Trial Outcomes & Findings for A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination (NCT NCT00835926)
NCT ID: NCT00835926
Last Updated: 2016-04-14
Results Overview
Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
Days 0 to 3 Post-vaccination
Results posted on
2016-04-14
Participant Flow
Participants were enrolled and treated from 25 July 2003 to 26 August 2003 at 1 US site.
A total of 121 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Fluzone® Vaccine Group 1
Participants were 18 to 59 years old at enrollment in the study
|
Fluzone® Vaccine Group 2
Participants were 60 years or older at enrollment in the study
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
COMPLETED
|
61
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
Baseline characteristics by cohort
| Measure |
Fluzone® Vaccine Group 1
n=61 Participants
Participants were 18 to 59 years old at enrollment in the study
|
Fluzone® Vaccine Group 2
n=60 Participants
Participants were 60 years or older at enrollment in the study
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Continuous
Age Continuous
|
40.7 Years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
73.7 Years
STANDARD_DEVIATION 6.16 • n=7 Participants
|
57.1 Years
STANDARD_DEVIATION 18.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
60 participants
n=7 Participants
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 3 Post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia
Outcome measures
| Measure |
Fluzone® Vaccine Group 1
n=61 Participants
Participants were 18 to 59 years old at enrollment in the study
|
Fluzone® Vaccine Group 2
n=60 Participants
Participants were 60 years or older at enrollment in the study
|
|---|---|---|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Erythema
|
15 Percentage of Participants
|
7 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Erythema (> 5 cm)
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Induration
|
20 Percentage of Participants
|
12 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Induration (> 5 cm)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Bruising
|
10 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Bruising (> 5 cm)
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Pain
|
75 Percentage of Participants
|
12 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Pain (Decreased ability to move arm)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Fever
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Fever (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Chills
|
5 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Chills (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Rash
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Rash (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Headache
|
23 Percentage of Participants
|
7 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Headache (Incapacitating)
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Cough
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Cough (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Runny Nose
|
5 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Runny Nose (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Nausea
|
7 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Nausea (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Vomiting
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Vomiting (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Diarrhea
|
3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Diarrhea (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Malaise
|
10 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Malaise (Incapacitating)
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Myalgia
|
13 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Myalgia (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Any Arthralgia
|
5 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Grade 3 Arthralgia (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 Post-vaccinationPopulation: The Geometric mean titers were analyzed in the per-protocol immunogenicity population.
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Outcome measures
| Measure |
Fluzone® Vaccine Group 1
n=61 Participants
Participants were 18 to 59 years old at enrollment in the study
|
Fluzone® Vaccine Group 2
n=60 Participants
Participants were 60 years or older at enrollment in the study
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
A/Panama/2007/99 Pre-Dose
|
29.6 Titers
Interval 22.6 to 38.7
|
20.4 Titers
Interval 15.9 to 26.2
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
A/Panama/2007/99 Post-Dose
|
67.1 Titers
Interval 50.7 to 88.7
|
37.5 Titers
Interval 29.5 to 47.7
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
A/New Caledonia/20/99 Pre-Dose
|
18.3 Titers
Interval 13.6 to 24.7
|
9.5 Titers
Interval 7.7 to 11.6
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
A/New Caledonia/20/99 Post-Dose
|
46.3 Titers
Interval 34.3 to 62.5
|
15.1 Titers
Interval 12.1 to 18.9
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
B/Hong Kong/1434/2002 Pre-Dose
|
10.7 Titers
Interval 8.6 to 13.3
|
8.2 Titers
Interval 6.8 to 9.7
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
B/Hong Kong/1434/2002 Post-Dose
|
27.8 Titers
Interval 22.1 to 34.9
|
15.9 Titers
Interval 12.6 to 20.1
|
PRIMARY outcome
Timeframe: Day 21 Post-vaccinationPopulation: The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population.
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Outcome measures
| Measure |
Fluzone® Vaccine Group 1
n=61 Participants
Participants were 18 to 59 years old at enrollment in the study
|
Fluzone® Vaccine Group 2
n=60 Participants
Participants were 60 years or older at enrollment in the study
|
|---|---|---|
|
Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
A/Panama/2007/99
|
28 Percentage of Participants
|
18 Percentage of Participants
|
|
Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
A/New Caledonia/20/99
|
30 Percentage of Participants
|
8 Percentage of Participants
|
|
Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
B/Hong Kong/1434/2002
|
38 Percentage of Participants
|
22 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 21 Post-vaccinationPopulation: The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population.
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay
Outcome measures
| Measure |
Fluzone® Vaccine Group 1
n=61 Participants
Participants were 18 to 59 years old at enrollment in the study
|
Fluzone® Vaccine Group 2
n=60 Participants
Participants were 60 years or older at enrollment in the study
|
|---|---|---|
|
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
A/Panama/2007/99
|
74 Percentage of Participants
|
60 Percentage of Participants
|
|
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
A/New Caledonia/20/99
|
62 Percentage of Participants
|
25 Percentage of Participants
|
|
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
B/Hong Kong/1434/2002
|
41 Percentage of Participants
|
25 Percentage of Participants
|
Adverse Events
Fluzone® Vaccine Group 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Fluzone® Vaccine Group 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluzone® Vaccine Group 1
n=61 participants at risk
Participants were 18 to 59 years old at enrollment in the study
|
Fluzone® Vaccine Group 2
n=60 participants at risk
Participants were 60 years or older at enrollment in the study
|
|---|---|---|
|
Nervous system disorders
Headache
|
13.1%
8/61 • Number of events 12 • 6 months
|
3.3%
2/60 • Number of events 2 • 6 months
|
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