Trial Outcomes & Findings for Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2 (NCT NCT04887948)
NCT ID: NCT04887948
Last Updated: 2022-12-14
Results Overview
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
570 participants
Primary outcome timeframe
Within 10 days after vaccination
Results posted on
2022-12-14
Participant Flow
Eligible participants who received 2 doses of ribonucleic acid (RNA)-based COVID-19 vaccine (BNT162b2) at least 6 months previously in study C4591001 (NCT04368728) were stratified by prior pneumococcal vaccine status (no previous pneumococcal vaccine \[naïve\] or receipt of at least 1 dose of a pneumococcal vaccine \[experienced\]) and randomized to 1 of the 3 vaccine groups in this study.
A total of 570 participants were enrolled in the study and randomized to a study treatment.
Participant milestones
| Measure |
Coadministration Group: 20vPnC+BNT162b2
On Day 1, participants were randomized to receive a single dose of 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group: 20vPnC+Saline
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group: BNT162b2+Saline
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|
|
Overall Study
STARTED
|
190
|
191
|
189
|
|
Overall Study
Vaccinated
|
187
|
187
|
185
|
|
Overall Study
COMPLETED
|
184
|
177
|
182
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
7
|
Reasons for withdrawal
| Measure |
Coadministration Group: 20vPnC+BNT162b2
On Day 1, participants were randomized to receive a single dose of 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group: 20vPnC+Saline
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group: BNT162b2+Saline
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
4
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
1
|
|
Overall Study
No longer met eligibility criteria
|
1
|
2
|
1
|
|
Overall Study
Other
|
2
|
1
|
1
|
Baseline Characteristics
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
Baseline characteristics by cohort
| Measure |
Coadministration Group: 20vPnC+BNT162b2
n=187 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group: 20vPnC+Saline
n=187 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group: BNT162b2+Saline
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
Total
n=559 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.0 Years
STANDARD_DEVIATION 4.22 • n=5 Participants
|
71.8 Years
STANDARD_DEVIATION 4.94 • n=7 Participants
|
71.8 Years
STANDARD_DEVIATION 4.95 • n=5 Participants
|
71.5 Years
STANDARD_DEVIATION 4.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
480 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
501 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 10 days after vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after vaccination.
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Outcome measures
| Measure |
Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site
n=186 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site
n=186 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Swelling: Moderate
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
3.8 Percentage of participants
Interval 1.5 to 7.6
|
3.2 Percentage of participants
Interval 1.2 to 6.9
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
4.9 Percentage of participants
Interval 2.2 to 9.0
|
1.1 Percentage of participants
Interval 0.1 to 3.9
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Redness: Mild
|
5.9 Percentage of participants
Interval 3.0 to 10.4
|
5.9 Percentage of participants
Interval 3.0 to 10.4
|
4.3 Percentage of participants
Interval 1.9 to 8.3
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
6.5 Percentage of participants
Interval 3.4 to 11.1
|
2.2 Percentage of participants
Interval 0.6 to 5.4
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Redness: Moderate
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
3.2 Percentage of participants
Interval 1.2 to 6.9
|
3.2 Percentage of participants
Interval 1.2 to 6.9
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Swelling: Any
|
8.1 Percentage of participants
Interval 4.6 to 13.0
|
9.7 Percentage of participants
Interval 5.9 to 14.9
|
8.6 Percentage of participants
Interval 5.0 to 13.6
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
11.4 Percentage of participants
Interval 7.2 to 16.8
|
1.1 Percentage of participants
Interval 0.1 to 3.9
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Swelling: Mild
|
5.4 Percentage of participants
Interval 2.6 to 9.7
|
5.9 Percentage of participants
Interval 3.0 to 10.4
|
5.4 Percentage of participants
Interval 2.6 to 9.7
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
6.5 Percentage of participants
Interval 3.4 to 11.1
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Swelling: Severe
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Pain at injection site: Any
|
73.0 Percentage of participants
Interval 66.0 to 79.2
|
72.4 Percentage of participants
Interval 65.4 to 78.7
|
60.2 Percentage of participants
Interval 52.8 to 67.3
|
9.7 Percentage of participants
Interval 5.8 to 14.9
|
67.6 Percentage of participants
Interval 60.3 to 74.3
|
16.8 Percentage of participants
Interval 11.7 to 22.9
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Pain at injection site: Mild
|
55.1 Percentage of participants
Interval 47.7 to 62.4
|
56.8 Percentage of participants
Interval 49.3 to 64.0
|
52.2 Percentage of participants
Interval 44.7 to 59.5
|
9.7 Percentage of participants
Interval 5.8 to 14.9
|
50.3 Percentage of participants
Interval 42.8 to 57.7
|
16.2 Percentage of participants
Interval 11.2 to 22.3
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Pain at injection site: Moderate
|
17.8 Percentage of participants
Interval 12.6 to 24.1
|
15.7 Percentage of participants
Interval 10.8 to 21.7
|
7.0 Percentage of participants
Interval 3.8 to 11.7
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
17.3 Percentage of participants
Interval 12.1 to 23.5
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Redness: Any
|
8.6 Percentage of participants
Interval 5.0 to 13.7
|
9.7 Percentage of participants
Interval 5.9 to 14.9
|
8.1 Percentage of participants
Interval 4.6 to 13.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
9.7 Percentage of participants
Interval 5.9 to 14.9
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Redness: Severe
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Pain at injection site: Severe
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
1.1 Percentage of participants
Interval 0.1 to 3.8
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants with any e-diary data reported after vaccination.
Systemic events including fever, fatigue, headache, chills, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Percentage of participants with systemic events within 7 days after vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Outcome measures
| Measure |
Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site
n=186 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.9 degree C to 40.0 degree C
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
1.1 Percentage of participants
Interval 0.1 to 3.9
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Any
|
54.1 Percentage of participants
Interval 46.6 to 61.4
|
36.0 Percentage of participants
Interval 29.1 to 43.4
|
54.6 Percentage of participants
Interval 47.1 to 61.9
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
17.8 Percentage of participants
Interval 12.6 to 24.1
|
23.7 Percentage of participants
Interval 17.7 to 30.4
|
27.0 Percentage of participants
Interval 20.8 to 34.0
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
33.0 Percentage of participants
Interval 26.3 to 40.3
|
12.4 Percentage of participants
Interval 8.0 to 18.0
|
24.9 Percentage of participants
Interval 18.8 to 31.7
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
3.2 Percentage of participants
Interval 1.2 to 6.9
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Any
|
30.3 Percentage of participants
Interval 23.7 to 37.4
|
17.2 Percentage of participants
Interval 12.1 to 23.4
|
33.0 Percentage of participants
Interval 26.3 to 40.3
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
17.8 Percentage of participants
Interval 12.6 to 24.1
|
14.5 Percentage of participants
Interval 9.8 to 20.4
|
24.9 Percentage of participants
Interval 18.8 to 31.7
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
11.9 Percentage of participants
Interval 7.6 to 17.4
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
7.6 Percentage of participants
Interval 4.2 to 12.4
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Chills: Any
|
26.5 Percentage of participants
Interval 20.3 to 33.5
|
7.0 Percentage of participants
Interval 3.8 to 11.7
|
22.2 Percentage of participants
Interval 16.4 to 28.8
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Chills: Mild
|
18.4 Percentage of participants
Interval 13.1 to 24.7
|
5.9 Percentage of participants
Interval 3.0 to 10.3
|
12.4 Percentage of participants
Interval 8.0 to 18.1
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Chills: Moderate
|
6.5 Percentage of participants
Interval 3.4 to 11.1
|
1.1 Percentage of participants
Interval 0.1 to 3.8
|
7.6 Percentage of participants
Interval 4.2 to 12.4
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Chills: Severe
|
1.6 Percentage of participants
Interval 0.3 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
2.2 Percentage of participants
Interval 0.6 to 5.4
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0 degree C
|
13.0 Percentage of participants
Interval 8.5 to 18.7
|
1.1 Percentage of participants
Interval 0.1 to 3.8
|
8.6 Percentage of participants
Interval 5.0 to 13.7
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0 degree C to 38.4 degree C
|
7.0 Percentage of participants
Interval 3.8 to 11.7
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.4 degree C to 38.9 degree C
|
5.4 Percentage of participants
Interval 2.6 to 9.7
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
4.9 Percentage of participants
Interval 2.2 to 9.0
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >40.0 degree C
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Any
|
32.4 Percentage of participants
Interval 25.7 to 39.7
|
14.5 Percentage of participants
Interval 9.8 to 20.4
|
31.9 Percentage of participants
Interval 25.2 to 39.1
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Mild
|
17.3 Percentage of participants
Interval 12.1 to 23.5
|
10.2 Percentage of participants
Interval 6.3 to 15.5
|
15.7 Percentage of participants
Interval 10.8 to 21.7
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Moderate
|
14.1 Percentage of participants
Interval 9.4 to 19.9
|
4.3 Percentage of participants
Interval 1.9 to 8.3
|
15.1 Percentage of participants
Interval 10.3 to 21.1
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Severe
|
1.1 Percentage of participants
Interval 0.1 to 3.9
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
1.1 Percentage of participants
Interval 0.1 to 3.9
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Any
|
26.5 Percentage of participants
Interval 20.3 to 33.5
|
9.1 Percentage of participants
Interval 5.4 to 14.2
|
24.9 Percentage of participants
Interval 18.8 to 31.7
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Mild
|
15.1 Percentage of participants
Interval 10.3 to 21.1
|
5.4 Percentage of participants
Interval 2.6 to 9.7
|
15.1 Percentage of participants
Interval 10.3 to 21.1
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Moderate
|
11.4 Percentage of participants
Interval 7.2 to 16.8
|
3.8 Percentage of participants
Interval 1.5 to 7.6
|
9.7 Percentage of participants
Interval 5.9 to 14.9
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Severe
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From day of vaccination (Day 1) up to 1 month after vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site
n=187 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site
n=187 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
|
5.3 Percentage of participants
Interval 2.6 to 9.6
|
4.3 Percentage of participants
Interval 1.9 to 8.3
|
6.5 Percentage of participants
Interval 3.4 to 11.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From day of vaccination (Day 1) up to 6 months after vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination.
A SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Outcome measures
| Measure |
Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site
n=187 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site
n=187 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site
n=185 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
1.1 Percentage of participants
Interval 0.1 to 3.8
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination with 20vPnCPopulation: Evaluable immunogenicity population (EIP): all randomized participants who received assigned vaccination; had at least 1 valid immunogenicity result from the blood sample collected within 20 to 49 days after vaccination at Day 1; had no other major protocol deviations as determined by clinician. Here, "Number Analyzed" signifies participants with valid OPA titers for the specified serotype.
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and 20vPnC only group (20vPnC + saline) as specified in protocol.
Outcome measures
| Measure |
Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site
n=184 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site
n=182 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 4
|
609 Titer
Interval 484.0 to 766.0
|
573 Titer
Interval 447.0 to 734.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 1
|
142 Titer
Interval 116.0 to 176.0
|
131 Titer
Interval 106.0 to 162.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 3
|
49 Titer
Interval 42.0 to 56.0
|
52 Titer
Interval 44.0 to 61.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 6B
|
1449 Titer
Interval 1153.0 to 1821.0
|
1478 Titer
Interval 1207.0 to 1810.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 7F
|
977 Titer
Interval 836.0 to 1142.0
|
1102 Titer
Interval 951.0 to 1275.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 5
|
81 Titer
Interval 65.0 to 100.0
|
98 Titer
Interval 80.0 to 120.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 6A
|
1377 Titer
Interval 1058.0 to 1792.0
|
1317 Titer
Interval 1042.0 to 1665.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 8
|
299 Titer
Interval 235.0 to 381.0
|
344 Titer
Interval 274.0 to 431.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 9V
|
1722 Titer
Interval 1365.0 to 2172.0
|
1531 Titer
Interval 1210.0 to 1936.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 10A
|
2252 Titer
Interval 1751.0 to 2898.0
|
2644 Titer
Interval 2023.0 to 3456.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 11A
|
1875 Titer
Interval 1414.0 to 2488.0
|
1932 Titer
Interval 1445.0 to 2583.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 12F
|
2165 Titer
Interval 1668.0 to 2809.0
|
2211 Titer
Interval 1695.0 to 2885.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 14
|
709 Titer
Interval 572.0 to 879.0
|
640 Titer
Interval 528.0 to 775.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 15B
|
1520 Titer
Interval 1092.0 to 2117.0
|
1852 Titer
Interval 1377.0 to 2491.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 18C
|
1059 Titer
Interval 869.0 to 1290.0
|
846 Titer
Interval 684.0 to 1046.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 19A
|
637 Titer
Interval 520.0 to 781.0
|
530 Titer
Interval 436.0 to 644.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 19F
|
305 Titer
Interval 242.0 to 383.0
|
377 Titer
Interval 299.0 to 476.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 22F
|
5225 Titer
Interval 3931.0 to 6943.0
|
4464 Titer
Interval 3354.0 to 5942.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 23F
|
336 Titer
Interval 251.0 to 450.0
|
385 Titer
Interval 283.0 to 524.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Serotype 33F
|
4907 Titer
Interval 3813.0 to 6316.0
|
5544 Titer
Interval 4234.0 to 7261.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination with BNT162b2Population: EIP: all randomized participants who received assigned vaccination; had at least 1 valid immunogenicity result from blood sample collected within 20 to 49 days after vaccination at Day 1; had no other major protocol deviations as determined by clinician. Participants with SARS-CoV-2 infection up to 1 month after vaccination (including subclinical infection, ie positive for N-binding antibody) were excluded from analysis. N=participants with valid assay results at specified sampling time point.
IgG levels were measured in serum samples using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length S-binding assay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in protocol.
Outcome measures
| Measure |
Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site
n=178 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site
n=177 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2
|
29114 Units per milliliter
Interval 26120.0 to 32451.0
|
26655 Units per milliliter
Interval 24003.0 to 29599.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination to 1 month after vaccination with BNT162b2Population: EIP: participants received assigned vaccination; at least 1 valid immunogenicity result from sample collected within 20 to 49 days after Day1 vaccination; no other major protocol deviations determined by clinician. Participants with SARS-CoV-2 infection upto 1 month after vaccination (including subclinical infection, ie positive for N-binding antibody)excluded from analysis. N=participants with valid full-length S-binding IgG from before and 1 month after BNT162b2 booster dose sample collection.
The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from before to approximately 1 month after vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in the protocol.
Outcome measures
| Measure |
Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site
n=178 Participants
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site
n=177 Participants
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2
|
35.5 Fold rise
Interval 30.9 to 40.7
|
39.0 Fold rise
Interval 33.5 to 45.5
|
—
|
—
|
—
|
—
|
Adverse Events
Coadministration Group: 20vPnC+BNT162b2
Serious events: 1 serious events
Other events: 157 other events
Deaths: 1 deaths
20vPnC Only Group: 20vPnC+Saline
Serious events: 2 serious events
Other events: 137 other events
Deaths: 0 deaths
BNT162b2 Only Group: BNT162b2+Saline
Serious events: 5 serious events
Other events: 149 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coadministration Group: 20vPnC+BNT162b2
n=187 participants at risk
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group: 20vPnC+Saline
n=187 participants at risk
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group: BNT162b2+Saline
n=185 participants at risk
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.53%
1/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.53%
1/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.54%
1/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.54%
1/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.53%
1/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.54%
1/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.54%
1/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.54%
1/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.54%
1/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Other adverse events
| Measure |
Coadministration Group: 20vPnC+BNT162b2
n=187 participants at risk
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
20vPnC Only Group: 20vPnC+Saline
n=187 participants at risk
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
BNT162b2 Only Group: BNT162b2+Saline
n=185 participants at risk
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
|---|---|---|---|
|
General disorders
Chills (CHILLS)
|
26.2%
49/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
7.0%
13/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
22.2%
41/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Fatigue (FATIGUE)
|
53.5%
100/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
35.8%
67/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
54.6%
101/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site erythema (REDNESS)
|
13.9%
26/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
8.0%
15/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
11.9%
22/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site pain (PAIN)
|
78.1%
146/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
61.5%
115/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
71.9%
133/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site swelling (SWELLING)
|
13.9%
26/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
8.6%
16/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
11.4%
21/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Pyrexia (FEVER)
|
12.8%
24/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.1%
2/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
8.6%
16/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.54%
1/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
26.2%
49/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
9.1%
17/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
24.9%
46/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
32.1%
60/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
14.4%
27/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
31.9%
59/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Dizziness
|
1.1%
2/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Headache (HEADACHE)
|
29.9%
56/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
17.1%
32/187 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
33.0%
61/185 • Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
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