Trial Outcomes & Findings for Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents (NCT NCT02250274)
NCT ID: NCT02250274
Last Updated: 2018-04-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
131 participants
Primary outcome timeframe
Change from Baseline to 28 days
Results posted on
2018-04-26
Participant Flow
Participant milestones
| Measure |
LAIV 2014-15
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
|
IIV 2014-15
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
\[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
46
|
|
Overall Study
COMPLETED
|
78
|
40
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
LAIV 2014-15
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
|
IIV 2014-15
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
\[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]
|
|---|---|---|
|
Overall Study
Insufficient blood draw amount
|
7
|
6
|
Baseline Characteristics
Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
Baseline characteristics by cohort
| Measure |
LAIV 2014-15
n=85 Participants
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
|
IIV 2014-15
n=46 Participants
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
\[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10 YEARS
STANDARD_DEVIATION 3.2 • n=93 Participants
|
12 YEARS
STANDARD_DEVIATION 2.5 • n=4 Participants
|
11 YEARS
STANDARD_DEVIATION 3.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 28 daysOutcome measures
| Measure |
LAIV 2014-15
n=78 Participants
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
|
IIV 2014-15
n=40 Participants
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
\[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]
|
LAIV-IIV
Participants receiving LAIV in 2013-14 and IIV in 2014-15.
|
LAIV-LAIV
Participants receiving LAIV in 2013-14 and LAIV in 2014-15.
|
Unvax-IIV
Participants unvaccinated in 2013-14 and receiving IIV in 2014-15.
|
Unvax-LAIV
Participants unvaccinated in 2013-14 and receiving LAIV in 2014-15.
|
|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
H3N2 Day 28 HI Titer
|
99 Titers
Interval 79.0 to 124.0
|
295 Titers
Interval 227.0 to 383.0
|
—
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
H3N2 Baseline HI Titer
|
96 Titers
Interval 76.0 to 122.0
|
100 Titers
Interval 67.0 to 149.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Onset >13 days after vaccination and before April 1, 2015Outcome measures
| Measure |
LAIV 2014-15
n=85 Participants
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
|
IIV 2014-15
n=46 Participants
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
\[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]
|
LAIV-IIV
Participants receiving LAIV in 2013-14 and IIV in 2014-15.
|
LAIV-LAIV
Participants receiving LAIV in 2013-14 and LAIV in 2014-15.
|
Unvax-IIV
Participants unvaccinated in 2013-14 and receiving IIV in 2014-15.
|
Unvax-LAIV
Participants unvaccinated in 2013-14 and receiving LAIV in 2014-15.
|
|---|---|---|---|---|---|---|
|
Polymerase Chain Reaction (PCR) Confirmed Influenza Illness
|
13 participants
|
5 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 28 daysPopulation: Fold change in NK cell degranulation
Outcome measures
| Measure |
LAIV 2014-15
n=19 Participants
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
|
IIV 2014-15
n=31 Participants
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
\[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]
|
LAIV-IIV
n=13 Participants
Participants receiving LAIV in 2013-14 and IIV in 2014-15.
|
LAIV-LAIV
n=28 Participants
Participants receiving LAIV in 2013-14 and LAIV in 2014-15.
|
Unvax-IIV
n=7 Participants
Participants unvaccinated in 2013-14 and receiving IIV in 2014-15.
|
Unvax-LAIV
n=10 Participants
Participants unvaccinated in 2013-14 and receiving LAIV in 2014-15.
|
|---|---|---|---|---|---|---|
|
Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
Fold change in NK cell degranulation to SW antigen
|
1.02 Fold change
Interval 0.76 to 1.36
|
0.99 Fold change
Interval 0.93 to 1.05
|
1.47 Fold change
Interval 1.03 to 2.09
|
0.86 Fold change
Interval 0.76 to 0.98
|
1.31 Fold change
Interval 0.96 to 1.8
|
1.08 Fold change
Interval 0.9 to 1.29
|
|
Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
Fold change in NK cell degranulation to TX antigen
|
1.10 Fold change
Interval 0.96 to 1.25
|
0.95 Fold change
Interval 0.86 to 1.06
|
1.39 Fold change
Interval 1.18 to 1.64
|
1.01 Fold change
Interval 0.92 to 1.11
|
1.13 Fold change
Interval 0.75 to 1.7
|
1.33 Fold change
Interval 1.18 to 1.49
|
SECONDARY outcome
Timeframe: Day 7Population: There were too few samples collected within each group to conduct a reasonable analysis of this outcome. The samples collected are being stored for potential future use.
Outcome measures
Outcome data not reported
Adverse Events
LAIV 2014-15
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IIV 2014-15
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
Director of the Center for Clinical Epidemiology & Population Health
Marshfield Clinic Research Foundation
Phone: 715-389-3444
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place