Trial Outcomes & Findings for Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults (NCT NCT01612000)
NCT ID: NCT01612000
Last Updated: 2015-11-25
Results Overview
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
341 participants
Primary outcome timeframe
42 Days
Results posted on
2015-11-25
Participant Flow
Participant milestones
| Measure |
PanBlok 3.8µg in 2% SE
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 15µg in 2% SE
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
84
|
85
|
86
|
|
Overall Study
COMPLETED
|
81
|
75
|
78
|
76
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
7
|
10
|
Reasons for withdrawal
| Measure |
PanBlok 3.8µg in 2% SE
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 15µg in 2% SE
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
4
|
8
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
2
|
Baseline Characteristics
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
PanBlok 15µg in 2% SE
n=84 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 3.8µg in 2% SE
n=86 Participants
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
n=85 Participants
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
n=86 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
31 years
n=7 Participants
|
32 years
n=5 Participants
|
30 years
n=4 Participants
|
31 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
207 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
134 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
299 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
86 participants
n=7 Participants
|
85 participants
n=5 Participants
|
86 participants
n=4 Participants
|
341 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 42 DaysPopulation: All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
Outcome measures
| Measure |
PanBlok 15µg in 2% SE
n=76 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 3.8µg in 2% SE
n=81 Participants
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
n=80 Participants
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
n=76 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
|
83 percentage of participants
Interval 72.5 to 90.6
|
70 percentage of participants
Interval 59.2 to 80.0
|
9 percentage of participants
Interval 3.6 to 17.2
|
76 percentage of participants
Interval 65.2 to 85.3
|
PRIMARY outcome
Timeframe: 42 DaysPopulation: All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.
Outcome measures
| Measure |
PanBlok 15µg in 2% SE
n=76 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 3.8µg in 2% SE
n=81 Participants
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
n=80 Participants
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
n=76 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
|
121.7 titer
Interval 88.2 to 168.0
|
76.1 titer
Interval 53.2 to 108.8
|
7.1 titer
Interval 5.9 to 8.4
|
77.5 titer
Interval 56.0 to 107.2
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.
Solicited events of local and systemic reactogenicity Days 0-7. These events are expected to occur and not considered or recorded as Adverse Events.
Outcome measures
| Measure |
PanBlok 15µg in 2% SE
n=82 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 3.8µg in 2% SE
n=86 Participants
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
n=84 Participants
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
n=84 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Injection site erythema
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Elevated temperature
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Fatigue
|
6 participants
|
9 participants
|
9 participants
|
9 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Chills
|
3 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Arthralgia
|
4 participants
|
2 participants
|
4 participants
|
4 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Myalgia
|
11 participants
|
17 participants
|
7 participants
|
13 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Headache
|
8 participants
|
19 participants
|
13 participants
|
8 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Nausea/Vomiting
|
1 participants
|
6 participants
|
8 participants
|
3 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Diarrhea
|
4 participants
|
4 participants
|
7 participants
|
3 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Injection site pain
|
34 participants
|
34 participants
|
6 participants
|
32 participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Injection site tenderness
|
47 participants
|
52 participants
|
8 participants
|
46 participants
|
SECONDARY outcome
Timeframe: 13 MonthsPopulation: All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.
Incidence of Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCIs) and Adverse Events of Special Interest (AESIs) over 12 months following vaccination. Study subjects were followed every three months (for one year following Day 42) by telephone and visit for reports of SAEs, NOCIs, and AESIs.
Outcome measures
| Measure |
PanBlok 15µg in 2% SE
n=84 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 3.8µg in 2% SE
n=86 Participants
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
n=85 Participants
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
n=86 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
Long-term Safety
SAEs
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Long-term Safety
NOCIs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Long-term Safety
AESIs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
PanBlok 15µg in 2% SE
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
PanBlok 3.8µg in 2% SE
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
PanBlok 7.5µg No Adjuvant
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
PanBlok 7.5µg in 2% SE
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PanBlok 15µg in 2% SE
n=84 participants at risk
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 3.8µg in 2% SE
n=86 participants at risk
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
n=85 participants at risk
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
n=86 participants at risk
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Infections and infestations
Community-acquired pneumonia
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
Other adverse events
| Measure |
PanBlok 15µg in 2% SE
n=84 participants at risk
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 3.8µg in 2% SE
n=86 participants at risk
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
PanBlok 7.5µg No Adjuvant
n=85 participants at risk
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
|
PanBlok 7.5µg in 2% SE
n=86 participants at risk
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
2/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
3.5%
3/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
General disorders
Fatigue
|
3.6%
3/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
3.5%
3/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
General disorders
Pain
|
1.2%
1/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
3.5%
3/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.3%
2/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.3%
2/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Infections and infestations
Sinusitis
|
2.4%
2/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Infections and infestations
Upper Respiratory Infection
|
1.2%
1/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.4%
2/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.3%
2/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.2%
1/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.4%
2/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.3%
2/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.6%
3/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Nervous system disorders
Headache
|
7.1%
6/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
4.7%
4/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
5.9%
5/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
4.7%
4/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
3.5%
3/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.3%
2/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
1/84 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
0.00%
0/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
1.2%
1/85 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
2.3%
2/86 • All AEs collected Days 0-42; Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset Chronic Illnesses (NOCIs) collected through month 13 following vaccination.
|
Additional Information
Lisa M. Dunkle, M.D., Chief Medical Officer
Protein Sciences Corproation
Phone: 203-599-6064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60