Trial Outcomes & Findings for Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine (NCT NCT00258830)
NCT ID: NCT00258830
Last Updated: 2016-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
Day 0 to 3 post-vaccination
Results posted on
2016-04-14
Participant Flow
Study participants were enrolled from 09 September to 18 October 2005 in one medical clinic in the US
A total of 120 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Age 18 to 59 Years
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Age 60 Years and Older
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
Baseline characteristics by cohort
| Measure |
Age 18 to 59 Years
n=60 Participants
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Age 60 Years and Older
n=60 Participants
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Total
n=120 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
|
59 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
75.7 Years
STANDARD_DEVIATION 6.24 • n=7 Participants
|
59.3 Years
STANDARD_DEVIATION 18.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 3 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated subjects intent-to-treat safety population with available reaction data.
Outcome measures
| Measure |
Age 18 to 59 Years
n=60 Participants
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Age 60 Years and Older
n=60 Participants
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Grade 3 Myalgia (Prevents daily activity)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Solicited Injection Site Reaction
|
40 Participants
|
10 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Erythema
|
4 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Grade 3 Erythema (≥ 5.0 cm)
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Swelling
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Grade 3 Swelling (≥ 5.0 cm)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Pain
|
39 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Grade 3 Pain (Unable to perform usual activities)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Solicited Systemic Reaction
|
25 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Fever
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Grade 3 Fever (≥ 102.3°F)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Headache
|
12 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Grade 3 Headache (Prevents daily activity)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Malaise
|
7 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Grade 3 Malaise (Prevents daily activity)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Any Myalgia
|
13 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: GMT results were assessed on the per-protocol population.
GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)
Outcome measures
| Measure |
Age 18 to 59 Years
n=60 Participants
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Age 60 Years and Older
n=60 Participants
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
A/New Caledonia/20/99 (H1N1), Pre
|
51.8 Titer
Interval 35.9 to 74.8
|
34.8 Titer
Interval 27.7 to 43.8
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
A/New Caledonia/20/99 (H1N1), Post
|
153.6 Titer
Interval 113.8 to 207.2
|
59.3 Titer
Interval 45.9 to 76.6
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
A/New York/55/2004 (H3N2), Pre
|
23.9 Titer
Interval 18.2 to 31.5
|
23.1 Titer
Interval 16.8 to 31.9
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
A/New York/55/2004 (H3N2), Post
|
341.0 Titer
Interval 241.0 to 482.5
|
174.5 Titer
Interval 116.8 to 260.7
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
B/Jiangsu/10/2003, Pre
|
25.9 Titer
Interval 19.4 to 34.6
|
42.6 Titer
Interval 33.3 to 54.6
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
B/Jiangsu/10/2003, Post
|
126.5 Titer
Interval 93.0 to 172.1
|
104.8 Titer
Interval 78.3 to 140.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 Days post-vaccinationPopulation: Seroprotection was assessed in the per-protocol population
Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.
Outcome measures
| Measure |
Age 18 to 59 Years
n=60 Participants
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Age 60 Years and Older
n=60 Participants
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
|---|---|---|
|
Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.
A/New Caledonia/20/99 (H1N1) ≥ 40
|
90 Percentage of participants
|
71 Percentage of participants
|
|
Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.
A/New York/55/2004 (H3N2) ≥ 40
|
95 Percentage of participants
|
83 Percentage of participants
|
|
Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.
B/Jiangsu/10/2003 ≥ 40
|
86 Percentage of participants
|
83 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 21 post-vaccinationPopulation: Seroconversion was assessed in the per-protocol population.
Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.
Outcome measures
| Measure |
Age 18 to 59 Years
n=60 Participants
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Age 60 Years and Older
n=60 Participants
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
|---|---|---|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination
A/New Caledonia/20/99 (H1N1) ≥ 4 fold-rise
|
29 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination
A/New York/55/2004 (H3N2) ≥ 4 fold-rise
|
93 Percentage of participants
|
67 Percentage of participants
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination
B/Jiangsu/10/2003 ≥ 4 fold-rise
|
54 Percentage of participants
|
27 Percentage of participants
|
Adverse Events
Age 18 to 59 Years
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Age 60 Years and Older
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Age 18 to 59 Years
n=60 participants at risk
Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
Age 60 Years and Older
n=60 participants at risk
Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/60 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
6.7%
4/60 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
4/60 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
1.7%
1/60 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
3/60 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
0.00%
0/60 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
|
Nervous system disorders
Headache
|
20.0%
12/60 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
0.00%
0/60 • Adverse events data were collected from the day of vaccination for 28 days 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