Trial Outcomes & Findings for A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age (NCT NCT01258595)
NCT ID: NCT01258595
Last Updated: 2016-05-16
Results Overview
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
300 participants
Primary outcome timeframe
Day 0 and Day 28 post-vaccination
Results posted on
2016-05-16
Participant Flow
Participants were enrolled from 15 November to 10 December 2010 in 4 clinical centers in the US.
A total of 300 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Fluzone® High-Dose Vaccine Group
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
152
|
|
Overall Study
COMPLETED
|
147
|
151
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Fluzone® High-Dose Vaccine Group
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
Baseline characteristics by cohort
| Measure |
Fluzone® High-Dose Vaccine Group
n=148 Participants
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
n=152 Participants
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 4.38 • n=99 Participants
|
57.7 Years
STANDARD_DEVIATION 4.14 • n=107 Participants
|
57.7 Years
STANDARD_DEVIATION 4.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
148 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Serum antibody titers to vaccine antigens were assessed in the full analysis set population.
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Outcome measures
| Measure |
Fluzone® High-Dose Vaccine Group
n=147 Participants
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
n=152 Participants
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
A/H1N1: California - Pre-vaccination (N=147, 152)
|
40.5 1/dilution (1/dil)
Interval 30.0 to 54.5
|
28.8 1/dilution (1/dil)
Interval 21.8 to 38.1
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
A/H3N2: Victoria - Pre-vaccination (N=147, 152)
|
36.4 1/dilution (1/dil)
Interval 28.0 to 47.4
|
41.4 1/dilution (1/dil)
Interval 31.4 to 54.6
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
B: Brisbane - Post-vaccination (N=145, 151)
|
203 1/dilution (1/dil)
Interval 171.0 to 241.0
|
127 1/dilution (1/dil)
Interval 104.0 to 154.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
B: Brisbane - Pre-vaccination (N=147, 152)
|
27.4 1/dilution (1/dil)
Interval 22.4 to 33.6
|
28.9 1/dilution (1/dil)
Interval 23.5 to 35.5
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
A/H1N1: California - Post-vaccination (N=145, 151)
|
1067 1/dilution (1/dil)
Interval 868.0 to 1312.0
|
745 1/dilution (1/dil)
Interval 585.0 to 948.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
A/H3N2: Victoria - Post-vaccination (N = 145, 151)
|
936 1/dilution (1/dil)
Interval 745.0 to 1176.0
|
567 1/dilution (1/dil)
Interval 459.0 to 699.0
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 Post-vaccinationPopulation: Serum antibody titers to vaccine antigens were assessed in the full analysis set population.
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Outcome measures
| Measure |
Fluzone® High-Dose Vaccine Group
n=145 Participants
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
n=151 Participants
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H1N1: California
|
21.8 1/dilution (1/dil)
Interval 16.1 to 29.6
|
21.2 1/dilution (1/dil)
Interval 15.8 to 28.4
|
|
Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H3N2: Victoria
|
22.0 1/dilution (1/dil)
Interval 17.2 to 28.1
|
12.0 1/dilution (1/dil)
Interval 9.21 to 15.5
|
|
Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
B: Brisbane
|
6.27 1/dilution (1/dil)
Interval 5.16 to 7.62
|
3.91 1/dilution (1/dil)
Interval 3.17 to 4.83
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Seroconversion to the vaccine antigens was assessed in the full analysis set population.
Seroconversion: For participants with a Day 0 (pre-vaccination) titer \< 10 (1/dilution \[1/dil\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Outcome measures
| Measure |
Fluzone® High-Dose Vaccine Group
n=145 Participants
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
n=151 Participants
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H3N2: Victoria
|
89 Percentage of Participants
|
76 Percentage of Participants
|
|
Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
B: Brisbane
|
64 Percentage of Participants
|
41 Percentage of Participants
|
|
Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H1N1: California
|
78 Percentage of Participants
|
78 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post vaccinationPopulation: Seroprotection was assessed in the full analysis set population.
Seroprotection was defined as a titer ≥ 40 (1/dilution \[1/dil\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Outcome measures
| Measure |
Fluzone® High-Dose Vaccine Group
n=147 Participants
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
n=152 Participants
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H1N1: California - Pre-vaccination (N=147, 152)
|
50 Percentage of Participants
|
41 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H3N2: Victoria - Pre-vaccination (N=147, 152)
|
50 Percentage of Participants
|
51 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
B: Brisbane - Pre-vaccination (N=147, 152)
|
46 Percentage of Participants
|
47 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H1N1: California - Post-vaccination (N=145, 151)
|
100 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
A/H3N2: Victoria - Post-vaccination (N=145, 151)
|
99 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
B: Brisbane - Post-vaccination (N=145, 151)
|
97 Percentage of Participants
|
87 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 0 through Day 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering
Outcome measures
| Measure |
Fluzone® High-Dose Vaccine Group
n=147 Participants
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
n=152 Participants
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Shivering
|
29 Participants
|
21 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Shivering (Prevents daily activity)
|
7 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grad 3 Injection site Pain-Prevents daily activity
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Injection Site Erythema
|
11 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Injection Site Erythema (>100 mm)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Injection Site Swelling
|
9 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Injection Site Swelling (>100 mm)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Injection Site Induration (>100 mm)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Myalgia
|
70 Participants
|
46 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Myalgia (Prevents daily activity)
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Injection Site Pain
|
112 Participants
|
85 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Injection Site Ecchymosis
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Injection Site Ecchymosis (>100 mm)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Injection Site Induration
|
13 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Headache
|
46 Participants
|
40 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Headache (Prevents daily activity)
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Any Malaise
|
44 Participants
|
38 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Grade 3 Malaise (Prevents daily activity)
|
10 Participants
|
5 Participants
|
Adverse Events
Fluzone® High-Dose Vaccine Group
Serious events: 0 serious events
Other events: 130 other events
Deaths: 0 deaths
Fluzone® Vaccine Group
Serious events: 0 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluzone® High-Dose Vaccine Group
n=148 participants at risk
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
|
Fluzone® Vaccine Group
n=152 participants at risk
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
|
|---|---|---|
|
General disorders
Solicited Injection Site Pain
|
75.7%
112/148 • Number of events 112 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
55.9%
85/152 • Number of events 85 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
General disorders
Solicited Injection Site Erythema
|
7.5%
11/147 • Number of events 11 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
1.3%
2/152 • Number of events 2 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
General disorders
Solicited Injection Site Swelling
|
6.1%
9/147 • Number of events 9 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
1.3%
2/152 • Number of events 2 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
General disorders
Solicited Injection Site Induration
|
8.8%
13/147 • Number of events 13 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
2.0%
3/152 • Number of events 3 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
General disorders
Solicited Malaise
|
29.9%
44/147 • Number of events 44 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
25.0%
38/152 • Number of events 38 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
General disorders
Solicited Shivering
|
19.7%
29/147 • Number of events 29 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
13.8%
21/152 • Number of events 21 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Solicited Myalgia
|
47.6%
70/147 • Number of events 70 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
30.3%
46/152 • Number of events 46 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
Nervous system disorders
Solicited Headache
|
31.3%
46/147 • Number of events 46 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
26.3%
40/152 • Number of events 40 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
11/148 • Number of events 11 • Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
|
5.3%
8/152 • Number of events 8 • Adverse events data were collected from the day of vaccination through 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