Trial Outcomes & Findings for Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle (NCT NCT02438423)
NCT ID: NCT02438423
Last Updated: 2019-07-05
Results Overview
Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after, and serious adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study product administration. Local and systemic reactions were graded using an Injection Site Reaction table listing local reactions (e.g., swelling, erythema, etc.) and grade levels from 0 to 4 for each local reaction, a General Adverse Reaction table listing systemic reactions (e.g., fatigue, myalgia, etc.) and grade levels from 0 to 4 for each systemic reaction, and a Clinical Adverse Event Grading Scale (grades 1-4) for safety labs. In all tables, the higher the grade, the worse the adverse event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
100 participants
Primary outcome timeframe
From Day 0 through Day 8
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
IIV Delivered by MN Patch by Study Staff
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
Baseline characteristics by cohort
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
n=25 Participants
Placebo delivered by microneedle patch administered by study staff
Placebo
|
Total
n=100 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
100 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
12 participants
n=7 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
14 participants
n=5 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
12 participants
n=4 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
49 participants
n=21 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=5 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
8 participants
n=7 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
8 participants
n=5 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
7 participants
n=4 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
31 participants
n=21 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
5 participants
n=7 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
3 participants
n=5 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
6 participants
n=4 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
20 participants
n=21 Participants • The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
|
PRIMARY outcome
Timeframe: From Day 0 through Day 8Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after, and serious adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study product administration. Local and systemic reactions were graded using an Injection Site Reaction table listing local reactions (e.g., swelling, erythema, etc.) and grade levels from 0 to 4 for each local reaction, a General Adverse Reaction table listing systemic reactions (e.g., fatigue, myalgia, etc.) and grade levels from 0 to 4 for each systemic reaction, and a Clinical Adverse Event Grading Scale (grades 1-4) for safety labs. In all tables, the higher the grade, the worse the adverse event.
Outcome measures
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
n=25 Participants
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (pruritus)
|
20 Reactions
|
4 Reactions
|
21 Reactions
|
4 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Pain)
|
5 Reactions
|
11 Reactions
|
5 Reactions
|
2 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Redness/Erythema)
|
10 Reactions
|
0 Reactions
|
10 Reactions
|
0 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Tenderness)
|
17 Reactions
|
15 Reactions
|
16 Reactions
|
4 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Nausea)
|
2 Reactions
|
4 Reactions
|
2 Reactions
|
1 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Fatigue)
|
13 Reactions
|
10 Reactions
|
4 Reactions
|
5 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Headache)
|
5 Reactions
|
7 Reactions
|
7 Reactions
|
2 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Swelling/Induration)
|
4 Reactions
|
1 Reactions
|
2 Reactions
|
0 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Myalgia)
|
4 Reactions
|
7 Reactions
|
1 Reactions
|
4 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Shivering/Shaking)
|
1 Reactions
|
2 Reactions
|
0 Reactions
|
1 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Arthralgia)
|
0 Reactions
|
2 Reactions
|
3 Reactions
|
1 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Fever)
|
1 Reactions
|
0 Reactions
|
0 Reactions
|
0 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Malaise)
|
4 Reactions
|
5 Reactions
|
0 Reactions
|
1 Reactions
|
|
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Reactions D1-D7 (Sweating)
|
3 Reactions
|
5 Reactions
|
2 Reactions
|
0 Reactions
|
PRIMARY outcome
Timeframe: From Day 0 until Day 180Outcome measures
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
n=25 Participants
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.
|
0 Serious adverse events
|
0 Serious adverse events
|
0 Serious adverse events
|
0 Serious adverse events
|
PRIMARY outcome
Timeframe: From Day 0 until Day 28Outcome measures
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
n=25 Participants
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.
|
0 Grade 3 adverse events
|
0 Grade 3 adverse events
|
0 Grade 3 adverse events
|
0 Grade 3 adverse events
|
SECONDARY outcome
Timeframe: At Day 28Outcome measures
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of HAI Antibody Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
A/Texas (H3N2)
|
287 HAI Antibody Titers (GMT)
Interval 191.5 to 430.2
|
223.2 HAI Antibody Titers (GMT)
Interval 159.8 to 311.7
|
—
|
—
|
|
Geometric Mean Titer (GMT) of HAI Antibody Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
A/Christchurch (H1N1)
|
1197 HAI Antibody Titers (GMT)
Interval 854.6 to 1675.0
|
997.3 HAI Antibody Titers (GMT)
Interval 703.0 to 1415.0
|
—
|
—
|
|
Geometric Mean Titer (GMT) of HAI Antibody Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
B/Massachusetts
|
125.8 HAI Antibody Titers (GMT)
Interval 85.92 to 184.1
|
94.48 HAI Antibody Titers (GMT)
Interval 73.5 to 121.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28Outcome measures
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Seroprotection (Defined as a HAI Antibody Titer of 1:40 or Greater) Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
A/Christchurch (H1N1)
|
100 percentage of subjects (seroprotected)
Interval 85.8 to 100.0
|
100 percentage of subjects (seroprotected)
Interval 86.3 to 100.0
|
—
|
—
|
|
Percentage of Subjects Achieving Seroprotection (Defined as a HAI Antibody Titer of 1:40 or Greater) Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
A/Texas (H3N2)
|
100 percentage of subjects (seroprotected)
Interval 85.8 to 100.0
|
100 percentage of subjects (seroprotected)
Interval 86.3 to 100.0
|
—
|
—
|
|
Percentage of Subjects Achieving Seroprotection (Defined as a HAI Antibody Titer of 1:40 or Greater) Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
B/Massachusetts
|
96 percentage of subjects (seroprotected)
Interval 78.9 to 99.9
|
100 percentage of subjects (seroprotected)
Interval 86.3 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer.
Outcome measures
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 Participants
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Seroconversion Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
A/Christchurch (H1N1)
|
92 percentage of subjects who seroconverted
Interval 73.0 to 99.0
|
80 percentage of subjects who seroconverted
Interval 59.3 to 93.2
|
—
|
—
|
|
Percentage of Subjects Achieving Seroconversion Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
A/Texas (H3N2)
|
83 percentage of subjects who seroconverted
Interval 62.6 to 95.3
|
76 percentage of subjects who seroconverted
Interval 54.9 to 90.6
|
—
|
—
|
|
Percentage of Subjects Achieving Seroconversion Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
B/Massachusetts
|
71 percentage of subjects who seroconverted
Interval 48.9 to 87.4
|
32 percentage of subjects who seroconverted
Interval 15.0 to 53.5
|
—
|
—
|
Adverse Events
IIV Delivered by MN Patch by Study Staff
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
IIV Delivered IM by Study Staff
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
IIV Delivered by MN Patch by Subject
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo MN Patch by Study Staff
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 participants at risk
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 participants at risk
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
n=25 participants at risk
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
n=25 participants at risk
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Severe acute enteritis
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
IIV Delivered by MN Patch by Study Staff
n=25 participants at risk
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered IM by Study Staff
n=25 participants at risk
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
IIV Delivered by MN Patch by Subject
n=25 participants at risk
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Inactivated influenza vaccine: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
|
Placebo MN Patch by Study Staff
n=25 participants at risk
Placebo delivered by microneedle patch administered by study staff
Placebo
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia (grade 1)
|
0.00%
0/25
|
4.0%
1/25
|
8.0%
2/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Leg pain (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Nervous system disorders
Headache (grade 1)
|
0.00%
0/25
|
24.0%
6/25
|
24.0%
6/25
|
0.00%
0/25
|
|
Infections and infestations
Tooth infection (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Toe infection (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Conjunctivitis (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Nervous system disorders
Presyncope (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Vascular disorders
Hypertension (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Investigations
Elevated ALT AST (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
4.0%
1/25
|
|
General disorders
Redness/Erythema (grade 2)
|
4.0%
1/25
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/25
|
|
General disorders
Tenderness (grade 2)
|
16.0%
4/25
|
24.0%
6/25
|
4.0%
1/25
|
4.0%
1/25
|
|
General disorders
Pruritis (grade 2)
|
12.0%
3/25
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/25
|
|
General disorders
Fatigue (grade 2)
|
48.0%
12/25
|
8.0%
2/25
|
8.0%
2/25
|
0.00%
0/25
|
|
General disorders
Pain (grade 2)
|
0.00%
0/25
|
12.0%
3/25
|
4.0%
1/25
|
0.00%
0/25
|
|
General disorders
Body ache (myalgia) (grade 2)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
|
General disorders
Shivering/shaking Body Movements (grade 2)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Malaise (grade 2)
|
0.00%
0/25
|
12.0%
3/25
|
12.0%
3/25
|
0.00%
0/25
|
|
General disorders
Joint pain (Arthralgia) (grade 2)
|
0.00%
0/25
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/25
|
|
General disorders
Nausea (grade 2)
|
0.00%
0/25
|
4.0%
1/25
|
4.0%
1/25
|
4.0%
1/25
|
|
General disorders
Swelling/Induration (grade 2)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Neutropenia (grade 2)
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
8.0%
2/25
|
|
Blood and lymphatic system disorders
Thrombocytopenia (grade 2)
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Nervous system disorders
Headache (grade 2)
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Vomiting (grade 2)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (grade 2)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Left hand bruise (grade 2)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Vascular disorders
Hypertension (grade 2)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
General disorders
Pruritis (grade 3)
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Fatigue (grade 3)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Elevated ALT (grade 3)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Swelling/Induration (grade 1)
|
16.0%
4/25
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/25
|
|
General disorders
Redness/Erythema (grade 1)
|
36.0%
9/25
|
0.00%
0/25
|
32.0%
8/25
|
0.00%
0/25
|
|
General disorders
Tenderness (grade 1)
|
52.0%
13/25
|
36.0%
9/25
|
56.0%
14/25
|
12.0%
3/25
|
|
General disorders
Pain (grade 1)
|
20.0%
5/25
|
32.0%
8/25
|
16.0%
4/25
|
8.0%
2/25
|
|
General disorders
Pruritis (itching) (grade 1)
|
64.0%
16/25
|
12.0%
3/25
|
80.0%
20/25
|
16.0%
4/25
|
|
General disorders
Fatigue
|
48.0%
12/25
|
28.0%
7/25
|
8.0%
2/25
|
20.0%
5/25
|
|
General disorders
Body ache (myalgia) (grade 1)
|
16.0%
4/25
|
24.0%
6/25
|
4.0%
1/25
|
12.0%
3/25
|
|
General disorders
Shivering/shaking body movements (grade 1)
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
|
General disorders
Sweating (grade 1)
|
12.0%
3/25
|
20.0%
5/25
|
8.0%
2/25
|
0.00%
0/25
|
|
General disorders
Malaise (grade 1)
|
16.0%
4/25
|
8.0%
2/25
|
0.00%
0/25
|
4.0%
1/25
|
|
General disorders
Nausea (grade 1)
|
8.0%
2/25
|
12.0%
3/25
|
4.0%
1/25
|
24.0%
6/25
|
|
General disorders
Fever (grade 1)
|
4.0%
1/25
|
0.00%
0/25
|
24.0%
6/25
|
0.00%
0/25
|
|
General disorders
Joint pain (arthralgia) (grade 1)
|
0.00%
0/25
|
4.0%
1/25
|
8.0%
2/25
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
Anemia (grade 1)
|
20.0%
5/25
|
8.0%
2/25
|
4.0%
1/25
|
12.0%
3/25
|
|
Blood and lymphatic system disorders
Decreased absolute lymphocytes (grade 1)
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Leukocytosis (grade 1)
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Leukopenia (grade 1)
|
12.0%
3/25
|
4.0%
1/25
|
4.0%
1/25
|
12.0%
3/25
|
|
Blood and lymphatic system disorders
Thrombocytopenia (grade 1)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Gastroenteritis (grade 1)
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Epigastric pain (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Infections and infestations
URI (grade 1)
|
4.0%
1/25
|
8.0%
2/25
|
4.0%
1/25
|
4.0%
1/25
|
|
Investigations
Elevated ALT (grade 1)
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
8.0%
2/25
|
|
Investigations
Transaminitis (grade 1)
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Investigations
Elevated CK (grade 1)
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Left elbow tendonitis (grade 1)
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Neck pain (grade 1)
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Tenderness (grade 3)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Acute enteritis
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Nervous system disorders
Headache (grade 3)
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Vascular disorders
Hypertension (grade 3)
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Investigations
Elevated AST (grade 4)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Investigations
Elevated CK (grade 4)
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place