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Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438423
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Mark Prausnitz, Georgia Institute of Technology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Inactivated influenza vaccine
Other: Placebo
Enrollment 100
Recruitment Details  
Pre-assignment Details  
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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

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

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 delivered by microneedle patch administered by study staff

Placebo

Period Title: Overall Study
Started 25 25 25 25
Completed 25 25 25 25
Not Completed 0 0 0 0
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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

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

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 delivered by microneedle patch administered by study staff

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 25 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
25
 100.0%
25
 100.0%
100
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
Female
12
  48.0%
11
  44.0%
12
  48.0%
12
  48.0%
47
  47.0%
Male
13
  52.0%
14
  56.0%
13
  52.0%
13
  52.0%
53
  53.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
White 11 12 14 12 49
Black 8 8 8 7 31
Other 6 5 3 6 20
[1]
Measure Analysis Population Description: The different rows describe subsets of the population and the numbers add up to the overall number (100 subjects)
1.Primary Outcome
Title Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Hide Description 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.
Time Frame From Day 0 through Day 8
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Hide Analysis Population Description
[Not Specified]
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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

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

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 delivered by microneedle patch administered by study staff

Placebo

Overall Number of Participants Analyzed 25 25 25 25
Measure Type: Number
Unit of Measure: Reactions
Reactions D1-D7 (pruritus) 20 4 21 4
Reactions D1-D7 (Pain) 5 11 5 2
Reactions D1-D7 (Redness/Erythema) 10 0 10 0
Reactions D1-D7 (Tenderness) 17 15 16 4
Reactions D1-D7 (Nausea) 2 4 2 1
Reactions D1-D7 (Fatigue) 13 10 4 5
Reactions D1-D7 (Headache) 5 7 7 2
Reactions D1-D7 (Swelling/Induration) 4 1 2 0
Reactions D1-D7 (Myalgia) 4 7 1 4
Reactions D1-D7 (Shivering/Shaking) 1 2 0 1
Reactions D1-D7 (Arthralgia) 0 2 3 1
Reactions D1-D7 (Fever) 1 0 0 0
Reactions D1-D7 (Malaise) 4 5 0 1
Reactions D1-D7 (Sweating) 3 5 2 0
2.Primary Outcome
Title Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.
Hide Description [Not Specified]
Time Frame From Day 0 until Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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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

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

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 delivered by microneedle patch administered by study staff

Placebo

Overall Number of Participants Analyzed 25 25 25 25
Measure Type: Number
Unit of Measure: Serious adverse events
0 0 0 0
3.Primary Outcome
Title Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.
Hide Description [Not Specified]
Time Frame From Day 0 until Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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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

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

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 delivered by microneedle patch administered by study staff

Placebo

Overall Number of Participants Analyzed 25 25 25 25
Measure Type: Number
Unit of Measure: Grade 3 adverse events
0 0 0 0
4.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Overall Number of Participants Analyzed 25 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: HAI Antibody Titers (GMT)
A/Christchurch (H1N1)
1197
(854.6 to 1675)
997.3
(703 to 1415)
A/Texas (H3N2)
287
(191.5 to 430.2)
223.2
(159.8 to 311.7)
B/Massachusetts
125.8
(85.92 to 184.1)
94.48
(73.5 to 121.5)
5.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects (seroprotected)
A/Christchurch (H1N1)
100
(85.8 to 100)
100
(86.3 to 100)
A/Texas (H3N2)
100
(85.8 to 100)
100
(86.3 to 100)
B/Massachusetts
96
(78.9 to 99.9)
100
(86.3 to 100)
6.Secondary Outcome
Title 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).
Hide Description Seroconversion 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.
Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects who seroconverted
A/Christchurch (H1N1)
92
(73 to 99)
80
(59.3 to 93.2)
A/Texas (H3N2)
83
(62.6 to 95.3)
76
(54.9 to 90.6)
B/Massachusetts
71
(48.9 to 87.4)
32
(15 to 53.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
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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

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

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 delivered by microneedle patch administered by study staff

Placebo

All-Cause Mortality
IIV Delivered by MN Patch by Study Staff IIV Delivered IM by Study Staff IIV Delivered by MN Patch by Subject Placebo MN Patch by Study Staff
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
IIV Delivered by MN Patch by Study Staff IIV Delivered IM by Study Staff IIV Delivered by MN Patch by Subject Placebo MN Patch by Study Staff
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)      1/25 (4.00%)      0/25 (0.00%)    
Gastrointestinal disorders         
Severe acute enteritis * [1]  0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
severe acute enteritis (i.e. abdominal pain, nausea, and vomiting)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
IIV Delivered by MN Patch by Study Staff IIV Delivered IM by Study Staff IIV Delivered by MN Patch by Subject Placebo MN Patch by Study Staff
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/25 (92.00%)      20/25 (80.00%)      23/25 (92.00%)      12/25 (48.00%)    
Blood and lymphatic system disorders         
Anemia (grade 1)  5/25 (20.00%)  2/25 (8.00%)  1/25 (4.00%)  3/25 (12.00%) 
Decreased absolute lymphocytes (grade 1)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Leukocytosis (grade 1)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Leukopenia (grade 1)  3/25 (12.00%)  1/25 (4.00%)  1/25 (4.00%)  3/25 (12.00%) 
Thrombocytopenia (grade 1)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%) 
Neutropenia (grade 2)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%)  2/25 (8.00%) 
Thrombocytopenia (grade 2)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders         
Gastroenteritis (grade 1)  2/25 (8.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Epigastric pain (grade 1)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Vomiting (grade 2)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%) 
Acute enteritis  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
General disorders         
Swelling/Induration (grade 1)  4/25 (16.00%)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%) 
Redness/Erythema (grade 1)  9/25 (36.00%)  0/25 (0.00%)  8/25 (32.00%)  0/25 (0.00%) 
Tenderness (grade 1)  13/25 (52.00%)  9/25 (36.00%)  14/25 (56.00%)  3/25 (12.00%) 
Pain (grade 1)  5/25 (20.00%)  8/25 (32.00%)  4/25 (16.00%)  2/25 (8.00%) 
Pruritis (itching) (grade 1)  16/25 (64.00%)  3/25 (12.00%)  20/25 (80.00%)  4/25 (16.00%) 
Fatigue  12/25 (48.00%)  7/25 (28.00%)  2/25 (8.00%)  5/25 (20.00%) 
Body ache (myalgia) (grade 1)  4/25 (16.00%)  6/25 (24.00%)  1/25 (4.00%)  3/25 (12.00%) 
Shivering/shaking body movements (grade 1)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%) 
Sweating (grade 1)  3/25 (12.00%)  5/25 (20.00%)  2/25 (8.00%)  0/25 (0.00%) 
Malaise (grade 1)  4/25 (16.00%)  2/25 (8.00%)  0/25 (0.00%)  1/25 (4.00%) 
Nausea (grade 1)  2/25 (8.00%)  3/25 (12.00%)  1/25 (4.00%)  6/25 (24.00%) 
Fever (grade 1)  1/25 (4.00%)  0/25 (0.00%)  6/25 (24.00%)  0/25 (0.00%) 
Joint pain (arthralgia) (grade 1)  0/25 (0.00%)  1/25 (4.00%)  2/25 (8.00%)  1/25 (4.00%) 
Redness/Erythema (grade 2)  1/25 (4.00%)  0/25 (0.00%)  2/25 (8.00%)  0/25 (0.00%) 
Tenderness (grade 2)  4/25 (16.00%)  6/25 (24.00%)  1/25 (4.00%)  1/25 (4.00%) 
Pruritis (grade 2)  3/25 (12.00%)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%) 
Fatigue (grade 2)  12/25 (48.00%)  2/25 (8.00%)  2/25 (8.00%)  0/25 (0.00%) 
Pain (grade 2)  0/25 (0.00%)  3/25 (12.00%)  1/25 (4.00%)  0/25 (0.00%) 
Body ache (myalgia) (grade 2)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%) 
Shivering/shaking Body Movements (grade 2)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Malaise (grade 2)  0/25 (0.00%)  3/25 (12.00%)  3/25 (12.00%)  0/25 (0.00%) 
Joint pain (Arthralgia) (grade 2)  0/25 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%) 
Nausea (grade 2)  0/25 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  1/25 (4.00%) 
Swelling/Induration (grade 2)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Pruritis (grade 3)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Fatigue (grade 3)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Tenderness (grade 3)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Infections and infestations         
URI (grade 1)  1/25 (4.00%)  2/25 (8.00%)  1/25 (4.00%)  1/25 (4.00%) 
Tooth infection (grade 1)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Toe infection (grade 1)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Conjunctivitis (grade 1)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Investigations         
Elevated ALT (grade 1)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  2/25 (8.00%) 
Transaminitis (grade 1)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Elevated CK (grade 1)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Elevated ALT AST (grade 1)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/25 (4.00%) 
Elevated ALT (grade 3)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Elevated AST (grade 4)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Elevated CK (grade 4)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders         
Left elbow tendonitis (grade 1)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Neck pain (grade 1)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Arthralgia (grade 1)  0/25 (0.00%)  1/25 (4.00%)  2/25 (8.00%)  1/25 (4.00%) 
Leg pain (grade 1)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Arthralgia (grade 2)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Left hand bruise (grade 2)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Nervous system disorders         
Headache (grade 1)  0/25 (0.00%)  6/25 (24.00%)  6/25 (24.00%)  0/25 (0.00%) 
Presyncope (grade 1)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Headache (grade 2)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%) 
Headache (grade 3)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Vascular disorders         
Hypertension (grade 1)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Hypertension (grade 2)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Hypertension (grade 3)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Prausnitz, PhD
Organization: Georgia Tech
Phone: 404-894-5135
EMail: prausnitz@gatech.edu
Layout table for additonal information
Responsible Party: Mark Prausnitz, Georgia Institute of Technology
ClinicalTrials.gov Identifier: NCT02438423    
Other Study ID Numbers: 2015 TIV-MNP
First Submitted: May 6, 2015
First Posted: May 8, 2015
Results First Submitted: February 27, 2018
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019