Trial Outcomes & Findings for Standard Versus High Dose Inactivated Influenza Vaccine in RA (NCT NCT02936180)
NCT ID: NCT02936180
Last Updated: 2024-08-13
Results Overview
Seroconversion rate (SCR): proportion of subjects in a given treatment group (SD- or HD) with either a ≥4-fold increase in reciprocal HI titres between D0 and D28 or a rise of undetectable HI titre (i.e. \<1:10) pre-vaccination (D0) to an HI titre of ≥1:40 at D28 post vaccination.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
279 participants
Primary outcome timeframe
Day 28
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Standard Dose Influenza Vaccine
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
139
|
|
Overall Study
COMPLETED
|
127
|
121
|
|
Overall Study
NOT COMPLETED
|
13
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Standard Versus High Dose Inactivated Influenza Vaccine in RA
Baseline characteristics by cohort
| Measure |
Standard Dose Influenza Vaccine
n=136 Participants
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
n=138 Participants
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
59 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 12.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Seroconversion rate (SCR): proportion of subjects in a given treatment group (SD- or HD) with either a ≥4-fold increase in reciprocal HI titres between D0 and D28 or a rise of undetectable HI titre (i.e. \<1:10) pre-vaccination (D0) to an HI titre of ≥1:40 at D28 post vaccination.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=136 Participants
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
n=138 Participants
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
|---|---|---|
|
Seroconversion Rate to HD- Versus SD-IV in People With RA
|
12 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Day 28Seroprotection rate (SPR): the proportion of subjects in a given treatment group attaining a reciprocal HI titre of ≥1:40 at D28 post-vaccination.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=136 Participants
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
n=138 Participants
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
|---|---|---|
|
Seroprotection Rate to HD- Versus SD-IV in People With RA
|
42 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: Day 28Geometric mean titres (GMTs) of HI at D28.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=136 Participants
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
n=138 Participants
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
|---|---|---|
|
Geometric Mean Titres (GMTs) of HI in People With RA Who Received HD- Versus SD-IV
|
1.56 titer
Interval 1.22 to 1.9
|
2.06 titer
Interval 1.12 to 3.0
|
SECONDARY outcome
Timeframe: Day 186Number of participants with detectable HI antibodies at Day 186
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=127 Participants
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
n=121 Participants
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
|---|---|---|
|
Durability of Detectable Levels of HI Antibody for SD- and HD- IV.
|
29 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Day 28Number of Participants with Side Effects
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=136 Participants
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
n=138 Participants
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
|---|---|---|
|
Rates of Side Effects During the Surveillance Period in SD- and HD-IV.
|
19 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 186Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 186Outcome measures
Outcome data not reported
Adverse Events
Standard Dose Influenza Vaccine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 1 deaths
High Dose Influenza Vaccine
Serious events: 0 serious events
Other events: 19 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Dose Influenza Vaccine
n=136 participants at risk
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
SD-QIV
|
High Dose Influenza Vaccine
n=138 participants at risk
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
HD-TIV
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Unsolicited adverse events
|
10.3%
14/136 • 6 months
|
13.8%
19/138 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place