Trial Outcomes & Findings for Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects (NCT NCT00388583)
NCT ID: NCT00388583
Last Updated: 2012-04-18
Results Overview
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
817 participants
Primary outcome timeframe
Pre-vaccination and Day 28 post-vaccination
Results posted on
2012-04-18
Participant Flow
Participants were enrolled from 28 September 2006 through 30 May 2007 in 16 clinics in the US
A total of 816 of the 817 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on the 807 participants that completed the study are presented.
Participant milestones
| Measure |
Fluzone Intradermal (ID) Vaccine Group
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
Overall Study
STARTED
|
407
|
410
|
|
Overall Study
COMPLETED
|
401
|
406
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Fluzone Intradermal (ID) Vaccine Group
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Serious Adverse Event
|
2
|
0
|
|
Overall Study
Did not receive vaccine
|
0
|
1
|
Baseline Characteristics
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
Baseline characteristics by cohort
| Measure |
Fluzone ID Vaccine Group
n=401 Participants
Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
|
Fluzone IM Vaccine Group
n=406 Participants
Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
|
Total
n=807 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
401 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
807 Participants
n=5 Participants
|
|
Age Continuous
|
72.8 Years
STANDARD_DEVIATION 6.08 • n=5 Participants
|
72.3 Years
STANDARD_DEVIATION 5.83 • n=7 Participants
|
72.5 Years
STANDARD_DEVIATION 5.955 • n=5 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
401 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
807 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination and Day 28 post-vaccinationPopulation: Immunogenicity determination was in all per protocol population
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Outcome measures
| Measure |
Fluzone Intradermal (ID) Vaccine Group
n=401 Participants
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
n=406 Participants
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
A/H1N1 Serogroup (N = 400, 406)
|
119 Participants
|
105 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
A/H3N2 Serogroup (N = 398, 404)
|
235 Participants
|
222 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
B Serogroup (N = 400, 405)
|
105 Participants
|
103 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Immunogenicity determination was in all per protocol population
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
Outcome measures
| Measure |
Fluzone Intradermal (ID) Vaccine Group
n=401 Participants
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
n=406 Participants
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
A/H1N1 Serogroup (N = 400, 406)
|
303 Participants
|
292 Participants
|
|
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
A/H3N2 Serogroup (N = 398, 405)
|
391 Participants
|
389 Participants
|
|
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
B Serogroup (N = 400, 406)
|
200 Participants
|
213 Participants
|
SECONDARY outcome
Timeframe: Pre- and Day 28 post-vaccinationPopulation: Immunogenicity determination was in all per protocol population
The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Outcome measures
| Measure |
Fluzone Intradermal (ID) Vaccine Group
n=401 Participants
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
n=406 Participants
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
A/H1N1 Serogroup (Pre-vaccination)
|
27.46 Titers
Interval 24.81 to 30.4
|
24.86 Titers
Interval 22.33 to 27.69
|
|
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
A/H1N1 Serogroup (Post-vaccination)
|
71.17 Titers
Interval 63.93 to 79.22
|
59.04 Titers
Interval 53.27 to 65.42
|
|
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
A/H3N2 Serogroup (Pre-vaccination)
|
75.95 Titers
Interval 65.42 to 88.17
|
64.95 Titers
Interval 55.91 to 75.45
|
|
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
A/H3N2 Serogroup (Post-vaccination)
|
500.65 Titers
Interval 442.4 to 566.56
|
360.42 Titers
Interval 317.68 to 408.91
|
|
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
B Serogroup (Pre-vaccination)
|
13.11 Titers
Interval 12.08 to 14.22
|
12.95 Titers
Interval 11.93 to 14.05
|
|
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
B Serogroup (Post-vaccination)
|
35.06 Titers
Interval 31.91 to 38.53
|
35.77 Titers
Interval 32.44 to 39.44
|
SECONDARY outcome
Timeframe: Day 0 up to 7 days post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population
Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
Fluzone Intradermal (ID) Vaccine Group
n=407 Participants
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
n=409 Participants
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Gr 3 Solicited Headache- Prevents daily activities
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Injection Site Pain
|
105 Participants
|
98 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grade 3 Injection Site Pain (Incapacitating)
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Injection Site Erythema
|
282 Participants
|
49 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grade 3 Injection Site Erythema (≥ 5 cm)
|
39 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Injection Site Swelling
|
186 Participants
|
20 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grade 3 Injection Site Swelling (≥ 5 cm)
|
17 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Injection Site Induration
|
178 Participants
|
17 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grade 3 Injection Site Induration (≥ 5 cm)
|
12 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Injection Site Ecchymosis
|
23 Participants
|
12 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grade 3 Injection Site Ecchymosis (Incapacitating)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Injection Site Pruritus
|
137 Participants
|
23 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grade 3 Injection Site Pruritus (Incapacitating)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Solicited Fever
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grade 3 Solicited Fever (>102.2°F)
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Solicited Headache
|
69 Participants
|
63 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Solicited Malaise
|
57 Participants
|
41 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grd 3 Solicited Malaise- Prevents daily activities
|
3 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Any Solicited Myalgia
|
68 Participants
|
56 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Grd 3 Solicited Myalgia- Prevents daily activities
|
4 Participants
|
0 Participants
|
Adverse Events
Fluzone Intradermal (ID) Vaccine Group
Serious events: 33 serious events
Other events: 282 other events
Deaths: 0 deaths
Fluzone Intramuscular (IM) Vaccine Group
Serious events: 34 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone Intradermal (ID) Vaccine Group
n=407 participants at risk
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
n=409 participants at risk
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
2/407 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Infections and infestations
Incision site infection
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Chest Pain
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Infections and infestations
Bronchitis acute
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.25%
1/407 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.49%
2/407 • Number of events 4 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.49%
2/409 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.25%
1/407 • Number of events 4 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.25%
1/407 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.74%
3/407 • Number of events 7 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Angina pectoris
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Diverticulum
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.49%
2/409 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/407 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Vascular disorders
Leriche syndrome
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
—
0/0 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the skin
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
—
0/0 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Surgical and medical procedures
Transuerethral prostatectomy
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Device electric finding
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus non insulin dependent
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.00%
0/409 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Chest pain
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.49%
2/409 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/407 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
0.24%
1/409 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
Other adverse events
| Measure |
Fluzone Intradermal (ID) Vaccine Group
n=407 participants at risk
Participants received a dose of Fluzone Intradermal vaccine on Day 0
|
Fluzone Intramuscular (IM) Vaccine Group
n=409 participants at risk
Participants received a dose of Fluzone Intramuscular vaccine on Day 0
|
|---|---|---|
|
General disorders
Vessel puncture site bruise
|
5.7%
23/407 • Number of events 23 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
3.7%
15/409 • Number of events 15 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited injection site pain
|
26.1%
105/402 • Number of events 105 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
24.0%
98/409 • Number of events 98 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited injection site erythema
|
70.1%
282/402 • Number of events 282 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
12.0%
49/409 • Number of events 49 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited injection site induration
|
44.5%
178/400 • Number of events 178 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
4.2%
17/409 • Number of events 17 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited injection site ecchymosis
|
5.8%
23/400 • Number of events 23 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
2.9%
12/409 • Number of events 12 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited injection site pruritus
|
34.1%
137/402 • Number of events 137 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
5.6%
23/409 • Number of events 23 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
Nervous system disorders
Solicited headache (Pyrexia)
|
17.2%
69/402 • Number of events 69 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
15.4%
63/409 • Number of events 63 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited malaise
|
14.2%
57/402 • Number of events 57 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
10.0%
41/409 • Number of events 41 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited myalgia
|
16.9%
68/402 • Number of events 68 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
13.7%
56/409 • Number of events 56 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
|
General disorders
Solicited injection site swelling
|
46.3%
186/402 • Number of events 186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
4.9%
20/409 • Number of events 20 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER