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Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults (NCT NCT05266456)

NCT ID: NCT05266456

Last Updated: 2024-04-18

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

835 participants

Primary outcome timeframe

7 days after vaccination

Results posted on

2024-04-18

Participant Flow

First subject was enrolled 22-Feb-2022 and last subject randomized/vaccinated was 01-Jul-22. Study sites were medical clinics.

In Phase 1, 95 participants were screened; 21 did not meet inclusion/exclusion criteria, 4 withdrew consent, and 6 discontinued for other reason. Five of Phase 1 screen failures were rescreened and enrolled in Phase 2. An additional 1001 participants were screened (for a total of 1006); of these, 235 failed screening: 173 did not meet inclusion/exclusion criteria, 12 withdrew consent, and 50 failed for other reasons.

Participant milestones

Participant milestones
Measure
VAX-24 Low Dose
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at the 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
Phase 1, Adults 18-49 Years of Age
STARTED
16
16
16
16
Phase 1, Adults 18-49 Years of Age
COMPLETED
15
15
16
15
Phase 1, Adults 18-49 Years of Age
NOT COMPLETED
1
1
0
1
Phase 2, Adults 50-64 Years
STARTED
193
192
192
194
Phase 2, Adults 50-64 Years
COMPLETED
186
186
187
192
Phase 2, Adults 50-64 Years
NOT COMPLETED
7
6
5
2

Reasons for withdrawal

Reasons for withdrawal
Measure
VAX-24 Low Dose
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at the 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
Phase 1, Adults 18-49 Years of Age
Lost to Follow-up
1
1
0
0
Phase 1, Adults 18-49 Years of Age
Withdrawal by Subject
0
0
0
1
Phase 2, Adults 50-64 Years
Lost to Follow-up
6
6
3
1
Phase 2, Adults 50-64 Years
Withdrawal by Subject
0
0
2
0
Phase 2, Adults 50-64 Years
Unavailable for follow up
1
0
0
1

Baseline Characteristics

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
VAX-24 Low Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=16 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
n=193 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
n=192 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
n=192 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
n=194 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on 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=835 Participants
Total of all reporting groups
Age, Continuous
39.5 Years
n=5 Participants
34.0 Years
n=7 Participants
39.0 Years
n=5 Participants
37.0 Years
n=4 Participants
57.0 Years
n=21 Participants
57.0 Years
n=10 Participants
57.0 Years
n=115 Participants
57.0 Years
n=6 Participants
57.0 Years
n=6 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
7 Participants
n=7 Participants
8 Participants
n=5 Participants
8 Participants
n=4 Participants
110 Participants
n=21 Participants
121 Participants
n=10 Participants
134 Participants
n=115 Participants
127 Participants
n=6 Participants
522 Participants
n=6 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
9 Participants
n=7 Participants
8 Participants
n=5 Participants
8 Participants
n=4 Participants
83 Participants
n=21 Participants
71 Participants
n=10 Participants
58 Participants
n=115 Participants
67 Participants
n=6 Participants
313 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
5 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
22 Participants
n=21 Participants
18 Participants
n=10 Participants
22 Participants
n=115 Participants
17 Participants
n=6 Participants
93 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=5 Participants
10 Participants
n=7 Participants
14 Participants
n=5 Participants
13 Participants
n=4 Participants
171 Participants
n=21 Participants
172 Participants
n=10 Participants
168 Participants
n=115 Participants
177 Participants
n=6 Participants
737 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=10 Participants
2 Participants
n=115 Participants
0 Participants
n=6 Participants
5 Participants
n=6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
2 Participants
n=6 Participants
3 Participants
n=6 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
3 Participants
n=6 Participants
8 Participants
n=6 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
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=5 Participants
7 Participants
n=7 Participants
4 Participants
n=5 Participants
10 Participants
n=4 Participants
40 Participants
n=21 Participants
32 Participants
n=10 Participants
29 Participants
n=115 Participants
29 Participants
n=6 Participants
156 Participants
n=6 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
8 Participants
n=7 Participants
12 Participants
n=5 Participants
4 Participants
n=4 Participants
145 Participants
n=21 Participants
157 Participants
n=10 Participants
156 Participants
n=115 Participants
154 Participants
n=6 Participants
646 Participants
n=6 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
1 Participants
n=10 Participants
4 Participants
n=115 Participants
3 Participants
n=6 Participants
11 Participants
n=6 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
2 Participants
n=10 Participants
1 Participants
n=115 Participants
3 Participants
n=6 Participants
10 Participants
n=6 Participants
Region of Enrollment
United States
16 participants
n=5 Participants
16 participants
n=7 Participants
16 participants
n=5 Participants
16 participants
n=4 Participants
193 participants
n=21 Participants
192 participants
n=10 Participants
192 participants
n=115 Participants
194 participants
n=6 Participants
835 participants
n=6 Participants
Height (cm)
176.1 cm
n=5 Participants
170.1 cm
n=7 Participants
167.1 cm
n=5 Participants
170.8 cm
n=4 Participants
168.3 cm
n=21 Participants
167.6 cm
n=10 Participants
167.6 cm
n=115 Participants
167.6 cm
n=6 Participants
167.6 cm
n=6 Participants
Weight (kg)
80.85 kg
n=5 Participants
92.10 kg
n=7 Participants
90.50 kg
n=5 Participants
78.07 kg
n=4 Participants
87.82 kg
n=21 Participants
86.72 kg
n=10 Participants
83.10 kg
n=115 Participants
82.83 kg
n=6 Participants
84.81 kg
n=6 Participants
Body Mass Index (kg/m^2) Median, Q1 - Q3
26.99 kg/m^2
n=5 Participants
31.09 kg/m^2
n=7 Participants
29.16 kg/m^2
n=5 Participants
26.91 kg/m^2
n=4 Participants
29.87 kg/m^2
n=21 Participants
30.65 kg/m^2
n=10 Participants
29.34 kg/m^2
n=115 Participants
29.06 kg/m^2
n=6 Participants
29.49 kg/m^2
n=6 Participants

PRIMARY outcome

Timeframe: 7 days after vaccination

Population: Safety population, defined as all patients exposed to study vaccine. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group

Outcome measures

Outcome measures
Measure
VAX-24 Low Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=16 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
n=193 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
n=196 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX24 Low Dose 18-64 Yrs
n=209 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
n=212 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on 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 Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
Any solicited local AE; Overall, Any Grade
56.3 percentage of participants
81.3 percentage of participants
81.3 percentage of participants
93.8 percentage of participants
73.6 percentage of participants
71.7 percentage of participants
77.5 percentage of participants
71.9 percentage of participants
72.2 percentage of participants
72.5 percentage of participants
77.8 percentage of participants
73.6 percentage of participants
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
Pain at injection site; Overall, Any Grade
56.3 percentage of participants
75.0 percentage of participants
81.3 percentage of participants
81.3 percentage of participants
71.0 percentage of participants
71.2 percentage of participants
77.0 percentage of participants
69.9 percentage of participants
69.9 percentage of participants
71.5 percentage of participants
77.3 percentage of participants
70.8 percentage of participants
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
Erythema (redness) at injection site; Overall, Any Grade
6.3 percentage of participants
6.3 percentage of participants
18.8 percentage of participants
25.0 percentage of participants
6.7 percentage of participants
7.9 percentage of participants
8.9 percentage of participants
8.7 percentage of participants
6.7 percentage of participants
7.7 percentage of participants
9.7 percentage of participants
9.9 percentage of participants
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
Edema (swelling) at injection site; Overall, Any Grade
18.8 percentage of participants
12.5 percentage of participants
25.0 percentage of participants
18.8 percentage of participants
8.8 percentage of participants
7.9 percentage of participants
7.9 percentage of participants
10.7 percentage of participants
9.6 percentage of participants
8.2 percentage of participants
9.2 percentage of participants
11.3 percentage of participants

PRIMARY outcome

Timeframe: 7 days after vaccination

Population: Safety population, which included all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain

Outcome measures

Outcome measures
Measure
VAX-24 Low Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=16 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
n=193 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
n=196 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX24 Low Dose 18-64 Yrs
n=209 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
n=212 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on 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 Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Any solicited systemic adverse event
50.0 Percentage of participants
62.5 Percentage of participants
56.3 Percentage of participants
75.0 Percentage of participants
69.4 Percentage of participants
69.6 Percentage of participants
71.2 Percentage of participants
64.8 Percentage of participants
67.9 Percentage of participants
69.1 Percentage of participants
70.0 Percentage of participants
65.6 Percentage of participants
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Fever (oral temperature >= 100.4ºF)
6.3 Percentage of participants
6.3 Percentage of participants
0.0 Percentage of participants
12.5 Percentage of participants
1.0 Percentage of participants
0.5 Percentage of participants
2.1 Percentage of participants
1.0 Percentage of participants
1.4 Percentage of participants
1.0 Percentage of participants
1.9 Percentage of participants
1.9 Percentage of participants
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Fatigue
37.5 Percentage of participants
31.3 Percentage of participants
37.5 Percentage of participants
50.0 Percentage of participants
42.5 Percentage of participants
40.8 Percentage of participants
40.8 Percentage of participants
39.8 Percentage of participants
42.1 Percentage of participants
40.1 Percentage of participants
40.6 Percentage of participants
40.6 Percentage of participants
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Headache
31.3 Percentage of participants
37.5 Percentage of participants
25.0 Percentage of participants
37.5 Percentage of participants
30.6 Percentage of participants
28.8 Percentage of participants
30.4 Percentage of participants
30.1 Percentage of participants
30.6 Percentage of participants
29.5 Percentage of participants
30.0 Percentage of participants
30.7 Percentage of participants
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Muscle Pain
37.5 Percentage of participants
37.5 Percentage of participants
18.8 Percentage of participants
56.3 Percentage of participants
57.0 Percentage of participants
56.0 Percentage of participants
60.2 Percentage of participants
53.1 Percentage of participants
55.5 Percentage of participants
54.6 Percentage of participants
57.0 Percentage of participants
53.3 Percentage of participants
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Joint Pain
25.0 Percentage of participants
12.5 Percentage of participants
12.5 Percentage of participants
43.8 Percentage of participants
24.9 Percentage of participants
16.2 Percentage of participants
27.7 Percentage of participants
24.0 Percentage of participants
24.9 Percentage of participants
15.9 Percentage of participants
26.6 Percentage of participants
25.5 Percentage of participants

PRIMARY outcome

Timeframe: 1 month after vaccination

Population: Safety population, including all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.

Outcome measures

Outcome measures
Measure
VAX-24 Low Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=16 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
n=193 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
n=196 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX24 Low Dose 18-64 Yrs
n=209 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
n=212 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on 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 Reporting Unsolicited Adverse Events (AE) in Each Age Group
12.5 Percentage of participants
12.5 Percentage of participants
6.3 Percentage of participants
6.3 Percentage of participants
15.5 Percentage of participants
11.5 Percentage of participants
13.1 Percentage of participants
16.8 Percentage of participants
15.3 Percentage of participants
11.6 Percentage of participants
12.6 Percentage of participants
16.0 Percentage of participants

PRIMARY outcome

Timeframe: 6 months after vaccination

Population: Safety population, including all subjects in the exposed population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Percentage of participants with SAEs and NOCIs

Outcome measures

Outcome measures
Measure
VAX-24 Low Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=16 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=16 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
n=193 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
n=196 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX24 Low Dose 18-64 Yrs
n=209 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
n=207 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
n=212 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on 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 Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
Subjects with at least one SAE
0 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
1.0 percentage of participants
1.6 percentage of participants
0.5 percentage of participants
2.0 percentage of participants
1.0 percentage of participants
1.4 percentage of participants
0.5 percentage of participants
1.9 percentage of participants
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
Subjects with at least one NOCI
0 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
1.6 percentage of participants
1.6 percentage of participants
3.1 percentage of participants
2.6 percentage of participants
1.4 percentage of participants
1.4 percentage of participants
2.9 percentage of participants
2.4 percentage of participants

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Prespecified analysis population included all subjects age 50-64 in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in \>5% of Subjects Aged 50 to 64 Years

Outcome measures

Outcome measures
Measure
VAX-24 Low Dose 18-49 Yrs
n=193 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=196 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX24 Low Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on 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 Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Bicarbonate: Low
14.4 percentage of participants
18.4 percentage of participants
15.0 percentage of participants
11.8 percentage of participants
—
—
—
—
—
—
—
—
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Cholesterol: High
7.2 percentage of participants
7.7 percentage of participants
8.7 percentage of participants
8.5 percentage of participants
—
—
—
—
—
—
—
—
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Triglycerides: High
9.1 percentage of participants
8.2 percentage of participants
9.7 percentage of participants
10.8 percentage of participants
—
—
—
—
—
—
—
—
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Creatinine: High
11.5 percentage of participants
11.1 percentage of participants
10.6 percentage of participants
8.5 percentage of participants
—
—
—
—
—
—
—
—
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Glucose: High
7.2 percentage of participants
3.9 percentage of participants
5.3 percentage of participants
7.1 percentage of participants
—
—
—
—
—
—
—
—
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Uric Acid: High
8.1 percentage of participants
7.2 percentage of participants
2.9 percentage of participants
5.7 percentage of participants
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20.

Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24

Outcome measures

Outcome measures
Measure
VAX-24 Low Dose 18-49 Yrs
n=193 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=191 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=196 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX24 Low Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
22F
6243.38 Titer
Interval 4988.03 to 7814.68
7164.92 Titer
Interval 5738.17 to 8946.42
4843.18 Titer
Interval 3869.91 to 6061.23
7631.74 Titer
Interval 6120.11 to 9516.73
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
23F
1000.62 Titer
Interval 740.33 to 1352.43
1368.00 Titer
Interval 1015.55 to 1842.76
857.41 Titer
Interval 634.33 to 1158.95
962.52 Titer
Interval 715.73 to 1294.42
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
1
190.08 Titer
Interval 147.05 to 245.69
317.62 Titer
Interval 246.32 to 409.56
228.09 Titer
Interval 176.35 to 295.01
358.18 Titer
Interval 278.29 to 461.0
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
2
1371.45 Titer
Interval 1135.7 to 1656.12
1698.18 Titer
Interval 1409.82 to 2045.51
1822.43 Titer
Interval 1509.74 to 2199.89
62.40 Titer
Interval 51.85 to 75.08
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
3
319.33 Titer
Interval 263.23 to 387.4
407.13 Titer
Interval 336.51 to 492.56
497.72 Titer
Interval 410.26 to 603.84
343.29 Titer
Interval 283.99 to 414.96
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
4
1229.24 Titer
Interval 1070.97 to 1576.17
1717.83 Titer
Interval 1419.2 to 2079.3
1326.49 Titer
Interval 1093.4 to 1609.25
1414.77 Titer
Interval 1169.79 to 1711.05
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
5
491.01 Titer
Interval 370.31 to 651.05
546.38 Titer
Interval 413.37 to 722.19
366.50 Titer
Interval 276.39 to 485.99
691.28 Titer
Interval 524.1 to 911.78
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
6A
3252.03 Titer
Interval 2439.24 to 4335.64
3604.41 Titer
Interval 2718.05 to 4779.81
3218.37 Titer
Interval 2416.99 to 4285.44
3932.31 Titer
Interval 2969.22 to 5207.78
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
6B
3506.32 Titer
Interval 2730.26 to 4502.96
4646.32 Titer
Interval 3630.07 to 5947.07
4867.77 Titer
Interval 3792.29 to 6248.24
3783.96 Titer
Interval 2961.89 to 4834.2
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
7F
3318.45 Titer
Interval 2768.67 to 3977.4
4359.57 Titer
Interval 3646.63 to 5211.9
5962.25 Titer
Interval 4965.38 to 7159.25
3975.12 Titer
Interval 3324.16 to 4753.56
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
8
2344.26 Titer
Interval 1954.41 to 2811.88
2483.57 Titer
Interval 2075.88 to 2971.34
2668.87 Titer
Interval 2224.94 to 3201.37
2267.98 Titer
Interval 1897.25 to 2711.15
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
9N
8217.87 Titer
Interval 6958.94 to 9704.54
9753.78 Titer
Interval 8278.27 to 11492.29
9066.94 Titer
Interval 7672.89 to 10714.27
1636.07 Titer
Interval 1387.32 to 1929.41
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
9V
2596.46 Titer
Interval 2006.38 to 3360.09
3028.18 Titer
Interval 2348.52 to 3904.52
3757.52 Titer
Interval 2903.4 to 4862.91
1733.44 Titer
Interval 1345.08 to 2233.92
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
10A
4156.84 Titer
Interval 3371.51 to 5125.1
5800.54 Titer
Interval 4722.94 to 7124.01
5366.49 Titer
Interval 4358.65 to 6607.37
5533.20 Titer
Interval 4507.79 to 6791.86
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
11A
1117.61 Titer
Interval 1044.46 to 1195.89
1076.79 Titer
Interval 1007.27 to 1151.11
1064.03 Titer
Interval 994.37 to 1138.58
1038.01 Titer
Interval 971.15 to 1109.47
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
12F
1550.61 Titer
Interval 1187.61 to 2024.56
2307.24 Titer
Interval 1773.76 to 3001.15
1549.29 Titer
Interval 1186.52 to 2022.97
1914.42 Titer
Interval 1472.75 to 2488.55
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
14
3398.89 Titer
Interval 2686.58 to 4300.06
4282.68 Titer
Interval 3393.98 to 5404.08
4107.89 Titer
Interval 3246.39 to 5198.01
3634.47 Titer
Interval 2885.63 to 4577.65
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
15B
2384.28 Titer
Interval 1857.24 to 3060.89
3242.54 Titer
Interval 2534.98 to 4147.58
2535.37 Titer
Interval 1975.01 to 3254.71
3137.65 Titer
Interval 2456.1 to 4008.34
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
17F
2317.55 Titer
Interval 2037.96 to 2635.49
2301.19 Titer
Interval 2027.23 to 2612.17
2290.15 Titer
Interval 2013.79 to 2604.43
666.74 Titer
Interval 586.52 to 757.92
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
18C
2735.58 Titer
Interval 2198.02 to 3404.6
3435.80 Titer
Interval 2770.54 to 4260.79
4103.02 Titer
Interval 3298.26 to 5104.14
1963.65 Titer
Interval 1584.4 to 2433.69
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
19A
4351.67 Titer
Interval 3577.95 to 5292.72
5653.21 Titer
Interval 4658.23 to 6860.7
6211.37 Titer
Interval 5106.76 to 7554.9
4813.63 Titer
Interval 3972.27 to 5833.2
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
19F
1928.24 Titer
Interval 1669.54 to 2227.03
2347.67 Titer
Interval 2036.83 to 2705.93
2453.82 Titer
Interval 2124.54 to 2834.14
1419.27 Titer
Interval 1232.17 to 1634.79
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
20B
8205.88 Titer
Interval 6476.81 to 10396.54
8545.04 Titer
Interval 6763.81 to 10795.35
7809.21 Titer
Interval 6150.35 to 9915.5
140.23 Titer
Interval 110.55 to 177.88
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
33F
11672.18 Titer
Interval 9582.4 to 14217.7
17099.25 Titer
Interval 14061.56 to 20793.17
11856.15 Titer
Interval 9732.71 to 14442.87
11030.39 Titer
Interval 9085.39 to 13391.78
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20.

Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24

Outcome measures

Outcome measures
Measure
VAX-24 Low Dose 18-49 Yrs
n=166 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=181 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=172 Participants
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=179 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX24 Low Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
22F
4.13 mcg/mL
Interval 3.41 to 5.0
5.45 mcg/mL
Interval 4.51 to 6.59
3.81 mcg/mL
Interval 3.15 to 4.61
7.32 mcg/mL
Interval 6.06 to 8.83
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
1
2.85 mcg/mL
Interval 2.29 to 3.55
4.65 mcg/mL
Interval 3.75 to 5.77
4.01 mcg/mL
Interval 3.22 to 4.99
4.39 mcg/mL
Interval 3.54 to 5.45
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
2
13.31 mcg/mL
Interval 10.99 to 16.11
16.37 mcg/mL
Interval 13.56 to 19.76
18.73 mcg/mL
Interval 15.47 to 22.68
1.02 mcg/mL
Interval 0.85 to 1.23
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
3
0.41 mcg/mL
Interval 0.34 to 0.5
0.53 mcg/mL
Interval 0.44 to 0.64
0.79 mcg/mL
Interval 0.65 to 0.97
0.48 mcg/mL
Interval 0.4 to 0.59
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
4
1.79 mcg/mL
Interval 1.45 to 2.21
2.52 mcg/mL
Interval 2.04 to 3.1
1.83 mcg/mL
Interval 1.48 to 2.26
2.02 mcg/mL
Interval 1.64 to 2.48
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
5
2.13 mcg/mL
Interval 1.66 to 2.73
2.42 mcg/mL
Interval 1.9 to 3.1
1.78 mcg/mL
Interval 1.39 to 2.28
3.70 mcg/mL
Interval 2.9 to 4.73
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
6A
3.92 mcg/mL
Interval 3.0 to 5.11
4.66 mcg/mL
Interval 3.59 to 6.06
4.38 mcg/mL
Interval 3.36 to 5.71
4.62 mcg/mL
Interval 3.56 to 5.99
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
6B
2.83 mcg/mL
Interval 2.14 to 3.73
3.78 mcg/mL
Interval 2.87 to 4.97
4.43 mcg/mL
Interval 3.36 to 5.86
2.44 mcg/mL
Interval 1.85 to 3.2
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
7F
4.97 mcg/mL
Interval 4.1 to 6.04
6.29 mcg/mL
Interval 5.2 to 7.61
8.82 mcg/mL
Interval 7.26 to 10.7
4.74 mcg/mL
Interval 3.92 to 5.73
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
8
8.94 mcg/mL
Interval 7.25 to 11.02
8.79 mcg/mL
Interval 7.15 to 10.81
8.94 mcg/mL
Interval 7.25 to 11.02
7.30 mcg/mL
Interval 5.95 to 8.97
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
9N
7.98 mcg/mL
Interval 6.72 to 9.48
10.78 mcg/mL
Interval 9.1 to 12.78
7.91 mcg/mL
Interval 6.66 to 9.4
2.52 mcg/mL
Interval 2.13 to 2.99
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
9V
3.93 mcg/mL
Interval 3.13 to 4.92
5.12 mcg/mL
Interval 4.1 to 6.4
7.15 mcg/mL
Interval 5.71 to 8.97
2.94 mcg/mL
Interval 2.36 to 3.67
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
10A
6.73 mcg/mL
Interval 5.3 to 8.54
7.90 mcg/mL
Interval 6.24 to 10.0
6.58 mcg/mL
Interval 5.18 to 8.36
9.38 mcg/mL
Interval 7.41 to 11.86
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
11A
5.62 mcg/mL
Interval 4.73 to 6.67
5.76 mcg/mL
Interval 4.86 to 6.83
4.87 mcg/mL
Interval 4.1 to 5.78
3.72 mcg/mL
Interval 3.14 to 4.4
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
12F
1.73 mcg/mL
Interval 1.4 to 2.15
2.13 mcg/mL
Interval 1.72 to 2.64
1.91 mcg/mL
Interval 1.54 to 2.38
1.15 mcg/mL
Interval 0.93 to 1.42
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
14
8.62 mcg/mL
Interval 6.54 to 11.36
10.47 mcg/mL
Interval 7.97 to 13.75
10.47 mcg/mL
Interval 7.93 to 13.81
8.17 mcg/mL
Interval 6.23 to 10.72
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
15B
10.67 mcg/mL
Interval 8.61 to 13.23
14.09 mcg/mL
Interval 11.41 to 17.4
11.59 mcg/mL
Interval 9.36 to 14.36
14.81 mcg/mL
Interval 12.0 to 18.27
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
17F
9.57 mcg/mL
Interval 7.92 to 11.56
10.51 mcg/mL
Interval 8.72 to 12.67
9.89 mcg/mL
Interval 8.18 to 11.95
0.46 mcg/mL
Interval 0.38 to 0.55
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
18C
6.66 mcg/mL
Interval 5.1 to 8.7
8.50 mcg/mL
Interval 6.53 to 11.07
10.35 mcg/mL
Interval 7.92 to 13.53
6.67 mcg/mL
Interval 5.13 to 8.67
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
19A
7.35 mcg/mL
Interval 5.8 to 9.31
9.21 mcg/mL
Interval 7.29 to 11.64
11.50 mcg/mL
Interval 9.07 to 14.58
8.84 mcg/mL
Interval 7.01 to 11.16
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
19F
4.98 mcg/mL
Interval 3.8 to 6.52
8.92 mcg/mL
Interval 6.83 to 11.64
9.96 mcg/mL
Interval 7.6 to 13.04
4.34 mcg/mL
Interval 3.33 to 5.66
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
20B
19.53 mcg/mL
Interval 16.82 to 22.68
24.90 mcg/mL
Interval 21.49 to 28.84
19.40 mcg/mL
Interval 16.71 to 22.52
4.06 mcg/mL
Interval 3.5 to 4.7
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
23F
4.60 mcg/mL
Interval 3.59 to 5.87
5.90 mcg/mL
Interval 4.63 to 7.52
5.27 mcg/mL
Interval 4.12 to 6.73
5.18 mcg/mL
Interval 4.07 to 6.59
—
—
—
—
—
—
—
—
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
33F
12.20 mcg/mL
Interval 10.11 to 14.72
17.58 mcg/mL
Interval 14.6 to 21.17
11.82 mcg/mL
Interval 9.77 to 14.3
9.73 mcg/mL
Interval 8.08 to 11.71
—
—
—
—
—
—
—
—

Adverse Events

VAX-24 Low Dose 18-49 Yrs

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

VAX-24 Mid Dose 18-49 Yrs

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

VAX-24 Mixed Dose 18-49 Yrs

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

PCV20 18-49 Yrs

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

VAX-24 Low Dose 50-64 Yrs

Serious events: 2 serious events
Other events: 161 other events
Deaths: 0 deaths

VAX-24 Mid Dose 50-64 Yrs

Serious events: 3 serious events
Other events: 155 other events
Deaths: 0 deaths

VAX-24 Mixed Dose 50-64 Yrs

Serious events: 1 serious events
Other events: 164 other events
Deaths: 0 deaths

PCV20 50-64 Yrs

Serious events: 4 serious events
Other events: 163 other events
Deaths: 0 deaths

VAX-24 Low Dose 18-64 Yrs

Serious events: 2 serious events
Other events: 170 other events
Deaths: 0 deaths

VAX-24 Mid Dose 18-64 Yrs

Serious events: 3 serious events
Other events: 168 other events
Deaths: 0 deaths

VAX-24 Mixed Dose 18-64 Yrs

Serious events: 1 serious events
Other events: 178 other events
Deaths: 0 deaths

PCV20 18-64 Yrs

Serious events: 4 serious events
Other events: 179 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
VAX-24 Low Dose 18-49 Yrs
n=16 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=16 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=16 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=16 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
n=193 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
n=191 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
n=191 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
n=196 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 18-64 Yrs
n=209 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
n=207 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
n=207 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
n=212 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
Injury, poisoning and procedural complications
Acetabulum fracture
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Injury, poisoning and procedural complications
Bladder Injury
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Injury, poisoning and procedural complications
Forearm Fracture
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Injury, poisoning and procedural complications
Lower limb fracture
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.0%
2/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.94%
2/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Gastrointestinal disorders
Gastric ulcer haemorrhage
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Vascular disorders
Deep vein thrombosis
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Gastrointestinal disorders
Colitis ulcerative
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Gastrointestinal disorders
Pancreatitis
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Nervous system disorders
Toxic encephalopathy
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Psychiatric disorders
Depression
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Renal and urinary disorders
Acute kidney injury
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Injury, poisoning and procedural complications
Pelvic Fracture
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Other adverse events

Other adverse events
Measure
VAX-24 Low Dose 18-49 Yrs
n=16 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-49 Yrs
n=16 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-49 Yrs
n=16 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-49 Yrs
n=16 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 50-64 Yrs
n=193 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 50-64 Yrs
n=191 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 50-64 Yrs
n=191 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 50-64 Yrs
n=196 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
VAX-24 Low Dose 18-64 Yrs
n=209 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose 18-64 Yrs
n=207 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose 18-64 Yrs
n=207 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20 18-64 Yrs
n=212 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.96%
2/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
General disorders
Fatigue
37.5%
6/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
31.2%
5/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
37.5%
6/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
50.0%
8/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
42.5%
82/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
40.8%
78/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
40.8%
78/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
39.8%
78/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
42.1%
88/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
40.1%
83/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
40.6%
84/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
40.6%
86/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
General disorders
Injection site bruising
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Skin and subcutaneous tissue disorders
Injection site pain
56.2%
9/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
75.0%
12/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
81.2%
13/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
81.2%
13/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
71.0%
137/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
71.2%
136/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
77.0%
147/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
69.9%
137/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
69.9%
146/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
71.5%
148/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
77.3%
160/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
70.8%
150/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Infections and infestations
Bronchitis
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Infections and infestations
Subcutaneous abscess
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Infections and infestations
Upper respiratory tract infection
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.0%
2/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.51%
1/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.4%
3/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.47%
1/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.0%
2/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
2.6%
5/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.96%
2/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.48%
1/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
2.4%
5/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Skin and subcutaneous tissue disorders
Erythema
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
18.8%
3/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
25.0%
4/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.7%
13/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
7.9%
15/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
8.9%
17/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
8.7%
17/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.7%
14/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
7.7%
16/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
9.7%
20/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
9.9%
21/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Skin and subcutaneous tissue disorders
Edema
18.8%
3/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
12.5%
2/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
25.0%
4/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
18.8%
3/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
8.8%
17/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
7.9%
15/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
7.9%
15/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
10.7%
21/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
9.6%
20/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
8.2%
17/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
9.2%
19/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
11.3%
24/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
General disorders
Headache
31.2%
5/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
37.5%
6/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
25.0%
4/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
37.5%
6/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
30.6%
59/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
28.8%
55/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
30.4%
58/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
30.1%
59/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
30.6%
64/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
29.5%
61/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
30.0%
62/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
30.7%
65/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Musculoskeletal and connective tissue disorders
Muscle pain
37.5%
6/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
37.5%
6/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
18.8%
3/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
56.2%
9/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
57.0%
110/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
56.0%
107/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
60.2%
115/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
53.1%
104/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
55.5%
116/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
54.6%
113/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
57.0%
118/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
53.3%
113/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Musculoskeletal and connective tissue disorders
Joint pain
25.0%
4/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
12.5%
2/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
12.5%
2/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
43.8%
7/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
24.9%
48/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
16.2%
31/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
27.7%
53/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
24.0%
47/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
24.9%
52/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
15.9%
33/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
26.6%
55/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
25.5%
54/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
General disorders
Fever
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
6.2%
1/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.00%
0/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
12.5%
2/16 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.0%
2/193 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.52%
1/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
2.1%
4/191 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.0%
2/196 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.4%
3/209 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
0.97%
2/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.9%
4/207 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
1.9%
4/212 • 6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days 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 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Additional Information

Vice President of Clinical Development

Vaxcyte

Phone: (650) 585-0029

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.
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Restriction type: OTHER