Trial Outcomes & Findings for Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years (NCT NCT01712984)
NCT ID: NCT01712984
Last Updated: 2015-05-07
Results Overview
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3360 participants
Primary outcome timeframe
Day 28 post-vaccination
Results posted on
2015-05-07
Participant Flow
The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States.
A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report.
Participant milestones
| Measure |
QIV ID Vaccine Group
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Overall Study
STARTED
|
1672
|
837
|
846
|
|
Overall Study
COMPLETED
|
1656
|
821
|
836
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
10
|
Reasons for withdrawal
| Measure |
QIV ID Vaccine Group
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
10
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
7
|
Baseline Characteristics
Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
Baseline characteristics by cohort
| Measure |
QIV ID Vaccine Group
n=1672 Participants
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=837 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=846 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
Total
n=3355 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1672 Participants
n=5 Participants
|
837 Participants
n=7 Participants
|
846 Participants
n=5 Participants
|
3355 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
41.6 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
41.2 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
41.9 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
41.6 Years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1022 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
528 Participants
n=5 Participants
|
2055 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
650 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
318 Participants
n=5 Participants
|
1300 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1672 Participants
n=5 Participants
|
837 Participants
n=7 Participants
|
846 Participants
n=5 Participants
|
3355 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Outcome measures
| Measure |
QIV ID Vaccine Group
n=1041 Participants
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=539 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=533 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H1N1 (N=1041, 539, 533)
|
589 Titers
Interval 546.0 to 636.0
|
728 Titers
Interval 653.0 to 811.0
|
635 Titers
Interval 568.0 to 709.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H3N2 (N=1041, 538, 533)
|
368 Titers
Interval 342.0 to 397.0
|
413 Titers
Interval 369.0 to 462.0
|
447 Titers
Interval 401.0 to 498.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B/Texas/6/2011 (B1; N=1041, 539, 533)
|
105 Titers
Interval 99.1 to 112.0
|
93.5 Titers
Interval 85.9 to 102.0
|
54.0 Titers
Interval 49.3 to 59.2
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B/Brisbane/60/2008 (B2; N=1041, 538, 533)
|
136 Titers
Interval 128.0 to 145.0
|
66.7 Titers
Interval 61.0 to 72.9
|
130 Titers
Interval 118.0 to 143.0
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer\< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).
Outcome measures
| Measure |
QIV ID Vaccine Group
n=1041 Participants
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=539 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=533 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H1N1 (N=1041, 539, 533)
|
600 Participants
|
333 Participants
Interval 0.0 to 0.0
|
314 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H3N2 (N=1040, 538, 533)
|
608 Participants
|
326 Participants
Interval 0.0 to 0.0
|
314 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B/Texas/6/2011 (B1; N=1041, 539, 533)
|
580 Participants
|
253 Participants
Interval 0.0 to 0.0
|
131 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B/Brisbane/60/2008 (B2; N=1041, 538, 533)
|
525 Participants
|
119 Participants
Interval 0.0 to 0.0
|
235 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Outcome measures
| Measure |
QIV ID Vaccine Group
n=1041 Participants
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=539 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=533 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B1 Day 28 (N=1041, 539, 533)
|
105 Titers
Interval 99.1 to 112.0
|
93.5 Titers
Interval 85.9 to 102.0
|
54.0 Titers
Interval 49.3 to 59.2
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H1N1 Day 0 (N=1041, 539, 533)
|
66.3 Titers
Interval 59.5 to 73.8
|
65.2 Titers
Interval 56.0 to 76.0
|
66.2 Titers
Interval 56.9 to 77.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H1N1 Day 28 (N=1041, 539, 533)
|
589 Titers
Interval 546.0 to 636.0
|
728 Titers
Interval 653.0 to 811.0
|
635 Titers
Interval 568.0 to 709.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H3N2 Day 0 (N=1040, 539, 533)
|
52.3 Titers
Interval 47.5 to 57.5
|
56.5 Titers
Interval 49.2 to 64.9
|
55.7 Titers
Interval 48.4 to 64.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H3N2 Day 28 (N=1041, 538, 533)
|
368 Titers
Interval 342.0 to 397.0
|
413 Titers
Interval 369.0 to 462.0
|
447 Titers
Interval 401.0 to 498.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B1 Day 0 (N=1041, 539, 533)
|
21.7 Titers
Interval 20.5 to 23.1
|
24.7 Titers
Interval 22.7 to 27.0
|
22.2 Titers
Interval 20.4 to 24.2
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B2 Day 0 (N=1041, 539, 533)
|
26.8 Titers
Interval 25.0 to 28.8
|
29.7 Titers
Interval 26.9 to 32.8
|
25.4 Titers
Interval 23.0 to 28.1
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B2 Day 28 (N=1041, 538, 533)
|
136 Titers
Interval 128.0 to 145.0
|
66.7 Titers
Interval 61.0 to 72.9
|
130 Titers
Interval 118.0 to 143.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 \[1/dil\] at baseline and 28 days after vaccination.
Outcome measures
| Measure |
QIV ID Vaccine Group
n=1041 Participants
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=539 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=533 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H1N1 Day 0 (N=1041, 539, 533)
|
672 Participants
|
334 Participants
Interval 0.0 to 0.0
|
353 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H1N1 Day 28 (N=1041, 539, 533)
|
1014 Participants
|
537 Participants
Interval 0.0 to 0.0
|
524 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H3N2 Day 0 (N=1040, 539, 533)
|
655 Participants
|
340 Participants
Interval 0.0 to 0.0
|
332 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
A/H3N2 Day 28 (N=1041, 538, 533)
|
1008 Participants
|
526 Participants
Interval 0.0 to 0.0
|
519 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B1 Day 0 (N=1041, 539, 533)
|
335 Participants
|
210 Participants
Interval 0.0 to 0.0
|
172 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B1 Day 28 (N=1041, 539, 533)
|
923 Participants
|
464 Participants
Interval 0.0 to 0.0
|
351 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B2 Day 0 (N=1041, 539, 533)
|
467 Participants
|
262 Participants
Interval 0.0 to 0.0
|
224 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
B2 Day 28 (N=1041, 538, 533)
|
976 Participants
|
403 Participants
Interval 0.0 to 0.0
|
477 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.
Outcome measures
| Measure |
QIV ID Vaccine Group
n=1672 Participants
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=837 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=846 Participants
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Injection site Pain (N=1656,820,838)
|
883 Participants
|
395 Participants
Interval 0.0 to 0.0
|
420 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Injection site Pain (N=1656,820,838)
|
24 Participants
|
10 Participants
Interval 0.0 to 0.0
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Injection site Erythema (N=1656,820,838)
|
607 Participants
|
279 Participants
Interval 0.0 to 0.0
|
269 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Injection site Erythema (N=1656,820,838)
|
7 Participants
|
1 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Injection site Swelling (N=1655,820,838)
|
322 Participants
|
121 Participants
Interval 0.0 to 0.0
|
123 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Injection site Swelling (N=1655,820,838)
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Injection site Induration (N=1656,820,837)
|
282 Participants
|
111 Participants
Interval 0.0 to 0.0
|
94 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Injection site Induration (N=1656,820,837)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Injection site Ecchymosis (N=1656,820,838)
|
43 Participants
|
15 Participants
Interval 0.0 to 0.0
|
15 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Injection site Ecchymosis (N=1656,820,838)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Fever (N=1649,819,836)
|
13 Participants
|
6 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Fever (N=1649,819,836)
|
3 Participants
|
1 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Headache (N=1656,820,838)
|
548 Participants
|
257 Participants
Interval 0.0 to 0.0
|
278 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Headache (N=1656,820,838)
|
53 Participants
|
20 Participants
Interval 0.0 to 0.0
|
15 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Malaise (N=1656,820,838)
|
459 Participants
|
216 Participants
Interval 0.0 to 0.0
|
255 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Malaise (N=1656,820,838)
|
49 Participants
|
15 Participants
Interval 0.0 to 0.0
|
21 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Myalgia (N=1656,820,838)
|
564 Participants
|
238 Participants
Interval 0.0 to 0.0
|
261 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Myalgia (N=1656,820,838)
|
43 Participants
|
12 Participants
Interval 0.0 to 0.0
|
21 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Shivering (N=1656,820,838)
|
200 Participants
|
85 Participants
Interval 0.0 to 0.0
|
94 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Shivering (N=1656,820,838)
|
24 Participants
|
5 Participants
Interval 0.0 to 0.0
|
13 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Injection site Pruritus (N=1656,820,838)
|
862 Participants
|
372 Participants
Interval 0.0 to 0.0
|
374 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Grade 3 Injection site Pruritus (N=1656,820,838)
|
47 Participants
|
15 Participants
Interval 0.0 to 0.0
|
19 Participants
Interval 0.0 to 0.0
|
Adverse Events
QIV ID Vaccine Group
Serious events: 20 serious events
Other events: 883 other events
Deaths: 0 deaths
TIV ID1 Vaccine Group
Serious events: 14 serious events
Other events: 395 other events
Deaths: 0 deaths
TIV ID2 Vaccine Group
Serious events: 11 serious events
Other events: 420 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QIV ID Vaccine Group
n=1672 participants at risk
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=837 participants at risk
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=846 participants at risk
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Cardiac disorders
Aortic valve disease
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Cardiac disorders
Cardiac tamponade
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Chest pain
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Dysplasia
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Immune system disorders
Sarcoidosis
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.12%
2/1672 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.24%
2/837 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Renal and urinary disorders
Renal failure acute
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1672 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/837 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.12%
1/846 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.06%
1/1672 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/837 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
0.00%
0/846 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
Other adverse events
| Measure |
QIV ID Vaccine Group
n=1672 participants at risk
Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
|
TIV ID1 Vaccine Group
n=837 participants at risk
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
|
TIV ID2 Vaccine Group
n=846 participants at risk
Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|---|---|---|---|
|
General disorders
Injection site Pain
|
53.3%
883/1656 • Number of events 883 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
48.2%
395/820 • Number of events 395 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
50.1%
420/838 • Number of events 420 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Injection site Erythema
|
36.7%
607/1656 • Number of events 607 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
34.0%
279/820 • Number of events 279 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
32.1%
269/838 • Number of events 269 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Injection site Swelling
|
19.5%
322/1655 • Number of events 322 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
14.8%
121/820 • Number of events 121 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
14.7%
123/838 • Number of events 123 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Injection site Induration
|
17.0%
282/1656 • Number of events 282 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
13.5%
111/820 • Number of events 111 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
11.2%
94/837 • Number of events 94 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Injection site Pruritus
|
52.1%
862/1656 • Number of events 862 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
45.4%
372/820 • Number of events 372 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
44.6%
374/838 • Number of events 374 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Nervous system disorders
Headache
|
33.1%
548/1656 • Number of events 548 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
31.3%
257/820 • Number of events 257 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
33.2%
278/838 • Number of events 278 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Malaise
|
27.7%
459/1656 • Number of events 459 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
26.3%
216/820 • Number of events 216 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
30.4%
255/838 • Number of events 255 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
34.1%
564/1656 • Number of events 564 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
29.0%
238/820 • Number of events 238 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
31.1%
261/838 • Number of events 261 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
|
General disorders
Shivering
|
12.1%
200/1656 • Number of events 200 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
10.4%
85/820 • Number of events 85 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
11.2%
94/838 • Number of events 94 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER