Trial Outcomes & Findings for Safety and Immunogenicity of CJCV2 With and Without ALFQ (NCT NCT05500417)
NCT ID: NCT05500417
Last Updated: 2026-02-02
Results Overview
Solicited local AEs were collected 30 minutes post-vaccination, and then daily for 7 days after each vaccination using a memory aid and graded on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). Local symptoms included ecchymosis, ecchymosis (measurement), erythema, erythema (measurement), induration/edema, induration/edema (measurement), pain, and tenderness.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
Days 1 through 8, Days 29 through 36, and Days 57 through 64
Results posted on
2026-02-02
Participant Flow
The study population was comprised of generally healthy young adults (males and non-pregnant or -lactating females) 18-50 years of age, inclusive, who met all eligibility criteria. Participants were recruited from existing volunteer populations and from the communities at large around the clinical site. Fifty-nine participants were enrolled between 13Sep2022 and 08Nov2023.
Participant milestones
| Measure |
1 µg CJCV2
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
|
1 µg CJCV2 + ALFQ
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
Army Liposome Formulation containing QS-21 (ALFQ) is a combination adjuvant composed of ALF55, QS-21, and Sorensen's Phosphate Buffer. ALF55 is an Army Liposome Formulation (ALF) containing the phospholipids dimyristoyl phosphatidyl choline and dimyristoyl phosphatidyl glycerol, 3D-PHAD®, and 55% cholesterol. QS-21 is a purified saponin extracted from the bark of the Quillaja saponaria tree. ALFQ was manufactured at the Walter Reed Army Institute for Research (WRAIR) Pilot Bioproduction Facility (Silver Spring, Maryland).
|
3 µg CJCV2
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
|
3 µg CJCV2 + ALFQ
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
Army Liposome Formulation containing QS-21 (ALFQ) is a combination adjuvant composed of ALF55, QS-21, and Sorensen's Phosphate Buffer. ALF55 is an Army Liposome Formulation (ALF) containing the phospholipids dimyristoyl phosphatidyl choline and dimyristoyl phosphatidyl glycerol, 3D-PHAD®, and 55% cholesterol. QS-21 is a purified saponin extracted from the bark of the Quillaja saponaria tree. ALFQ was manufactured at the Walter Reed Army Institute for Research (WRAIR) Pilot Bioproduction Facility (Silver Spring, Maryland).
|
10 µg CJCV2
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
|
10 µg CJCV2 + ALFQ
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
Army Liposome Formulation containing QS-21 (ALFQ) is a combination adjuvant composed of ALF55, QS-21, and Sorensen's Phosphate Buffer. ALF55 is an Army Liposome Formulation (ALF) containing the phospholipids dimyristoyl phosphatidyl choline and dimyristoyl phosphatidyl glycerol, 3D-PHAD®, and 55% cholesterol. QS-21 is a purified saponin extracted from the bark of the Quillaja saponaria tree. ALFQ was manufactured at the Walter Reed Army Institute for Research (WRAIR) Pilot Bioproduction Facility (Silver Spring, Maryland).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
9
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
1 µg CJCV2
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
|
1 µg CJCV2 + ALFQ
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
Army Liposome Formulation containing QS-21 (ALFQ) is a combination adjuvant composed of ALF55, QS-21, and Sorensen's Phosphate Buffer. ALF55 is an Army Liposome Formulation (ALF) containing the phospholipids dimyristoyl phosphatidyl choline and dimyristoyl phosphatidyl glycerol, 3D-PHAD®, and 55% cholesterol. QS-21 is a purified saponin extracted from the bark of the Quillaja saponaria tree. ALFQ was manufactured at the Walter Reed Army Institute for Research (WRAIR) Pilot Bioproduction Facility (Silver Spring, Maryland).
|
3 µg CJCV2
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
|
3 µg CJCV2 + ALFQ
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
Army Liposome Formulation containing QS-21 (ALFQ) is a combination adjuvant composed of ALF55, QS-21, and Sorensen's Phosphate Buffer. ALF55 is an Army Liposome Formulation (ALF) containing the phospholipids dimyristoyl phosphatidyl choline and dimyristoyl phosphatidyl glycerol, 3D-PHAD®, and 55% cholesterol. QS-21 is a purified saponin extracted from the bark of the Quillaja saponaria tree. ALFQ was manufactured at the Walter Reed Army Institute for Research (WRAIR) Pilot Bioproduction Facility (Silver Spring, Maryland).
|
10 µg CJCV2
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
|
10 µg CJCV2 + ALFQ
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) is a purified HS23/36 capsular polysaccharide (CPS) of Campylobacter jejuni (C. jejuni) conjugated to cross-reactive material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin, at a CPS:CRM197 ratio of 2:1. The CJCV2 vaccine product was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa).
Army Liposome Formulation containing QS-21 (ALFQ) is a combination adjuvant composed of ALF55, QS-21, and Sorensen's Phosphate Buffer. ALF55 is an Army Liposome Formulation (ALF) containing the phospholipids dimyristoyl phosphatidyl choline and dimyristoyl phosphatidyl glycerol, 3D-PHAD®, and 55% cholesterol. QS-21 is a purified saponin extracted from the bark of the Quillaja saponaria tree. ALFQ was manufactured at the Walter Reed Army Institute for Research (WRAIR) Pilot Bioproduction Facility (Silver Spring, Maryland).
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of CJCV2 With and Without ALFQ
Baseline characteristics by cohort
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 6.9 • n=13 Participants
|
31.9 years
STANDARD_DEVIATION 6.7 • n=15 Participants
|
39.8 years
STANDARD_DEVIATION 7.2 • n=28 Participants
|
34.4 years
STANDARD_DEVIATION 9.3 • n=2 Participants
|
38.1 years
STANDARD_DEVIATION 6.6 • n=32 Participants
|
33.8 years
STANDARD_DEVIATION 8.2 • n=43 Participants
|
34.9 years
STANDARD_DEVIATION 7.8 • n=615 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=13 Participants
|
7 Participants
n=15 Participants
|
6 Participants
n=28 Participants
|
7 Participants
n=2 Participants
|
5 Participants
n=32 Participants
|
7 Participants
n=43 Participants
|
37 Participants
n=615 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=13 Participants
|
3 Participants
n=15 Participants
|
4 Participants
n=28 Participants
|
3 Participants
n=2 Participants
|
4 Participants
n=32 Participants
|
3 Participants
n=43 Participants
|
22 Participants
n=615 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
4 Participants
n=615 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=13 Participants
|
9 Participants
n=15 Participants
|
10 Participants
n=28 Participants
|
9 Participants
n=2 Participants
|
9 Participants
n=32 Participants
|
10 Participants
n=43 Participants
|
55 Participants
n=615 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
2 Participants
n=43 Participants
|
4 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=43 Participants
|
4 Participants
n=615 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=13 Participants
|
7 Participants
n=15 Participants
|
9 Participants
n=28 Participants
|
8 Participants
n=2 Participants
|
8 Participants
n=32 Participants
|
7 Participants
n=43 Participants
|
48 Participants
n=615 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
2 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=615 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=13 Participants
|
10 Participants
n=15 Participants
|
10 Participants
n=28 Participants
|
10 Participants
n=2 Participants
|
9 Participants
n=32 Participants
|
10 Participants
n=43 Participants
|
59 Participants
n=615 Participants
|
|
Height
|
174.44 cm
STANDARD_DEVIATION 13.59 • n=13 Participants
|
171.60 cm
STANDARD_DEVIATION 7.96 • n=15 Participants
|
174.10 cm
STANDARD_DEVIATION 11.24 • n=28 Participants
|
167.05 cm
STANDARD_DEVIATION 10.45 • n=2 Participants
|
175.89 cm
STANDARD_DEVIATION 12.57 • n=32 Participants
|
171.55 cm
STANDARD_DEVIATION 14.19 • n=43 Participants
|
172.38 cm
STANDARD_DEVIATION 11.68 • n=615 Participants
|
|
Weight
|
82.39 kg
STANDARD_DEVIATION 24.76 • n=13 Participants
|
75.21 kg
STANDARD_DEVIATION 14.15 • n=15 Participants
|
87.89 kg
STANDARD_DEVIATION 18.10 • n=28 Participants
|
76.28 kg
STANDARD_DEVIATION 11.70 • n=2 Participants
|
79.81 kg
STANDARD_DEVIATION 18.00 • n=32 Participants
|
84.87 kg
STANDARD_DEVIATION 25.57 • n=43 Participants
|
81.10 kg
STANDARD_DEVIATION 19.11 • n=615 Participants
|
|
Body Mass Index
|
26.50 kg/m^2
STANDARD_DEVIATION 5.13 • n=13 Participants
|
25.68 kg/m^2
STANDARD_DEVIATION 5.30 • n=15 Participants
|
29.04 kg/m^2
STANDARD_DEVIATION 5.49 • n=28 Participants
|
27.38 kg/m^2
STANDARD_DEVIATION 3.74 • n=2 Participants
|
25.83 kg/m^2
STANDARD_DEVIATION 5.70 • n=32 Participants
|
28.58 kg/m^2
STANDARD_DEVIATION 6.55 • n=43 Participants
|
27.19 kg/m^2
STANDARD_DEVIATION 5.30 • n=615 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 8, Days 29 through 36, and Days 57 through 64Population: The Safety Population includes all participants who received at least one study vaccination.
Solicited local AEs were collected 30 minutes post-vaccination, and then daily for 7 days after each vaccination using a memory aid and graded on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). Local symptoms included ecchymosis, ecchymosis (measurement), erythema, erythema (measurement), induration/edema, induration/edema (measurement), pain, and tenderness.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Post-Vaccination 1
|
4 Participants
|
9 Participants
|
2 Participants
|
10 Participants
|
5 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Post-Vaccination 2
|
2 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
|
Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Post-Vaccination 3
|
6 Participants
|
8 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 8, Days 29 through 36, and Days 57 through 64Population: The Safety Population includes all participants who received at least one study vaccination.
Solicited systemic AEs were collected prior to vaccination, 30 minutes post-vaccination, and then daily for 7 days after each vaccination using a memory aid and graded on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). Systemic symptoms included arthralgia, fatigue, fever, feverishness (chills/shivering/sweating), headache, malaise, myalgia, nausea, and vomiting.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Solicited Systemic Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Post-Vaccination 1
|
7 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Post-Vaccination 2
|
5 Participants
|
10 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Solicited Systemic Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Post-Vaccination 3
|
6 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The Safety Population includes all participants who received at least one study vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, regardless of its causal relationship to the study treatment. The FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. The occurrence of an AE could have come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor. An AE was considered related if there was a reasonable possibility that the study product caused the AE. Reasonable possibility means that there was evidence to suggest a causal relationship between the study product and the AE.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Vaccine-related Unsolicited AEs Through 28 Days Post Last Vaccination
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 420Population: The Safety Population includes all participants who received at least one study vaccination.
An AE or suspected adverse reaction was considered a SAE if, in the view of either the PI or sponsor, it resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not have resulted in these outcomes could be considered serious when, based upon appropriate medical judgment, they could have jeopardized the participant and could have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 420Population: The Safety Population includes all participants who received at least one study vaccination.
Medically attended adverse events (MAAEs) are any unsolicited AE for which a participant received medical attention, defined as hospitalization, an ER visit, or an otherwise unscheduled visit to or from medical personnel.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Medically Attended Adverse Events (MAAEs) From First Study Vaccination Through End of Study Participation
|
5 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 420Population: The Safety Population includes all participants who received at least one study vaccination.
New-onset chronic medical conditions (NOCMCs) are defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study product, that is expected to continue for at least 3 months and requires continued health care intervention.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With New-onset Chronic Medical Conditions (NOCMCs) From First Study Vaccination Through End of Study Participation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 420Population: The Safety Population includes all participants who received at least one study vaccination.
Potentially immune-mediated medical conditions (PIMMCs) constitute a group of AEs that includes diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Potentially Immune-mediated Medical Conditions (PIMMCs) From First Study Vaccination Through End of Study Participation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 64, 85, and 113Population: The Full Immunogenicity Population consists of all participants who received any study product and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported.
Serum from blood collected at Study Days 1, 8, 29, 36, 57, 64, 85, and 113 was analyzed using an enzyme-linked immunosorbent assay (ELISA) to measure C. jejuni capsule-specific Immunoglobulin G (IgG) serum antibody titers. Results below the lower limit of quantification (LLOQ) were imputed as LLOQ/2. The percentage of participants with at least a 4-fold rise in antibody titer compared to pre-vaccination 1 is presented by arm with exact 95% Clopper-Pearson confidence interval.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=9 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Day 8
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
0.0 Percentage of participants
Interval 0.0 to 33.6
|
0.0 Percentage of participants
Interval 0.0 to 33.6
|
0.0 Percentage of participants
Interval 0.0 to 3.8
|
|
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Day 29
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
0.0 Percentage of participants
Interval 0.0 to 33.6
|
0.0 Percentage of participants
Interval 0.0 to 33.6
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Day 36
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
100.0 Percentage of participants
Interval 66.4 to 100.0
|
33.3 Percentage of participants
Interval 7.5 to 70.1
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
|
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Day 57
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
100.0 Percentage of participants
Interval 66.4 to 100.0
|
33.3 Percentage of participants
Interval 7.5 to 70.1
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
|
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Day 64
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
100.0 Percentage of participants
Interval 66.4 to 100.0
|
50.0 Percentage of participants
Interval 15.7 to 84.3
|
77.8 Percentage of participants
Interval 40.0 to 97.2
|
|
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Day 85
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
100.0 Percentage of participants
Interval 66.4 to 100.0
|
33.3 Percentage of participants
Interval 7.5 to 70.1
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
|
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Day 113
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
55.6 Percentage of participants
Interval 21.2 to 86.3
|
100.0 Percentage of participants
Interval 66.4 to 100.0
|
33.3 Percentage of participants
Interval 7.5 to 70.1
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Full Immunogenicity Population consists of all participants who received any study product and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported.
Serum from blood collected at Study Days 1, 8, 29, 36, 57, 64, 85, and 113 was analyzed using an enzyme-linked immunosorbent assay (ELISA) to measure C. jejuni capsule-specific Immunoglobulin G (IgG) serum antibody titers. Results below the lower limit of quantification (LLOQ) were imputed as LLOQ/2. For each participant, peak fold-rise from baseline is defined as the maximum fold-rise in antibody titer that occurred throughout all follow-up visits with available data (Day 8 up to Day 113) as compared to baseline (Day 1). The peak fold-rise from baseline per participant is summarized by study arm via geometric mean and 95% confidence interval based on Student's t distribution.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=9 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Peak Fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibody Titer
|
7.13 fold rise from baseline
Interval 3.27 to 15.53
|
1621.88 fold rise from baseline
Interval 441.35 to 5960.04
|
6.81 fold rise from baseline
Interval 2.13 to 21.82
|
369.59 fold rise from baseline
Interval 163.72 to 834.33
|
5.72 fold rise from baseline
Interval 2.21 to 14.85
|
61.66 fold rise from baseline
Interval 11.96 to 317.83
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Full Immunogenicity Population consists of all participants who received any study product and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported.
Serum from blood collected at Study Days 1, 8, 29, 36, 57, 64, 85, and 113 was analyzed using an enzyme-linked immunosorbent assay (ELISA) to measure C. jejuni capsule-specific Immunoglobulin G (IgG) serum antibody titers. Results below the lower limit of quantification (LLOQ) were imputed as LLOQ/2. For each participant, the maximum antibody titer measured throughout all follow-up visits with available data (Day 8 up to Day 113) was recorded. The maximum post-baseline titer per participant is summarized by study arm via geometric mean and 95% confidence interval based on Student's t distribution.
Outcome measures
| Measure |
1 µg CJCV2
n=10 Participants
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 Participants
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 Participants
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=9 Participants
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 Participants
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 Participants
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Maximum C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibody Titer
|
1004.6 titer
Interval 518.0 to 1948.4
|
233346.5 titer
Interval 53306.1 to 1021471.1
|
977.2 titer
Interval 305.2 to 3129.1
|
44213.8 titer
Interval 20874.7 to 93647.4
|
812.8 titer
Interval 355.3 to 1859.0
|
9727.4 titer
Interval 2047.9 to 46205.9
|
Adverse Events
1 µg CJCV2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
1 µg CJCV2 + ALFQ
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
3 µg CJCV2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
3 µg CJCV2 + ALFQ
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
10 µg CJCV2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
10 µg CJCV2 + ALFQ
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 µg CJCV2
n=10 participants at risk
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 participants at risk
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 participants at risk
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 participants at risk
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 participants at risk
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 participants at risk
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
Other adverse events
| Measure |
1 µg CJCV2
n=10 participants at risk
1 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
1 µg CJCV2 + ALFQ
n=10 participants at risk
1 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2
n=10 participants at risk
3 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
3 µg CJCV2 + ALFQ
n=10 participants at risk
3 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2
n=9 participants at risk
10 µg of CJCV2 administered intramuscularly on Days 1, 29, and 57.
|
10 µg CJCV2 + ALFQ
n=10 participants at risk
10 µg of CJCV2 with fixed dose (200 µg 3D-PHAD®, 100 µg QS-21) of ALFQ, administered intramuscularly on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
10.0%
1/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Injection site pain
|
50.0%
5/10 • Number of events 8 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
100.0%
10/10 • Number of events 39 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
50.0%
5/10 • Number of events 8 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
100.0%
10/10 • Number of events 41 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
77.8%
7/9 • Number of events 13 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
90.0%
9/10 • Number of events 37 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Injection site pruritus
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Injection site warmth
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
60.0%
6/10 • Number of events 11 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
60.0%
6/10 • Number of events 12 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
70.0%
7/10 • Number of events 11 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
22.2%
2/9 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Ear infection
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Hordeolum
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
33.3%
3/9 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
40.0%
4/10 • Number of events 4 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood iron decreased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood pressure diastolic increased
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood pressure increased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood pressure systolic increased
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Heart rate increased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
40.0%
4/10 • Number of events 9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
40.0%
4/10 • Number of events 5 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
50.0%
5/10 • Number of events 8 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
100.0%
10/10 • Number of events 25 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
30.0%
3/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
90.0%
9/10 • Number of events 19 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
22.2%
2/9 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
80.0%
8/10 • Number of events 16 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
100.0%
10/10 • Number of events 19 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
50.0%
5/10 • Number of events 7 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
70.0%
7/10 • Number of events 18 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
66.7%
6/9 • Number of events 8 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
70.0%
7/10 • Number of events 14 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Nervous system disorders
Taste disorder
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Reproductive system and breast disorders
Heterogeneously dense breasts
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 5 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
50.0%
5/10 • Number of events 9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
22.2%
2/9 • Number of events 5 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
50.0%
5/10 • Number of events 7 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
90.0%
9/10 • Number of events 23 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
40.0%
4/10 • Number of events 8 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
90.0%
9/10 • Number of events 18 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
44.4%
4/9 • Number of events 4 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
80.0%
8/10 • Number of events 17 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Injection site erythema
|
20.0%
2/10 • Number of events 5 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
22.2%
2/9 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
50.0%
5/10 • Number of events 9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Injection site haemorrhage
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Injection site induration
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
30.0%
3/10 • Number of events 4 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
40.0%
4/10 • Number of events 6 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
22.2%
2/9 • Number of events 4 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
40.0%
4/10 • Number of events 6 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
General disorders
Malaise
|
50.0%
5/10 • Number of events 7 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
90.0%
9/10 • Number of events 18 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
80.0%
8/10 • Number of events 15 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
55.6%
5/9 • Number of events 6 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
90.0%
9/10 • Number of events 15 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Haemoglobin decreased
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 4 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 4 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 3 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
11.1%
1/9 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
White blood cell count decreased
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
20.0%
2/10 • Number of events 2 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
30.0%
3/10 • Number of events 4 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
30.0%
3/10 • Number of events 5 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
33.3%
3/9 • Number of events 5 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
10.0%
1/10 • Number of events 1 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/9 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
0.00%
0/10 • Unsolicited adverse events (AEs) were collected from first study vaccination through the end of study participation (up to Day 420). Solicited AEs and clinical safety laboratory AEs were collected after each study vaccination through 7 days post-vaccination.
|
Additional Information
Robert W Frenck, Jr, M.D.
Cincinnati Children's Hospital Medical Center
Phone: 513-636-4463
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place