Immunologic Response to FluMist vs. Flucelvax
Sponsor
Richard Zimmerman MD (Other)
Overall Status
Completed
CT.gov ID
NCT03982069
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
465
2
2
14.7
232.5
15.9
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-21 years given one of two FDA approved and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or Flucelvax. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 28 (range 21-35 days). The primary objective of the study is to determine pre- and post-serologic responses to each vaccine type.
Study Design
Study Type:
Interventional
Actual Enrollment
:
465 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
Actual Study Start Date
:
Sep 20, 2019
Actual Primary Completion Date
:
Dec 9, 2020
Actual Study Completion Date
:
Dec 9, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: FluMist live attenuated influenza vaccine Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally |
Biological: FluMist live attenuated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
| Active Comparator: Flucelvax inactivated influenza vaccine Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly |
Biological: Flucelvax inactivated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Seroconversion Response In 2019 [Post-vaccination (at Day 28 timepoint)]
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >=10 and a final HI titer of >=40.
- Number of Participants With Seroconversion Response In 2020 [Post-vaccination (at Day 28 timepoint)]
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >=10 and a final HI titer of >=40.
Secondary Outcome Measures
- Number of Participants With Seroprotection Response in 2019 [Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)]
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point.
- Geometric Mean Titers (GMTs) at Each Time Point 2019 [Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)]
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition assay was conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers
- Number of Participants With Seroprotection Response in 2020 [Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)]
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point.
- Geometric Mean Titers (GMTs) at Each Time Point 2020 [Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)]
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
aged 4-21 years;
-
has prior vaccination history available (which can be determined based either on medical record review or through state registry review);
-
plans to receive the current seasonal influenza vaccination at one of the recruiting sites
Exclusion Criteria:
-
unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork;
-
has already received influenza vaccine for the current season;
-
has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids >10 days);
-
is known to be pregnant;
-
has a history of severe allergy to eggs or to influenza vaccine or any of its components
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Academic Pediatrics | Pittsburgh | Pennsylvania | United States | 15213 |
| 2 | University of Pittsburgh Department of Family Medicine | Pittsburgh | Pennsylvania | United States | 15260 |
Sponsors and Collaborators
- Richard Zimmerman MD
- Centers for Disease Control and Prevention
Investigators
- Principal Investigator: Richard K Zimmerman, MD, MPH, MA, University of Pittsburgh, School of Medicine, Dept. Family Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Richard Zimmerman MD,
Professor,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03982069
Other Study ID Numbers:
- STUDY19040242
- 1U01|P001035-01
First Posted:
Jun 11, 2019
Last Update Posted:
Oct 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2019 | Flucelvax Inactivated Influenza Vaccine 2019 | FluMist Live Attenuated Influenza Vaccine 2020 | Flucelvax Inactivated Influenza Vaccine 2020 |
|---|---|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. |
| Period Title: Overall Study | ||||
| STARTED | 108 | 110 | 127 | 120 |
| COMPLETED | 98 | 100 | 118 | 112 |
| NOT COMPLETED | 10 | 10 | 9 | 8 |
Baseline Characteristics
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2019 | Flucelvax Inactivated Influenza Vaccine 2019 | FluMist Live Attenuated Influenza Vaccine 2020 | Flucelvax Inactivated Influenza Vaccine 2020 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | Total of all reporting groups |
| Overall Participants | 108 | 110 | 127 | 120 | 465 |
| Age (Count of Participants) | |||||
| <=18 years |
47
43.5%
|
56
50.9%
|
76
59.8%
|
74
61.7%
|
253
54.4%
|
| Between 18 and 65 years |
61
56.5%
|
54
49.1%
|
51
40.2%
|
46
38.3%
|
212
45.6%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
16.8
(4.6)
|
16.6
(4.2)
|
15.6
(5.0)
|
15.1
(5.2)
|
16.0
(4.8)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
67
62%
|
71
64.5%
|
57
44.9%
|
59
49.2%
|
254
54.6%
|
| Male |
41
38%
|
39
35.5%
|
70
55.1%
|
61
50.8%
|
211
45.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
7
6.5%
|
6
5.5%
|
6
4.7%
|
4
3.3%
|
23
4.9%
|
| Not Hispanic or Latino |
99
91.7%
|
104
94.5%
|
120
94.5%
|
116
96.7%
|
439
94.4%
|
| Unknown or Not Reported |
2
1.9%
|
0
0%
|
1
0.8%
|
0
0%
|
3
0.6%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
0.8%
|
0
0%
|
1
0.2%
|
| Asian |
6
5.6%
|
7
6.4%
|
4
3.1%
|
5
4.2%
|
22
4.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
43
39.8%
|
41
37.3%
|
33
26%
|
21
17.5%
|
138
29.7%
|
| White |
45
41.7%
|
51
46.4%
|
79
62.2%
|
84
70%
|
259
55.7%
|
| More than one race |
10
9.3%
|
9
8.2%
|
6
4.7%
|
9
7.5%
|
34
7.3%
|
| Unknown or Not Reported |
4
3.7%
|
2
1.8%
|
4
3.1%
|
1
0.8%
|
11
2.4%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
108
100%
|
110
100%
|
127
100%
|
120
100%
|
465
100%
|
Outcome Measures
| Title | Number of Participants With Seroconversion Response In 2019 |
|---|---|
| Description | Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >=10 and a final HI titer of >=40. |
| Time Frame | Post-vaccination (at Day 28 timepoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2019 Participants |
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2019 | Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. |
| Measure Participants | 98 | 100 |
| A/H1N1-A/Brisbane |
5
4.6%
|
33
30%
|
| A/H3N2-A/Kansas egg grown virus |
11
10.2%
|
44
40%
|
| A/H3N2-A/Kansas cell grown virus |
8
7.4%
|
47
42.7%
|
| B/Victoria-B/Colorado |
9
8.3%
|
28
25.5%
|
| B/Yamagata-B/Phuket |
4
3.7%
|
29
26.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | All listed antigens | |
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants With Seroconversion Response In 2020 |
|---|---|
| Description | Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >=10 and a final HI titer of >=40. |
| Time Frame | Post-vaccination (at Day 28 timepoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2020 Participants |
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2020 | Flucelvax Inactivated Influenza Vaccine 2020 |
|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. |
| Measure Participants | 118 | 112 |
| A/H1N1-A/Hawaii66 egg based antigen |
8
7.4%
|
59
53.6%
|
| A/H1N1-A/Hawaii70 cell based antigen |
10
9.3%
|
58
52.7%
|
| A/H1N1-A/Delaware |
2
1.9%
|
38
34.5%
|
| A/H3N2-A/Hong Kong |
14
13%
|
48
43.6%
|
| B/Victoria-B/Washington |
13
12%
|
36
32.7%
|
| B/Yamagata-B/Phuket |
11
10.2%
|
32
29.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | All listed antigens | |
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants With Seroprotection Response in 2019 |
|---|---|
| Description | Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point. |
| Time Frame | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2019 Participants |
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2019 | Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. |
| Measure Participants | 98 | 100 |
| A/H1N1-A/Birsbane:Day 0 |
54
50%
|
61
55.5%
|
| A/H1N1-A/Birsbane:Day 28 |
58
53.7%
|
93
84.5%
|
| A/H3N2-AKansas egg grown virus: Day 0 |
34
31.5%
|
41
37.3%
|
| A/H3N2-AKansas egg grown virus: Day 28 |
41
38%
|
77
70%
|
| A/H3N2-AKansas cell grown virus: Day 0 |
14
13%
|
24
21.8%
|
| A/H3N2-AKansas cell grown virus: Day 28 |
26
24.1%
|
65
59.1%
|
| B/Victoria-B/Colorado: Day 0 |
34
31.5%
|
34
30.9%
|
| B/Victoria-B/Colorado: Day 28 |
36
33.3%
|
71
64.5%
|
| B/Yamagata-B/Phuket: Day 0 |
57
52.8%
|
51
46.4%
|
| B/Yamagata-B/Phuket: Day 28 |
57
52.8%
|
84
76.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Day 28 for all listed antigens | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | Day 0, A/H1N1-A/Brisbane | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.36 |
| Comments | Day 0 A/H1N1-A/Kansas egg grown virus | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.08 |
| Comments | Day 0 A/H1N1-A/Kansas cell grown virus | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.91 |
| Comments | Day 0 B/Victoria-B/Colorado | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.31 |
| Comments | Day 0 B/Yamagata-B/Phuket | |
| Method | Chi-squared | |
| Comments | ||
| Title | Geometric Mean Titers (GMTs) at Each Time Point 2019 |
|---|---|
| Description | Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition assay was conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers |
| Time Frame | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2019 Participants |
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2019 | Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. |
| Measure Participants | 98 | 100 |
| A/H1N1-A/Brisbane: Day 0 |
94
|
90
|
| A/H1N1-A/Brisbane: Day 28 |
108
|
269
|
| A/H3N2-A/Kansas egg grown virus: Day 0 |
75
|
78
|
| A/H3N2-A/Kansas egg grown virus: Day 28 |
96
|
205
|
| A/H3N2-A/Kansas cell grown virus: Day 0 |
50
|
46
|
| A/H3N2-A/Kansas cell grown virus: Day 28 |
63
|
136
|
| B/Victoria-B/Colorado: Day 0 |
65
|
65
|
| B/Victoria-B/Colorado: Day 28 |
78
|
158
|
| B/Yamagata-B/Phuket: Day 0 |
101
|
89
|
| B/Yamagata-B/Phuket: Day 28 |
107
|
215
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | Day 0 A/H1N1-A/Brisbane | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | Day 0 A/H3N2-A/Kansas egg grown virus | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.56 |
| Comments | Day 0 A/H3N2-A/Kansas cell grown virus | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.95 |
| Comments | Day 0 B/Victoria-B/Colorado | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.44 |
| Comments | Day 0 B/Yamagata-B/Phuket | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Day 28 for all listed variables | |
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Number of Participants With Seroprotection Response in 2020 |
|---|---|
| Description | Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point. |
| Time Frame | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2020 Participants |
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2020 | Flucelvax Inactivated Influenza Vaccine 2020 |
|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. |
| Measure Participants | 118 | 112 |
| A/H1N1-A/Hawaii66 egg: Day 0 |
25
23.1%
|
25
22.7%
|
| A/H1N1-A/Hawaii66 egg: Day 28 |
33
30.6%
|
79
71.8%
|
| A/H1N1-A/Hawaii70 cell grown virus: Day 0 |
59
54.6%
|
54
49.1%
|
| A/H1N1-A/Hawaii70 cell grown virus: Day 28 |
65
60.2%
|
102
92.7%
|
| A/H1N1-A/Delaware: Day 0 |
37
34.3%
|
32
29.1%
|
| A/H1N1-A/Delaware: Day 28 |
43
39.8%
|
65
59.1%
|
| A/H3N2-A/Hong Kong: Day 0 |
90
83.3%
|
73
66.4%
|
| A/H3N2-A/Hong Kong: Day 28 |
102
94.4%
|
99
90%
|
| B/Victoria-B/Washington: Day 0 |
62
57.4%
|
59
53.6%
|
| B/Victoria-B/Washington: Day 28 |
71
65.7%
|
86
78.2%
|
| B/Yamagata-B/Phuket: Day 0 |
66
61.1%
|
54
49.1%
|
| B/Yamagata-B/Phuket: Day 28 |
64
59.3%
|
92
83.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Day 0: A/H1N1-A/Hawaii66-egg based antigen | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Day 0: A/H1N1-A/Hawaii70-cell based antigen | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Day 0: A/H1N1-A/Delaware | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Day 0: A/H3N2-A/Hong Kong | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Day 0: B/Victoria-B/Washington | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Day 0: B/Yamagata-B/Phuket | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Day 28: A/H1N1-A/Hawaii66-egg based antigen, A/H1N1-A/Hawaii70-cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.66 |
| Comments | ||
| Method | Chi-squared | |
| Comments | A/H3N2-A/Hong Kong | |
| Title | Geometric Mean Titers (GMTs) at Each Time Point 2020 |
|---|---|
| Description | Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers |
| Time Frame | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2020 Participants |
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine 2020 | Flucelvax Inactivated Influenza Vaccine 2020 |
|---|---|---|
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. |
| Measure Participants | 118 | 112 |
| A/H1N1-A/Hawaii66 egg grown virus: Day 0 |
42
|
34
|
| A/H1N1-A/Hawaii66 egg grown virus: Day 28 |
51
|
171
|
| A/H1N1-A/Hawaii70 cell grown virus: Day 0 |
97
|
84
|
| A/H1N1-A/Hawaii70 cell grown virus: Day 28 |
121
|
380
|
| A/H1N1-A/Delaware: Day 0 |
58
|
46
|
| A/H1N1-A/Delaware: Day 28 |
62
|
120
|
| A/H3N2-A/Hong Kong: Day 0 |
174
|
119
|
| A/H3N2-A/Hong Kong: Day 28 |
234
|
370
|
| B/Victoria-B/Washington: Day 0 |
92
|
88
|
| B/Victoria-B/Washington: Day 28 |
116
|
212
|
| B/Yamagata-B/Phuket: Day 0 |
98
|
87
|
| B/Yamagata-B/Phuket: Day 28 |
114
|
214
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | Day 0: A/H1N1-A/Hawaii66 egg based antigen | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | Day 0: A/H1N1-A/Hawaii70 cell based antigen | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | Day 0: A/H1N1-A/Delaware | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | Day 0: A/H3N2-A/Hong Kong | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | Day 0: B/Victoria-B/Washington | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.36 |
| Comments | Day 0: B/Yamagata-B/Phuket | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Day 28: A/H1N1-A/Hawaii66 egg based antigen, A/H1N1-A/Hawaii70 cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | FluMist Live Attenuated Influenza Vaccine 2019, Flucelvax Inactivated Influenza Vaccine 2019 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | Day 28: A/H3N2-A/Hong Kong | |
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | 5 weeks in relation to baseline | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | FluMist Live Attenuated Influenza Vaccine | Flucelvax Inactivated Influenza Vaccine | ||
| Arm/Group Description | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | ||
All Cause Mortality |
||||
| FluMist Live Attenuated Influenza Vaccine | Flucelvax Inactivated Influenza Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/235 (0%) | 0/230 (0%) | ||
Serious Adverse Events |
||||
| FluMist Live Attenuated Influenza Vaccine | Flucelvax Inactivated Influenza Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/235 (0%) | 0/230 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| FluMist Live Attenuated Influenza Vaccine | Flucelvax Inactivated Influenza Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/235 (0%) | 0/230 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Katherine Williams |
|---|---|
| Organization | University of Pittsburgh |
| Phone | 412-383-1979 |
| kvw3@pitt.edu |
Responsible Party:
Richard Zimmerman MD,
Professor,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03982069
Other Study ID Numbers:
- STUDY19040242
- 1U01|P001035-01
First Posted:
Jun 11, 2019
Last Update Posted:
Oct 14, 2021
Last Verified:
Sep 1, 2021