Trial Outcomes & Findings for Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age (NCT NCT05489328)
NCT ID: NCT05489328
Last Updated: 2024-04-18
Results Overview
Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\>) 2.0 cm to 5.0 cm, moderate: \>5.0 cm to 10.0 cm and severe \> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
394 participants
Primary outcome timeframe
Within 7 days after study intervention
Results posted on
2024-04-18
Participant Flow
The study was conducted at 17 sites in the United States.
A total of 394 participants were enrolled and randomized in the study of which 3 participants were not vaccinated and, 391 were administered study intervention. One participant randomized to Candidate-Control received Candidate-4.
Participant milestones
| Measure |
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
39
|
43
|
45
|
46
|
47
|
44
|
47
|
|
Overall Study
Vaccinated
|
41
|
42
|
39
|
43
|
45
|
46
|
46
|
43
|
46
|
|
Overall Study
COMPLETED
|
41
|
42
|
38
|
43
|
43
|
46
|
46
|
41
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
2
|
0
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Baseline characteristics by cohort
| Measure |
Candidate-1
n=41 Participants
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 Participants
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=39 Participants
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=44 Participants
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=45 Participants
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=46 Participants
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=45 Participants
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
n=43 Participants
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
n=46 Participants
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.9 Years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
35.2 Years
STANDARD_DEVIATION 9.11 • n=7 Participants
|
35.3 Years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
33.2 Years
STANDARD_DEVIATION 9.39 • n=4 Participants
|
33.3 Years
STANDARD_DEVIATION 9.29 • n=21 Participants
|
35.2 Years
STANDARD_DEVIATION 8.35 • n=10 Participants
|
34.1 Years
STANDARD_DEVIATION 7.68 • n=115 Participants
|
35.6 Years
STANDARD_DEVIATION 8.86 • n=24 Participants
|
35.7 Years
STANDARD_DEVIATION 7.38 • n=42 Participants
|
34.8 Years
STANDARD_DEVIATION 8.71 • n=42 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
19 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
227 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
24 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
164 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
128 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
29 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
262 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
69 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
286 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after study interventionPopulation: Safety population included all participants who received the study intervention.
Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\>) 2.0 cm to 5.0 cm, moderate: \>5.0 cm to 10.0 cm and severe \> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Candidate-1
n=41 Participants
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 Participants
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=39 Participants
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=44 Participants
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=45 Participants
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=46 Participants
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=45 Participants
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
n=43 Participants
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
n=46 Participants
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Swelling: Mild
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
6.5 Percentage of participants
Interval 1.4 to 17.9
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
8.7 Percentage of participants
Interval 2.4 to 20.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Swelling: Severe
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Redness: Mild
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
2.3 Percentage of participants
Interval 0.1 to 12.0
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
4.3 Percentage of participants
Interval 0.5 to 14.8
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Redness: Moderate
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Redness: Severe
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Swelling: Moderate
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
2.3 Percentage of participants
Interval 0.1 to 12.0
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Pain At Injection Site: Mild
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
26.2 Percentage of participants
Interval 13.9 to 42.0
|
20.5 Percentage of participants
Interval 9.3 to 36.5
|
25.0 Percentage of participants
Interval 13.2 to 40.3
|
37.8 Percentage of participants
Interval 23.8 to 53.5
|
23.9 Percentage of participants
Interval 12.6 to 38.8
|
11.1 Percentage of participants
Interval 3.7 to 24.1
|
37.2 Percentage of participants
Interval 23.0 to 53.3
|
54.3 Percentage of participants
Interval 39.0 to 69.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Pain At Injection Site: Moderate
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
4.8 Percentage of participants
Interval 0.6 to 16.2
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
2.3 Percentage of participants
Interval 0.1 to 12.0
|
6.7 Percentage of participants
Interval 1.4 to 18.3
|
17.4 Percentage of participants
Interval 7.8 to 31.4
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
30.2 Percentage of participants
Interval 17.2 to 46.1
|
6.5 Percentage of participants
Interval 1.4 to 17.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Pain At Injection Site: Severe
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
PRIMARY outcome
Timeframe: Within 7 days after study interventionPopulation: Safety population included all participants who received the study intervention.
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Candidate-1
n=41 Participants
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 Participants
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=39 Participants
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=44 Participants
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=45 Participants
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=46 Participants
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=45 Participants
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
n=43 Participants
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
n=46 Participants
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Fever: >38.4 degrees C to 38.9 degrees C
|
2.4 Percentage of participants
Interval 0.1 to 12.9
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
4.4 Percentage of participants
Interval 0.5 to 15.1
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
4.3 Percentage of participants
Interval 0.5 to 14.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Fever: >/=38.0 degrees C to 38.4 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
4.3 Percentage of participants
Interval 0.5 to 14.8
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
2.3 Percentage of participants
Interval 0.1 to 12.3
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Fever: >38.9 degrees C to 40.0 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Fever: >40.0 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Fatigue: Mild
|
17.1 Percentage of participants
Interval 7.2 to 32.1
|
19.0 Percentage of participants
Interval 8.6 to 34.1
|
20.5 Percentage of participants
Interval 9.3 to 36.5
|
13.6 Percentage of participants
Interval 5.2 to 27.4
|
11.1 Percentage of participants
Interval 3.7 to 24.1
|
21.7 Percentage of participants
Interval 10.9 to 36.4
|
22.2 Percentage of participants
Interval 11.2 to 37.1
|
20.9 Percentage of participants
Interval 10.0 to 36.0
|
21.7 Percentage of participants
Interval 10.9 to 36.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Fatigue: Moderate
|
14.6 Percentage of participants
Interval 5.6 to 29.2
|
26.2 Percentage of participants
Interval 13.9 to 42.0
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
25.0 Percentage of participants
Interval 13.2 to 40.3
|
31.1 Percentage of participants
Interval 18.2 to 46.6
|
19.6 Percentage of participants
Interval 9.4 to 33.9
|
11.1 Percentage of participants
Interval 3.7 to 24.1
|
30.2 Percentage of participants
Interval 17.2 to 46.1
|
15.2 Percentage of participants
Interval 6.3 to 28.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Fatigue: Severe
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
4.5 Percentage of participants
Interval 0.6 to 15.5
|
4.4 Percentage of participants
Interval 0.5 to 15.1
|
4.3 Percentage of participants
Interval 0.5 to 14.8
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
2.3 Percentage of participants
Interval 0.1 to 12.3
|
8.7 Percentage of participants
Interval 2.4 to 20.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Headache: Mild
|
34.1 Percentage of participants
Interval 20.1 to 50.6
|
23.8 Percentage of participants
Interval 12.1 to 39.5
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
18.2 Percentage of participants
Interval 8.2 to 32.7
|
13.3 Percentage of participants
Interval 5.1 to 26.8
|
17.4 Percentage of participants
Interval 7.8 to 31.4
|
15.6 Percentage of participants
Interval 6.5 to 29.5
|
14.0 Percentage of participants
Interval 5.3 to 27.9
|
13.0 Percentage of participants
Interval 4.9 to 26.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Headache: Moderate
|
7.3 Percentage of participants
Interval 1.5 to 19.9
|
11.9 Percentage of participants
Interval 4.0 to 25.6
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
9.1 Percentage of participants
Interval 2.5 to 21.7
|
20.0 Percentage of participants
Interval 9.6 to 34.6
|
6.5 Percentage of participants
Interval 1.4 to 17.9
|
6.7 Percentage of participants
Interval 1.4 to 18.3
|
14.0 Percentage of participants
Interval 5.3 to 27.9
|
10.9 Percentage of participants
Interval 3.6 to 23.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Headache: Severe
|
2.4 Percentage of participants
Interval 0.1 to 12.9
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
7.0 Percentage of participants
Interval 1.5 to 19.1
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Muscle Pain: Mild
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
7.1 Percentage of participants
Interval 1.5 to 19.5
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
13.6 Percentage of participants
Interval 5.2 to 27.4
|
8.9 Percentage of participants
Interval 2.5 to 21.2
|
13.0 Percentage of participants
Interval 4.9 to 26.3
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
11.6 Percentage of participants
Interval 3.9 to 25.1
|
17.4 Percentage of participants
Interval 7.8 to 31.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Muscle Pain: Moderate
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
14.3 Percentage of participants
Interval 5.4 to 28.5
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
9.1 Percentage of participants
Interval 2.5 to 21.7
|
6.7 Percentage of participants
Interval 1.4 to 18.3
|
13.0 Percentage of participants
Interval 4.9 to 26.3
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
18.6 Percentage of participants
Interval 8.4 to 33.4
|
13.0 Percentage of participants
Interval 4.9 to 26.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Muscle Pain: Severe
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
4.3 Percentage of participants
Interval 0.5 to 14.8
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
4.3 Percentage of participants
Interval 0.5 to 14.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Joint Pain: Mild
|
2.4 Percentage of participants
Interval 0.1 to 12.9
|
9.5 Percentage of participants
Interval 2.7 to 22.6
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
2.3 Percentage of participants
Interval 0.1 to 12.0
|
6.7 Percentage of participants
Interval 1.4 to 18.3
|
10.9 Percentage of participants
Interval 3.6 to 23.6
|
4.4 Percentage of participants
Interval 0.5 to 15.1
|
11.6 Percentage of participants
Interval 3.9 to 25.1
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Joint Pain: Moderate
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
4.8 Percentage of participants
Interval 0.6 to 16.2
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
9.1 Percentage of participants
Interval 2.5 to 21.7
|
4.4 Percentage of participants
Interval 0.5 to 15.1
|
6.5 Percentage of participants
Interval 1.4 to 17.9
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
9.3 Percentage of participants
Interval 2.6 to 22.1
|
13.0 Percentage of participants
Interval 4.9 to 26.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Joint Pain: Severe
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
PRIMARY outcome
Timeframe: Within 1 month after study interventionPopulation: Safety population included all participants who received the study intervention.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Candidate-1
n=41 Participants
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 Participants
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=39 Participants
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=44 Participants
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=45 Participants
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=46 Participants
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=45 Participants
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
n=43 Participants
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
n=46 Participants
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
|
2.4 Percentage of participants
Interval 0.1 to 12.9
|
4.8 Percentage of participants
Interval 0.6 to 16.2
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
8.9 Percentage of participants
Interval 2.5 to 21.2
|
4.3 Percentage of participants
Interval 0.5 to 14.8
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
2.3 Percentage of participants
Interval 0.1 to 12.3
|
2.2 Percentage of participants
Interval 0.1 to 11.5
|
PRIMARY outcome
Timeframe: Within 1 month after study interventionPopulation: Safety population included all participants who received the study intervention.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Candidate-1
n=41 Participants
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 Participants
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=39 Participants
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=44 Participants
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=45 Participants
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=46 Participants
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=45 Participants
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
n=43 Participants
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
n=46 Participants
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 8.4
|
0.0 Percentage of participants
Interval 0.0 to 9.0
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
2.2 Percentage of participants
Interval 0.1 to 11.8
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
0.0 Percentage of participants
Interval 0.0 to 7.9
|
0.0 Percentage of participants
Interval 0.0 to 8.2
|
0.0 Percentage of participants
Interval 0.0 to 7.7
|
SECONDARY outcome
Timeframe: 1 month after study interventionPopulation: Evaluable immunogenicity population included eligible participants who received study intervention as randomized, had at least 1 valid assay result within 27 to 49 days after administration, and had no major protocol deviations. Participants from each candidate and candidate control group were included as per the protocol specified objective. Number of Participants Analyzed= participants in evaluable immunogenicity population \& had valid result 1 month after study intervention.
GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution).
Outcome measures
| Measure |
Candidate-1
n=41 Participants
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 Participants
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=38 Participants
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=43 Participants
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=43 Participants
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=45 Participants
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=43 Participants
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
|
231 Titer
Interval 162.0 to 328.0
|
428 Titer
Interval 318.0 to 575.0
|
350 Titer
Interval 254.0 to 481.0
|
354 Titer
Interval 271.0 to 461.0
|
324 Titer
Interval 239.0 to 439.0
|
536 Titer
Interval 372.0 to 774.0
|
168 Titer
Interval 116.0 to 244.0
|
—
|
—
|
Adverse Events
Candidate-1
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Candidate-2
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Candidate-3
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Candidate-4
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Candidate-5
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Candidate-6
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Candidate - Control
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
PCV15
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
13vPnC
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Candidate-1
n=41 participants at risk
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 participants at risk
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=39 participants at risk
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=44 participants at risk
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=45 participants at risk
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=46 participants at risk
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=45 participants at risk
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
n=43 participants at risk
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
n=46 participants at risk
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.2%
1/45 • Number of events 1 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
Other adverse events
| Measure |
Candidate-1
n=41 participants at risk
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-2
n=42 participants at risk
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-3
n=39 participants at risk
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-4
n=44 participants at risk
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-5
n=45 participants at risk
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate-6
n=46 participants at risk
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
Candidate - Control
n=45 participants at risk
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
PCV15
n=43 participants at risk
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
13vPnC
n=46 participants at risk
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue (FATIGUE)
|
31.7%
13/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
47.6%
20/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
33.3%
13/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
43.2%
19/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
46.7%
21/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
45.7%
21/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
35.6%
16/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
53.5%
23/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
45.7%
21/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
|
General disorders
Injection site erythema (REDNESS)
|
0.00%
0/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.4%
1/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.3%
1/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
4.4%
2/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
6.5%
3/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
9.3%
4/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.2%
1/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
|
General disorders
Injection site pain (PAIN)
|
12.2%
5/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
31.0%
13/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
20.5%
8/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
27.3%
12/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
44.4%
20/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
41.3%
19/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
13.3%
6/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
67.4%
29/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
63.0%
29/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
|
General disorders
Injection site swelling (SWELLING)
|
0.00%
0/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.4%
1/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.6%
1/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.3%
1/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
4.4%
2/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
8.7%
4/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
9.3%
4/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
8.7%
4/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
|
General disorders
Pyrexia (FEVER)
|
2.4%
1/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.4%
1/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.6%
1/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
6.7%
3/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
4.3%
2/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
0.00%
0/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
2.3%
1/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
6.5%
3/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
2.4%
1/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
14.3%
6/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
5.1%
2/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
11.4%
5/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
11.1%
5/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
19.6%
9/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
4.4%
2/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
20.9%
9/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
17.4%
8/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
12.2%
5/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
23.8%
10/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
12.8%
5/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
22.7%
10/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
17.8%
8/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
30.4%
14/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
4.4%
2/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
30.2%
13/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
34.8%
16/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
|
Nervous system disorders
Headache (HEADACHE)
|
43.9%
18/41 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
35.7%
15/42 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
38.5%
15/39 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
27.3%
12/44 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
33.3%
15/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
26.1%
12/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
22.2%
10/45 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
34.9%
15/43 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
23.9%
11/46 • Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER