated Influenza Vaccine (IIV) | Hemagglutinin Immunoglobulin A (IgA) Responses | IgA anti-H1N1 HA Day 7 | 2.32 Fold change | Standard Error 0.4 |
| Inactivated Influenza Vaccine (IIV) | Hemagglutinin Immunoglobulin A (IgA) Responses | IgA anti-H3N2 Day 7 | 1.77 Fold change | Standard Error 0.24 |
| Inactivated Influenza Vaccine (IIV) | Hemagglutinin Immunoglobulin A (IgA) Responses | IgA anti-Influenza B Day 7 | 1.94 Fold change | Standard Error 0.58 |
| Live Attenuated Influenza Vaccine (LAIV) | Hemagglutinin Immunoglobulin A (IgA) Responses | IgA anti-H1N1 HA Day 7 | 8.42 Fold change | Standard Error 3.51 |
| Live Attenuated Influenza Vaccine (LAIV) | Hemagglutinin Immunoglobulin A (IgA) Responses | IgA anti-H3N2 Day 7 | 9.42 Fold change | Standard Error 4.98 |
| Live Attenuated Influenza Vaccine (LAIV) | Hemagglutinin Immunoglobulin A (IgA) Responses | IgA anti-Influenza B Day 7 | 9.55 Fold change | Standard Error 4.52 |
Comparison: Fold increase IgA anti-H1N1 HA, Day 7p-value: 0.02Fisher Exact
Comparison: Fold increase IgA anti-H3N2, Day 7p-value: 0.67Fisher Exact
Comparison: Fold increase IgA anti-influenza B HA, Day 7p-value: 0.3Fisher Exact
Primary
Secretory Immunoglobulin A (IgA) Responses
Influenza virus strain-specific nasal wash secretory immunoglobulin A (IgA) titers by ELISA was measured
Time frame: Day 0 and Day 45
Population: For IIV group, 18 subjects completed Visit 03. For LAIV group, 18 subjects completed Visit 03.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Inactivated Influenza Vaccine (IIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H1N1 Day 45 | 20.75 Titers |
| Inactivated Influenza Vaccine (IIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H3N2 Day 45 | 31.5 Titers |
| Inactivated Influenza Vaccine (IIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H1N1 Day 0 | 18 Titers |
| Inactivated Influenza Vaccine (IIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza B Day 0 | 16 Titers |
| Inactivated Influenza Vaccine (IIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H3N2 Day 0 | 26.5 Titers |
| Inactivated Influenza Vaccine (IIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza B Day 45 | 16.5 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H3N2 Day 0 | 32.25 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H1N1 Day 0 | 16.25 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H1N1 Day 45 | 28.5 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza B Day 45 | 16.75 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza A/H3N2 Day 45 | 57.25 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Secretory Immunoglobulin A (IgA) Responses | Influenza B Day 0 | 9.75 Titers |
Comparison: Influenza A/H1N1 HA, Day 0 and Day 45p-value: 0.72Wilcoxon (Mann-Whitney)
Comparison: Influenza A/H3N2 HA, Day 0 and 45p-value: 0.06Wilcoxon (Mann-Whitney)
Comparison: Influenza B HA, Day 0 and Day 45p-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: Influenza A/H1N1 HA, Day 0 and Day 45p-value: 0.05Wilcoxon (Mann-Whitney)
Comparison: Influenza A/H3N2 HA, Day 0 and Day 45p-value: 0.0004Wilcoxon (Mann-Whitney)
Comparison: Influenza B HA, Day 0 and Day 45p-value: 0.02Wilcoxon (Mann-Whitney)
Primary
Serum Antibody Responses
Geometric mean hemagglutination inhibition titers to three different influenza viruses
Time frame: Day 0, Day 7, and Day 45
Population: For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.~For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | A/H1N1 Day 7 | 47.03 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | A/H3N2 Day 45 | 32.00 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | Influenza A virus subtype H3N2 (A/H3N2) Day 0 | 6.35 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | Influenza B Day 0 | 7.41 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | A/H1N1 Day 45 | 101.59 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | Influenza B Day 7 | 21.77 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | A/H3N2 Day 7 | 17.96 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | Influenza B Day 45 | 40.32 Titers |
| Inactivated Influenza Vaccine (IIV) | Serum Antibody Responses | Influenza A virus subtype H1N1 (A/H1N1) Day 0 | 11.76 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | Influenza B Day 45 | 12.70 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | Influenza A virus subtype H1N1 (A/H1N1) Day 0 | 11.11 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | A/H1N1 Day 7 | 9.33 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | A/H1N1 Day 45 | 12.70 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | Influenza A virus subtype H3N2 (A/H3N2) Day 0 | 7.44 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | A/H3N2 Day 7 | 7.13 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | A/H3N2 Day 45 | 9.70 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | Influenza B Day 0 | 10.71 Titers |
| Live Attenuated Influenza Vaccine (LAIV) | Serum Antibody Responses | Influenza B Day 7 | 11.31 Titers |
Comparison: A/H1N1 Day 0p-value: 0.89t-test, 2 sided
Comparison: A/H1N1 Day 7p-value: 0.00082t-test, 2 sided
Comparison: A/H1N1 Day 45p-value: 0.000076t-test, 2 sided
Comparison: A/H3N2 Day 0p-value: 0.63t-test, 2 sided
Comparison: A/H3N2 Day 7p-value: 0.0186t-test, 2 sided
Comparison: A/H3N2 Day 45p-value: 0.0052t-test, 2 sided
Comparison: Influenza B Day 0p-value: 0.25t-test, 2 sided
Comparison: Influenza B Day 7p-value: 0.061t-test, 2 sided
Comparison: Influenza B Day 45p-value: 0.0025t-test, 2 sided
Primary
T-cell Responses
Number of Interferon gamma ELISPOT spot forming cells (SFC) per million Peripheral Blood Mononuclear Cells (PBMCs) were calculated.
Time frame: Day 0, Day 7, and Day 45
Population: For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.~For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Medium Alone Day 0 | 1.53 Cells/Million PBMC | Standard Error 0.51 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Peptide Pool 1 + Peptide Pool 2 Day 45 | 69.94 Cells/Million PBMC | Standard Error 19.03 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Live H3N2 Day 7 | 256.79 Cells/Million PBMC | Standard Error 60.12 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Medium Alone Day 45 | 1.11 Cells/Million PBMC | Standard Error 0.31 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Live H3N2 Day 45 | 180.99 Cells/Million PBMC | Standard Error 35.49 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Live H3N2 Day 0 | 157.90 Cells/Million PBMC | Standard Error 29.93 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | FluMist Day 0 | 39.26 Cells/Million PBMC | Standard Error 12.61 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Peptide Pool 1 + Peptide Pool 2 Day 0 | 75.55 Cells/Million PBMC | Standard Error 23.12 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | FluMist Day 7 | 90.25 Cells/Million PBMC | Standard Error 24.83 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Medium Alone Day 7 | 6.17 Cells/Million PBMC | Standard Error 4.21 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Flu Mist Day 45 | 70.00 Cells/Million PBMC | Standard Error 21.07 |
| Inactivated Influenza Vaccine (IIV) | T-cell Responses | Peptide Pool 1 + Peptide Pool 2 Day 7 | 88.76 Cells/Million PBMC | Standard Error 26.98 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Flu Mist Day 45 | 49.48 Cells/Million PBMC | Standard Error 13.68 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Live H3N2 Day 0 | 126.20 Cells/Million PBMC | Standard Error 28.71 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Medium Alone Day 0 | 2.51 Cells/Million PBMC | Standard Error 1.05 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Medium Alone Day 7 | 1.05 Cells/Million PBMC | Standard Error 0.29 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Medium Alone Day 45 | 2.35 Cells/Million PBMC | Standard Error 0.9 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Peptide Pool 1 + Peptide Pool 2 Day 0 | 61.52 Cells/Million PBMC | Standard Error 17.09 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Peptide Pool 1 + Peptide Pool 2 Day 7 | 81.11 Cells/Million PBMC | Standard Error 14.55 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Live H3N2 Day 7 | 254.26 Cells/Million PBMC | Standard Error 49.36 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Live H3N2 Day 45 | 146.99 Cells/Million PBMC | Standard Error 19.72 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | FluMist Day 0 | 43.16 Cells/Million PBMC | Standard Error 12.46 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | FluMist Day 7 | 104.81 Cells/Million PBMC | Standard Error 43.29 |
| Live Attenuated Influenza Vaccine (LAIV) | T-cell Responses | Peptide Pool 1 + Peptide Pool 2 Day 45 | 65.55 Cells/Million PBMC | Standard Error 15.14 |
Comparison: Peptide Pool 1 and 2, Day 0 and Day 7p-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 and 2, Day 0 and Day 45p-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: Live H3N2, Day 0 and Day 7p-value: 0.06Wilcoxon (Mann-Whitney)
Comparison: Live H3N2, Day 0 and Day 45p-value: 0.56Wilcoxon (Mann-Whitney)
Comparison: Flumist, Day 0 and Day 7p-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: Flumist, Day 0 and Day 45p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 and 2, Day 0 and Day 7p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Peptide Pool 1 and 2, Day 0 and Day 45p-value: 0.94Wilcoxon (Mann-Whitney)
Comparison: Live H3N2, Day 0 and Day 7p-value: 0.002Wilcoxon (Mann-Whitney)
Comparison: Live H3N2, Day 0 and Day 45p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: Flumist, Day 0 and Day 7p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Flumist, Day 0 and Day 45p-value: 0.98Wilcoxon (Mann-Whitney)