Adults 6 Weeks to 24 Months, any sex, with Vaccination or Skin Absorption. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Placebo Microneedle Patch-related Serious Adverse Events (SAE).Primary· 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.
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Number of Participants With Grade 3 Placebo Microneedle Patch-related Solicited Adverse Events (AE).Primary· Up to Day 8 for Patch 1, Day 8 to Day 15 if received Patches 2 and 3
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).
Significant irritability
Group
Value
95% CI
Cohort 1, Patch 1
0
Cohort 1, Patches 2 and 3
0
Cohort 2, Patch 1
0
Cohort 2, Patches 2 and 3
1
Significant lethargy
Group
Value
95% CI
Cohort 1, Patch 1
0
Cohort 1, Patches 2 and 3
0
Cohort 2, Patch 1
0
Cohort 2, Patches 2 and 3
0
Significantly decreased appetite
Group
Value
95% CI
Cohort 1, Patch 1
0
Cohort 1, Patches 2 and 3
0
Cohort 2, Patch 1
0
Cohort 2, Patches 2 and 3
0
Significant vomiting
Group
Value
95% CI
Cohort 1, Patch 1
0
Cohort 1, Patches 2 and 3
0
Cohort 2, Patch 1
0
Cohort 2, Patches 2 and 3
0
Fever >102.1 F
Group
Value
95% CI
Cohort 1, Patch 1
0
Cohort 1, Patches 2 and 3
0
Cohort 2, Patch 1
0
Cohort 2, Patches 2 and 3
0
Number of Participants With Solicited Application Site Reactogenicity Events.Primary· Up to Day 8 for Patch 1, Day 8 to Day 15 if received 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 subjec
Induration/swelling Grade 0 (absent)
Group
Value
95% CI
Cohort 1, Patch 1
7
Cohort 1, Patch 2
3
Cohort 1, Patch 3
3
Cohort 2, Patch 1
25
Cohort 2, Patch 2
23
Cohort 2, Patch 3
23
Erythema Grade 0 (absent)
Group
Value
95% CI
Cohort 1, Patch 1
6
Cohort 1, Patch 2
3
Cohort 1, Patch 3
3
Cohort 2, Patch 1
25
Cohort 2, Patch 2
23
Cohort 2, Patch 3
23
Erythema Grade 1 (mild)
Group
Value
95% CI
Cohort 1, Patch 1
1
Cohort 1, Patch 2
0
Cohort 1, Patch 3
0
Cohort 2, Patch 1
0
Cohort 2, Patch 2
0
Cohort 2, Patch 3
0
Ecchymosis Grade 0 (absent)
Group
Value
95% CI
Cohort 1, Patch 1
7
Cohort 1, Patch 2
3
Cohort 1, Patch 3
3
Cohort 2, Patch 1
25
Cohort 2, Patch 2
23
Cohort 2, Patch 3
23
Itching Grade 0 (absent)
Group
Value
95% CI
Cohort 1, Patch 1
6
Cohort 1, Patch 2
3
Cohort 1, Patch 3
3
Cohort 2, Patch 1
25
Cohort 2, Patch 2
23
Cohort 2, Patch 3
23
Itching Grade 1 (mild)
Group
Value
95% CI
Cohort 1, Patch 1
1
Cohort 1, Patch 2
0
Cohort 1, Patch 3
0
Cohort 2, Patch 1
0
Cohort 2, Patch 2
0
Cohort 2, Patch 3
0
Pain Grade 0 (absent)
Group
Value
95% CI
Cohort 1, Patch 1
6
Cohort 1, Patch 2
3
Cohort 1, Patch 3
3
Cohort 2, Patch 1
25
Cohort 2, Patch 2
23
Cohort 2, Patch 3
23
Pain Grade 1 (mild)
Group
Value
95% CI
Cohort 1, Patch 1
1
Cohort 1, Patch 2
0
Cohort 1, Patch 3
0
Cohort 2, Patch 1
0
Cohort 2, Patch 2
0
Cohort 2, Patch 3
0
Number of Participants With Grade 3 Placebo Microneedle Patch-related Unsolicited Adverse EventsSecondary· 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.
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Number of New-onset Medical Conditions (NOMC)Secondary· 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.
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Acceptability of Vaccination MethodsSecondary· Final Visit (Day 27 - 38)
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).
Shot or spray by healthcare worker
Group
Value
95% CI
Cohort 1
7.1
± 2.5
Cohort 2
4.8
± 4.1
Patch by healthcare worker
Group
Value
95% CI
Cohort 1
8.4
± 1.8
Cohort 2
9.4
± 1.2
Patch by LAR monitored by healthcare worker
Group
Value
95% CI
Cohort 1
8.1
± 1.7
Cohort 2
6.8
± 3.6
Patch by LAR at home
Group
Value
95% CI
Cohort 1
6.1
± 2.9
Cohort 2
6.0
± 3.7
Overall ExperienceSecondary· Day 1, Day 2, Day 8, Final Visit (Day 27-38)
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.
Patch 1, Day 1
Group
Value
95% CI
Cohort 1
4.6
± 0.5
Cohort 2
4.5
± 0.6
Patch 1, Day 2
Group
Value
95% CI
Cohort 1
4.6
± 0.5
Cohort 2
4.6
± 0.5
Patch 1, Day 8
Group
Value
95% CI
Cohort 1
4.5
± 0.5
Cohort 2
4.6
± 0.7
Patches 2 and 3, Day 8
Group
Value
95% CI
Cohort 1
4.2
± 1.3
Cohort 2
4.4
± 0.8
Patches 2 and 3, Day 9
Group
Value
95% CI
Cohort 1
4.4
± 0.9
Cohort 2
4.7
± 0.6
Patches 2 and 3, Day 15
Group
Value
95% CI
Cohort 1
4.4
± 0.5
Cohort 2
4.7
± 0.5
All patchesFinal Visit (Day 27-38)
Group
Value
95% CI
Cohort 1
4.5
± 0.6
Cohort 2
4.8
± 0.4
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1
Serious: 0/8 (0%)
Deaths: 0/8
Cohort 2
Serious: 0/25 (0%)
Deaths: 0/25
Other adverse events (7 terms — click to expand)
Reaction
System
Cohort 1
Cohort 2
Teething
Gastrointestinal disorders
—
—
Viral gastroenteritis
Gastrointestinal disorders
—
—
Cold symptoms of viral illness
Infections and infestations
—
—
Bug bite
Infections and infestations
—
—
Bacterial ear infection
Ear and labyrinth disorders
—
—
Papular rash around site of prior microneedle patch
Skin and subcutaneous tissue disorders
—
—
Hyperpigmented and macular rash at site of prior microneedle patch
Microneedles can be prepared as a low-cost patch that is simple for patients to apply for vaccine delivery targeting the many antigen-presenting cells present in the skin. Data regarding the safety, reactogenicity, tolerability, and acceptability of a microneedle patch in children are lacking. The goal of this study is to evaluate the safety, reactogenicity, and acceptability of placement of a placebo microneedle patch to the skin of children.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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· active not recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 10 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03207763.