Trial Outcomes & Findings for Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine (NCT NCT06077656)
NCT ID: NCT06077656
Last Updated: 2026-03-17
Results Overview
Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
220 participants
Primary outcome timeframe
7 days post-vaccination (Day 8)
Results posted on
2026-03-17
Participant Flow
Participant milestones
| Measure |
Group A: IVT PCV-25 Formulation A
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
60
|
80
|
40
|
|
Overall Study
COMPLETED
|
40
|
60
|
80
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Baseline characteristics by cohort
| Measure |
Group A: IVT PCV-25 Formulation A
n=40 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=60 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=80 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=40 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 6.78 • n=10 Participants
|
36.2 years
STANDARD_DEVIATION 6.40 • n=50 Participants
|
37.0 years
STANDARD_DEVIATION 7.83 • n=108 Participants
|
35.5 years
STANDARD_DEVIATION 8.38 • n=9 Participants
|
36.8 years
STANDARD_DEVIATION 7.40 • n=22 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=10 Participants
|
41 Participants
n=50 Participants
|
57 Participants
n=108 Participants
|
29 Participants
n=9 Participants
|
154 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=10 Participants
|
19 Participants
n=50 Participants
|
23 Participants
n=108 Participants
|
11 Participants
n=9 Participants
|
66 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=10 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
5 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=10 Participants
|
53 Participants
n=50 Participants
|
73 Participants
n=108 Participants
|
39 Participants
n=9 Participants
|
203 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=22 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=10 Participants
|
60 participants
n=50 Participants
|
80 participants
n=108 Participants
|
40 participants
n=9 Participants
|
220 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 7 days post-vaccination (Day 8)Population: Safety population (One participant was missing the Memory Aid so the denominator for safety outcomes is 219 in this specific safety endpoint)
Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=40 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=60 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=80 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=39 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
n=219 Participants
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Solicited Local Adverse Events (AEs)
Injection site pain and / or tenderness: Grade 2: Moderate
|
14 events
|
19 events
|
40 events
|
19 events
|
92 events
|
|
Solicited Local Adverse Events (AEs)
Injection site pain and / or tenderness: Grade 1: Mild
|
16 events
|
36 events
|
32 events
|
14 events
|
98 events
|
|
Solicited Local Adverse Events (AEs)
Injection site redness: Grade 4: Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Local Adverse Events (AEs)
Injection site redness: Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Local Adverse Events (AEs)
Injection site redness: Grade 2: Moderate
|
0 events
|
0 events
|
3 events
|
1 events
|
4 events
|
|
Solicited Local Adverse Events (AEs)
Injection site redness: Grade 1: Mild
|
0 events
|
0 events
|
1 events
|
1 events
|
2 events
|
|
Solicited Local Adverse Events (AEs)
Injection site swelling: Grade 4: Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Local Adverse Events (AEs)
Injection site swelling: Grade 3: Severe
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Solicited Local Adverse Events (AEs)
Injection site swelling: Grade 2: Moderate
|
0 events
|
1 events
|
0 events
|
1 events
|
2 events
|
|
Solicited Local Adverse Events (AEs)
Injection site swelling: Grade 1: Mild
|
1 events
|
1 events
|
3 events
|
1 events
|
6 events
|
|
Solicited Local Adverse Events (AEs)
Injection site pain and / or tenderness: Grade 4: Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Local Adverse Events (AEs)
Injection site pain and / or tenderness: Grade 3: Severe
|
2 events
|
0 events
|
1 events
|
0 events
|
3 events
|
|
Solicited Local Adverse Events (AEs)
Local Solicited AE: Grade 3: Severe
|
2 events
|
0 events
|
2 events
|
0 events
|
4 events
|
|
Solicited Local Adverse Events (AEs)
Local Solicited AE: Grade 2: Moderate
|
14 events
|
20 events
|
39 events
|
19 events
|
92 events
|
|
Solicited Local Adverse Events (AEs)
Local Solicited AE: Grade 1: Mild
|
16 events
|
35 events
|
32 events
|
14 events
|
97 events
|
|
Solicited Local Adverse Events (AEs)
Local Solicited AE: Grade 4: Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: 7 days post-vaccination (Day 8)Population: Safety population (One participant was missing the Memory Aid so the denominator for safety outcomes is 219)
Number and severity of solicited systemic AEs within 7 days after vaccination by group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=40 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=60 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=80 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=39 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
n=219 Participants
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Solicited Systemic AEs
Arthralgia: Grade 4; Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Arthralgia: Grade 3; Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Arthralgia: Grade 2; Moderate
|
0 events
|
1 events
|
3 events
|
3 events
|
7 events
|
|
Solicited Systemic AEs
Rash: Grade 3; Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Rash: Grade 2; Moderate
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Solicited Systemic AEs
Systemic Solicited AE: Grade 4; Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Systemic Solicited AE: Grade 3; Severe
|
2 events
|
2 events
|
1 events
|
0 events
|
5 events
|
|
Solicited Systemic AEs
Systemic Solicited AE: Grade 2; Moderate
|
5 events
|
16 events
|
28 events
|
8 events
|
57 events
|
|
Solicited Systemic AEs
Systemic Solicited AE: Grade 1; Mild
|
14 events
|
19 events
|
26 events
|
11 events
|
70 events
|
|
Solicited Systemic AEs
Fever: Grade 4; Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Fever: Grade 3; Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Fever: Grade 2; Moderate
|
0 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Solicited Systemic AEs
Fever: Grade 1; Mild
|
0 events
|
1 events
|
2 events
|
0 events
|
3 events
|
|
Solicited Systemic AEs
Headache: Grade 4; Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Headache: Grade 3; Severe
|
1 events
|
2 events
|
0 events
|
0 events
|
3 events
|
|
Solicited Systemic AEs
Headache: Grade 2; Moderate
|
2 events
|
7 events
|
12 events
|
5 events
|
26 events
|
|
Solicited Systemic AEs
Headache: Grade 1; Mild
|
8 events
|
13 events
|
21 events
|
8 events
|
50 events
|
|
Solicited Systemic AEs
Fatigue: Grade 4; Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Fatigue: Grade 3; Severe
|
1 events
|
0 events
|
0 events
|
0 events
|
1 events
|
|
Solicited Systemic AEs
Fatigue: Grade 2; Moderate
|
2 events
|
8 events
|
17 events
|
4 events
|
31 events
|
|
Solicited Systemic AEs
Fatigue: Grade 1; Mild
|
7 events
|
14 events
|
14 events
|
7 events
|
42 events
|
|
Solicited Systemic AEs
Myalgia: Grade 4; Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Myalgia: Grade 3; Severe
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Solicited Systemic AEs
Myalgia: Grade 2; Moderate
|
4 events
|
7 events
|
16 events
|
3 events
|
30 events
|
|
Solicited Systemic AEs
Arthralgia: Grade 1; Mild
|
1 events
|
6 events
|
6 events
|
1 events
|
14 events
|
|
Solicited Systemic AEs
Rash: Grade 4; Potentially Life Threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Solicited Systemic AEs
Rash: Grade 1; Mild
|
0 events
|
0 events
|
3 events
|
1 events
|
4 events
|
|
Solicited Systemic AEs
Myalgia: Grade 1; Mild
|
8 events
|
17 events
|
19 events
|
9 events
|
53 events
|
PRIMARY outcome
Timeframe: 28 days post-vaccination (Day 29)Population: Safety population for whom specific safety endpoint data is available
Number and severity of unsolicited AEs within 28 days after vaccination by group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=40 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=60 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=80 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=40 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
n=220 Participants
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Unsolicited AEs
Unsolicited AEs; Grade 2: Moderate
|
17 events
|
12 events
|
22 events
|
22 events
|
73 events
|
|
Unsolicited AEs
Unsolicited AEs; Grade1: Mild
|
12 events
|
24 events
|
18 events
|
12 events
|
66 events
|
|
Unsolicited AEs
Gastrointestinal disorder; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Gastrointestinal disorder; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Gastrointestinal disorder; Grade 3: Severe
|
0 events
|
0 events
|
2 events
|
0 events
|
2 events
|
|
Unsolicited AEs
Gastrointestinal disorder; Grade 2: Moderate
|
3 events
|
0 events
|
1 events
|
12 events
|
16 events
|
|
Unsolicited AEs
Gastrointestinal disorder; Grade1: Mild
|
1 events
|
3 events
|
1 events
|
0 events
|
5 events
|
|
Unsolicited AEs
General disorders and administration site conditions; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Infections and infestations; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Infections and infestations; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Infections and infestations; Grade 3: Severe
|
0 events
|
2 events
|
0 events
|
0 events
|
2 events
|
|
Unsolicited AEs
Injury, poisoning, and procedural complications; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Injury, poisoning, and procedural complications; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Injury, poisoning, and procedural complications; Grade 2: Moderate
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Injury, poisoning, and procedural complications; Grade1: Mild
|
0 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Unsolicited AEs
Investigations; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Investigations; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Investigations; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Investigations; Grade 2: Moderate
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Investigations; Grade1: Mild
|
0 events
|
4 events
|
4 events
|
0 events
|
8 events
|
|
Unsolicited AEs
Metabolism and nutrition disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Metabolism and nutrition disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Metabolism and nutrition disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Metabolism and nutrition disorders; Grade 2: Moderate
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Unsolicited AEs
Metabolism and nutrition disorders; Grade1: Mild
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Unsolicited AEs
Musculoskeletal and connective tissue disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Musculoskeletal and connective tissue disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Musculoskeletal and connective tissue disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Musculoskeletal and connective tissue disorders; Grade 2: Moderate
|
0 events
|
2 events
|
1 events
|
1 events
|
4 events
|
|
Unsolicited AEs
Musculoskeletal and connective tissue disorders; Grade1: Mild
|
1 events
|
4 events
|
1 events
|
1 events
|
7 events
|
|
Unsolicited AEs
Nervous system disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Nervous system disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Nervous system disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Nervous system disorders; Grade 2: Moderate
|
3 events
|
1 events
|
2 events
|
2 events
|
8 events
|
|
Unsolicited AEs
Psychiatric disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Psychiatric disorders; Grade 2: Moderate
|
1 events
|
2 events
|
0 events
|
0 events
|
3 events
|
|
Unsolicited AEs
Psychiatric disorders; Grade1: Mild
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Reproductive system and breast disorder; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Reproductive system and breast disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Reproductive system and breast disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Reproductive system and breast disorders; Grade 2: Moderate
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Reproductive system and breast disorders; Grade1: Mild
|
0 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Unsolicited AEs
Respiratory, thoracic and mediastinal disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Respiratory, thoracic and mediastinal disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Respiratory, thoracic and mediastinal disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Respiratory, thoracic and mediastinal disorders; Grade 2: Moderate
|
0 events
|
0 events
|
2 events
|
1 events
|
3 events
|
|
Unsolicited AEs
Respiratory, thoracic and mediastinal disorders; Grade1: Mild
|
1 events
|
3 events
|
3 events
|
0 events
|
7 events
|
|
Unsolicited AEs
Skin and subcutaneous tissue disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Skin and subcutaneous tissue disorders; Grade 4: Life threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Skin and subcutaneous tissue disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Skin and subcutaneous tissue disorders; Grade 2: Moderate
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Skin and subcutaneous tissue disorders; Grade 1: Mild
|
0 events
|
0 events
|
1 events
|
2 events
|
3 events
|
|
Unsolicited AEs
Surgical and medical procedures; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Surgical and medical procedures; Grade 4: Life threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Surgical and medical procedures; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Surgical and medical procedures; Grade 2: Moderate
|
0 events
|
0 events
|
0 events
|
2 events
|
2 events
|
|
Unsolicited AEs
Surgical and medical procedures; Grade 1: Mild
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Vascular disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Vascular disorders; Grade 4: Life threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Vascular disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Vascular disorders; Grade 2: Moderate
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Vascular disorders; Grade 1: Mild
|
1 events
|
1 events
|
0 events
|
0 events
|
2 events
|
|
Unsolicited AEs
Unsolicited AEs; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Unsolicited AEs; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Unsolicited AEs; Grade 3: Severe
|
0 events
|
2 events
|
2 events
|
1 events
|
5 events
|
|
Unsolicited AEs
Blood and lymphatic system disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Blood and lymphatic system disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Blood and lymphatic system disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Blood and lymphatic system disorders; Grade 2: Moderate
|
0 events
|
1 events
|
0 events
|
1 events
|
2 events
|
|
Unsolicited AEs
Blood and lymphatic system disorders; Grade1: Mild
|
0 events
|
4 events
|
1 events
|
2 events
|
7 events
|
|
Unsolicited AEs
Cardiac disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Cardiac disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Cardiac disorders; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Cardiac disorders; Grade 2: Moderate
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Cardiac disorders; Grade: Mild
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Unsolicited AEs
General disorders and administration site conditions; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
General disorders and administration site condition; Grade 3: Severe
|
0 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Unsolicited AEs
General disorders and administration site conditions; Grade 2: Moderate
|
3 events
|
2 events
|
3 events
|
1 events
|
9 events
|
|
Unsolicited AEs
General disorders and administration site conditions; Grade1: Mild
|
1 events
|
3 events
|
1 events
|
0 events
|
5 events
|
|
Unsolicited AEs
Infections and infestations; Grade 2: Moderate
|
7 events
|
4 events
|
12 events
|
2 events
|
25 events
|
|
Unsolicited AEs
Infections and infestations; Grade1: Mild
|
5 events
|
2 events
|
4 events
|
4 events
|
15 events
|
|
Unsolicited AEs
Injury, poisoning, and procedural complications; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Nervous system disorders; Grade1: Mild
|
2 events
|
0 events
|
0 events
|
1 events
|
3 events
|
|
Unsolicited AEs
Psychiatric disorders; Grade 5: Fatal
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited AEs
Psychiatric disorders; Grade 4: Life-threatening
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: 6 months post-vaccination (Day 169)Population: Safety population for whom specific safety endpoint data is available
Number of SAEs within 6 months after vaccination by group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=40 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=60 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=80 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=40 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
n=220 Participants
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Severe Adverse Events (SAEs)
|
0 event
|
0 event
|
1 event
|
0 event
|
1 event
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and 28 days post-vaccination (Day 29)Population: Per Protocol (Six participants excluded from PP population: Two participants received systemic corticosteroids within 29 days following study vaccine administration. Two participants received an influenza vaccination within 29 days following study vaccine administration. One participant had an out-of-window visit at V3 adjudicated by the data review committee to potentially affect immunogenicity results, and the last participant did not meet inclusion criteria for the study
Geometric mean concentrations (GMC) of serotype-specific IgG at Day 1 and Day 29 by group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=39 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=57 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=79 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=39 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 15B
|
1.19 mcg/mL
Interval 0.77 to 1.83
|
1.47 mcg/mL
Interval 1.03 to 2.09
|
1.37 mcg/mL
Interval 0.99 to 1.9
|
1.68 mcg/mL
Interval 1.2 to 2.37
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 22F
|
0.66 mcg/mL
Interval 0.47 to 0.94
|
0.66 mcg/mL
Interval 0.49 to 0.9
|
0.63 mcg/mL
Interval 0.48 to 0.83
|
0.79 mcg/mL
Interval 0.55 to 1.12
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 23F
|
0.35 mcg/mL
Interval 0.22 to 0.55
|
0.42 mcg/mL
Interval 0.3 to 0.6
|
0.37 mcg/mL
Interval 0.27 to 0.5
|
0.49 mcg/mL
Interval 0.32 to 0.76
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 33F
|
1.02 mcg/mL
Interval 0.66 to 1.56
|
0.94 mcg/mL
Interval 0.7 to 1.26
|
0.77 mcg/mL
Interval 0.6 to 0.99
|
1.16 mcg/mL
Interval 0.8 to 1.69
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 2
|
2.17 mcg/mL
Interval 1.67 to 2.81
|
2.19 mcg/mL
Interval 1.69 to 2.84
|
1.72 mcg/mL
Interval 1.36 to 2.18
|
2.55 mcg/mL
Interval 1.7 to 3.84
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 1
|
3.04 mcg/mL
Interval 2.3 to 4.01
|
2.56 mcg/mL
Interval 1.97 to 3.31
|
4.21 mcg/mL
Interval 3.48 to 5.09
|
6.35 mcg/mL
Interval 4.61 to 8.76
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 3
|
0.76 mcg/mL
Interval 0.59 to 0.99
|
0.68 mcg/mL
Interval 0.56 to 0.84
|
0.80 mcg/mL
Interval 0.66 to 0.98
|
1.10 mcg/mL
Interval 0.82 to 1.48
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 4
|
1.86 mcg/mL
Interval 1.33 to 2.61
|
1.87 mcg/mL
Interval 1.39 to 2.5
|
1.83 mcg/mL
Interval 1.45 to 2.31
|
2.66 mcg/mL
Interval 1.83 to 3.87
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 5
|
5.65 mcg/mL
Interval 3.37 to 9.45
|
6.13 mcg/mL
Interval 4.15 to 9.06
|
5.90 mcg/mL
Interval 4.33 to 8.05
|
5.01 mcg/mL
Interval 3.06 to 8.19
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 6B
|
6.08 mcg/mL
Interval 3.51 to 10.51
|
6.42 mcg/mL
Interval 4.61 to 8.93
|
6.22 mcg/mL
Interval 4.6 to 8.42
|
7.92 mcg/mL
Interval 5.11 to 12.28
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 7F
|
3.35 mcg/mL
Interval 2.21 to 5.06
|
4.22 mcg/mL
Interval 3.22 to 5.53
|
4.22 mcg/mL
Interval 3.13 to 5.67
|
6.36 mcg/mL
Interval 4.33 to 9.35
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V2 (D8): Serotype 8
|
8.06 mcg/mL
Interval 5.77 to 11.28
|
9.02 mcg/mL
Interval 7.24 to 11.25
|
12.59 mcg/mL
Interval 9.98 to 15.87
|
7.27 mcg/mL
Interval 5.12 to 10.33
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 9V
|
4.15 mcg/mL
Interval 2.87 to 6.0
|
4.12 mcg/mL
Interval 3.08 to 5.51
|
5.77 mcg/mL
Interval 4.53 to 7.34
|
5.41 mcg/mL
Interval 3.85 to 7.6
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 10A
|
6.71 mcg/mL
Interval 4.31 to 10.45
|
9.02 mcg/mL
Interval 6.35 to 12.8
|
9.21 mcg/mL
Interval 7.15 to 11.87
|
12.95 mcg/mL
Interval 8.36 to 20.06
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 1
|
0.48 mcg/mL
Interval 0.33 to 0.69
|
0.39 mcg/mL
Interval 0.31 to 0.49
|
0.43 mcg/mL
Interval 0.33 to 0.54
|
0.32 mcg/mL
Interval 0.24 to 0.43
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 3
|
0.33 mcg/mL
Interval 0.23 to 0.48
|
0.29 mcg/mL
Interval 0.21 to 0.38
|
0.24 mcg/mL
Interval 0.18 to 0.31
|
0.26 mcg/mL
Interval 0.19 to 0.36
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 4
|
0.15 mcg/mL
Interval 0.11 to 0.19
|
0.18 mcg/mL
Interval 0.14 to 0.23
|
0.17 mcg/mL
Interval 0.13 to 0.2
|
0.19 mcg/mL
Interval 0.14 to 0.25
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 5
|
0.51 mcg/mL
Interval 0.37 to 0.7
|
0.42 mcg/mL
Interval 0.34 to 0.51
|
0.40 mcg/mL
Interval 0.32 to 0.48
|
0.44 mcg/mL
Interval 0.33 to 0.58
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 6B
|
0.40 mcg/mL
Interval 0.27 to 0.58
|
0.34 mcg/mL
Interval 0.25 to 0.47
|
0.31 mcg/mL
Interval 0.25 to 0.4
|
0.34 mcg/mL
Interval 0.25 to 0.48
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 7F
|
0.62 mcg/mL
Interval 0.43 to 0.88
|
0.74 mcg/mL
Interval 0.57 to 0.97
|
0.59 mcg/mL
Interval 0.47 to 0.75
|
0.61 mcg/mL
Interval 0.44 to 0.83
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 8
|
0.73 mcg/mL
Interval 0.49 to 1.09
|
0.67 mcg/mL
Interval 0.53 to 0.86
|
0.71 mcg/mL
Interval 0.56 to 0.9
|
0.79 mcg/mL
Interval 0.53 to 1.19
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 10A
|
0.63 mcg/mL
Interval 0.45 to 0.9
|
0.70 mcg/mL
Interval 0.53 to 0.92
|
0.65 mcg/mL
Interval 0.51 to 0.83
|
0.72 mcg/mL
Interval 0.49 to 1.05
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 12F
|
0.19 mcg/mL
Interval 0.14 to 0.24
|
0.15 mcg/mL
Interval 0.12 to 0.18
|
0.15 mcg/mL
Interval 0.13 to 0.18
|
0.17 mcg/mL
Interval 0.13 to 0.22
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 14
|
1.45 mcg/mL
Interval 0.97 to 2.16
|
1.49 mcg/mL
Interval 1.01 to 2.18
|
1.28 mcg/mL
Interval 0.97 to 1.69
|
1.22 mcg/mL
Interval 0.8 to 1.86
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 12F
|
1.78 mcg/mL
Interval 1.18 to 2.67
|
1.29 mcg/mL
Interval 0.94 to 1.77
|
1.65 mcg/mL
Interval 1.24 to 2.19
|
2.11 mcg/mL
Interval 1.5 to 2.98
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 14
|
9.11 mcg/mL
Interval 5.26 to 15.78
|
8.73 mcg/mL
Interval 6.15 to 12.39
|
11.44 mcg/mL
Interval 8.39 to 15.6
|
15.52 mcg/mL
Interval 9.03 to 26.66
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 15B
|
15.26 mcg/mL
Interval 11.19 to 20.82
|
15.76 mcg/mL
Interval 11.58 to 21.46
|
18.21 mcg/mL
Interval 14.04 to 23.63
|
23.47 mcg/mL
Interval 16.41 to 33.56
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 18C
|
7.11 mcg/mL
Interval 4.72 to 10.7
|
6.12 mcg/mL
Interval 4.59 to 8.16
|
6.19 mcg/mL
Interval 4.72 to 8.13
|
10.79 mcg/mL
Interval 7.79 to 14.94
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 19A
|
12.57 mcg/mL
Interval 8.85 to 17.86
|
15.81 mcg/mL
Interval 11.8 to 21.18
|
17.72 mcg/mL
Interval 14.01 to 22.42
|
16.47 mcg/mL
Interval 12.12 to 22.37
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 19F
|
11.28 mcg/mL
Interval 7.73 to 16.47
|
15.09 mcg/mL
Interval 11.34 to 20.09
|
15.56 mcg/mL
Interval 12.02 to 20.14
|
10.99 mcg/mL
Interval 7.96 to 15.19
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 22F
|
5.88 mcg/mL
Interval 4.41 to 7.83
|
6.04 mcg/mL
Interval 4.46 to 8.17
|
7.16 mcg/mL
Interval 5.64 to 9.07
|
11.93 mcg/mL
Interval 8.39 to 16.95
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 23F
|
4.83 mcg/mL
Interval 3.31 to 7.03
|
5.53 mcg/mL
Interval 4.03 to 7.57
|
8.12 mcg/mL
Interval 5.99 to 11.03
|
9.62 mcg/mL
Interval 6.19 to 14.94
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 33F
|
2.31 mcg/mL
Interval 1.61 to 3.31
|
2.51 mcg/mL
Interval 1.89 to 3.33
|
2.56 mcg/mL
Interval 2.04 to 3.21
|
10.23 mcg/mL
Interval 7.16 to 14.61
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 2
|
24.75 mcg/mL
Interval 17.07 to 35.89
|
20.18 mcg/mL
Interval 15.78 to 25.8
|
34.74 mcg/mL
Interval 28.14 to 42.88
|
3.07 mcg/mL
Interval 2.1 to 4.47
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 6C
|
22.84 mcg/mL
Interval 13.91 to 37.53
|
23.96 mcg/mL
Interval 17.32 to 33.16
|
34.33 mcg/mL
Interval 24.82 to 47.48
|
23.32 mcg/mL
Interval 15.23 to 35.73
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 9N
|
5.10 mcg/mL
Interval 3.45 to 7.53
|
4.16 mcg/mL
Interval 3.02 to 5.74
|
5.98 mcg/mL
Interval 4.54 to 7.88
|
1.23 mcg/mL
Interval 0.88 to 1.71
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 15A
|
33.58 mcg/mL
Interval 23.05 to 48.92
|
33.89 mcg/mL
Interval 24.81 to 46.3
|
37.52 mcg/mL
Interval 29.0 to 48.54
|
9.31 mcg/mL
Interval 6.35 to 13.66
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 16F
|
32.26 mcg/mL
Interval 22.03 to 47.24
|
28.13 mcg/mL
Interval 20.61 to 38.4
|
32.04 mcg/mL
Interval 24.61 to 41.71
|
8.96 mcg/mL
Interval 6.52 to 12.32
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 24F
|
36.42 mcg/mL
Interval 20.57 to 64.5
|
24.16 mcg/mL
Interval 14.87 to 39.26
|
31.59 mcg/mL
Interval 21.33 to 46.79
|
8.22 mcg/mL
Interval 6.12 to 11.05
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 35B
|
22.47 mcg/mL
Interval 16.26 to 31.03
|
17.41 mcg/mL
Interval 13.98 to 21.68
|
19.75 mcg/mL
Interval 16.43 to 23.74
|
8.76 mcg/mL
Interval 6.35 to 12.09
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V3 (D29): Serotype 6A
|
3.65 mcg/mL
Interval 2.25 to 5.92
|
3.82 mcg/mL
Interval 2.75 to 5.31
|
5.17 mcg/mL
Interval 3.7 to 7.21
|
10.00 mcg/mL
Interval 6.49 to 15.41
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 19F
|
1.18 mcg/mL
Interval 0.82 to 1.69
|
1.33 mcg/mL
Interval 1.0 to 1.77
|
0.93 mcg/mL
Interval 0.77 to 1.12
|
1.30 mcg/mL
Interval 0.87 to 1.95
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 6C
|
2.05 mcg/mL
Interval 1.35 to 3.1
|
1.92 mcg/mL
Interval 1.34 to 2.76
|
1.92 mcg/mL
Interval 1.4 to 2.64
|
2.07 mcg/mL
Interval 1.26 to 3.41
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 9N
|
0.39 mcg/mL
Interval 0.28 to 0.55
|
0.39 mcg/mL
Interval 0.3 to 0.5
|
0.41 mcg/mL
Interval 0.33 to 0.5
|
0.43 mcg/mL
Interval 0.31 to 0.59
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 15A
|
3.21 mcg/mL
Interval 2.38 to 4.33
|
3.51 mcg/mL
Interval 2.74 to 4.49
|
3.09 mcg/mL
Interval 2.47 to 3.86
|
2.97 mcg/mL
Interval 2.21 to 3.99
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 16F
|
5.19 mcg/mL
Interval 4.0 to 6.75
|
5.43 mcg/mL
Interval 3.97 to 7.44
|
5.26 mcg/mL
Interval 4.11 to 6.73
|
5.15 mcg/mL
Interval 3.64 to 7.28
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 24F
|
5.18 mcg/mL
Interval 3.68 to 7.31
|
5.03 mcg/mL
Interval 3.77 to 6.71
|
5.62 mcg/mL
Interval 4.3 to 7.33
|
5.76 mcg/mL
Interval 3.9 to 8.51
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 35B
|
7.60 mcg/mL
Interval 5.16 to 11.19
|
8.83 mcg/mL
Interval 6.45 to 12.09
|
6.33 mcg/mL
Interval 5.02 to 7.99
|
7.49 mcg/mL
Interval 5.28 to 10.63
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 6A
|
0.36 mcg/mL
Interval 0.25 to 0.54
|
0.36 mcg/mL
Interval 0.26 to 0.5
|
0.39 mcg/mL
Interval 0.3 to 0.52
|
0.41 mcg/mL
Interval 0.27 to 0.61
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 9V
|
0.37 mcg/mL
Interval 0.28 to 0.48
|
0.43 mcg/mL
Interval 0.33 to 0.55
|
0.40 mcg/mL
Interval 0.32 to 0.49
|
0.37 mcg/mL
Interval 0.28 to 0.49
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 18C
|
0.53 mcg/mL
Interval 0.35 to 0.8
|
0.50 mcg/mL
Interval 0.35 to 0.7
|
0.49 mcg/mL
Interval 0.38 to 0.64
|
0.68 mcg/mL
Interval 0.49 to 0.95
|
—
|
|
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
V1 (D1): Serotype 19A
|
1.72 mcg/mL
Interval 1.32 to 2.24
|
1.78 mcg/mL
Interval 1.32 to 2.4
|
1.45 mcg/mL
Interval 1.19 to 1.77
|
1.89 mcg/mL
Interval 1.33 to 2.69
|
—
|
SECONDARY outcome
Timeframe: 28 days post-vaccination (Day 29)Population: Per Protocol (Six participants excluded from PP population: Two participants received systemic corticosteroids within 29 days following study vaccine administration. Two participants received an influenza vaccination within 29 days following study vaccine administration. One participant had an out-of-window visit at V3 adjudicated by the data review committee to potentially affect immunogenicity results, and the last participant did not meet inclusion criteria for the study)
Geometric Mean Fold Rise in serotype specific IgG GMC's from baseline (D1) to Day 29 after vaccination by group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=39 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=57 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=79 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=39 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 1
|
6.39 fold rise
Interval 4.53 to 9.0
|
6.54 fold rise
Interval 5.14 to 8.33
|
9.90 fold rise
Interval 7.77 to 12.61
|
19.67 fold rise
Interval 14.81 to 26.12
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 6B
|
15.26 fold rise
Interval 9.58 to 24.32
|
18.67 fold rise
Interval 13.77 to 25.3
|
19.83 fold rise
Interval 14.76 to 26.65
|
23.01 fold rise
Interval 16.75 to 31.61
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 19F
|
9.57 fold rise
Interval 6.6 to 13.86
|
11.35 fold rise
Interval 8.08 to 15.95
|
16.75 fold rise
Interval 12.82 to 21.88
|
8.43 fold rise
Interval 5.94 to 11.96
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 22F
|
8.87 fold rise
Interval 6.04 to 13.02
|
9.14 fold rise
Interval 6.38 to 13.11
|
11.36 fold rise
Interval 8.45 to 15.27
|
15.16 fold rise
Interval 10.18 to 22.58
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 24F
|
7.03 fold rise
Interval 4.64 to 10.63
|
4.80 fold rise
Interval 3.33 to 6.93
|
5.62 fold rise
Interval 4.24 to 7.45
|
1.43 fold rise
Interval 1.19 to 1.71
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 35B
|
2.96 fold rise
Interval 2.16 to 4.05
|
1.97 fold rise
Interval 1.58 to 2.46
|
3.12 fold rise
Interval 2.6 to 3.74
|
1.17 fold rise
Interval 0.96 to 1.43
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 23F
|
13.91 fold rise
Interval 9.21 to 20.99
|
13.14 fold rise
Interval 9.14 to 18.88
|
21.85 fold rise
Interval 15.9 to 30.04
|
19.49 fold rise
Interval 12.55 to 30.26
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 33F
|
2.27 fold rise
Interval 1.84 to 2.8
|
2.68 fold rise
Interval 2.14 to 3.36
|
3.31 fold rise
Interval 2.77 to 3.95
|
8.80 fold rise
Interval 5.71 to 13.56
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 2
|
11.42 fold rise
Interval 7.65 to 17.06
|
9.20 fold rise
Interval 6.83 to 12.41
|
20.16 fold rise
Interval 15.19 to 26.74
|
1.20 fold rise
Interval 1.04 to 1.39
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 6C
|
11.15 fold rise
Interval 7.42 to 16.75
|
12.45 fold rise
Interval 8.7 to 17.83
|
17.84 fold rise
Interval 12.58 to 25.3
|
11.24 fold rise
Interval 7.16 to 17.66
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 16F
|
6.21 fold rise
Interval 4.63 to 8.34
|
5.18 fold rise
Interval 3.78 to 7.09
|
6.09 fold rise
Interval 4.76 to 7.78
|
1.74 fold rise
Interval 1.42 to 2.13
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 6A
|
10.01 fold rise
Interval 6.71 to 14.93
|
10.32 fold rise
Interval 7.77 to 13.7
|
13.12 fold rise
Interval 9.47 to 18.17
|
24.66 fold rise
Interval 16.37 to 37.15
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 3
|
2.28 fold rise
Interval 1.78 to 2.92
|
2.40 fold rise
Interval 1.95 to 2.96
|
3.38 fold rise
Interval 2.75 to 4.16
|
4.23 fold rise
Interval 3.05 to 5.87
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 4
|
12.84 fold rise
Interval 9.21 to 17.92
|
10.54 fold rise
Interval 8.11 to 13.7
|
11.09 fold rise
Interval 8.78 to 14.01
|
14.29 fold rise
Interval 9.58 to 21.31
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 5
|
11.14 fold rise
Interval 7.64 to 16.26
|
14.62 fold rise
Interval 10.46 to 20.42
|
14.91 fold rise
Interval 11.51 to 19.32
|
11.45 fold rise
Interval 7.42 to 17.66
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 7F
|
5.41 fold rise
Interval 3.93 to 7.44
|
5.67 fold rise
Interval 4.38 to 7.35
|
7.10 fold rise
Interval 5.53 to 9.11
|
10.46 fold rise
Interval 6.91 to 15.84
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 8
|
11.00 fold rise
Interval 7.2 to 16.8
|
13.41 fold rise
Interval 10.15 to 17.71
|
17.67 fold rise
Interval 13.45 to 23.21
|
9.18 fold rise
Interval 5.79 to 14.54
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 9V
|
11.36 fold rise
Interval 7.79 to 16.58
|
9.63 fold rise
Interval 7.57 to 12.25
|
14.60 fold rise
Interval 11.45 to 18.62
|
14.68 fold rise
Interval 10.37 to 20.77
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 10A
|
10.58 fold rise
Interval 7.33 to 15.29
|
12.94 fold rise
Interval 9.48 to 17.68
|
14.14 fold rise
Interval 11.31 to 17.66
|
18.05 fold rise
Interval 12.68 to 25.71
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 12F
|
9.60 fold rise
Interval 6.36 to 14.48
|
8.88 fold rise
Interval 6.62 to 11.91
|
10.72 fold rise
Interval 8.42 to 13.67
|
12.31 fold rise
Interval 8.52 to 17.77
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 14
|
6.29 fold rise
Interval 4.26 to 9.29
|
5.86 fold rise
Interval 4.36 to 7.88
|
8.92 fold rise
Interval 6.93 to 11.47
|
12.72 fold rise
Interval 7.77 to 20.82
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 15B
|
12.85 fold rise
Interval 8.34 to 19.82
|
10.75 fold rise
Interval 7.87 to 14.67
|
13.26 fold rise
Interval 10.02 to 17.55
|
13.95 fold rise
Interval 9.04 to 21.52
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 18C
|
13.43 fold rise
Interval 8.74 to 20.65
|
12.29 fold rise
Interval 9.05 to 16.69
|
12.52 fold rise
Interval 9.47 to 16.55
|
15.88 fold rise
Interval 10.66 to 23.65
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 19A
|
7.32 fold rise
Interval 4.94 to 10.86
|
8.87 fold rise
Interval 6.17 to 12.75
|
12.20 fold rise
Interval 9.29 to 16.03
|
8.69 fold rise
Interval 5.92 to 12.75
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 9N
|
13.05 fold rise
Interval 8.18 to 20.82
|
10.72 fold rise
Interval 7.91 to 14.51
|
14.66 fold rise
Interval 11.71 to 18.36
|
2.88 fold rise
Interval 2.09 to 3.97
|
—
|
|
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
V3 (D29): Serotype 15A
|
10.47 fold rise
Interval 6.86 to 15.97
|
9.65 fold rise
Interval 7.05 to 13.22
|
12.16 fold rise
Interval 9.22 to 16.04
|
3.14 fold rise
Interval 2.35 to 4.18
|
—
|
SECONDARY outcome
Timeframe: 28 days post-vaccination (Day 29)Population: Per Protocol (Six participants excluded from PP population: Two participants received systemic corticosteroids within 29 days following study vaccine administration. Two participants received an influenza vaccination within 29 days following study vaccine administration. One participant had an out-of-window visit at V3 adjudicated by the data review committee to potentially affect immunogenicity results, and the last participant did not meet inclusion criteria for the study)
Percentage of participants achieving a \> 4-fold IgG rise from baseline to Day 29 by treatment group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=39 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=57 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=79 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=39 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 18C
|
82.05 Percentage of Participants
Interval 66.5 to 92.5
|
82.46 Percentage of Participants
Interval 70.1 to 91.3
|
79.75 Percentage of Participants
Interval 69.2 to 88.0
|
89.74 Percentage of Participants
Interval 75.8 to 97.1
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 19A
|
64.10 Percentage of Participants
Interval 47.2 to 78.8
|
66.67 Percentage of Participants
Interval 52.9 to 78.6
|
81.01 Percentage of Participants
Interval 70.6 to 89.0
|
76.92 Percentage of Participants
Interval 60.7 to 88.9
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 19F
|
79.49 Percentage of Participants
Interval 63.5 to 90.7
|
75.44 Percentage of Participants
Interval 62.2 to 85.9
|
88.61 Percentage of Participants
Interval 79.5 to 94.7
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 22F
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
71.93 Percentage of Participants
Interval 58.5 to 83.0
|
72.15 Percentage of Participants
Interval 60.9 to 81.7
|
84.62 Percentage of Participants
Interval 69.5 to 94.1
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 23F
|
79.49 Percentage of Participants
Interval 63.5 to 90.7
|
73.68 Percentage of Participants
Interval 60.3 to 84.5
|
88.61 Percentage of Participants
Interval 79.5 to 94.7
|
87.18 Percentage of Participants
Interval 72.6 to 95.7
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 33F
|
20.51 Percentage of Participants
Interval 9.3 to 36.5
|
19.30 Percentage of Participants
Interval 10.0 to 31.9
|
36.71 Percentage of Participants
Interval 26.1 to 48.3
|
69.23 Percentage of Participants
Interval 52.4 to 83.0
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 2
|
76.92 Percentage of Participants
Interval 60.7 to 88.9
|
70.18 Percentage of Participants
Interval 56.6 to 81.6
|
88.61 Percentage of Participants
Interval 79.5 to 94.7
|
0.00 Percentage of Participants
Interval 0.0 to 9.0
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 6C
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
73.68 Percentage of Participants
Interval 60.3 to 84.5
|
79.75 Percentage of Participants
Interval 69.2 to 88.0
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 9N
|
82.05 Percentage of Participants
Interval 66.5 to 92.5
|
78.95 Percentage of Participants
Interval 66.1 to 88.6
|
92.41 Percentage of Participants
Interval 84.2 to 97.2
|
25.64 Percentage of Participants
Interval 13.0 to 42.1
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 16F
|
64.10 Percentage of Participants
Interval 47.2 to 78.8
|
54.39 Percentage of Participants
Interval 40.7 to 67.6
|
63.29 Percentage of Participants
Interval 51.7 to 73.9
|
10.26 Percentage of Participants
Interval 2.9 to 24.2
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 24F
|
64.10 Percentage of Participants
Interval 47.2 to 78.8
|
49.12 Percentage of Participants
Interval 35.6 to 62.7
|
48.10 Percentage of Participants
Interval 36.7 to 59.6
|
5.13 Percentage of Participants
Interval 0.6 to 17.3
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 35B
|
28.21 Percentage of Participants
Interval 15.0 to 44.9
|
19.30 Percentage of Participants
Interval 10.0 to 31.9
|
36.71 Percentage of Participants
Interval 26.1 to 48.3
|
7.69 Percentage of Participants
Interval 1.6 to 20.9
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 6A
|
79.49 Percentage of Participants
Interval 63.5 to 90.7
|
80.70 Percentage of Participants
Interval 68.1 to 90.0
|
73.42 Percentage of Participants
Interval 62.3 to 82.7
|
89.74 Percentage of Participants
Interval 75.8 to 97.1
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 1
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
70.18 Percentage of Participants
Interval 56.6 to 81.6
|
74.68 Percentage of Participants
Interval 63.6 to 83.8
|
94.87 Percentage of Participants
Interval 82.7 to 99.4
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 6B
|
84.62 Percentage of Participants
Interval 69.5 to 94.1
|
92.98 Percentage of Participants
Interval 83.0 to 98.1
|
86.08 Percentage of Participants
Interval 76.5 to 92.8
|
97.44 Percentage of Participants
Interval 86.5 to 99.9
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 7F
|
61.54 Percentage of Participants
Interval 44.6 to 76.6
|
63.16 Percentage of Participants
Interval 49.3 to 75.6
|
59.49 Percentage of Participants
Interval 47.9 to 70.4
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 8
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
87.72 Percentage of Participants
Interval 76.3 to 94.9
|
89.87 Percentage of Participants
Interval 81.0 to 95.5
|
69.23 Percentage of Participants
Interval 52.4 to 83.0
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 9V
|
84.62 Percentage of Participants
Interval 69.5 to 94.1
|
82.46 Percentage of Participants
Interval 70.1 to 91.3
|
88.61 Percentage of Participants
Interval 79.5 to 94.7
|
87.18 Percentage of Participants
Interval 72.6 to 95.7
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 10A
|
82.05 Percentage of Participants
Interval 66.5 to 92.5
|
80.70 Percentage of Participants
Interval 68.1 to 90.0
|
87.34 Percentage of Participants
Interval 78.0 to 93.8
|
92.31 Percentage of Participants
Interval 79.1 to 98.4
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 12F
|
71.79 Percentage of Participants
Interval 55.1 to 85.0
|
75.44 Percentage of Participants
Interval 62.2 to 85.9
|
79.75 Percentage of Participants
Interval 69.2 to 88.0
|
79.49 Percentage of Participants
Interval 63.5 to 90.7
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 14
|
58.97 Percentage of Participants
Interval 42.1 to 74.4
|
61.40 Percentage of Participants
Interval 47.6 to 74.0
|
70.89 Percentage of Participants
Interval 59.6 to 80.6
|
76.92 Percentage of Participants
Interval 60.7 to 88.9
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 15B
|
79.49 Percentage of Participants
Interval 63.5 to 90.7
|
75.44 Percentage of Participants
Interval 62.2 to 85.9
|
82.28 Percentage of Participants
Interval 72.1 to 90.0
|
76.92 Percentage of Participants
Interval 60.7 to 88.9
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 3
|
20.51 Percentage of Participants
Interval 9.3 to 36.5
|
28.07 Percentage of Participants
Interval 17.0 to 41.5
|
39.24 Percentage of Participants
Interval 28.4 to 50.9
|
53.85 Percentage of Participants
Interval 37.2 to 69.9
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 4
|
89.74 Percentage of Participants
Interval 75.8 to 97.1
|
87.72 Percentage of Participants
Interval 76.3 to 94.9
|
82.28 Percentage of Participants
Interval 72.1 to 90.0
|
82.05 Percentage of Participants
Interval 66.5 to 92.5
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 5
|
79.49 Percentage of Participants
Interval 63.5 to 90.7
|
84.21 Percentage of Participants
Interval 72.1 to 92.5
|
86.08 Percentage of Participants
Interval 76.5 to 92.8
|
74.36 Percentage of Participants
Interval 57.9 to 87.0
|
—
|
|
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Visit 3 (D29): Serotype 15A
|
76.92 Percentage of Participants
Interval 60.7 to 88.9
|
75.44 Percentage of Participants
Interval 62.2 to 85.9
|
81.01 Percentage of Participants
Interval 70.6 to 89.0
|
38.46 Percentage of Participants
Interval 23.4 to 55.4
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and 28 days post-vaccination (Day 29)Population: Per Protocol (Six participants excluded from PP population: Two participants received systemic corticosteroids within 29 days following study vaccine administration. Two participants received an influenza vaccination within 29 days following study vaccine administration. One participant had an out-of-window visit at V3 adjudicated by the data review committee to potentially affect immunogenicity results, and the last participant did not meet inclusion criteria for the study)
Geometric mean titer of serotype-specific OPA antibodies by group and timepoint
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=39 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=57 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=79 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=39 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 1
|
16.75 titer
Interval 11.42 to 24.57
|
15.11 titer
Interval 11.47 to 19.89
|
14.47 titer
Interval 11.62 to 18.01
|
9.92 titer
Interval 8.83 to 11.54
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 3
|
38.19 titer
Interval 22.95 to 63.54
|
29.72 titer
Interval 21.05 to 41.97
|
29.66 titer
Interval 22.03 to 39.94
|
27.28 titer
Interval 18.54 to 40.16
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 4
|
40.18 titer
Interval 19.59 to 82.4
|
41.90 titer
Interval 23.99 to 73.17
|
31.17 titer
Interval 19.86 to 48.91
|
85.17 titer
Interval 42.19 to 171.93
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 5
|
11.87 titer
Interval 7.83 to 18.0
|
10.86 titer
Interval 8.16 to 14.46
|
8.08 titer
Interval 6.69 to 9.76
|
9.66 titer
Interval 7.17 to 13.01
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 14
|
600.21 titer
Interval 343.97 to 1047.32
|
730.11 titer
Interval 469.11 to 1136.34
|
619.51 titer
Interval 422.37 to 908.68
|
429.18 titer
Interval 216.17 to 852.1
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 15B
|
1271.62 titer
Interval 834.79 to 1937.03
|
1228.83 titer
Interval 835.41 to 1807.52
|
1247.57 titer
Interval 905.16 to 1719.5
|
1489.88 titer
Interval 976.31 to 2273.59
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 18C
|
48.83 titer
Interval 24.07 to 99.07
|
60.32 titer
Interval 32.26 to 112.79
|
64.12 titer
Interval 38.22 to 107.58
|
57.55 titer
Interval 26.38 to 125.56
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 19A
|
146.92 titer
Interval 65.37 to 330.19
|
236.86 titer
Interval 126.16 to 444.68
|
186.31 titer
Interval 116.65 to 297.55
|
233.16 titer
Interval 120.1 to 452.68
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 19F
|
92.38 titer
Interval 45.75 to 186.54
|
88.94 titer
Interval 52.68 to 150.16
|
83.46 titer
Interval 55.38 to 125.77
|
102.59 titer
Interval 50.17 to 209.77
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 6C
|
430.05 titer
Interval 201.42 to 918.23
|
784.92 titer
Interval 469.23 to 1313.0
|
510.92 titer
Interval 303.87 to 859.03
|
449.51 titer
Interval 229.79 to 879.29
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 9N
|
1581.17 titer
Interval 969.16 to 2579.64
|
1961.95 titer
Interval 1420.3 to 2710.17
|
1551.74 titer
Interval 1128.48 to 2133.73
|
1535.48 titer
Interval 934.79 to 2522.18
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 15A
|
1897.24 titer
Interval 1423.11 to 2529.32
|
2539.52 titer
Interval 1824.28 to 3535.19
|
2306.69 titer
Interval 1836.68 to 2896.97
|
2285.75 titer
Interval 1558.31 to 3352.75
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 35B
|
4373.61 titer
Interval 3786.88 to 5051.25
|
4315.54 titer
Interval 3745.88 to 4971.82
|
3950.08 titer
Interval 3475.48 to 4489.5
|
4680.11 titer
Interval 4080.87 to 5367.33
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 6A
|
59.44 titer
Interval 28.87 to 122.36
|
95.62 titer
Interval 50.57 to 180.8
|
66.45 titer
Interval 39.46 to 111.9
|
69.69 titer
Interval 33.93 to 143.14
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 1
|
124.89 titer
Interval 77.79 to 200.51
|
153.89 titer
Interval 103.0 to 229.91
|
195.99 titer
Interval 141.22 to 272.01
|
336.00 titer
Interval 208.94 to 540.32
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 3
|
149.21 titer
Interval 107.6 to 206.9
|
142.72 titer
Interval 107.15 to 190.11
|
215.19 titer
Interval 164.56 to 281.4
|
270.61 titer
Interval 210.67 to 347.6
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 4
|
3310.64 titer
Interval 2255.0 to 4860.46
|
2589.80 titer
Interval 2020.29 to 3319.85
|
3108.44 titer
Interval 2430.57 to 3975.37
|
4961.29 titer
Interval 3782.33 to 6507.73
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 5
|
841.20 titer
Interval 462.63 to 1529.56
|
1052.36 titer
Interval 668.64 to 1656.29
|
984.46 titer
Interval 703.88 to 1376.89
|
667.86 titer
Interval 392.07 to 1137.67
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 6B
|
5170.17 titer
Interval 3067.04 to 8715.47
|
6139.39 titer
Interval 4673.12 to 8065.73
|
6149.53 titer
Interval 4717.58 to 8016.11
|
6458.35 titer
Interval 4512.74 to 9242.77
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 7F
|
3285.69 titer
Interval 2382.65 to 4530.99
|
3404.93 titer
Interval 2689.6 to 4310.5
|
4353.52 titer
Interval 3552.47 to 5335.21
|
7997.72 titer
Interval 5772.63 to 11080.48
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V2 (D8): Serotype 8
|
2640.26 titer
Interval 1984.5 to 3512.71
|
2535.77 titer
Interval 2035.52 to 3158.97
|
3553.26 titer
Interval 2918.11 to 4326.65
|
2061.49 titer
Interval 1523.42 to 2789.59
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 9V
|
3890.14 titer
Interval 2738.0 to 5527.09
|
3274.75 titer
Interval 2464.88 to 4350.73
|
4913.62 titer
Interval 3963.69 to 6091.19
|
5258.10 titer
Interval 3736.64 to 7399.06
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 15B
|
24500.46 titer
Interval 16217.95 to 37012.85
|
22062.94 titer
Interval 15467.32 to 31471.08
|
29225.96 titer
Interval 22870.73 to 37347.15
|
38620.16 titer
Interval 27640.73 to 53960.83
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 18C
|
2978.51 titer
Interval 1871.59 to 4740.1
|
3238.63 titer
Interval 2351.95 to 4459.59
|
3243.16 titer
Interval 2474.26 to 4251.01
|
3591.41 titer
Interval 2629.77 to 4904.68
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 19A
|
6043.80 titer
Interval 4111.64 to 8883.92
|
5485.65 titer
Interval 4422.24 to 6804.78
|
6910.78 titer
Interval 5655.28 to 8445.01
|
6875.42 titer
Interval 4984.51 to 9483.64
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 19F
|
3500.72 titer
Interval 2417.67 to 5068.95
|
3418.27 titer
Interval 2551.52 to 4579.46
|
4006.70 titer
Interval 3301.84 to 4862.04
|
2384.06 titer
Interval 1825.35 to 3113.77
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 22F
|
16086.32 titer
Interval 11225.9 to 23051.15
|
12828.54 titer
Interval 9195.78 to 17896.41
|
13698.09 titer
Interval 10507.2 to 17858.01
|
22248.72 titer
Interval 15880.42 to 31170.79
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 23F
|
3064.04 titer
Interval 1996.45 to 4702.53
|
3630.62 titer
Interval 2756.37 to 4782.17
|
4054.29 titer
Interval 3236.75 to 5078.32
|
5780.10 titer
Interval 4385.91 to 7617.46
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 33F
|
20523.46 titer
Interval 14007.51 to 30070.47
|
22832.36 titer
Interval 16428.77 to 31731.94
|
26679.55 titer
Interval 20326.28 to 35018.64
|
51071.30 titer
Interval 32840.01 to 79423.76
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 6C
|
12309.35 titer
Interval 8747.47 to 17321.58
|
12362.08 titer
Interval 9266.23 to 16492.25
|
14273.06 titer
Interval 11792.28 to 17275.71
|
12361.70 titer
Interval 8829.65 to 17306.65
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 9N
|
39549.11 titer
Interval 30213.59 to 51769.16
|
31023.77 titer
Interval 23944.52 to 40196.02
|
38859.32 titer
Interval 31652.83 to 47706.53
|
5759.51 titer
Interval 3989.91 to 8313.97
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 15A
|
20104.71 titer
Interval 13962.24 to 28949.48
|
19108.88 titer
Interval 14061.19 to 25968.58
|
23975.88 titer
Interval 18758.08 to 30645.07
|
9941.25 titer
Interval 6536.13 to 15120.32
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 16F
|
5545.11 titer
Interval 4719.32 to 6515.4
|
6057.22 titer
Interval 5698.13 to 6438.93
|
6212.33 titer
Interval 5882.67 to 6560.47
|
3825.65 titer
Interval 3129.13 to 4677.2
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 24F
|
2949.69 titer
Interval 2032.99 to 4279.75
|
3519.95 titer
Interval 2994.08 to 4138.18
|
3240.19 titer
Interval 2765.08 to 3796.93
|
464.05 titer
Interval 221.98 to 970.09
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 35B
|
5573.50 titer
Interval 5465.97 to 5683.16
|
5559.27 titer
Interval 5422.2 to 5699.81
|
5565.54 titer
Interval 5454.49 to 5678.85
|
5005.11 titer
Interval 4551.34 to 5504.12
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 6A
|
3444.88 titer
Interval 2215.31 to 5356.9
|
3976.99 titer
Interval 2700.43 to 5857.0
|
5787.36 titer
Interval 4402.56 to 7607.73
|
9508.91 titer
Interval 6689.15 to 13517.32
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 6B
|
87.74 titer
Interval 44.81 to 171.83
|
96.89 titer
Interval 54.19 to 173.2
|
77.40 titer
Interval 50.05 to 119.69
|
85.26 titer
Interval 44.64 to 162.84
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 7F
|
325.97 titer
Interval 146.32 to 726.18
|
683.06 titer
Interval 448.31 to 1040.73
|
330.52 titer
Interval 190.25 to 574.21
|
622.27 titer
Interval 321.72 to 1203.59
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 8
|
54.27 titer
Interval 28.62 to 102.9
|
33.16 titer
Interval 20.34 to 54.05
|
47.89 titer
Interval 30.61 to 74.92
|
70.49 titer
Interval 35.43 to 140.23
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 9V
|
115.46 titer
Interval 56.65 to 235.35
|
155.14 titer
Interval 88.01 to 273.48
|
202.44 titer
Interval 128.05 to 320.05
|
168.09 titer
Interval 79.68 to 354.61
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 10A
|
2944.48 titer
Interval 2029.76 to 4271.42
|
1619.93 titer
Interval 1037.56 to 2529.17
|
1731.93 titer
Interval 1287.73 to 2329.34
|
3250.60 titer
Interval 2125.98 to 4970.13
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 12F
|
23.26 titer
Interval 12.53 to 43.19
|
19.81 titer
Interval 11.64 to 33.71
|
33.05 titer
Interval 20.33 to 53.74
|
27.10 titer
Interval 12.99 to 56.54
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 22F
|
730.22 titer
Interval 408.19 to 1306.32
|
842.71 titer
Interval 550.37 to 1290.34
|
651.65 titer
Interval 437.43 to 970.78
|
1265.91 titer
Interval 811.72 to 1974.25
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 23F
|
52.35 titer
Interval 24.29 to 112.8
|
87.47 titer
Interval 48.44 to 157.95
|
53.17 titer
Interval 31.23 to 90.5
|
63.15 titer
Interval 27.82 to 143.32
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 33F
|
6100.82 titer
Interval 4439.21 to 8384.38
|
6987.01 titer
Interval 5115.06 to 9544.03
|
6665.80 titer
Interval 4978.45 to 8925.06
|
6994.61 titer
Interval 4632.75 to 10560.6
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 2
|
196.53 titer
Interval 133.15 to 290.09
|
217.39 titer
Interval 155.71 to 303.52
|
178.47 titer
Interval 131.38 to 242.43
|
292.84 titer
Interval 192.11 to 446.39
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 16F
|
2202.43 titer
Interval 1559.44 to 3110.53
|
2620.83 titer
Interval 1844.76 to 3723.38
|
2998.71 titer
Interval 2561.94 to 3509.94
|
2795.78 titer
Interval 1961.04 to 3985.85
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V1 (D1): Serotype 24F
|
364.03 titer
Interval 176.33 to 751.54
|
377.33 titer
Interval 206.09 to 690.87
|
332.89 titer
Interval 208.51 to 531.45
|
420.10 titer
Interval 204.46 to 863.16
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 10A
|
30587.83 titer
Interval 21327.4 to 43869.15
|
20768.56 titer
Interval 15512.08 to 27806.25
|
21695.25 titer
Interval 16569.16 to 28407.23
|
44247.89 titer
Interval 31544.83 to 62066.47
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 12F
|
9577.25 titer
Interval 6668.27 to 13755.26
|
9963.90 titer
Interval 7588.44 to 13082.97
|
8941.84 titer
Interval 6596.92 to 12120.26
|
13419.88 titer
Interval 10133.14 to 17772.68
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 14
|
5866.88 titer
Interval 3431.5 to 10030.69
|
5876.29 titer
Interval 3903.91 to 8845.17
|
8861.98 titer
Interval 6584.0 to 11928.12
|
13896.98 titer
Interval 9436.46 to 20465.95
|
—
|
|
OPA Geometric Mean Concentration Titer (GMT)
V3 (D29): Serotype 2
|
2513.19 titer
Interval 1834.88 to 3442.27
|
2633.60 titer
Interval 2191.05 to 3165.55
|
4035.78 titer
Interval 3463.44 to 4702.72
|
384.91 titer
Interval 247.84 to 597.78
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to 28 days post-vaccination (Day 29)Population: Per Protocol (Six participants excluded from PP population: Two participants received systemic corticosteroids within 29 days following study vaccine administration. Two participants received an influenza vaccination within 29 days following study vaccine administration. One participant had an out-of-window visit at V3 adjudicated by the data review committee to potentially affect immunogenicity results, and the last participant did not meet inclusion criteria for the study)
Geometric mean fold rise (GMFR) of serotype-specific OPA antibodies from baseline to 28 days post-vaccination by group
Outcome measures
| Measure |
Group A: IVT PCV-25 Formulation A
n=39 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=57 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=79 Participants
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=39 Participants
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
Total Subjects Analyzed (Local Solicited AE's)
Total Number of Local Solicited AEs from safety population for whom specific study endpoint data is available
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 1
|
7.45 fold rise
Interval 4.69 to 11.84
|
10.36 fold rise
Interval 7.3 to 14.7
|
13.46 fold rise
Interval 9.82 to 18.44
|
33.88 fold rise
Interval 21.32 to 53.83
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 3
|
3.91 fold rise
Interval 2.73 to 5.59
|
4.90 fold rise
Interval 3.65 to 6.59
|
7.25 fold rise
Interval 5.26 to 9.99
|
9.92 fold rise
Interval 6.65 to 14.8
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 8
|
48.65 fold rise
Interval 22.92 to 103.26
|
80.72 fold rise
Interval 46.62 to 139.77
|
74.12 fold rise
Interval 45.78 to 120.0
|
29.25 fold rise
Interval 13.38 to 63.91
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 9V
|
36.09 fold rise
Interval 16.31 to 79.86
|
21.93 fold rise
Interval 12.66 to 38.0
|
24.00 fold rise
Interval 14.73 to 39.09
|
31.28 fold rise
Interval 13.61 to 71.88
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 10A
|
10.99 fold rise
Interval 7.67 to 15.74
|
13.25 fold rise
Interval 8.78 to 19.98
|
12.12 fold rise
Interval 9.18 to 16.0
|
13.61 fold rise
Interval 8.69 to 21.33
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 12F
|
411.70 fold rise
Interval 203.05 to 834.73
|
551.77 fold rise
Interval 319.59 to 952.63
|
272.03 fold rise
Interval 153.71 to 481.43
|
495.18 fold rise
Interval 216.85 to 1130.72
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 14
|
9.77 fold rise
Interval 5.27 to 18.13
|
8.25 fold rise
Interval 5.11 to 13.3
|
14.46 fold rise
Interval 9.34 to 22.38
|
32.38 fold rise
Interval 15.47 to 67.76
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 15B
|
19.27 fold rise
Interval 11.94 to 31.1
|
18.37 fold rise
Interval 12.1 to 27.87
|
22.84 fold rise
Interval 15.64 to 33.36
|
25.92 fold rise
Interval 15.23 to 44.13
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 22F
|
22.03 fold rise
Interval 10.49 to 46.26
|
15.39 fold rise
Interval 9.33 to 25.38
|
20.72 fold rise
Interval 12.94 to 33.17
|
17.58 fold rise
Interval 10.31 to 29.96
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 23F
|
58.53 fold rise
Interval 27.23 to 125.85
|
40.72 fold rise
Interval 21.74 to 76.26
|
79.08 fold rise
Interval 47.89 to 130.59
|
91.54 fold rise
Interval 38.93 to 215.22
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 6C
|
29.86 fold rise
Interval 14.1 to 63.25
|
15.90 fold rise
Interval 9.39 to 26.9
|
28.31 fold rise
Interval 16.92 to 47.37
|
27.50 fold rise
Interval 12.89 to 58.66
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 9N
|
25.01 fold rise
Interval 14.23 to 43.98
|
16.14 fold rise
Interval 11.96 to 21.79
|
24.49 fold rise
Interval 18.06 to 33.22
|
3.75 fold rise
Interval 2.54 to 5.54
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 15A
|
10.60 fold rise
Interval 7.19 to 15.62
|
7.71 fold rise
Interval 5.69 to 10.45
|
10.11 fold rise
Interval 7.87 to 12.98
|
4.35 fold rise
Interval 2.94 to 6.43
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 35B
|
1.27 fold rise
Interval 1.1 to 1.47
|
1.29 fold rise
Interval 1.13 to 1.48
|
1.39 fold rise
Interval 1.23 to 1.57
|
1.07 fold rise
Interval 0.98 to 1.17
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 6A
|
56.27 fold rise
Interval 27.9 to 113.5
|
43.33 fold rise
Interval 23.99 to 78.27
|
88.41 fold rise
Interval 51.06 to 153.07
|
136.45 fold rise
Interval 63.96 to 291.1
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 18C
|
60.99 fold rise
Interval 26.9 to 138.29
|
55.12 fold rise
Interval 29.38 to 103.41
|
52.61 fold rise
Interval 30.93 to 89.49
|
62.40 fold rise
Interval 27.77 to 140.21
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 19A
|
41.14 fold rise
Interval 16.47 to 102.76
|
23.55 fold rise
Interval 12.58 to 44.07
|
37.86 fold rise
Interval 22.68 to 63.21
|
29.49 fold rise
Interval 13.97 to 62.26
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 19F
|
37.89 fold rise
Interval 16.87 to 85.09
|
37.35 fold rise
Interval 20.56 to 67.87
|
48.85 fold rise
Interval 29.94 to 79.72
|
23.89 fold rise
Interval 10.55 to 54.07
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 33F
|
3.36 fold rise
Interval 2.39 to 4.74
|
3.41 fold rise
Interval 2.51 to 4.64
|
3.87 fold rise
Interval 3.0 to 5.0
|
7.30 fold rise
Interval 4.6 to 11.58
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 2
|
12.79 fold rise
Interval 8.12 to 20.14
|
12.38 fold rise
Interval 8.39 to 18.28
|
22.63 fold rise
Interval 15.9 to 32.21
|
1.38 fold rise
Interval 1.17 to 1.63
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 16F
|
2.52 fold rise
Interval 1.95 to 3.26
|
2.35 fold rise
Interval 1.69 to 3.28
|
2.03 fold rise
Interval 1.76 to 2.35
|
1.37 fold rise
Interval 1.07 to 1.75
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 24F
|
7.98 fold rise
Interval 4.23 to 15.04
|
9.60 fold rise
Interval 5.38 to 17.14
|
9.68 fold rise
Interval 6.36 to 14.72
|
1.10 fold rise
Interval 0.97 to 1.25
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 4
|
82.40 fold rise
Interval 37.88 to 179.25
|
65.63 fold rise
Interval 36.36 to 118.47
|
103.74 fold rise
Interval 63.62 to 169.17
|
57.73 fold rise
Interval 26.63 to 125.11
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 5
|
68.52 fold rise
Interval 42.08 to 111.57
|
100.50 fold rise
Interval 65.85 to 153.37
|
123.80 fold rise
Interval 89.16 to 171.91
|
69.14 fold rise
Interval 44.65 to 107.06
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 6B
|
58.92 fold rise
Interval 27.81 to 124.83
|
64.82 fold rise
Interval 36.68 to 114.55
|
81.09 fold rise
Interval 51.91 to 126.69
|
75.06 fold rise
Interval 37.92 to 148.56
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Visit 3 (D29): Serotype 7F
|
10.08 fold rise
Interval 4.78 to 21.23
|
5.07 fold rise
Interval 3.3 to 7.78
|
13.36 fold rise
Interval 7.92 to 22.54
|
12.77 fold rise
Interval 6.14 to 26.55
|
—
|
Adverse Events
Group A: IVT PCV-25 Formulation A
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Group B: IVT PCV-25 Formulation B
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Group C: IVT PCV-25 Formulation C
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Group D: PCV-20
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: IVT PCV-25 Formulation A
n=40 participants at risk
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=60 participants at risk
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=80 participants at risk
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=40 participants at risk
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
Other adverse events
| Measure |
Group A: IVT PCV-25 Formulation A
n=40 participants at risk
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
Group B: IVT PCV-25 Formulation B
n=60 participants at risk
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
Group C: IVT PCV-25 Formulation C
n=80 participants at risk
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
Group D: PCV-20
n=40 participants at risk
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20: 20 valent pneumococcal conjugate vaccine
|
|---|---|---|---|---|
|
General disorders
Influenza like illness
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
General disorders
Injection site induration
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
3.3%
2/60 • Number of events 2 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
7.5%
3/40 • Number of events 4 • After receipt of vaccination through Day 169
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
General disorders
Application site acne
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
General disorders
Axillary pain
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
General disorders
Chills
|
5.0%
2/40 • Number of events 2 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
2.5%
2/80 • Number of events 2 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
General disorders
Hangover
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
General disorders
Inflammation
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
5.0%
3/60 • Number of events 3 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
5.0%
2/40 • Number of events 2 • After receipt of vaccination through Day 169
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
5.0%
2/40 • Number of events 3 • After receipt of vaccination through Day 169
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40 • Number of events 2 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
5.0%
2/40 • Number of events 3 • After receipt of vaccination through Day 169
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
General disorders
Pain
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
General disorders
Pyrexia
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
COVID-19
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
3.8%
3/80 • Number of events 3 • After receipt of vaccination through Day 169
|
5.0%
2/40 • Number of events 2 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Conjunctivitis
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Eye Infection
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
2.5%
2/80 • Number of events 2 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Gasteroenteritis viral
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • Number of events 2 • After receipt of vaccination through Day 169
|
3.3%
2/60 • Number of events 2 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Otitis media
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Respiratory tract infection
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
4/40 • Number of events 4 • After receipt of vaccination through Day 169
|
3.3%
2/60 • Number of events 2 • After receipt of vaccination through Day 169
|
2.5%
2/80 • Number of events 2 • After receipt of vaccination through Day 169
|
5.0%
2/40 • Number of events 2 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Infections and infestations
Sweating fever
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Investigations
Blood creatinine increased
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
3.3%
2/60 • Number of events 2 • After receipt of vaccination through Day 169
|
2.5%
2/80 • Number of events 2 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Investigations
Platelet count decreased
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
3.3%
2/60 • Number of events 3 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 2 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • Number of events 5 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
7.5%
3/40 • Number of events 3 • After receipt of vaccination through Day 169
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Psychiatric disorders
Attention deficit disorder
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 2 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
2.5%
2/80 • Number of events 2 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
5.0%
3/60 • Number of events 3 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
1.2%
1/80 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Surgical and medical procedures
Oral appliance application
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/60 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
1.7%
1/60 • Number of events 1 • After receipt of vaccination through Day 169
|
0.00%
0/80 • After receipt of vaccination through Day 169
|
0.00%
0/40 • After receipt of vaccination through Day 169
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place