Trial Outcomes & Findings for Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults (NCT NCT01147068)

NCT ID: NCT01147068

Last Updated: 2012-11-26

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 non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 392 participants
• Primary outcome timeframe: 42 Days
• Results posted on: 2012-11-26

Participant Flow

Healthy adults 18-49 years of age were screened in participating outpatient clinics for eligibility within 30 days of randomization during the 2010 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	Placebo 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Subjects That Received 1st Dose STARTED	60	57	55	56	56	53	55
Subjects That Received 1st Dose COMPLETED	60	57	55	56	56	53	55
Subjects That Received 1st Dose NOT COMPLETED	0	0	0	0	0	0	0
Subjects That Received 2nd Dose STARTED	60	57	55	56	56	53	55
Subjects That Received 2nd Dose COMPLETED	59	52	52	56	55	51	55
Subjects That Received 2nd Dose NOT COMPLETED	1	5	3	0	1	2	0
Subjects That Completed Safety Follow-up STARTED	60	57	55	56	56	53	55
Subjects That Completed Safety Follow-up COMPLETED	59	56	55	54	56	52	54
Subjects That Completed Safety Follow-up NOT COMPLETED	1	1	0	2	0	1	1

Reasons for withdrawal

Measure	Placebo 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Subjects That Received 2nd Dose Lost to Follow-up	1	0	0	0	0	1	0
Subjects That Received 2nd Dose Ineligible	0	1	0	0	0	0	0
Subjects That Received 2nd Dose Did not complete the study	0	1	0	0	0	1	0
Subjects That Received 2nd Dose Other	0	3	3	0	1	0	0
Subjects That Completed Safety Follow-up Lost to Follow-up	1	0	0	0	0	1	1
Subjects That Completed Safety Follow-up Withdrawal by Subject	0	0	0	2	0	0	0
Subjects That Completed Safety Follow-up Ineligible	0	1	0	0	0	0	0

Baseline Characteristics

Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

Baseline characteristics by cohort

Measure	Placebo n=60 Participants 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant n=57 Participants 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant n=55 Participants 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% n=56 Participants 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% n=56 Participants 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% n=53 Participants 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% n=55 Participants 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	Total n=392 Participants Total of all reporting groups
Age Continuous	32.0 years n=5 Participants	30.0 years n=7 Participants	32.0 years n=5 Participants	31.0 years n=4 Participants	33.5 years n=21 Participants	27.0 years n=10 Participants	33.0 years n=115 Participants	32.2 years n=24 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	35 Participants n=7 Participants	32 Participants n=5 Participants	30 Participants n=4 Participants	43 Participants n=21 Participants	34 Participants n=10 Participants	25 Participants n=115 Participants	232 Participants n=24 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	26 Participants n=4 Participants	13 Participants n=21 Participants	19 Participants n=10 Participants	30 Participants n=115 Participants	160 Participants n=24 Participants

PRIMARY outcome

Timeframe: 42 Days

Population: All randomized subjects who received study vaccine and had Day 0 and Day 42 efficacy data. The analysis results are generated by Southern Research Institute on the intention to treat efficacy population using whole virus.

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 non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.

Outcome measures

Measure	Placebo n=57 Participants 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant n=54 Participants 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant n=54 Participants 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% n=54 Participants 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% n=56 Participants 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% n=53 Participants 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% n=53 Participants 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.	0 percentage of participants Interval 0.0 to 0.0	32 percentage of participants Interval 21.0 to 45.0	15 percentage of participants Interval 8.0 to 27.0	82 percentage of participants Interval 69.0 to 90.0	75 percentage of participants Interval 62.0 to 84.0	66 percentage of participants Interval 53.0 to 77.0	72 percentage of participants Interval 58.0 to 82.0

SECONDARY outcome

Timeframe: Day 0, and Day 42

Population: All randomized subjects who received study vaccine and had Day 0 and Day 42 geometric mean titers. Analysis of results were generated by Southern Research Institute on the overall population using whole virus.

Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.

Outcome measures

Measure	Placebo n=57 Participants 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant n=54 Participants 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant n=54 Participants 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% n=54 Participants 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% n=56 Participants 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% n=53 Participants 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% n=53 Participants 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age. Day 0	NA titer Titer was below limit of detection	NA titer Titer was below limit of detection	NA titer Titer was below limit of detection	NA titer Titer was below limit of detection	NA titer Titer was below limit of detection	NA titer Titer was below limit of detection	NA titer Titer was below limit of detection
Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age. Day 42	NA titer Titer was below limit of detection	16.7 titer Interval 12.0 to 24.0	10.7 titer Interval 8.0 to 14.0	128.4 titer Interval 93.0 to 177.0	94.5 titer Interval 63.0 to 142.0	68.7 titer Interval 45.0 to 104.0	71.7 titer Interval 47.0 to 108.0

SECONDARY outcome

Timeframe: 21 Days

Population: All randomized subjects with Day 0 and Day 21 data analyzed by Cincinnati Children's Hospital Medical Center using the intent to treat population and CBER antigen.

Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults

Outcome measures

Measure	Placebo n=60 Participants 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant n=56 Participants 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant n=54 Participants 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% n=56 Participants 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% n=56 Participants 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% n=52 Participants 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% n=55 Participants 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age	3 percentage of participants Interval 0.4 to 11.5	4 percentage of participants Interval 0.4 to 12.3	4 percentage of participants Interval 0.5 to 12.7	11 percentage of participants Interval 4.0 to 21.9	7 percentage of participants Interval 2.0 to 17.3	8 percentage of participants Interval 2.1 to 18.5	2 percentage of participants Interval 0.0 to 9.7

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

PanBlok 135µg No Adjuvant

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

PanBlok 45µg No Adjuvant

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

PanBlok 45µg and GLA 1.0µg, SE 2%

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

PanBlok 15µg and GLA 1.0µg, SE 2%

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

PanBlok 7.5µg and GLA 1.0µg, SE 2%

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

PanBlok 3.8µg and GLA 1.0µg, SE 2%

Serious events: 3 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=60 participants at risk 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant n=57 participants at risk 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant n=55 participants at risk 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% n=56 participants at risk 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% n=56 participants at risk 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% n=53 participants at risk 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% n=55 participants at risk 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
General disorders Worsening of Right Ankle Instability	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Gastrointestinal disorders Incisional Hernia	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Gastrointestinal disorders Abdominopelvic Mass	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Surgical and medical procedures Fractured/Cracked Vertebrae	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Nervous system disorders Seizure	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Gastrointestinal disorders Appendicitis	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Reproductive system and breast disorders Intrauterine Fetal Demise	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Cardiac disorders Costochondritis	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Respiratory, thoracic and mediastinal disorders Left Upper Lobe Lung Nodule with Organizing Abscess	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Surgical and medical procedures Pinched nerve between C3-6	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Infections and infestations Post-operative Infection	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Metabolism and nutrition disorders Unspecified Protein Calorie Malnutrition	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.

Other adverse events

Measure	Placebo n=60 participants at risk 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant n=57 participants at risk 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg No Adjuvant n=55 participants at risk 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 45µg and GLA 1.0µg, SE 2% n=56 participants at risk 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 15µg and GLA 1.0µg, SE 2% n=56 participants at risk 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 7.5µg and GLA 1.0µg, SE 2% n=53 participants at risk 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 3.8µg and GLA 1.0µg, SE 2% n=55 participants at risk 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Respiratory, thoracic and mediastinal disorders Nasal Congestion	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.5% 2/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Infections and infestations Nasopharyngitis	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Neutrophil Count Decreased	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Red Cell Distribution Width Increased	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.9% 1/53 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Infections and infestations Sinusitis	3.3% 2/60 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Blood and lymphatic system disorders Blood Cholesterol Increased	10.0% 6/60 • Number of events 6 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.0% 4/57 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	12.7% 7/55 • Number of events 7 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	8.9% 5/56 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	8.9% 5/56 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.7% 3/53 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	16.4% 9/55 • Number of events 9 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Hepatobiliary disorders Alanine Aminotransferase Increased	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.3% 3/57 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	9.4% 5/53 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.5% 3/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Hepatobiliary disorders Aspartate Aminotransferase Increased	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.3% 4/55 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Blood Glucose Increased	6.7% 4/60 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	8.8% 5/57 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.3% 4/55 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.1% 4/56 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.1% 4/56 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.9% 1/53 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.5% 3/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.1% 4/56 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.5% 4/53 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Mean Cell Haemoglobin Concentration Decreased	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.5% 2/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.1% 4/56 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	8.9% 5/56 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.9% 1/53 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Carbon Dioxide Decreased	3.3% 2/60 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Gamma-Glutamyltransferase Increased	3.3% 2/60 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.5% 2/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.7% 3/53 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Haemoglobin Decreased	3.3% 2/60 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.9% 1/53 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Nervous system disorders Headache	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.7% 3/53 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Neutrophil Count Increased	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.5% 3/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Respiratory, thoracic and mediastinal disorders Oropharngeal Pain	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.5% 2/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.7% 3/53 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
General disorders Pyrexia	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.5% 2/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.7% 3/53 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Infections and infestations Rhinitis	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.7% 3/53 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations White Blood Cell Count Increased	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.0% 4/57 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.4% 3/56 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.5% 3/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Blood Creatinine Increased	8.3% 5/60 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.3% 4/55 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Blood Lactate Dehydrogenase Increased	5.0% 3/60 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Blood Urea Nitrogen/Creatinine Ratio Decreased	8.3% 5/60 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Cardiac disorders Bradycardia	5.0% 3/60 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.5% 3/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Haematocrit Decreased	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Blood Cholesterol Increased	10.0% 6/60 • Number of events 6 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	7.0% 4/57 • Number of events 4 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	12.7% 7/55 • Number of events 7 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	8.9% 5/56 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	8.9% 5/56 • Number of events 5 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.7% 3/53 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	16.4% 9/55 • Number of events 9 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Investigations Haematocrit Increased	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.9% 1/53 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
General disorders Fatigue	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/56 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Metabolism and nutrition disorders Hyperglycaemia	1.7% 1/60 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.5% 2/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/55 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.9% 1/53 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/55 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.8% 1/57 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/53 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	5.5% 3/55 • Number of events 3 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Injury, poisoning and procedural complications Joint Sprain	0.00% 0/60 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/57 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.8% 2/53 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.
Blood and lymphatic system disorders Lymphocytosis	3.3% 2/60 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.5% 2/57 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/56 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	3.6% 2/56 • Number of events 2 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	1.9% 1/53 • Number of events 1 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.	0.00% 0/55 • All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.

Additional Information

Dr. Ruvim Izikson, M.D.

Protein Sciences Corporation

Phone: 203-599-6064

Email: rizikson@proteinsciences.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place