Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults (NCT NCT06151288)
NCT ID: NCT06151288
Last Updated: 2025-07-28
Results Overview
Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1015 participants
Primary outcome timeframe
7 days after vaccination
Results posted on
2025-07-28
Participant Flow
First subject was enrolled 08-Nov-2023 and last subject randomized/vaccinated was 10-Jan-2024. Study sites were medical clinics.
1165 participants were screened. Of these, 150 failed screening, 98 did not meet eligibility criteria and 52 were excluded for other reasons. 13 participants were lost to follow-up and 11 withdrew from study.
Participant milestones
| Measure |
VAX-31 Low Dose
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
255
|
254
|
253
|
253
|
|
Overall Study
COMPLETED
|
247
|
247
|
248
|
249
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
5
|
4
|
Reasons for withdrawal
| Measure |
VAX-31 Low Dose
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
1
|
1
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults
Baseline characteristics by cohort
| Measure |
VAX-31 Low Dose
n=255 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20
n=253 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
Total
n=1015 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
58.0 years
n=7 Participants
|
59.0 years
n=5 Participants
|
60.0 years
n=4 Participants
|
59.0 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
609 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
406 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
210 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
836 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
760 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Height (cm)
|
167.6 cm
n=5 Participants
|
169.1 cm
n=7 Participants
|
168.0 cm
n=5 Participants
|
167.6 cm
n=4 Participants
|
167.9 cm
n=21 Participants
|
|
Weight (kg)
|
82.56 kg
n=5 Participants
|
85.80 kg
n=7 Participants
|
84.00 kg
n=5 Participants
|
83.64 kg
n=4 Participants
|
83.92 kg
n=21 Participants
|
|
Body Mass Index (kg/m^2)
|
28.90 kg/m^2
n=5 Participants
|
30.42 kg/m^2
n=7 Participants
|
28.82 kg/m^2
n=5 Participants
|
29.11 kg/m^2
n=4 Participants
|
29.27 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 days after vaccinationPopulation: Safety population, defined as all subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine as received.
Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=253 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=252 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
n=145 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
n=144 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
n=140 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
n=116 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
n=108 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
n=110 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
n=113 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
n=136 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
n=58 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
n=59 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
n=53 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
n=67 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group
Pain at injection site; Overall, Any Grade
|
66.0 percentage of participants
|
66.9 percentage of participants
|
73.5 percentage of participants
|
59.9 percentage of participants
|
71.7 percentage of participants
|
73.6 percentage of participants
|
75.0 percentage of participants
|
68.1 percentage of participants
|
58.3 percentage of participants
|
58.2 percentage of participants
|
71.7 percentage of participants
|
52.9 percentage of participants
|
62.1 percentage of participants
|
49.2 percentage of participants
|
67.9 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group
Any solicited local AE; Overall, Any Grade
|
66.8 percentage of participants
|
67.7 percentage of participants
|
74.3 percentage of participants
|
60.3 percentage of participants
|
72.4 percentage of participants
|
75.0 percentage of participants
|
76.4 percentage of participants
|
68.1 percentage of participants
|
59.3 percentage of participants
|
58.2 percentage of participants
|
71.7 percentage of participants
|
53.7 percentage of participants
|
63.8 percentage of participants
|
49.2 percentage of participants
|
67.9 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group
Erythema (redness) at injection site; Overall, Any Grade
|
6.3 percentage of participants
|
7.5 percentage of participants
|
7.1 percentage of participants
|
4.4 percentage of participants
|
7.6 percentage of participants
|
10.4 percentage of participants
|
7.1 percentage of participants
|
5.2 percentage of participants
|
4.6 percentage of participants
|
3.6 percentage of participants
|
7.1 percentage of participants
|
3.7 percentage of participants
|
1.7 percentage of participants
|
1.7 percentage of participants
|
3.8 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group
Edema (swelling) at injection site; Overall, Any Grade
|
5.5 percentage of participants
|
7.9 percentage of participants
|
7.1 percentage of participants
|
3.6 percentage of participants
|
6.9 percentage of participants
|
7.6 percentage of participants
|
7.1 percentage of participants
|
5.2 percentage of participants
|
3.7 percentage of participants
|
8.2 percentage of participants
|
7.1 percentage of participants
|
2.2 percentage of participants
|
1.7 percentage of participants
|
5.1 percentage of participants
|
5.7 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 7 days after vaccinationPopulation: Safety population, defined as all subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine they received.
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=253 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=252 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
n=145 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
n=144 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
n=140 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
n=116 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
n=108 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
n=110 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
n=113 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
n=136 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
n=58 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
n=59 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
n=53 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
n=67 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group
Any solicited systemic AE (any grade)
|
58.5 percentage of participants
|
61.4 percentage of participants
|
68.0 percentage of participants
|
57.1 percentage of participants
|
64.1 percentage of participants
|
65.3 percentage of participants
|
71.4 percentage of participants
|
59.5 percentage of participants
|
50.9 percentage of participants
|
56.4 percentage of participants
|
63.7 percentage of participants
|
55.1 percentage of participants
|
50.0 percentage of participants
|
54.2 percentage of participants
|
60.4 percentage of participants
|
55.2 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group
Fever (any grade)
|
1.2 percentage of participants
|
1.2 percentage of participants
|
1.6 percentage of participants
|
0.8 percentage of participants
|
1.4 percentage of participants
|
1.4 percentage of participants
|
2.1 percentage of participants
|
0.9 percentage of participants
|
0.9 percentage of participants
|
0.9 percentage of participants
|
0.9 percentage of participants
|
0.7 percentage of participants
|
1.7 percentage of participants
|
1.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group
Fatigue (any grade)
|
36.8 percentage of participants
|
36.2 percentage of participants
|
46.2 percentage of participants
|
38.9 percentage of participants
|
40.0 percentage of participants
|
40.3 percentage of participants
|
49.3 percentage of participants
|
37.1 percentage of participants
|
32.4 percentage of participants
|
30.9 percentage of participants
|
42.5 percentage of participants
|
40.4 percentage of participants
|
31.0 percentage of participants
|
28.8 percentage of participants
|
41.5 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group
Headache (any grade)
|
32.0 percentage of participants
|
31.9 percentage of participants
|
33.2 percentage of participants
|
26.6 percentage of participants
|
35.2 percentage of participants
|
37.5 percentage of participants
|
34.3 percentage of participants
|
30.2 percentage of participants
|
27.8 percentage of participants
|
24.5 percentage of participants
|
31.9 percentage of participants
|
23.5 percentage of participants
|
22.4 percentage of participants
|
23.7 percentage of participants
|
26.4 percentage of participants
|
23.9 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group
Muscle pain (any grade)
|
41.9 percentage of participants
|
46.9 percentage of participants
|
54.9 percentage of participants
|
41.3 percentage of participants
|
49.0 percentage of participants
|
51.4 percentage of participants
|
57.1 percentage of participants
|
41.4 percentage of participants
|
32.4 percentage of participants
|
40.9 percentage of participants
|
52.2 percentage of participants
|
41.2 percentage of participants
|
32.8 percentage of participants
|
42.4 percentage of participants
|
49.1 percentage of participants
|
40.3 percentage of participants
|
|
Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group
Joint pain (any grade)
|
17.4 percentage of participants
|
22.0 percentage of participants
|
23.3 percentage of participants
|
16.7 percentage of participants
|
17.9 percentage of participants
|
25.7 percentage of participants
|
22.9 percentage of participants
|
14.7 percentage of participants
|
16.7 percentage of participants
|
17.3 percentage of participants
|
23.9 percentage of participants
|
18.4 percentage of participants
|
20.7 percentage of participants
|
16.9 percentage of participants
|
20.8 percentage of participants
|
17.9 percentage of participants
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 1 month after vaccination.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
n=147 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
n=144 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
n=140 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
n=116 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
n=108 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
n=110 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
n=113 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
n=137 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
n=58 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
n=59 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
n=53 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
n=67 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group
|
16.5 percentage of participants
|
16.9 percentage of participants
|
18.6 percentage of participants
|
16.6 percentage of participants
|
18.4 percentage of participants
|
16.7 percentage of participants
|
22.9 percentage of participants
|
18.1 percentage of participants
|
13.9 percentage of participants
|
17.3 percentage of participants
|
13.3 percentage of participants
|
15.3 percentage of participants
|
17.2 percentage of participants
|
18.6 percentage of participants
|
13.2 percentage of participants
|
14.9 percentage of participants
|
PRIMARY outcome
Timeframe: 6 months after vaccinationPopulation: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
Percentage of participants with SAEs.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
n=147 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
n=144 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
n=140 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
n=116 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
n=108 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
n=110 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
n=113 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
n=137 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
n=58 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
n=59 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
n=53 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
n=67 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Reporting Serious Adverse Event
|
0.8 percentage of participants
|
1.2 percentage of participants
|
2.0 percentage of participants
|
1.2 percentage of participants
|
1.4 percentage of participants
|
0.7 percentage of participants
|
2.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
1.8 percentage of participants
|
2.2 percentage of participants
|
0.0 percentage of participants
|
1.7 percentage of participants
|
3.8 percentage of participants
|
3.0 percentage of participants
|
PRIMARY outcome
Timeframe: 6 months after vaccinationPopulation: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
Percentage of participants with NOCIs
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
n=147 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
n=144 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
n=140 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
n=116 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
n=108 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
n=110 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
n=113 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
n=137 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
n=58 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
n=59 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
n=53 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
n=67 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Reporting New Onset of Chronic Illness
|
0.8 percentage of participants
|
2.4 percentage of participants
|
2.0 percentage of participants
|
2.0 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
2.1 percentage of participants
|
0.9 percentage of participants
|
1.9 percentage of participants
|
3.6 percentage of participants
|
1.8 percentage of participants
|
2.9 percentage of participants
|
3.4 percentage of participants
|
3.4 percentage of participants
|
1.9 percentage of participants
|
1.5 percentage of participants
|
PRIMARY outcome
Timeframe: 6 months after vaccinationPopulation: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
Percentage of participants with MAAEs.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
n=147 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
n=144 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
n=140 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
n=116 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
n=108 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
n=110 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
n=113 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
n=137 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
n=58 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
n=59 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
n=53 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
n=67 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Reporting Medically Attended Adverse Event
|
17.6 percentage of participants
|
16.5 percentage of participants
|
13.8 percentage of participants
|
12.3 percentage of participants
|
17.0 percentage of participants
|
18.1 percentage of participants
|
15.0 percentage of participants
|
13.8 percentage of participants
|
18.5 percentage of participants
|
14.5 percentage of participants
|
12.4 percentage of participants
|
10.9 percentage of participants
|
22.4 percentage of participants
|
15.3 percentage of participants
|
9.4 percentage of participants
|
11.9 percentage of participants
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Safety population, including all subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine they received.
Laboratory values that resulted in treatment and reporting as adverse events 1 month following vaccination.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Hemoglobin (low)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Platelets (low)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Platelets (high)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Leukocytes (low)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Leukocytes (high)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Alanine aminotransferase (high)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Aspartate aminotransferase (high)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Cholesterol (high)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Creatinine (high)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Gamma glutamyl transferase (high)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Glucose (low)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Glucose (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Potassium (low)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Potassium (high)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Sodium (low)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Triglycerides (high)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Urine glucose
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Urine hemoglobin
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Eosinophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Neutrophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Alkaline phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Albumin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Bicarbonate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Direct bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Calcium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Chloride
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Lactate dehydrogenase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Phosphate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Protein
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Urate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Urea nitrogen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Ketones
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Leukocyte esterase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Urine bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Urine protein
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Nitrite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Urobilinogen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Safety population, defined as all subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine they received.
Shifts from Normal at Baseline to Abnormal on Month 1 (30 days after vaccination) in Hematology, Clinical Chemistry and Urinalysis Parameters Occurring in Subjects Aged 50+ Years.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Eosinophils (10^9/L)
|
1.6 percentage of participants
|
1.2 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Hemoglobin (g/L)
|
2.8 percentage of participants
|
1.2 percentage of participants
|
4.0 percentage of participants
|
1.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Neutrophils (10^9/L)
|
5.1 percentage of participants
|
4.7 percentage of participants
|
5.1 percentage of participants
|
2.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Platelets (10^9/L)
|
1.2 percentage of participants
|
2.0 percentage of participants
|
1.2 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Leukocytes (10^9/L)
|
6.3 percentage of participants
|
4.7 percentage of participants
|
4.7 percentage of participants
|
4.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Albumin (g/L)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Alkaline phosphatase (U/L)
|
2.4 percentage of participants
|
1.6 percentage of participants
|
1.6 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Alanine aminotransferase (U/L)
|
2.4 percentage of participants
|
4.3 percentage of participants
|
2.0 percentage of participants
|
2.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Aspartate aminotransferase (U/L)
|
2.0 percentage of participants
|
2.0 percentage of participants
|
0.4 percentage of participants
|
2.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Bicarbonate (mmol/L)
|
1.2 percentage of participants
|
2.0 percentage of participants
|
2.0 percentage of participants
|
3.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Direct bilirubin (umol/L)
|
0.8 percentage of participants
|
0.0 percentage of participants
|
0.4 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Bilirubin (umol/L)
|
1.2 percentage of participants
|
0.8 percentage of participants
|
0.4 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Calcium (mmol/L)
|
6.7 percentage of participants
|
5.9 percentage of participants
|
7.1 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Cholesterol (mmol/L)
|
5.1 percentage of participants
|
6.7 percentage of participants
|
4.0 percentage of participants
|
5.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Chloride (mmol/L)
|
3.1 percentage of participants
|
3.9 percentage of participants
|
6.3 percentage of participants
|
2.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Creatinine (umol/L)
|
9.0 percentage of participants
|
5.5 percentage of participants
|
9.5 percentage of participants
|
10.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Gamma glutamyl transferase (U/L)
|
1.6 percentage of participants
|
2.0 percentage of participants
|
1.2 percentage of participants
|
2.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Glucose (mmol/L)
|
18.0 percentage of participants
|
21.3 percentage of participants
|
21.0 percentage of participants
|
24.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Potassium (mmol/L)
|
3.5 percentage of participants
|
2.8 percentage of participants
|
2.8 percentage of participants
|
2.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Lactate dehydrogenase (U/L)
|
0.4 percentage of participants
|
0.4 percentage of participants
|
0.0 percentage of participants
|
0.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Phosphate (mmol/L)
|
5.9 percentage of participants
|
3.2 percentage of participants
|
5.2 percentage of participants
|
4.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Protein (g/L)
|
1.2 percentage of participants
|
1.6 percentage of participants
|
1.2 percentage of participants
|
2.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Sodium (mmol/L)
|
3.9 percentage of participants
|
3.1 percentage of participants
|
4.0 percentage of participants
|
2.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Triglycerides (mmol/L)
|
6.7 percentage of participants
|
9.1 percentage of participants
|
7.5 percentage of participants
|
8.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Urate (umol/L)
|
7.1 percentage of participants
|
7.9 percentage of participants
|
6.3 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Urea nitrogen (mmol/L)
|
7.5 percentage of participants
|
5.1 percentage of participants
|
7.5 percentage of participants
|
8.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Ketones
|
1.6 percentage of participants
|
0.8 percentage of participants
|
0.0 percentage of participants
|
1.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Leukocyte esterase
|
6.5 percentage of participants
|
7.1 percentage of participants
|
7.8 percentage of participants
|
8.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Urine bilirubin
|
1.2 percentage of participants
|
2.4 percentage of participants
|
2.0 percentage of participants
|
1.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Urine glucose
|
0.8 percentage of participants
|
0.8 percentage of participants
|
1.3 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Urine hemoglobin
|
1.2 percentage of participants
|
2.4 percentage of participants
|
2.4 percentage of participants
|
2.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Urine protein
|
1.2 percentage of participants
|
2.0 percentage of participants
|
2.0 percentage of participants
|
3.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Nitrite
|
0.4 percentage of participants
|
1.2 percentage of participants
|
2.8 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Urobilinogen
|
0.0 percentage of participants
|
0.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Immunogenicity Evaluable Population included all subjects 50+ years who received study vaccine, with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Month 1 within required time frames. Data were analyzed according to vaccine received.
Antibody geometric mean titers as measured by OPA for the 31 pneumococcal serotypes in VAX-31.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=247 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=245 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=244 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=247 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
1
|
412.94 mcg/mL
Interval 346.34 to 492.35
|
474.22 mcg/mL
Interval 397.08 to 566.36
|
509.76 mcg/mL
Interval 426.79 to 608.85
|
410.32 mcg/mL
Interval 343.55 to 490.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
2
|
1984.89 mcg/mL
Interval 1687.63 to 2334.51
|
2158.32 mcg/mL
Interval 1830.96 to 2544.21
|
2376.00 mcg/mL
Interval 2016.93 to 2798.99
|
160.47 mcg/mL
Interval 136.23 to 189.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
3
|
247.34 mcg/mL
Interval 215.11 to 284.39
|
301.19 mcg/mL
Interval 261.87 to 346.41
|
369.12 mcg/mL
Interval 320.89 to 424.61
|
351.45 mcg/mL
Interval 305.59 to 404.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
4
|
1909.83 mcg/mL
Interval 1697.83 to 2148.29
|
1923.46 mcg/mL
Interval 1708.37 to 2165.64
|
2204.29 mcg/mL
Interval 1957.32 to 2482.43
|
1909.84 mcg/mL
Interval 1696.64 to 2149.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
5
|
453.32 mcg/mL
Interval 366.56 to 560.62
|
553.68 mcg/mL
Interval 446.96 to 685.89
|
643.83 mcg/mL
Interval 519.5 to 797.91
|
518.71 mcg/mL
Interval 418.91 to 642.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
6A
|
3017.66 mcg/mL
Interval 2421.39 to 3760.77
|
3649.18 mcg/mL
Interval 2920.0 to 4560.43
|
5476.69 mcg/mL
Interval 4383.39 to 6842.69
|
5039.25 mcg/mL
Interval 4034.7 to 6293.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
6B
|
3114.80 mcg/mL
Interval 2534.6 to 3827.81
|
3430.49 mcg/mL
Interval 2784.9 to 4225.76
|
4778.40 mcg/mL
Interval 3874.7 to 5892.86
|
4032.19 mcg/mL
Interval 3277.67 to 4960.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
7C
|
5333.37 mcg/mL
Interval 4722.15 to 6023.7
|
5642.80 mcg/mL
Interval 4991.2 to 6379.48
|
6230.76 mcg/mL
Interval 5507.58 to 7048.89
|
656.15 mcg/mL
Interval 578.74 to 743.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
7F
|
4889.66 mcg/mL
Interval 4224.12 to 5660.06
|
5647.05 mcg/mL
Interval 4857.85 to 6540.22
|
6584.45 mcg/mL
Interval 5686.59 to 7624.08
|
4990.65 mcg/mL
Interval 4311.96 to 5776.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
8
|
1614.83 mcg/mL
Interval 1399.07 to 1863.87
|
1943.14 mcg/mL
Interval 1680.15 to 2247.28
|
2329.26 mcg/mL
Interval 2010.27 to 2698.88
|
2077.75 mcg/mL
Interval 1798.13 to 2400.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
9N
|
6245.38 mcg/mL
Interval 5374.4 to 7257.52
|
7075.75 mcg/mL
Interval 6082.9 to 8230.66
|
7924.85 mcg/mL
Interval 6808.85 to 9223.76
|
1484.59 mcg/mL
Interval 1274.23 to 1729.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
9V
|
4709.89 mcg/mL
Interval 4015.67 to 5524.13
|
5572.21 mcg/mL
Interval 4748.0 to 6539.5
|
5353.40 mcg/mL
Interval 4560.06 to 6284.77
|
3700.19 mcg/mL
Interval 3153.92 to 4341.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
10A
|
2718.18 mcg/mL
Interval 2272.32 to 3251.53
|
4553.86 mcg/mL
Interval 3800.58 to 5456.44
|
4715.10 mcg/mL
Interval 3936.02 to 5648.37
|
4849.53 mcg/mL
Interval 4052.41 to 5803.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
11A
|
1130.91 mcg/mL
Interval 1061.75 to 1204.58
|
1101.72 mcg/mL
Interval 1033.84 to 1174.07
|
1147.21 mcg/mL
Interval 1076.37 to 1222.72
|
946.05 mcg/mL
Interval 887.55 to 1008.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
12F
|
1199.57 mcg/mL
Interval 968.68 to 1485.49
|
1389.71 mcg/mL
Interval 1119.73 to 1724.78
|
1658.63 mcg/mL
Interval 1335.19 to 2060.42
|
1382.15 mcg/mL
Interval 1115.8 to 1712.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
14
|
3574.38 mcg/mL
Interval 3048.13 to 4191.5
|
4000.68 mcg/mL
Interval 3404.71 to 4700.99
|
4657.38 mcg/mL
Interval 3965.48 to 5469.99
|
4306.60 mcg/mL
Interval 3670.73 to 5052.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
15A
|
8705.55 mcg/mL
Interval 7402.46 to 10238.03
|
9982.41 mcg/mL
Interval 8488.71 to 11738.94
|
10153.26 mcg/mL
Interval 8613.07 to 11968.86
|
2696.64 mcg/mL
Interval 2290.66 to 3174.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
15B
|
2891.81 mcg/mL
Interval 2423.77 to 3450.24
|
3548.99 mcg/mL
Interval 2969.28 to 4241.87
|
3877.44 mcg/mL
Interval 3243.71 to 4634.98
|
2568.68 mcg/mL
Interval 2149.28 to 3069.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
16F
|
7931.81 mcg/mL
Interval 6996.4 to 8992.27
|
9980.42 mcg/mL
Interval 8794.73 to 11325.96
|
11055.25 mcg/mL
Interval 9739.33 to 12548.96
|
2130.17 mcg/mL
Interval 1876.88 to 2417.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
17F
|
2146.39 mcg/mL
Interval 1904.03 to 2419.61
|
2112.12 mcg/mL
Interval 1871.11 to 2384.19
|
2160.76 mcg/mL
Interval 1913.48 to 2439.99
|
405.86 mcg/mL
Interval 358.82 to 459.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
18C
|
1928.40 mcg/mL
Interval 1599.06 to 2325.57
|
2302.99 mcg/mL
Interval 1910.36 to 2776.31
|
2640.00 mcg/mL
Interval 2190.27 to 3182.06
|
1845.17 mcg/mL
Interval 1531.2 to 2223.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
19A
|
4199.53 mcg/mL
Interval 3606.89 to 4889.55
|
4726.99 mcg/mL
Interval 4055.05 to 5510.27
|
5032.82 mcg/mL
Interval 4316.05 to 5868.63
|
4271.98 mcg/mL
Interval 3666.77 to 4977.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
19F
|
1754.37 mcg/mL
Interval 1541.08 to 1997.18
|
1817.82 mcg/mL
Interval 1595.18 to 2071.52
|
2185.14 mcg/mL
Interval 1917.0 to 2490.78
|
1321.85 mcg/mL
Interval 1160.51 to 1505.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
20B
|
9756.59 mcg/mL
Interval 8193.85 to 11617.39
|
10664.95 mcg/mL
Interval 8936.58 to 12727.6
|
9988.69 mcg/mL
Interval 8381.5 to 11904.07
|
427.17 mcg/mL
Interval 358.03 to 509.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
22F
|
7196.50 mcg/mL
Interval 6125.39 to 8454.92
|
8843.18 mcg/mL
Interval 7517.43 to 10402.73
|
8633.65 mcg/mL
Interval 7333.92 to 10163.72
|
9989.08 mcg/mL
Interval 8496.59 to 11743.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
23A
|
2778.60 mcg/mL
Interval 2235.23 to 3454.05
|
2929.12 mcg/mL
Interval 2354.16 to 3644.51
|
3253.49 mcg/mL
Interval 2612.93 to 4051.07
|
175.01 mcg/mL
Interval 139.54 to 219.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
23B
|
1919.13 mcg/mL
Interval 1555.79 to 2367.32
|
1855.53 mcg/mL
Interval 1501.21 to 2293.47
|
2010.19 mcg/mL
Interval 1625.78 to 2485.48
|
248.33 mcg/mL
Interval 200.25 to 307.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
23F
|
1829.26 mcg/mL
Interval 1475.0 to 2268.62
|
2128.26 mcg/mL
Interval 1714.84 to 2641.34
|
2491.49 mcg/mL
Interval 2007.55 to 3092.09
|
1433.09 mcg/mL
Interval 1156.18 to 1776.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
31
|
7199.08 mcg/mL
Interval 5973.44 to 8676.19
|
7821.34 mcg/mL
Interval 6480.26 to 9439.94
|
8605.44 mcg/mL
Interval 7127.04 to 10390.5
|
623.66 mcg/mL
Interval 515.16 to 755.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
33F
|
10686.74 mcg/mL
Interval 9102.59 to 12546.58
|
12553.75 mcg/mL
Interval 10684.65 to 14749.82
|
12763.17 mcg/mL
Interval 10869.89 to 14986.22
|
10332.19 mcg/mL
Interval 8815.38 to 12109.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
35B
|
9264.48 mcg/mL
Interval 8193.76 to 10475.12
|
9913.10 mcg/mL
Interval 8758.88 to 11219.41
|
10659.18 mcg/mL
Interval 9415.66 to 12066.95
|
2845.55 mcg/mL
Interval 2511.8 to 3223.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Immunogenicity Evaluable Population included all subjects 50+ years who received study vaccine, with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Month 1 within required time frames. Data were analyzed according to vaccine received.
Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31.
Outcome measures
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=247 Participants
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=245 Participants
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=244 Participants
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=247 Participants
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 50-59 Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 50-59 Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 50-59 Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 50-59 Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 60+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 60+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 60+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 60+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
VAX-31 Low Dose Age 65+ Years
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Age 65+ Years
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Age 65+ Years
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Age 65+ Years
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
19F
|
5.94 mcg/mL
Interval 4.82 to 7.34
|
6.94 mcg/mL
Interval 5.62 to 8.58
|
8.91 mcg/mL
Interval 7.2 to 11.02
|
4.37 mcg/mL
Interval 3.54 to 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
20B
|
16.33 mcg/mL
Interval 13.89 to 19.19
|
20.44 mcg/mL
Interval 17.37 to 24.05
|
20.24 mcg/mL
Interval 17.2 to 23.83
|
3.91 mcg/mL
Interval 3.33 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
22F
|
3.45 mcg/mL
Interval 2.93 to 4.06
|
4.05 mcg/mL
Interval 3.43 to 4.77
|
4.60 mcg/mL
Interval 3.9 to 5.43
|
4.37 mcg/mL
Interval 3.71 to 5.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
23A
|
3.05 mcg/mL
Interval 2.43 to 3.84
|
3.23 mcg/mL
Interval 2.57 to 4.07
|
4.01 mcg/mL
Interval 3.18 to 5.05
|
0.52 mcg/mL
Interval 0.42 to 0.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
23B
|
23.14 mcg/mL
Interval 19.65 to 27.27
|
25.41 mcg/mL
Interval 21.54 to 29.97
|
28.61 mcg/mL
Interval 24.25 to 33.76
|
11.27 mcg/mL
Interval 9.56 to 13.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
23F
|
4.58 mcg/mL
Interval 3.79 to 5.53
|
5.51 mcg/mL
Interval 4.56 to 6.66
|
6.45 mcg/mL
Interval 5.33 to 7.8
|
4.60 mcg/mL
Interval 3.81 to 5.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
31
|
6.84 mcg/mL
Interval 5.64 to 8.31
|
10.46 mcg/mL
Interval 8.61 to 12.72
|
11.92 mcg/mL
Interval 9.8 to 14.5
|
0.44 mcg/mL
Interval 0.36 to 0.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
33F
|
13.10 mcg/mL
Interval 11.12 to 15.43
|
14.21 mcg/mL
Interval 12.05 to 16.76
|
15.88 mcg/mL
Interval 13.46 to 18.73
|
12.24 mcg/mL
Interval 10.39 to 14.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
35B
|
25.39 mcg/mL
Interval 21.52 to 29.96
|
31.05 mcg/mL
Interval 26.28 to 36.68
|
36.39 mcg/mL
Interval 30.77 to 43.03
|
3.05 mcg/mL
Interval 2.58 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
1
|
5.56 mcg/mL
Interval 4.78 to 6.48
|
5.55 mcg/mL
Interval 4.76 to 6.48
|
6.40 mcg/mL
Interval 5.49 to 7.46
|
4.32 mcg/mL
Interval 3.71 to 5.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
2
|
12.64 mcg/mL
Interval 10.6 to 15.08
|
14.78 mcg/mL
Interval 12.37 to 17.66
|
15.04 mcg/mL
Interval 12.59 to 17.97
|
0.93 mcg/mL
Interval 0.78 to 1.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
3
|
0.47 mcg/mL
Interval 0.4 to 0.55
|
0.53 mcg/mL
Interval 0.45 to 0.61
|
0.61 mcg/mL
Interval 0.52 to 0.71
|
0.60 mcg/mL
Interval 0.52 to 0.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
4
|
1.22 mcg/mL
Interval 1.02 to 1.46
|
1.56 mcg/mL
Interval 1.3 to 1.86
|
1.73 mcg/mL
Interval 1.44 to 2.06
|
1.50 mcg/mL
Interval 1.26 to 1.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
7C
|
11.96 mcg/mL
Interval 9.47 to 15.09
|
14.02 mcg/mL
Interval 11.09 to 17.73
|
13.71 mcg/mL
Interval 10.83 to 17.36
|
0.56 mcg/mL
Interval 0.44 to 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
5
|
2.38 mcg/mL
Interval 2.01 to 2.83
|
2.82 mcg/mL
Interval 2.38 to 3.35
|
2.80 mcg/mL
Interval 2.36 to 3.33
|
2.47 mcg/mL
Interval 2.08 to 2.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
6A
|
2.97 mcg/mL
Interval 2.42 to 3.66
|
3.15 mcg/mL
Interval 2.56 to 3.89
|
4.28 mcg/mL
Interval 3.48 to 5.27
|
3.14 mcg/mL
Interval 2.55 to 3.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
6B
|
3.26 mcg/mL
Interval 2.58 to 4.13
|
3.88 mcg/mL
Interval 3.06 to 4.92
|
5.01 mcg/mL
Interval 3.95 to 6.35
|
3.08 mcg/mL
Interval 2.43 to 3.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
7F
|
5.81 mcg/mL
Interval 4.97 to 6.8
|
6.59 mcg/mL
Interval 5.63 to 7.72
|
7.10 mcg/mL
Interval 6.06 to 8.32
|
5.14 mcg/mL
Interval 4.39 to 6.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
8
|
6.13 mcg/mL
Interval 5.24 to 7.16
|
7.44 mcg/mL
Interval 6.36 to 8.7
|
9.69 mcg/mL
Interval 8.27 to 11.34
|
6.99 mcg/mL
Interval 5.97 to 8.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
9N
|
6.52 mcg/mL
Interval 5.49 to 7.73
|
6.60 mcg/mL
Interval 5.56 to 7.84
|
7.92 mcg/mL
Interval 6.67 to 9.41
|
1.00 mcg/mL
Interval 0.84 to 1.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
9V
|
3.77 mcg/mL
Interval 3.12 to 4.55
|
4.31 mcg/mL
Interval 3.57 to 5.2
|
3.78 mcg/mL
Interval 3.12 to 4.57
|
2.63 mcg/mL
Interval 2.18 to 3.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
10A
|
6.67 mcg/mL
Interval 5.27 to 8.43
|
7.55 mcg/mL
Interval 5.96 to 9.56
|
8.21 mcg/mL
Interval 6.47 to 10.4
|
10.82 mcg/mL
Interval 8.55 to 13.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
11A
|
4.78 mcg/mL
Interval 4.0 to 5.71
|
5.70 mcg/mL
Interval 4.76 to 6.82
|
5.37 mcg/mL
Interval 4.49 to 6.42
|
3.75 mcg/mL
Interval 3.13 to 4.48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
12F
|
1.52 mcg/mL
Interval 1.24 to 1.86
|
1.96 mcg/mL
Interval 1.6 to 2.4
|
1.70 mcg/mL
Interval 1.39 to 2.08
|
1.38 mcg/mL
Interval 1.13 to 1.68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
14
|
7.41 mcg/mL
Interval 6.02 to 9.12
|
10.33 mcg/mL
Interval 8.38 to 12.74
|
11.58 mcg/mL
Interval 9.38 to 14.28
|
9.15 mcg/mL
Interval 7.42 to 11.27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
15A
|
20.93 mcg/mL
Interval 17.27 to 25.38
|
26.40 mcg/mL
Interval 21.75 to 32.06
|
25.91 mcg/mL
Interval 21.32 to 31.5
|
4.22 mcg/mL
Interval 3.48 to 5.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
15B
|
12.34 mcg/mL
Interval 10.04 to 15.16
|
4.06 mcg/mL
Interval 3.45 to 4.79
|
18.25 mcg/mL
Interval 14.82 to 22.46
|
13.17 mcg/mL
Interval 10.71 to 16.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
16F
|
3.03 mcg/mL
Interval 2.57 to 3.57
|
4.06 mcg/mL
Interval 3.45 to 4.79
|
3.82 mcg/mL
Interval 3.24 to 4.51
|
0.95 mcg/mL
Interval 0.81 to 1.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
17F
|
9.54 mcg/mL
Interval 8.08 to 11.27
|
11.05 mcg/mL
Interval 9.35 to 13.06
|
12.67 mcg/mL
Interval 10.72 to 14.99
|
0.56 mcg/mL
Interval 0.47 to 0.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
18C
|
7.15 mcg/mL
Interval 5.91 to 8.67
|
8.34 mcg/mL
Interval 6.87 to 10.11
|
8.31 mcg/mL
Interval 6.85 to 10.09
|
6.62 mcg/mL
Interval 5.46 to 8.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
19A
|
8.08 mcg/mL
Interval 6.64 to 9.83
|
11.00 mcg/mL
Interval 9.03 to 13.39
|
11.83 mcg/mL
Interval 9.71 to 14.41
|
8.53 mcg/mL
Interval 7.01 to 10.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
VAX-31 Low Dose Overall (Age 50+)
Serious events: 2 serious events
Other events: 189 other events
Deaths: 0 deaths
VAX-31 Mid Dose Overall (Age 50+)
Serious events: 3 serious events
Other events: 196 other events
Deaths: 0 deaths
VAX-31 High Dose Overall (Age 50+)
Serious events: 5 serious events
Other events: 209 other events
Deaths: 0 deaths
PCV20 Overall (Age 50+)
Serious events: 3 serious events
Other events: 178 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 participants at risk
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 participants at risk
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 participants at risk
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 participants at risk
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
General disorders
Gait disturbance
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.39%
1/255 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.79%
2/253 • Number of events 2 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.39%
1/254 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.39%
1/254 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.39%
1/255 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/255 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.39%
1/254 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
Other adverse events
| Measure |
VAX-31 Low Dose Overall (Age 50+)
n=255 participants at risk
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 Mid Dose Overall (Age 50+)
n=254 participants at risk
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
VAX-31 High Dose Overall (Age 50+)
n=253 participants at risk
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
|
PCV20 Overall (Age 50+)
n=253 participants at risk
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain at injection site
|
65.5%
167/255 • Number of events 167 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
66.9%
170/254 • Number of events 170 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
73.5%
186/253 • Number of events 186 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
59.9%
151/252 • Number of events 151 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.3%
16/255 • Number of events 16 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
7.5%
19/254 • Number of events 19 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
7.1%
18/253 • Number of events 18 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
4.4%
11/252 • Number of events 11 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Skin and subcutaneous tissue disorders
Edema
|
5.5%
14/255 • Number of events 14 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
7.9%
20/254 • Number of events 20 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
7.1%
18/253 • Number of events 18 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
3.6%
9/252 • Number of events 9 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
General disorders
Fever
|
1.2%
3/255 • Number of events 3 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
1.2%
3/254 • Number of events 3 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
1.6%
4/253 • Number of events 4 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.79%
2/252 • Number of events 2 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
General disorders
Headache
|
31.8%
81/255 • Number of events 81 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
31.9%
81/254 • Number of events 81 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
33.2%
84/253 • Number of events 84 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
26.6%
67/252 • Number of events 67 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
General disorders
Tiredness
|
36.5%
93/255 • Number of events 93 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
36.2%
92/254 • Number of events 92 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
46.2%
117/253 • Number of events 117 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
38.9%
98/252 • Number of events 98 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
41.6%
106/255 • Number of events 106 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
46.9%
119/254 • Number of events 119 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
54.9%
139/253 • Number of events 139 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
41.3%
104/252 • Number of events 104 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
17.3%
44/255 • Number of events 44 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
22.0%
56/254 • Number of events 56 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
23.3%
59/253 • Number of events 59 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
16.7%
42/252 • Number of events 42 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
General disorders
Injection site pruritis
|
0.39%
1/255 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
1.6%
4/254 • Number of events 4 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.79%
2/253 • Number of events 2 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/253 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
3/255 • Number of events 3 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.00%
0/254 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
0.40%
1/253 • Number of events 1 • 6 months
All subjects had safety labs analyzed at Baseline and 1 month post-vaccination. Solicited AEs were collected for 7 days and unsolicited AEs for 1 month post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall review within the ninety (90) day period. Upon receiving any notification from Sponsor requesting deletion of Confidential Information, correction of inaccuracies, or a delay in publication to allow the filing of patent application, Institution or Investigator shall take the requested action of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER