Trial Outcomes & Findings for A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination (NCT NCT00743275)
NCT ID: NCT00743275
Last Updated: 2016-05-16
Results Overview
Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
Days 0-3 post-vaccination
Results posted on
2016-05-16
Participant Flow
Participants were enrolled from 26 August to 03 September 2008 at one US clinical center.
A total of 122 participants who met the inclusion and exclusion criteria were enrolled. Of these, 120 participants were vaccinated.
Participant milestones
| Measure |
Age 18-60 Years
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
Participants received one dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
|
Overall Study
COMPLETED
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Age 18-60 Years
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
Participants received one dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
Baseline characteristics by cohort
| Measure |
Age 18-60 Years
n=59 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
n=61 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Age, Continuous
|
43.2 Years
STANDARD_DEVIATION 12.14 • n=93 Participants
|
74.7 Years
STANDARD_DEVIATION 7.67 • n=4 Participants
|
59.2 Years
STANDARD_DEVIATION 18.74 • n=27 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=93 Participants
|
61 participants
n=4 Participants
|
120 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 0-3 post-vaccinationPopulation: Safety profile was assessed in the intent-to-treat (ITT) population
Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Outcome measures
| Measure |
Age 18-60 Years
n=59 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
n=61 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Solicited Injection Site Reaction
|
35 Participants
|
18 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Pain
|
34 Participants
|
16 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Pain (Incapacitating)
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Erythema (Redness)
|
7 Participants
|
2 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Erythema (Redness)
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Swelling
|
4 Participants
|
1 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Swelling (≥ 5 cm)
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Induration
|
5 Participants
|
1 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Induration (≥ 5 cm)
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Ecchymosis
|
2 Participants
|
1 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Ecchymosis (≥ 5 cm)
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Solicited Systemic Reaction
|
25 Participants
|
14 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Fever (> 102.2 ºF)
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Headache
|
17 Participants
|
6 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Headache
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Malaise
|
9 Participants
|
2 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Malaise (Prevents daily activities)
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Myalgia
|
19 Participants
|
10 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Myalgia (Prevents daily activities)
|
1 Participants
|
1 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Any Shivering
|
4 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Grade 3 Shivering (Prevents daily activities)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 and 21 days post-vaccinationPopulation: Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)
Outcome measures
| Measure |
Age 18-60 Years
n=50 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
n=49 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
A/Brisbane/59/2007 (H1N1) IVR-148 Pre-dose
|
26.9 Titers
Interval 18.8 to 38.6
|
16.9 Titers
Interval 13.3 to 21.4
|
|
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
A/Uruguay (H3N2) X-175-C Pre-dose
|
34.9 Titers
Interval 22.5 to 54.2
|
31.5 Titers
Interval 21.5 to 46.0
|
|
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
B/Florida/04/2006 Pre-dose
|
28.5 Titers
Interval 21.0 to 38.6
|
21.6 Titers
Interval 16.6 to 28.1
|
|
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
A/Brisbane/59/2007 (H1N1) IVR-148 Post-dose
|
130.9 Titers
Interval 91.1 to 188.1
|
46.1 Titers
Interval 35.0 to 60.7
|
|
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
A/Uruguay (H3N2) X-175-C Post-dose
|
528.7 Titers
Interval 351.1 to 796.3
|
300.3 Titers
Interval 217.9 to 413.7
|
|
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
B/Florida/04/2006 Post-dose
|
84.0 Titers
Interval 64.9 to 108.6
|
56.2 Titers
Interval 40.9 to 77.2
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)
Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
Outcome measures
| Measure |
Age 18-60 Years
n=50 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
n=49 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
A/Brisbane/59/2007 (H1N1) IVR-148
|
88 Percentage of Participants
|
63 Percentage of Participants
|
|
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
A/Uruguay (H3N2) X-175-C
|
98 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
B/Florida/04/2006
|
82 Percentage of Participants
|
67 Percentage of Participants
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)
Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is \< 10, then 10 is used as the baseline value for the purposes of this calculation
Outcome measures
| Measure |
Age 18-60 Years
n=50 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
n=49 Participants
Participants received one dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
B/Florida/04/2006
|
36 Percentage of Participants
|
31 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
A/Brisbane/59/2007 (H1N1) IVR-148
|
42 Percentage of Participants
|
33 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
A/Uruguay (H3N2) X 175-C
|
77 Percentage of Participants
|
84 Percentage of Participants
|
Adverse Events
Age 18-60 Years
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Age 61 Years and Older
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Age 18-60 Years
n=59 participants at risk
Participants received one dose of Fluzone® vaccine on Day 0.
|
Age 61 Years and Older
n=61 participants at risk
Participants received one dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
5/59 • Number of events 5 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
0.00%
0/61 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
4/59 • Number of events 4 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
0.00%
0/61 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
10.2%
6/59 • Number of events 6 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.1%
3/59 • Number of events 3 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
General disorders
Injection site pain
|
57.6%
34/59 • Number of events 34 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
26.2%
16/61 • Number of events 16 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
General disorders
Injection site erythema
|
11.9%
7/59 • Number of events 7 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
3.3%
2/61 • Number of events 2 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
General disorders
Injection site swelling
|
6.8%
4/59 • Number of events 4 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
General disorders
Injection site induration
|
8.5%
5/59 • Number of events 5 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
Nervous system disorders
Headache
|
28.8%
17/59 • Number of events 17 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
9.8%
6/61 • Number of events 6 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
General disorders
Malaise
|
15.3%
9/59 • Number of events 9 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
3.3%
2/61 • Number of events 2 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.2%
19/59 • Number of events 19 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
16.4%
10/61 • Number of events 10 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
|
General disorders
Chills
|
6.8%
4/59 • Number of events 4 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
0.00%
0/61 • Adverse events data were collected throughout the study from Day 0 to Day 21.
|
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