Trial Outcomes & Findings for Immunologic Response to Influenza Vaccination in Children and Adolescents (NCT NCT03614975)
NCT ID: NCT03614975
Last Updated: 2020-01-18
Results Overview
Hemagglutination inhibition (HI) assay will be 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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
166 participants
Primary outcome timeframe
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
Flucelvax Inactivated Influenza Vaccine
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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
Fluzone Inactivated Influenza Vaccine
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
81
|
|
Overall Study
COMPLETED
|
75
|
73
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Flucelvax Inactivated Influenza Vaccine
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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
Fluzone Inactivated Influenza Vaccine
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
|---|---|---|
|
Overall Study
Physician Decision
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Specimens not in lab batch shipment
|
1
|
1
|
Baseline Characteristics
Only subjects who completed the study to day 21 were included in this analysis
Baseline characteristics by cohort
| Measure |
Flucelvax Inactivated Influenza Vaccine
n=85 Participants
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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
Fluzone Inactivated Influenza Vaccine
n=81 Participants
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.03 years
n=75 Participants • Only subjects who completed the study to day 21 were included in this analysis
|
14.21 years
n=73 Participants • Only subjects who completed the study to day 21 were included in this analysis
|
14.07 years
n=148 Participants • Only subjects who completed the study to day 21 were included in this analysis
|
|
Sex: Female, Male
Female
|
39 Participants
n=75 Participants • Only participants who completed the study through day 21 were included in this analysis
|
40 Participants
n=73 Participants • Only participants who completed the study through day 21 were included in this analysis
|
79 Participants
n=148 Participants • Only participants who completed the study through day 21 were included in this analysis
|
|
Sex: Female, Male
Male
|
36 Participants
n=75 Participants • Only participants who completed the study through day 21 were included in this analysis
|
33 Participants
n=73 Participants • Only participants who completed the study through day 21 were included in this analysis
|
69 Participants
n=148 Participants • Only participants who completed the study through day 21 were included in this analysis
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=75 Participants • Only data on participants who completed day 21 of the study are reported.
|
1 Participants
n=73 Participants • Only data on participants who completed day 21 of the study are reported.
|
1 Participants
n=148 Participants • Only data on participants who completed day 21 of the study are reported.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=75 Participants • Only data on participants who completed day 21 of the study are reported.
|
0 Participants
n=73 Participants • Only data on participants who completed day 21 of the study are reported.
|
0 Participants
n=148 Participants • Only data on participants who completed day 21 of the study are reported.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=75 Participants • Only data on participants who completed day 21 of the study are reported.
|
1 Participants
n=73 Participants • Only data on participants who completed day 21 of the study are reported.
|
1 Participants
n=148 Participants • Only data on participants who completed day 21 of the study are reported.
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=75 Participants • Only data on participants who completed day 21 of the study are reported.
|
50 Participants
n=73 Participants • Only data on participants who completed day 21 of the study are reported.
|
103 Participants
n=148 Participants • Only data on participants who completed day 21 of the study are reported.
|
|
Race (NIH/OMB)
White
|
14 Participants
n=75 Participants • Only data on participants who completed day 21 of the study are reported.
|
14 Participants
n=73 Participants • Only data on participants who completed day 21 of the study are reported.
|
28 Participants
n=148 Participants • Only data on participants who completed day 21 of the study are reported.
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=75 Participants • Only data on participants who completed day 21 of the study are reported.
|
7 Participants
n=73 Participants • Only data on participants who completed day 21 of the study are reported.
|
14 Participants
n=148 Participants • Only data on participants who completed day 21 of the study are reported.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=75 Participants • Only data on participants who completed day 21 of the study are reported.
|
0 Participants
n=73 Participants • Only data on participants who completed day 21 of the study are reported.
|
1 Participants
n=148 Participants • Only data on participants who completed day 21 of the study are reported.
|
|
Region of Enrollment
United States
|
85 participants
n=85 Participants
|
81 participants
n=81 Participants
|
166 participants
n=166 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)Population: Participants who completed study through day 21
Hemagglutination inhibition (HI) assay will be 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.
Outcome measures
| Measure |
Flucelvax Inactivated Influenza Vaccine
n=75 Participants
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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
Fluzone Inactivated Influenza Vaccine
n=73 Participants
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
|---|---|---|
|
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Vaccine Strain: A/H1N1
|
20 Participants
|
14 Participants
|
|
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Vaccine Strain: A/H3N2
|
9 Participants
|
11 Participants
|
|
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Vaccine Strain: B/Colorado
|
22 Participants
|
24 Participants
|
|
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Vaccine Strain: B/Phuket
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)Population: Data was analyzed on participants who completed day 21 visit.
Hemagglutination inhibition assay will be conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point.
Outcome measures
| Measure |
Flucelvax Inactivated Influenza Vaccine
n=75 Participants
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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
Fluzone Inactivated Influenza Vaccine
n=73 Participants
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
|---|---|---|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: A/H1N1 : Day 0
|
45 Participants
|
39 Participants
|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: A/H1N1 : Day 21
|
66 Participants
|
58 Participants
|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: A/H3N2 : Day 0
|
51 Participants
|
45 Participants
|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: A/H3N2 : Day 21
|
62 Participants
|
60 Participants
|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: B/Colorado : Day 0
|
37 Participants
|
35 Participants
|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: B/Colorado : Day 21
|
56 Participants
|
56 Participants
|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: B/Phuket : Day 0
|
48 Participants
|
41 Participants
|
|
Determining Seroprotection Level at Each Time Point
Vaccine Strain: B/Phuket : Day 21
|
61 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)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
Outcome measures
| Measure |
Flucelvax Inactivated Influenza Vaccine
n=75 Participants
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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
Fluzone Inactivated Influenza Vaccine
n=73 Participants
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
|
|---|---|---|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: A/H1N1 : Day 0
|
6.63 Dilution
Interval 6.29 to 7.01
|
6.42 Dilution
Interval 6.05 to 6.82
|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: A/H1N1 : Day 21
|
8.08 Dilution
Interval 7.82 to 8.36
|
7.76 Dilution
Interval 7.46 to 8.08
|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: A/H3N2 : Day 0
|
7.42 Dilution
Interval 7.16 to 7.69
|
6.94 Dilution
Interval 6.58 to 7.32
|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: A/H3N2 : Day 21
|
7.90 Dilution
Interval 7.63 to 8.18
|
7.96 Dilution
Interval 7.7 to 8.22
|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: B/Colorado : Day 0
|
6.55 Dilution
Interval 6.19 to 6.93
|
6.42 Dilution
Interval 6.03 to 6.83
|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: B/Colorado : Day 21
|
7.56 Dilution
Interval 7.21 to 7.92
|
7.71 Dilution
Interval 7.39 to 8.05
|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: B/Phuket : Day 0
|
6.78 Dilution
Interval 6.43 to 7.15
|
6.52 Dilution
Interval 6.16 to 6.91
|
|
Determining Geometric Mean Titers (GMTs) at Each Time Point
Vaccine Strain: B/Phuket : Day 21
|
7.34 Dilution
Interval 7.01 to 7.69
|
7.46 Dilution
Interval 7.11 to 7.8
|
Adverse Events
Flucelvax Inactivated Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluzone Inactivated Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard Zimmerman, MD
University of Pittsburgh, Department of Family Medicine
Phone: 412-383-2354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place