Trial Outcomes & Findings for Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV (NCT NCT00539864)
NCT ID: NCT00539864
Last Updated: 2011-07-27
Results Overview
Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
602 participants
Primary outcome timeframe
Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization
Results posted on
2011-07-27
Participant Flow
Subjects 50 - \<64 years of age were screened in participating outpatient clinics for eligibility within 30 days of randomization during the 2007 influenza season.
Subjects whose laboratory values were exclusionary were not randomized. Women of child-bearing potential were required to have a negative pregnancy test.
Participant milestones
| Measure |
FluBlok
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
302
|
|
Overall Study
COMPLETED
|
299
|
300
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
FluBlok
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
Baseline characteristics by cohort
| Measure |
FluBlok
n=300 Participants
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
n=302 Participants
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
Total
n=602 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
|
300 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
602 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
55.9 years
STANDARD_DEVIATION 3.71 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 3.64 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 3.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
300 participants
n=5 Participants
|
302 participants
n=7 Participants
|
602 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunizationPopulation: Safety population included all randomized subjects who received a dose of study vaccine.
Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.
Outcome measures
| Measure |
FluBlok
n=300 Participants
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
n=302 Participants
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Fatigue
|
40 participants
|
62 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Chills
|
12 participants
|
15 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Arthralgias
|
15 participants
|
19 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Myalgia
|
40 participants
|
63 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Headache
|
59 participants
|
63 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Nausea
|
13 participants
|
15 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Injection Site Pain
|
154 participants
|
165 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Injection Site Bruising
|
16 participants
|
14 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Injection Site Erythema
|
24 participants
|
25 participants
|
|
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Injection Site Swelling
|
25 participants
|
30 participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 28Population: All randomized subjects who received study vaccine and had Day 0 and Day 28 HAI titers
Immunogenicity was assessed by measuring the difference in values in Hemagglutination-Inhibition Assay (HAI) titers in participants from Day 0 to Day 28, using Geometric Mean Titers (GMTs). The GMTs from the FluBlok and TIV groups were then compared.
Outcome measures
| Measure |
FluBlok
n=299 Participants
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
n=302 Participants
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
A/Solomon Islands (H1N1) - Day 0
|
28.71 HAI Titers
Interval 25.59 to 32.21
|
27.77 HAI Titers
Interval 25.07 to 30.76
|
|
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
A/Solomon Islands (H1N1) - Day 28
|
181.34 HAI Titers
Interval 159.61 to 206.02
|
139.74 HAI Titers
Interval 124.64 to 156.66
|
|
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
A/Wisconsin (H3N2) - Day 0
|
18.57 HAI Titers
Interval 16.37 to 21.06
|
18.20 HAI Titers
Interval 16.07 to 20.62
|
|
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
A/Wisconsin (H3N2) - Day 28
|
105.41 HAI Titers
Interval 91.01 to 122.09
|
60.88 HAI Titers
Interval 53.58 to 69.18
|
|
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
B/Malaysia - Day 0
|
48.49 HAI Titers
Interval 43.38 to 54.19
|
49.18 HAI Titers
Interval 43.77 to 55.25
|
|
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
B/Malaysia - Day 28
|
110.93 HAI Titers
Interval 100.07 to 122.97
|
116.03 HAI Titers
Interval 104.16 to 129.25
|
SECONDARY outcome
Timeframe: Day 28 following immunization at Day 0Population: All randomized subjects who received study vaccine and who had day 0 and day 28 HAI titers
Percentage of participants with greater than or equal to a 4-fold rise in Hemagglutination-Inhibition Assay (HAI) titer over Day 0 at Day 28 following immunization
Outcome measures
| Measure |
FluBlok
n=100 % of participants
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
n=100 % of participants
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Percentage of Participants With Seroconversion
A/Solomon Islands (H1N1)
|
72 Percentage of participants
Interval 66.8 to 77.2
|
66 Percentage of participants
Interval 60.6 to 71.5
|
|
Percentage of Participants With Seroconversion
A/Wisconsin (H3N2)
|
61 Percentage of participants
Interval 55.4 to 66.8
|
44 Percentage of participants
Interval 38.0 to 69.2
|
|
Percentage of Participants With Seroconversion
B/Malaysia
|
41 Percentage of participants
Interval 35.2 to 46.6
|
41 Percentage of participants
Interval 35.5 to 46.8
|
SECONDARY outcome
Timeframe: Day 28 following immunization at Day 0Percentage of participants with (HAI titer greater than or equal to 40) at Day 28
Outcome measures
| Measure |
FluBlok
n=300 Participants
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
n=302 Participants
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Percentage of Participants With Seroprotection
Influenza A/Solomon Islands (H1N1)
|
96 Percentage of participants
Interval 93.5 to 98.1
|
96 Percentage of participants
Interval 92.8 to 97.7
|
|
Percentage of Participants With Seroprotection
Influenza A/Wisconsin (H3N2)
|
85 Percentage of participants
Interval 80.8 to 89.1
|
75 Percentage of participants
Interval 69.9 to 79.9
|
|
Percentage of Participants With Seroprotection
Influenza B/Malaysia
|
93 Percentage of participants
Interval 89.5 to 95.6
|
94 Percentage of participants
Interval 91.1 to 96.7
|
Adverse Events
FluBlok
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
TIV (Fluzone)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FluBlok
n=300 participants at risk
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
n=302 participants at risk
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Cardiac disorders
Vasovagal Syncope
|
0.33%
1/300 • Number of events 1 • All AEs - 28 days following immunization; SAEs for duration of influenza season.
|
0.00%
0/302 • All AEs - 28 days following immunization; SAEs for duration of influenza season.
|
Other adverse events
| Measure |
FluBlok
n=300 participants at risk
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total
|
TIV (Fluzone)
n=302 participants at risk
Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.3%
4/300 • Number of events 4 • All AEs - 28 days following immunization; SAEs for duration of influenza season.
|
3.0%
9/302 • Number of events 9 • All AEs - 28 days following immunization; SAEs for duration of influenza season.
|
Additional Information
Lisa M. Dunkle, M.D., Chief Medical Officer
Protein Sciences Corporation
Phone: 203-599-6064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place