Trial Outcomes & Findings for Age and Response to Flu Vaccines (NCT NCT03328325)
NCT ID: NCT03328325
Last Updated: 2021-05-24
Results Overview
A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
152 participants
Primary outcome timeframe
Through Day 28
Results posted on
2021-05-24
Participant Flow
Healthy adults and children ages 9 and over
Participant milestones
| Measure |
Arm 1
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Overall Study
STARTED
|
152
|
|
Overall Study
COMPLETED
|
141
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Arm 1
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Early Study Termination due to COVID-19 pandemic
|
3
|
Baseline Characteristics
Age and Response to Flu Vaccines
Baseline characteristics by cohort
| Measure |
Arm 1
n=152 Participants
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
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Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through Day 28A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018
Outcome measures
| Measure |
Arm 1
n=18 Participants
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
|
528 titer
Geometric Coefficient of Variation 1.38
|
PRIMARY outcome
Timeframe: Day 28A/Hong Kong/4801/2014 (H3N2) Day 28 MN Season 2017-2018
Outcome measures
| Measure |
Arm 1
n=18 Participants
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Magnitude of the Serum Antibody Response by Microneutralization (MN)
|
806 titer
Geometric Coefficient of Variation 1.21
|
PRIMARY outcome
Timeframe: Day 90A/Hong Kong/4801/2014 (H3N2) Day 90 Season 2017-2018
Outcome measures
| Measure |
Arm 1
n=17 Participants
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Serum Antibody Response by Hemagglutination-inhibition (HAI)
|
115 titer
Geometric Coefficient of Variation 3.08
|
PRIMARY outcome
Timeframe: Day 90A/Hong Kong/4801/2014 (H3N2) Day 90 MN Season 2017-2018
Outcome measures
| Measure |
Arm 1
n=17 Participants
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Serum Antibody Response by Microneutralization (MN)
|
1389 titer
Geometric Coefficient of Variation 1.08
|
PRIMARY outcome
Timeframe: Day 28A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-2018
Outcome measures
| Measure |
Arm 1
n=18 Participants
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Specificity of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
|
665 titer
Geometric Coefficient of Variation 1.73
|
PRIMARY outcome
Timeframe: Day 28A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-18
Outcome measures
| Measure |
Arm 1
n=18 Participants
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Specificity of the Serum Antibody Response by Microneutralization (MN)
|
2281 titer
Geometric Coefficient of Variation 2.86
|
SECONDARY outcome
Timeframe: BaselineComparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineComparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineComparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Outcome measures
Outcome data not reported
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=152 participants at risk
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Mass, S/P Wedge resection, GIST Sarcoma
|
0.66%
1/152 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Arm 1
n=152 participants at risk
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
|
|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.8%
24/152 • Number of events 26 • 6 months
|
Additional Information
Angela Branche, MD, Site Principal Investigator
University of Rochester
Phone: 585-275-5871
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place