Trial Outcomes & Findings for Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe (NCT NCT01644149)
NCT ID: NCT01644149
Last Updated: 2019-06-20
Results Overview
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
28 days
Results posted on
2019-06-20
Participant Flow
Up to 100 subjects between the ages of 18 and 59 were planned with 83 subjects enrolled and 82 subjects vaccinated. Pre- and post-vaccination serum samples were collected from 78 subjects and were analyzed in the Efficacy population.
A total of 83 subjects were recruited and 78 (39 Stratis® and 39 NS) completed the study. One Stratis® group subject (subject # 23) discontinued from the study prior to vaccination.
Participant milestones
| Measure |
Stratis Jet Injector
Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using the STRATIS needle-free injection device. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region.
STRATIS needle-free injection device
|
Needle-Syringe
Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using a needle and syringe. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region.
Needle-Syringe
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
40
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Stratis Jet Injector
Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using the STRATIS needle-free injection device. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region.
STRATIS needle-free injection device
|
Needle-Syringe
Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using a needle and syringe. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region.
Needle-Syringe
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
Baseline characteristics by cohort
| Measure |
PharmaJet Stratis Injector
n=39 Participants
Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector
Stratis Jet Injector: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
2011-2012 Fluzone trivalent inactivated influenza vaccine
|
Needle and Syringe
n=39 Participants
Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe
Needle and Syringe: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
2011-2012 Fluzone trivalent inactivated influenza vaccine
|
Total
n=78 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
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The immunogenicity analyses were conducted using data from subjects in the immunogenicity population.
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
Outcome measures
| Measure |
Stratis Jet Injector
n=39 Participants
Patients assigned to this arm will receive Fluzone vaccine administered using the PharmaJet (PJ) STRATIS needle-free injection device.
Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.
PJ STRATIS needle-free injection device
|
Needle and Syringe
n=39 Participants
Patients assigned to this arm will receive Fluzone vaccine administered using needle and syringe.
Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.
Needle-Syringe.
|
|---|---|---|
|
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
A/ H1N1 Day 0
|
3.55 Titers
Standard Deviation 1.19
|
3.49 Titers
Standard Deviation 1.28
|
|
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
A H1N1 Day 28
|
6.19 Titers
Standard Deviation 0.98
|
6.13 Titers
Standard Deviation 1.05
|
|
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
A/ H3N2 Day 0
|
3.55 Titers
Standard Deviation 1.30
|
3.49 Titers
Standard Deviation 1.40
|
|
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
A/H3N2 Day 28
|
6.31 Titers
Standard Deviation 1.28
|
6.14 Titers
Standard Deviation 1.16
|
|
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
B Day 0
|
2.57 Titers
Standard Deviation 0.51
|
2.53 Titers
Standard Deviation 0.45
|
|
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
B Day 28
|
4.17 Titers
Standard Deviation 1.00
|
4.17 Titers
Standard Deviation 1.10
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Immunogenicity Population.
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40.
Outcome measures
| Measure |
Stratis Jet Injector
n=39 Participants
Patients assigned to this arm will receive Fluzone vaccine administered using the PharmaJet (PJ) STRATIS needle-free injection device.
Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.
PJ STRATIS needle-free injection device
|
Needle and Syringe
n=39 Participants
Patients assigned to this arm will receive Fluzone vaccine administered using needle and syringe.
Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.
Needle-Syringe.
|
|---|---|---|
|
The Percentage of Participants Achieving Seroconversion
A/H1N1
|
79.5 Percentage of Subjects Seroconverted
|
85.0 Percentage of Subjects Seroconverted
|
|
The Percentage of Participants Achieving Seroconversion
A/H3N2
|
89.7 Percentage of Subjects Seroconverted
|
85.0 Percentage of Subjects Seroconverted
|
|
The Percentage of Participants Achieving Seroconversion
B
|
59.0 Percentage of Subjects Seroconverted
|
65.0 Percentage of Subjects Seroconverted
|
SECONDARY outcome
Timeframe: 4 daysPopulation: Data included in the analysis were collected on a 4-Day Diary Card from the safety population and grade \>1.
Vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus.
Outcome measures
| Measure |
Stratis Jet Injector
n=39 Participants
Patients assigned to this arm will receive Fluzone vaccine administered using the PharmaJet (PJ) STRATIS needle-free injection device.
Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.
PJ STRATIS needle-free injection device
|
Needle and Syringe
n=39 Participants
Patients assigned to this arm will receive Fluzone vaccine administered using needle and syringe.
Fluzone vaccine (2011-2012 formulation): Patients will receive a single 0.5 mL injection of Fluzone vaccine in the deltoid region.
Needle-Syringe.
|
|---|---|---|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Redness
|
61 Percentage of Subjects
|
25 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Headache
|
34 Percentage of Subjects
|
28 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Decreased Appetite
|
16 Percentage of Subjects
|
20 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Fever
|
16 Percentage of Subjects
|
18 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Pruritis
|
24 Percentage of Subjects
|
10 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Tenderness
|
95 Percentage of Subjects
|
80 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Pain
|
68 Percentage of Subjects
|
58 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Swelling
|
50 Percentage of Subjects
|
20 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Itching
|
34 Percentage of Subjects
|
13 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Bruising
|
26 Percentage of Subjects
|
20 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Fatigue
|
34 Percentage of Subjects
|
38 Percentage of Subjects
|
|
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Muscle Aches
|
47 Percentage of Subjects
|
33 Percentage of Subjects
|
Adverse Events
PharmaJet Stratis Injector
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Needle and Syringe
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PharmaJet Stratis Injector
n=39 participants at risk
Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector
Stratis Jet Injector: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
2011-2012 Fluzone trivalent inactivated influenza vaccine
|
Needle and Syringe
n=39 participants at risk
Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe
Needle and Syringe: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
2011-2012 Fluzone trivalent inactivated influenza vaccine
|
|---|---|---|
|
General disorders
Tenderness
|
92.3%
36/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
82.1%
32/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
General disorders
Pain
|
66.7%
26/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
59.0%
23/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
General disorders
Redness
|
59.0%
23/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
25.6%
10/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
General disorders
Swelling
|
48.7%
19/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
20.5%
8/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
General disorders
Itching
|
33.3%
13/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
12.8%
5/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
General disorders
Bruising
|
25.6%
10/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
20.5%
8/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
Immune system disorders
Fatigue
|
33.3%
13/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
38.5%
15/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
46.2%
18/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
33.3%
13/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
Nervous system disorders
Headache
|
33.3%
13/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
28.2%
11/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
Gastrointestinal disorders
Decreased Appetite
|
15.4%
6/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
20.5%
8/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
Nervous system disorders
Fever
|
15.4%
6/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
17.9%
7/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
23.1%
9/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
10.3%
4/39 • Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
|
Additional Information
Marilyn Dysart, Clinical Affairs Manager
PharmaJet, Inc.
Phone: 720-214-9399
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60