Trial Outcomes & Findings for Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation) (NCT NCT01959945)
NCT ID: NCT01959945
Last Updated: 2016-09-23
Results Overview
Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
219 participants
Primary outcome timeframe
Day 0 up to Day 28 post vaccination
Results posted on
2016-09-23
Participant Flow
The randomized population (219 subjects) includes all subjects who were randomized and the safety population (217 subjects) includes all randomized subjects who received any dose of study vaccine and provided any safety. Two (2) randomized subjects did not fit the criteria to be included in the safety population and were excluded from the analysis.
Participant milestones
| Measure |
Study Group 1, Flublok Cohort A
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
78
|
28
|
31
|
|
Overall Study
COMPLETED
|
76
|
75
|
9
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
19
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)
Baseline characteristics by cohort
| Measure |
Study Group 1, Flublok Cohort A
n=80 Participants
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
n=78 Participants
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
n=28 Participants
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
n=31 Participants
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
9-17 years
|
80 participants
n=99 Participants
|
78 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
158 participants
n=31 Participants
|
|
Age, Customized
6-8 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
28 participants
n=206 Participants
|
31 participants
n=7 Participants
|
59 participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
111 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
106 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=99 Participants
|
78 participants
n=107 Participants
|
28 participants
n=206 Participants
|
31 participants
n=7 Participants
|
217 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 28 post vaccinationSolicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.
Outcome measures
| Measure |
Study Group 1, Flublok Cohort A
n=80 Participants
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
n=28 Participants
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
n=78 Participants
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
n=31 Participants
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.
Solicited Systemic Events
|
47 participants
|
16 participants
|
53 participants
|
18 participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.
Solicited Local Events
|
39 participants
|
14 participants
|
42 participants
|
14 participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.
Unsolicited Adverse Events
|
19 participants
|
13 participants
|
26 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)Population: The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and \~28 days following completion of immunization (\~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.
Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.
Outcome measures
| Measure |
Study Group 1, Flublok Cohort A
n=75 Participants
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
n=77 Participants
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
n=26 Participants
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
n=28 Participants
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 0 - A/California/7/2009
|
54.94 titer
Interval 38.83 to 77.73
|
59.79 titer
Interval 43.05 to 83.02
|
85.89 titer
Interval 44.83 to 164.57
|
57.04 titer
Interval 31.29 to 103.98
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 28 - A/California/7/2009
|
914.92 titer
Interval 693.4 to 1207.19
|
564.23 titer
Interval 449.6 to 708.07
|
1224.31 titer
Interval 749.8 to 1999.05
|
695.03 titer
Interval 501.5 to 963.32
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 0 - A/Texas/50/2012
|
181.57 titer
Interval 140.4 to 234.83
|
141.91 titer
Interval 108.7 to 185.25
|
272.74 titer
Interval 181.7 to 409.37
|
161.32 titer
Interval 113.0 to 230.37
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 28 - A/Texas/50/2012
|
852.30 titer
Interval 698.1 to 1040.64
|
531.36 titer
Interval 449.8 to 627.75
|
1071.58 titer
Interval 776.2 to 1479.45
|
629.48 titer
Interval 451.4 to 877.78
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 0 - B/Massachusetts/2/2012
|
20.44 titer
Interval 16.11 to 25.94
|
21.17 titer
Interval 16.15 to 27.75
|
13.89 titer
Interval 9.54 to 20.23
|
12.19 titer
Interval 8.89 to 16.72
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 28 - B/Massachusetts/2/2012
|
161.02 titer
Interval 124.8 to 207.83
|
119.96 titer
Interval 95.07 to 151.37
|
111.14 titer
Interval 69.87 to 176.79
|
122.90 titer
Interval 81.92 to 184.38
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 0 - B/Brisbane/60/2008
|
12.49 titer
Interval 10.17 to 15.33
|
10.56 titer
Interval 8.62 to 12.94
|
11.43 titer
Interval 8.32 to 15.69
|
9.36 titer
Interval 7.05 to 12.43
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Day 28 - B/Brisbane/60/2008
|
51.73 titer
Interval 39.73 to 67.34
|
59.67 titer
Interval 47.3 to 75.27
|
73.82 titer
Interval 45.05 to 120.96
|
60.74 titer
Interval 40.35 to 91.42
|
SECONDARY outcome
Timeframe: Day 28 after final vaccinationPopulation: The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and \~28 days following completion of immunization (\~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.
Seroconversion is defined as: Either a pre vaccination titer \< 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.
Outcome measures
| Measure |
Study Group 1, Flublok Cohort A
n=75 Participants
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
n=77 Participants
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
n=26 Participants
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
n=28 Participants
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
|---|---|---|---|---|
|
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
H1N1: A/California/07/2009
|
87 percentage of participants
Interval 76.8 to 93.4
|
68 percentage of participants
Interval 55.9 to 77.8
|
88 percentage of participants
Interval 69.8 to 97.6
|
75 percentage of participants
Interval 55.1 to 89.3
|
|
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
H3N2: A/Texas/50/2012
|
59 percentage of participants
Interval 46.7 to 69.9
|
49 percentage of participants
Interval 37.8 to 61.0
|
54 percentage of participants
Interval 33.4 to 73.4
|
50 percentage of participants
Interval 30.6 to 69.4
|
|
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
B/Massachusetts/2/2012
|
69 percentage of participants
Interval 57.6 to 79.5
|
61 percentage of participants
Interval 49.2 to 72.0
|
77 percentage of participants
Interval 56.4 to 91.0
|
82 percentage of participants
Interval 63.1 to 93.9
|
|
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
B/Brisbane/60/2008
|
52 percentage of participants
Interval 39.4 to 65.1
|
67 percentage of participants
Interval 53.7 to 78.0
|
69 percentage of participants
Interval 48.2 to 85.7
|
73 percentage of participants
Interval 52.2 to 88.4
|
SECONDARY outcome
Timeframe: Day 28 after final vaccinationPopulation: The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and \~28 days following completion of immunization (\~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.
Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.
Outcome measures
| Measure |
Study Group 1, Flublok Cohort A
n=75 Participants
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
n=77 Participants
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
n=26 Participants
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
n=28 Participants
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
|---|---|---|---|---|
|
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
H1N1: A/California/07/2009
|
97 percentage of participants
Interval 90.7 to 99.7
|
99 percentage of participants
Interval 93.0 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
|
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
H3N2: A/Texas/50/2012
|
100 percentage of participants
Interval 95.2 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
|
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
B/Massachusetts/2/2012
|
91 percentage of participants
Interval 81.7 to 96.2
|
90 percentage of participants
Interval 80.6 to 95.4
|
85 percentage of participants
Interval 65.1 to 95.6
|
89 percentage of participants
Interval 71.8 to 97.7
|
|
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
B/Brisbane/60/2008
|
78 percentage of participants
Interval 65.5 to 87.3
|
86 percentage of participants
Interval 74.6 to 93.3
|
85 percentage of participants
Interval 65.1 to 95.6
|
81 percentage of participants
Interval 60.6 to 93.4
|
Adverse Events
Study Group 1, Flublok Cohort A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Study Group 3, Flublok Cohort B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Study Group 2, Fluarix Cohort A
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Study Group 4, Fluarix Cohort B
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group 1, Flublok Cohort A
n=80 participants at risk
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
n=28 participants at risk
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
n=78 participants at risk
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
n=31 participants at risk
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
0.00%
0/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
0.00%
0/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.2%
1/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
Other adverse events
| Measure |
Study Group 1, Flublok Cohort A
n=80 participants at risk
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 3, Flublok Cohort B
n=28 participants at risk
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 2, Fluarix Cohort A
n=78 participants at risk
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
Study Group 4, Fluarix Cohort B
n=31 participants at risk
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.6%
1/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
2.6%
2/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
9.7%
3/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
7.1%
2/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
2.6%
2/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
6.5%
2/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
General disorders
Injection site erythema
|
2.5%
2/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.6%
1/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
0.00%
0/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.2%
1/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
General disorders
Injection site pain
|
1.2%
1/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
7.1%
2/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
2.6%
2/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
6.5%
2/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
0.00%
0/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
1.3%
1/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
12.9%
4/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
Infections and infestations
Viral infection
|
1.2%
1/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
7.1%
2/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
0.00%
0/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.2%
1/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
Nervous system disorders
Headache
|
0.00%
0/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.6%
1/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
2.6%
2/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.2%
1/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
3.6%
1/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
1.3%
1/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
9.7%
3/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.8%
3/80 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
0.00%
0/28 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
5.1%
4/78 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
0.00%
0/31 • All AEs collected 28 days after final study immunization and all Serious Adverse Events (SAEs) collected through one (1) year after last study immunization.
|
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
Restriction type: LTE60