Trial Outcomes & Findings for Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults (NCT NCT03828617)
NCT ID: NCT03828617
Last Updated: 2020-11-23
Results Overview
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1710 participants
Primary outcome timeframe
Within 10 days after vaccination
Results posted on
2020-11-23
Participant Flow
A total of 1718 participants were enrolled, out of which only 1710 were randomized. There were 8 participants who were enrolled (signed informed consent document) but were not randomized into the study as the randomization system had reached the pre-specified capacity.
Participant milestones
| Measure |
20vPnC Lot 1
Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 2
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
489
|
490
|
486
|
245
|
|
Overall Study
Vaccinated
|
488
|
489
|
486
|
245
|
|
Overall Study
Safety Population
|
488
|
489
|
486
|
245
|
|
Overall Study
Evaluable Immunogenicity Population(EIP)
|
463
|
473
|
456
|
232
|
|
Overall Study
COMPLETED
|
465
|
475
|
460
|
235
|
|
Overall Study
NOT COMPLETED
|
24
|
15
|
26
|
10
|
Reasons for withdrawal
| Measure |
20vPnC Lot 1
Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 2
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
12
|
23
|
7
|
|
Overall Study
No longer met eligibility criteria
|
0
|
1
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
0
|
Baseline Characteristics
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Baseline characteristics by cohort
| Measure |
20vPnC Lot 1
n=488 Participants
Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 2
n=489 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
n=486 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=245 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
Total
n=1708 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 9.03 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 8.70 • n=4 Participants
|
35.3 years
STANDARD_DEVIATION 9.03 • n=21 Participants
|
|
Sex: Female, Male
Female
|
331 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
1115 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
593 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
434 Participants
n=5 Participants
|
427 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
1503 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
316 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
367 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
1241 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 10 days after vaccinationPopulation: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Outcome measures
| Measure |
Pooled 20vPnC
n=1456 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=243 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Any
|
7.0 percentage of participants
Interval 5.7 to 8.4
|
6.2 percentage of participants
Interval 3.5 to 10.0
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Mild
|
3.9 percentage of participants
Interval 3.0 to 5.0
|
3.3 percentage of participants
Interval 1.4 to 6.4
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Moderate
|
2.6 percentage of participants
Interval 1.9 to 3.6
|
2.9 percentage of participants
Interval 1.2 to 5.8
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Severe
|
0.5 percentage of participants
Interval 0.2 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Any
|
8.5 percentage of participants
Interval 7.1 to 10.1
|
8.6 percentage of participants
Interval 5.4 to 12.9
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Mild
|
5.4 percentage of participants
Interval 4.3 to 6.7
|
5.3 percentage of participants
Interval 2.9 to 9.0
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Moderate
|
2.9 percentage of participants
Interval 2.1 to 3.9
|
3.3 percentage of participants
Interval 1.4 to 6.4
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Severe
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
0 percentage of participants
Interval 0.0 to 1.5
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Any
|
78.7 percentage of participants
Interval 76.5 to 80.8
|
75.7 percentage of participants
Interval 69.8 to 81.0
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Mild
|
50.0 percentage of participants
Interval 47.4 to 52.6
|
46.5 percentage of participants
Interval 40.1 to 53.0
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Moderate
|
27.5 percentage of participants
Interval 25.3 to 29.9
|
27.6 percentage of participants
Interval 22.1 to 33.6
|
—
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Severe
|
1.2 percentage of participants
Interval 0.7 to 1.9
|
1.6 percentage of participants
Interval 0.5 to 4.2
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=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, 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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Outcome measures
| Measure |
Pooled 20vPnC
n=1456 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=243 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0 degree C (Any)
|
1.2 percentage of participants
Interval 0.7 to 1.9
|
0.8 percentage of participants
Interval 0.1 to 2.9
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0 degree C to 38.4 degree C
|
0.8 percentage of participants
Interval 0.4 to 1.3
|
0.4 percentage of participants
Interval 0.0 to 2.3
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.4 degree C to 38.9 degree C
|
0.3 percentage of participants
Interval 0.1 to 0.7
|
0.4 percentage of participants
Interval 0.0 to 2.3
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.9 degree C to 40.0 degree C
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
0 percentage of participants
Interval 0.0 to 1.5
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >40.0 degree C
|
0 percentage of participants
Interval 0.0 to 0.3
|
0 percentage of participants
Interval 0.0 to 1.5
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Any
|
47.6 percentage of participants
Interval 45.0 to 50.2
|
43.6 percentage of participants
Interval 37.3 to 50.1
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
24.7 percentage of participants
Interval 22.5 to 27.0
|
24.3 percentage of participants
Interval 19.0 to 30.2
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
21.2 percentage of participants
Interval 19.1 to 23.4
|
17.7 percentage of participants
Interval 13.1 to 23.1
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
1.7 percentage of participants
Interval 1.1 to 2.5
|
1.6 percentage of participants
Interval 0.5 to 4.2
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Any
|
36.2 percentage of participants
Interval 33.7 to 38.7
|
37.9 percentage of participants
Interval 31.7 to 44.3
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
22.6 percentage of participants
Interval 20.5 to 24.8
|
27.2 percentage of participants
Interval 21.7 to 33.2
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
12.0 percentage of participants
Interval 10.4 to 13.8
|
9.9 percentage of participants
Interval 6.4 to 14.3
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
1.6 percentage of participants
Interval 1.0 to 2.4
|
0.8 percentage of participants
Interval 0.1 to 2.9
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Any
|
62.1 percentage of participants
Interval 59.5 to 64.6
|
60.5 percentage of participants
Interval 54.0 to 66.7
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Mild
|
38.5 percentage of participants
Interval 36.0 to 41.0
|
38.7 percentage of participants
Interval 32.5 to 45.1
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Moderate
|
22.5 percentage of participants
Interval 20.4 to 24.8
|
19.8 percentage of participants
Interval 14.9 to 25.3
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Severe
|
1.1 percentage of participants
Interval 0.6 to 1.8
|
2.1 percentage of participants
Interval 0.7 to 4.7
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Any
|
16.8 percentage of participants
Interval 14.9 to 18.8
|
14.0 percentage of participants
Interval 9.9 to 19.0
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Mild
|
10.0 percentage of participants
Interval 8.5 to 11.6
|
7.8 percentage of participants
Interval 4.8 to 11.9
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Moderate
|
6.5 percentage of participants
Interval 5.2 to 7.8
|
5.3 percentage of participants
Interval 2.9 to 9.0
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Severe
|
0.4 percentage of participants
Interval 0.2 to 0.9
|
0.8 percentage of participants
Interval 0.1 to 2.9
|
—
|
PRIMARY outcome
Timeframe: Within 1 month after vaccinationPopulation: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Outcome measures
| Measure |
Pooled 20vPnC
n=1463 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=245 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination
|
6.8 percentage of participants
Interval 5.6 to 8.3
|
5.3 percentage of participants
Interval 2.9 to 8.9
|
—
|
PRIMARY outcome
Timeframe: Within 6 month after vaccinationPopulation: Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Outcome measures
| Measure |
Pooled 20vPnC
n=1463 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=245 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination
|
0.7 percentage of participants
Interval 0.3 to 1.3
|
0 percentage of participants
Interval 0.0 to 1.5
|
—
|
PRIMARY outcome
Timeframe: Within 6 months after vaccinationPopulation: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Outcome measures
| Measure |
Pooled 20vPnC
n=1463 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=245 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
|
1.0 percentage of participants
Interval 0.6 to 1.7
|
2.0 percentage of participants
Interval 0.7 to 4.7
|
—
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Outcome measures
| Measure |
Pooled 20vPnC
n=463 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=473 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
n=456 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 5
|
125.8 titer
Interval 108.6 to 145.7
|
135.6 titer
Interval 117.3 to 156.7
|
116.8 titer
Interval 100.9 to 135.2
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 6A
|
4654.1 titer
Interval 4033.0 to 5371.0
|
3748.3 titer
Interval 3255.7 to 4315.4
|
3330.4 titer
Interval 2885.1 to 3844.6
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 6B
|
4403.3 titer
Interval 3832.6 to 5059.0
|
4349.9 titer
Interval 3796.4 to 4984.1
|
3907.3 titer
Interval 3401.4 to 4488.3
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 7F
|
1820.6 titer
Interval 1588.5 to 2086.5
|
1865.6 titer
Interval 1629.7 to 2135.7
|
1875.7 titer
Interval 1632.6 to 2154.9
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 9V
|
5120.4 titer
Interval 4464.6 to 5872.7
|
4604.1 titer
Interval 4024.4 to 5267.5
|
4921.7 titer
Interval 4292.4 to 5643.2
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 14
|
2240.2 titer
Interval 1965.4 to 2553.5
|
2091.2 titer
Interval 1839.9 to 2376.8
|
2001.9 titer
Interval 1760.4 to 2276.5
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 18C
|
3903.7 titer
Interval 3339.6 to 4563.2
|
4450.7 titer
Interval 3818.1 to 5188.0
|
4221.7 titer
Interval 3615.8 to 4929.2
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 19A
|
1457.8 titer
Interval 1287.5 to 1650.6
|
1528.1 titer
Interval 1353.2 to 1725.6
|
1434.4 titer
Interval 1267.8 to 1623.0
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 19F
|
524.5 titer
Interval 450.7 to 610.3
|
529.2 titer
Interval 455.6 to 614.6
|
549.0 titer
Interval 472.2 to 638.3
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 23F
|
1416.1 titer
Interval 1182.4 to 1696.1
|
1547.5 titer
Interval 1294.9 to 1849.2
|
1434.6 titer
Interval 1197.8 to 1718.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 8
|
1595.0 titer
Interval 1402.7 to 1813.7
|
1345.9 titer
Interval 1185.9 to 1527.6
|
1624.3 titer
Interval 1430.4 to 1844.5
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 10A
|
6328.1 titer
Interval 5407.7 to 7405.2
|
5692.6 titer
Interval 4890.2 to 6626.6
|
5962.2 titer
Interval 5121.3 to 6941.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 11A
|
8656.2 titer
Interval 7308.4 to 10252.5
|
6728.5 titer
Interval 5693.2 to 7952.0
|
8720.3 titer
Interval 7408.6 to 10264.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 12F
|
8563.0 titer
Interval 7321.5 to 10015.0
|
7907.5 titer
Interval 6764.8 to 9243.3
|
7412.4 titer
Interval 6331.8 to 8677.4
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 15B
|
7342.8 titer
Interval 6108.1 to 8827.2
|
6356.9 titer
Interval 5325.0 to 7588.7
|
7018.9 titer
Interval 5853.8 to 8416.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 22F
|
12507.5 titer
Interval 10318.3 to 15161.1
|
11213.4 titer
Interval 9337.1 to 13466.9
|
12728.6 titer
Interval 10571.7 to 15325.5
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 33F
|
10745.7 titer
Interval 9042.0 to 12770.5
|
10328.2 titer
Interval 8737.0 to 12209.3
|
10418.2 titer
Interval 8815.3 to 12312.5
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 1
|
199.5 titer
Interval 173.5 to 229.6
|
175.1 titer
Interval 152.5 to 201.0
|
164.6 titer
Interval 143.1 to 189.3
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 3
|
47.3 titer
Interval 42.7 to 52.4
|
46.8 titer
Interval 42.3 to 51.8
|
43.1 titer
Interval 38.9 to 47.8
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 4
|
1499.7 titer
Interval 1288.3 to 1745.6
|
1568.2 titer
Interval 1350.2 to 1821.4
|
1505.6 titer
Interval 1294.4 to 1751.3
|
SECONDARY outcome
Timeframe: Before vaccination to 1 month after vaccinationPopulation: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Outcome measures
| Measure |
Pooled 20vPnC
n=463 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=473 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
n=456 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 1
|
20.2 fold rise
Interval 17.6 to 23.1
|
17.8 fold rise
Interval 15.6 to 20.3
|
17.3 fold rise
Interval 15.0 to 19.8
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 3
|
5.0 fold rise
Interval 4.4 to 5.5
|
5.0 fold rise
Interval 4.5 to 5.5
|
4.6 fold rise
Interval 4.1 to 5.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 4
|
77.6 fold rise
Interval 63.8 to 94.4
|
94.7 fold rise
Interval 79.4 to 112.9
|
81.0 fold rise
Interval 67.0 to 97.8
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 5
|
8.7 fold rise
Interval 7.5 to 10.0
|
9.4 fold rise
Interval 8.2 to 10.7
|
8.0 fold rise
Interval 6.9 to 9.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 6A
|
157.2 fold rise
Interval 132.6 to 186.3
|
119.6 fold rise
Interval 100.5 to 142.3
|
128.4 fold rise
Interval 107.6 to 153.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 6B
|
72.5 fold rise
Interval 59.9 to 87.8
|
75.4 fold rise
Interval 62.9 to 90.4
|
70.5 fold rise
Interval 58.1 to 85.6
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 7F
|
18.3 fold rise
Interval 15.5 to 21.7
|
19.5 fold rise
Interval 16.5 to 23.0
|
19.0 fold rise
Interval 16.1 to 22.5
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 9V
|
25.4 fold rise
Interval 21.1 to 30.7
|
23.3 fold rise
Interval 19.4 to 27.9
|
21.6 fold rise
Interval 17.7 to 26.4
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 14
|
18.2 fold rise
Interval 14.8 to 22.3
|
16.3 fold rise
Interval 13.2 to 20.0
|
18.1 fold rise
Interval 14.6 to 22.3
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 18C
|
80.4 fold rise
Interval 63.9 to 101.2
|
95.0 fold rise
Interval 76.6 to 117.7
|
79.9 fold rise
Interval 63.8 to 100.0
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 19A
|
35.9 fold rise
Interval 29.9 to 43.2
|
39.1 fold rise
Interval 32.4 to 47.1
|
41.8 fold rise
Interval 34.9 to 50.2
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 19F
|
14.0 fold rise
Interval 12.0 to 16.5
|
14.7 fold rise
Interval 12.6 to 17.2
|
15.4 fold rise
Interval 13.1 to 18.0
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 23F
|
99.5 fold rise
Interval 80.4 to 123.1
|
125.1 fold rise
Interval 102.4 to 152.7
|
120.9 fold rise
Interval 97.9 to 149.5
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 8
|
38.3 fold rise
Interval 31.3 to 46.8
|
38.8 fold rise
Interval 32.1 to 46.9
|
46.1 fold rise
Interval 37.9 to 56.0
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 10A
|
20.8 fold rise
Interval 16.6 to 26.1
|
19.0 fold rise
Interval 15.2 to 23.7
|
20.2 fold rise
Interval 15.9 to 25.6
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 11A
|
6.9 fold rise
Interval 5.4 to 8.9
|
5.0 fold rise
Interval 3.9 to 6.4
|
5.3 fold rise
Interval 4.2 to 6.7
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 12F
|
175.5 fold rise
Interval 141.3 to 217.9
|
174.6 fold rise
Interval 140.8 to 216.7
|
175.7 fold rise
Interval 141.6 to 218.1
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 15B
|
112.5 fold rise
Interval 83.8 to 150.9
|
84.2 fold rise
Interval 64.5 to 110.0
|
91.7 fold rise
Interval 69.4 to 121.3
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 22F
|
83.8 fold rise
Interval 59.2 to 118.6
|
63.3 fold rise
Interval 46.8 to 85.7
|
77.8 fold rise
Interval 56.8 to 106.6
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 33F
|
8.3 fold rise
Interval 6.7 to 10.4
|
8.6 fold rise
Interval 7.0 to 10.6
|
7.4 fold rise
Interval 6.0 to 9.1
|
SECONDARY outcome
Timeframe: Before vaccination to 1 month after vaccinationPopulation: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Outcome measures
| Measure |
Pooled 20vPnC
n=463 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=473 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
n=456 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 1
|
83.7 percentage of participants
Interval 80.0 to 87.0
|
82.9 percentage of participants
Interval 79.2 to 86.2
|
82.4 percentage of participants
Interval 78.6 to 85.8
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 3
|
56.1 percentage of participants
Interval 51.4 to 60.8
|
57.8 percentage of participants
Interval 53.1 to 62.3
|
53.0 percentage of participants
Interval 48.3 to 57.7
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 4
|
85.0 percentage of participants
Interval 81.4 to 88.2
|
87.6 percentage of participants
Interval 84.1 to 90.5
|
86.2 percentage of participants
Interval 82.6 to 89.3
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 5
|
65.7 percentage of participants
Interval 61.2 to 70.1
|
67.2 percentage of participants
Interval 62.7 to 71.4
|
65.3 percentage of participants
Interval 60.7 to 69.7
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 6A
|
94.5 percentage of participants
Interval 91.9 to 96.4
|
93.1 percentage of participants
Interval 90.4 to 95.3
|
93.0 percentage of participants
Interval 90.2 to 95.2
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 6B
|
90.3 percentage of participants
Interval 87.1 to 93.0
|
91.4 percentage of participants
Interval 88.4 to 93.8
|
89.2 percentage of participants
Interval 85.8 to 91.9
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 7F
|
76.8 percentage of participants
Interval 72.4 to 80.7
|
76.7 percentage of participants
Interval 72.3 to 80.6
|
80.0 percentage of participants
Interval 75.8 to 83.9
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 9V
|
79.1 percentage of participants
Interval 74.8 to 83.0
|
79.5 percentage of participants
Interval 75.2 to 83.3
|
75.7 percentage of participants
Interval 71.1 to 79.9
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 14
|
70.0 percentage of participants
Interval 65.4 to 74.3
|
67.7 percentage of participants
Interval 63.0 to 72.0
|
67.7 percentage of participants
Interval 63.1 to 72.1
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 18C
|
83.0 percentage of participants
Interval 79.1 to 86.4
|
88.2 percentage of participants
Interval 84.8 to 91.0
|
84.5 percentage of participants
Interval 80.8 to 87.8
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 19A
|
81.7 percentage of participants
Interval 77.8 to 85.2
|
81.8 percentage of participants
Interval 77.9 to 85.2
|
85.5 percentage of participants
Interval 81.8 to 88.6
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 19F
|
74.0 percentage of participants
Interval 69.7 to 78.0
|
76.2 percentage of participants
Interval 72.0 to 80.0
|
75.2 percentage of participants
Interval 71.0 to 79.2
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 23F
|
85.6 percentage of participants
Interval 82.0 to 88.7
|
88.2 percentage of participants
Interval 84.9 to 91.0
|
88.8 percentage of participants
Interval 85.5 to 91.5
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 8
|
82.0 percentage of participants
Interval 77.9 to 85.5
|
82.3 percentage of participants
Interval 78.3 to 85.8
|
82.5 percentage of participants
Interval 78.5 to 86.1
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 10A
|
74.9 percentage of participants
Interval 70.0 to 79.3
|
74.5 percentage of participants
Interval 69.7 to 78.8
|
70.8 percentage of participants
Interval 65.9 to 75.4
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 11A
|
52.4 percentage of participants
Interval 46.7 to 57.9
|
48.0 percentage of participants
Interval 42.4 to 53.6
|
42.2 percentage of participants
Interval 36.8 to 47.7
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 12F
|
91.8 percentage of participants
Interval 88.6 to 94.3
|
93.1 percentage of participants
Interval 90.1 to 95.4
|
91.5 percentage of participants
Interval 88.2 to 94.1
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 15B
|
81.6 percentage of participants
Interval 77.2 to 85.4
|
82.0 percentage of participants
Interval 77.9 to 85.7
|
81.0 percentage of participants
Interval 76.7 to 84.9
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 22F
|
79.8 percentage of participants
Interval 75.0 to 84.1
|
82.1 percentage of participants
Interval 77.7 to 85.9
|
81.4 percentage of participants
Interval 76.8 to 85.4
|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 33F
|
62.7 percentage of participants
Interval 57.3 to 67.9
|
62.7 percentage of participants
Interval 57.5 to 67.8
|
62.7 percentage of participants
Interval 57.5 to 67.7
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
The percentage of participants with OPA titers \>=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Outcome measures
| Measure |
Pooled 20vPnC
n=463 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=473 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
20vPnC Lot 3
n=456 Participants
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|---|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 1
|
91.8 percentage of participants
Interval 88.9 to 94.1
|
92.8 percentage of participants
Interval 90.0 to 94.9
|
91.0 percentage of participants
Interval 87.9 to 93.4
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 3
|
89.7 percentage of participants
Interval 86.6 to 92.4
|
89.6 percentage of participants
Interval 86.4 to 92.2
|
88.9 percentage of participants
Interval 85.6 to 91.7
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 4
|
97.6 percentage of participants
Interval 95.7 to 98.8
|
97.0 percentage of participants
Interval 95.0 to 98.4
|
97.1 percentage of participants
Interval 95.1 to 98.5
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 5
|
80.3 percentage of participants
Interval 76.4 to 83.9
|
84.3 percentage of participants
Interval 80.7 to 87.5
|
81.3 percentage of participants
Interval 77.4 to 84.8
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 6A
|
99.1 percentage of participants
Interval 97.8 to 99.8
|
98.1 percentage of participants
Interval 96.4 to 99.1
|
98.2 percentage of participants
Interval 96.5 to 99.2
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 6B
|
97.6 percentage of participants
Interval 95.7 to 98.8
|
99.6 percentage of participants
Interval 98.5 to 99.9
|
98.9 percentage of participants
Interval 97.4 to 99.6
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 7F
|
94.7 percentage of participants
Interval 92.2 to 96.6
|
94.0 percentage of participants
Interval 91.4 to 96.0
|
96.6 percentage of participants
Interval 94.5 to 98.1
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 9V
|
98.5 percentage of participants
Interval 96.8 to 99.4
|
98.9 percentage of participants
Interval 97.5 to 99.7
|
98.2 percentage of participants
Interval 96.5 to 99.2
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 14
|
98.9 percentage of participants
Interval 97.5 to 99.6
|
99.4 percentage of participants
Interval 98.1 to 99.9
|
97.8 percentage of participants
Interval 96.0 to 98.9
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 18C
|
96.9 percentage of participants
Interval 94.9 to 98.3
|
98.1 percentage of participants
Interval 96.4 to 99.1
|
98.7 percentage of participants
Interval 97.1 to 99.5
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 19A
|
99.3 percentage of participants
Interval 98.1 to 99.9
|
100.0 percentage of participants
Interval 99.2 to 100.0
|
99.3 percentage of participants
Interval 98.1 to 99.9
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 19F
|
91.2 percentage of participants
Interval 88.2 to 93.6
|
91.0 percentage of participants
Interval 88.0 to 93.4
|
90.7 percentage of participants
Interval 87.6 to 93.2
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 23F
|
94.3 percentage of participants
Interval 91.8 to 96.3
|
95.8 percentage of participants
Interval 93.5 to 97.4
|
94.9 percentage of participants
Interval 92.5 to 96.8
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 8
|
98.6 percentage of participants
Interval 97.0 to 99.5
|
99.1 percentage of participants
Interval 97.7 to 99.8
|
99.1 percentage of participants
Interval 97.7 to 99.7
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 10A
|
99.7 percentage of participants
Interval 98.6 to 100.0
|
99.0 percentage of participants
Interval 97.6 to 99.7
|
99.3 percentage of participants
Interval 97.9 to 99.8
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 11A
|
99.2 percentage of participants
Interval 97.8 to 99.8
|
99.5 percentage of participants
Interval 98.2 to 99.9
|
99.5 percentage of participants
Interval 98.2 to 99.9
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 12F
|
99.0 percentage of participants
Interval 97.6 to 99.7
|
99.3 percentage of participants
Interval 97.9 to 99.9
|
99.0 percentage of participants
Interval 97.5 to 99.7
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 15B
|
99.0 percentage of participants
Interval 97.4 to 99.7
|
98.6 percentage of participants
Interval 97.0 to 99.5
|
99.3 percentage of participants
Interval 97.8 to 99.8
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 22F
|
99.7 percentage of participants
Interval 98.5 to 100.0
|
99.2 percentage of participants
Interval 97.8 to 99.8
|
99.5 percentage of participants
Interval 98.1 to 99.9
|
|
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Serotype 33F
|
99.0 percentage of participants
Interval 97.4 to 99.7
|
98.8 percentage of participants
Interval 97.1 to 99.6
|
98.5 percentage of participants
Interval 96.8 to 99.5
|
Adverse Events
Pooled 20vPnC
Serious events: 10 serious events
Other events: 1275 other events
Deaths: 0 deaths
13vPnC
Serious events: 0 serious events
Other events: 206 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled 20vPnC
n=1463 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=245 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|
|
Blood and lymphatic system disorders
Splenic cyst
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Infections and infestations
Abdominal abscess
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Infections and infestations
Osteomyelitis
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Psychiatric disorders
Suicidal ideation
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.07%
1/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.00%
0/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
Other adverse events
| Measure |
Pooled 20vPnC
n=1463 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
|
13vPnC
n=245 participants at risk
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
|
|---|---|---|
|
General disorders
Fatigue
|
47.4%
693/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
43.3%
106/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
General disorders
Injection site erythema (REDNESS)
|
7.0%
102/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
6.1%
15/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
General disorders
Injection site pain (PAIN)
|
78.3%
1146/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
75.1%
184/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
General disorders
Injection site swelling (SWELLING)
|
8.5%
124/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
8.6%
21/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
General disorders
Pyrexia (FEVER)
|
1.2%
18/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
0.82%
2/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
16.7%
245/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
13.9%
34/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
61.8%
904/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
60.0%
147/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
|
Nervous system disorders
Headache
|
36.0%
527/1463 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
37.6%
92/245 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
|
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