Trial Outcomes & Findings for Microneedle Patch Study in Healthy Infants/Young Children (NCT NCT03207763)
NCT ID: NCT03207763
Last Updated: 2020-11-10
Results Overview
To evaluate safety following application of the patch topically, microneedle patch-related serious adverse events were recorded. Information collected included event description, date of onset, severity and date of resolution/stabilization of the event. Severity and relationship to study product was assessed by the Investigator or sub-investigator.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Day 1 through the Final Study Visit (Day 27 - 38)
Results posted on
2020-11-10
Participant Flow
Participants were enrolled at the Emory Children's Center in Atlanta, Georgia. Enrollment began on July 11, 2017 and all follow up was complete by May 15, 2019.
Participant milestones
| Measure |
Cohort 1
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
25
|
|
Overall Study
Eligible and Opted for Patches 2 and 3
|
5
|
23
|
|
Overall Study
Completed Patches 2 and 3 Study
|
5
|
23
|
|
Overall Study
COMPLETED
|
7
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Microneedle Patch Study in Healthy Infants/Young Children
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=25 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
6 weeks to 4 months old
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
5 to 11 months old
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
12 to 24 months old
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through the Final Study Visit (Day 27 - 38)To evaluate safety following application of the patch topically, microneedle patch-related serious adverse events were recorded. Information collected included event description, date of onset, severity and date of resolution/stabilization of the event. Severity and relationship to study product was assessed by the Investigator or sub-investigator.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=25 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2, Patch 1
Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
|
Cohort 2, Patches 2 and 3
Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
|
Cohort 2, Patch 2
Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
|
Cohort 2, Patch 3
Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Placebo Microneedle Patch-related Serious Adverse Events (SAE).
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3Population: The memory aid to log solicited adverse events was not returned for one participant in Cohort 1 receiving the first patch. The memory aid was not returned for two participants in Cohort 1 receiving the second and third patches.
The occurrence of Grade 3 solicited adverse events related to the placebo microneedle patch was recorded. Solicited adverse events were irritability (fussiness), lethargy (drowsiness), decreased appetite, vomiting, and fever. The severity of these adverse events was graded on a scale from 0 to 3 where 0 = not present and 3 = significant, preventing daily activity or a fever of \>102.1 degrees Fahrenheit (F).
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=3 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2, Patch 1
n=25 Participants
Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
|
Cohort 2, Patches 2 and 3
n=23 Participants
Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
|
Cohort 2, Patch 2
Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
|
Cohort 2, Patch 3
Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).
Significant irritability
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).
Significant lethargy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).
Significantly decreased appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).
Significant vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).
Fever >102.1 F
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3Population: Memory aids were not returned for one participant in Cohort 1 for Patch 1 and two participants in Cohort 1 receiving Patches 2 and 3.
The occurrence of solicited reactogenicity events at the application site was recorded. The solicited reactogenicity events are reactions that are common or expected to occur with application of a microneedle patch and include induration/swelling, erythema, ecchymosis, itching, pain, and tenderness. The Legally Authorized Representatives (LARs) of participants were provided with a memory aid, thermometer and ruler to record the presence of solicited symptoms and oral temperature. Reactogenicity event details were collected via review of the subject's memory aid and by interview with the subject LAR. Reactogenicity events were graded on a scale from 0 (not present) to 3 (significant or severe).
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=3 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2, Patch 1
n=3 Participants
Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
|
Cohort 2, Patches 2 and 3
n=25 Participants
Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
|
Cohort 2, Patch 2
n=23 Participants
Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
|
Cohort 2, Patch 3
n=23 Participants
Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Induration/swelling Grade 0 (absent)
|
7 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Erythema Grade 0 (absent)
|
6 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Erythema Grade 1 (mild)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Ecchymosis Grade 0 (absent)
|
7 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Itching Grade 0 (absent)
|
6 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Itching Grade 1 (mild)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Pain Grade 0 (absent)
|
6 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Pain Grade 1 (mild)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Tenderness Grade 0 (absent)
|
6 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Solicited Application Site Reactogenicity Events.
Tenderness Grade 1 (mild)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through the Final Study Visit (Day 27 - 38)Grade 3, patch-related unsolicited adverse events (AEs) were recorded. An adverse event is graded as Grade 3 if the event is significant or prevents daily activity.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=25 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2, Patch 1
Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
|
Cohort 2, Patches 2 and 3
Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
|
Cohort 2, Patch 2
Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
|
Cohort 2, Patch 3
Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 Placebo Microneedle Patch-related Unsolicited Adverse Events
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through the Final Study Visit (Day 27 - 38).The number of new-onset medical conditions (NOMC) were recorded. NOMC were tabulated by overall and treatment related events.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=25 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2, Patch 1
Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
|
Cohort 2, Patches 2 and 3
Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
|
Cohort 2, Patch 2
Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
|
Cohort 2, Patch 3
Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
|
|---|---|---|---|---|---|---|
|
Number of New-onset Medical Conditions (NOMC)
|
0 new-onset medical conditions
|
0 new-onset medical conditions
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Final Visit (Day 27 - 38)Population: This analysis includes participants who completed the study.
LARs were asked to state their preference for different methods of vaccine delivery, assuming that a vaccine patch were to be available in the next two years. LARs reported their preference for their child receiving 1) a vaccine by shot or nasal spray given by a healthcare worker, 2) a vaccine patch given by a healthcare worker, 3) a vaccine patch given by the LAR but monitored by a healthcare worker, or 4) a vaccine patch given by the LAR at home. LARs rated their preference on a scale from 0 (definitely not) to 10 (definitely so).
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=25 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2, Patch 1
Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
|
Cohort 2, Patches 2 and 3
Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
|
Cohort 2, Patch 2
Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
|
Cohort 2, Patch 3
Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
|
|---|---|---|---|---|---|---|
|
Acceptability of Vaccination Methods
Shot or spray by healthcare worker
|
7.1 units on a scale
Standard Deviation 2.5
|
4.8 units on a scale
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
|
Acceptability of Vaccination Methods
Patch by healthcare worker
|
8.4 units on a scale
Standard Deviation 1.8
|
9.4 units on a scale
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
|
Acceptability of Vaccination Methods
Patch by LAR monitored by healthcare worker
|
8.1 units on a scale
Standard Deviation 1.7
|
6.8 units on a scale
Standard Deviation 3.6
|
—
|
—
|
—
|
—
|
|
Acceptability of Vaccination Methods
Patch by LAR at home
|
6.1 units on a scale
Standard Deviation 2.9
|
6.0 units on a scale
Standard Deviation 3.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 8, Final Visit (Day 27-38)Population: The population in this analysis includes LARs who completed this question of the study visit survey.
LARs were asked to report their overall experience with the study so far at each study visit related to Patch 1. Experiences were rated on a scale from 1 to 5 where 1 = very negative and 5 = very positive.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=25 Participants
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2, Patch 1
Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
|
Cohort 2, Patches 2 and 3
Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
|
Cohort 2, Patch 2
Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
|
Cohort 2, Patch 3
Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
|
|---|---|---|---|---|---|---|
|
Overall Experience
Patch 1, Day 1
|
4.6 units on a scale
Standard Deviation 0.5
|
4.5 units on a scale
Standard Deviation 0.6
|
—
|
—
|
—
|
—
|
|
Overall Experience
Patch 1, Day 2
|
4.6 units on a scale
Standard Deviation 0.5
|
4.6 units on a scale
Standard Deviation 0.5
|
—
|
—
|
—
|
—
|
|
Overall Experience
Patch 1, Day 8
|
4.5 units on a scale
Standard Deviation 0.5
|
4.6 units on a scale
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
|
Overall Experience
Patches 2 and 3, Day 8
|
4.2 units on a scale
Standard Deviation 1.3
|
4.4 units on a scale
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
|
Overall Experience
Patches 2 and 3, Day 9
|
4.4 units on a scale
Standard Deviation 0.9
|
4.7 units on a scale
Standard Deviation 0.6
|
—
|
—
|
—
|
—
|
|
Overall Experience
Patches 2 and 3, Day 15
|
4.4 units on a scale
Standard Deviation 0.5
|
4.7 units on a scale
Standard Deviation 0.5
|
—
|
—
|
—
|
—
|
|
Overall Experience
All patchesFinal Visit (Day 27-38)
|
4.5 units on a scale
Standard Deviation 0.6
|
4.8 units on a scale
Standard Deviation 0.4
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=8 participants at risk
Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
Cohort 2
n=25 participants at risk
Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
|
|---|---|---|
|
Gastrointestinal disorders
Teething
|
25.0%
2/8 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
0.00%
0/25 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
|
Ear and labyrinth disorders
Bacterial ear infection
|
12.5%
1/8 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
0.00%
0/25 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
|
Skin and subcutaneous tissue disorders
Papular rash around site of prior microneedle patch
|
12.5%
1/8 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
0.00%
0/25 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmented and macular rash at site of prior microneedle patch
|
12.5%
1/8 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
0.00%
0/25 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
|
Gastrointestinal disorders
Viral gastroenteritis
|
0.00%
0/8 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
8.0%
2/25 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
|
Infections and infestations
Bug bite
|
12.5%
1/8 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
0.00%
0/25 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
|
Infections and infestations
Cold symptoms of viral illness
|
0.00%
0/8 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
8.0%
2/25 • Data collection for adverse events began at the first study visit and continued through the Final Study Visit, which was a follow up telephone call on Day 27-38.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place