Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY) (NCT NCT03547167)
NCT ID: NCT03547167
Last Updated: 2021-01-15
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1515 participants
Primary outcome timeframe
Up to 5 days after Vaccination 1
Results posted on
2021-01-15
Participant Flow
Participant milestones
| Measure |
V114
Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Overall Study
STARTED
|
1135
|
380
|
|
Overall Study
Vaccination 1 - (V114 or Prevnar 13™, Day 1)
|
1133
|
379
|
|
Overall Study
Vaccination 2 - (PNEUMOVAX™23, Month 6)
|
1035
|
346
|
|
Overall Study
COMPLETED
|
1038
|
350
|
|
Overall Study
NOT COMPLETED
|
97
|
30
|
Reasons for withdrawal
| Measure |
V114
Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
34
|
12
|
|
Overall Study
Screen Failure
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
59
|
15
|
|
Overall Study
Death
|
4
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
Baseline characteristics by cohort
| Measure |
V114
n=1135 Participants
Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=380 Participants
Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Total
n=1515 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
581 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
782 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
554 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
733 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
135 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
984 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
1322 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
445 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
593 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
33 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
582 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
774 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after Vaccination 1Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=1134 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=378 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Injection site tenderness/pain
|
75.8 Percentage of Participants
Interval 73.2 to 78.3
|
68.8 Percentage of Participants
Interval 63.8 to 73.4
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Injection site swelling
|
21.7 Percentage of Participants
Interval 19.3 to 24.2
|
22.2 Percentage of Participants
Interval 18.1 to 26.8
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Injection site redness/erythema
|
15.1 Percentage of Participants
Interval 13.0 to 17.3
|
14.0 Percentage of Participants
Interval 10.7 to 17.9
|
PRIMARY outcome
Timeframe: Up to 14 days after Vaccination 1Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=1134 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=378 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Joint pain/arthralgia
|
12.7 Percentage of Participants
Interval 10.8 to 14.8
|
11.6 Percentage of Participants
Interval 8.6 to 15.3
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Tiredness/fatigue
|
34.3 Percentage of Participants
Interval 31.5 to 37.1
|
36.8 Percentage of Participants
Interval 31.9 to 41.9
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Headache
|
26.5 Percentage of Participants
Interval 23.9 to 29.1
|
24.9 Percentage of Participants
Interval 20.6 to 29.5
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Muscle pain/myalgia
|
28.8 Percentage of Participants
Interval 26.2 to 31.6
|
25.5 Percentage of Participants
Interval 22.1 to 31.2
|
PRIMARY outcome
Timeframe: Up to Month 6 (before Vaccination 2)Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=1134 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=378 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™
|
0.0 Percentage of Participants
Interval 0.0 to 0.3
|
0.0 Percentage of Participants
Interval 0.0 to 0.8
|
PRIMARY outcome
Timeframe: Day 30Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 1 (Shared)
|
268.6 Titers
Interval 243.7 to 296.0
|
267.2 Titers
Interval 220.4 to 323.9
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 3 (Shared)
|
199.3 Titers
Interval 184.6 to 215.2
|
150.6 Titers
Interval 130.6 to 173.8
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 4 (Shared)
|
1416.0 Titers
Interval 1308.9 to 1531.8
|
2576.1 Titers
Interval 2278.0 to 2913.2
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 5 (Shared)
|
564.8 Titers
Interval 512.7 to 622.2
|
731.1 Titers
Interval 613.6 to 871.0
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 6A (Shared)
|
12928.8 Titers
Interval 11923.4 to 14019.0
|
11282.4 Titers
Interval 9718.8 to 13097.5
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 6B (Shared)
|
10336.9 Titers
Interval 9649.4 to 11073.4
|
6995.7 Titers
Interval 6024.7 to 8123.2
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 18C (Shared)
|
5709.0 Titers
Interval 5331.1 to 6113.6
|
3063.2 Titers
Interval 2699.8 to 3475.5
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 19A (Shared)
|
5369.9 Titers
Interval 5017.7 to 5746.8
|
5888.0 Titers
Interval 5228.2 to 6631.0
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 19F (Shared)
|
3266.3 Titers
Interval 3064.4 to 3481.4
|
3272.7 Titers
Interval 2948.2 to 3632.9
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 23F (Shared)
|
4853.5 Titers
Interval 4469.8 to 5270.2
|
3887.3 Titers
Interval 3335.8 to 4530.0
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 22F (Unique to V114)
|
3926.5 Titers
Interval 3645.9 to 4228.7
|
291.6 Titers
Interval 221.8 to 383.6
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 33F (Unique to V114)
|
11627.8 Titers
Interval 10824.6 to 12490.7
|
2180.6 Titers
Interval 1828.7 to 2600.2
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 7F (Shared)
|
5756.4 Titers
Interval 5410.4 to 6124.6
|
7588.9 Titers
Interval 6775.3 to 8500.2
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 9V (Shared)
|
3355.1 Titers
Interval 3135.4 to 3590.1
|
3983.7 Titers
Interval 3557.8 to 4460.7
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
Serotype 14 (Shared)
|
5228.9 Titers
Interval 4847.6 to 5640.2
|
5889.8 Titers
Interval 5218.2 to 6647.8
|
SECONDARY outcome
Timeframe: Up to 5 days after Vaccination 2 (Month 6)Population: All randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Outcome measures
| Measure |
V114
n=1036 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=345 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Injection site redness/erythema
|
22.6 Percentage of Participants
Interval 20.1 to 25.3
|
25.5 Percentage of Participants
Interval 21.0 to 30.5
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Injection site swelling
|
29.4 Percentage of Participants
Interval 26.7 to 32.3
|
32.2 Percentage of Participants
Interval 27.3 to 37.4
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Injection site tenderness/pain
|
68.8 Percentage of Participants
Interval 65.9 to 71.6
|
67.0 Percentage of Participants
Interval 61.7 to 71.9
|
SECONDARY outcome
Timeframe: Up to 14 days after Vaccination 2 (Month 6)Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=1036 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=345 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Joint pain/arthralgia
|
12.0 Percentage of Participants
Interval 10.1 to 14.1
|
11.0 Percentage of Participants
Interval 7.9 to 14.8
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Tiredness/fatigue
|
30.1 Percentage of Participants
Interval 27.3 to 33.0
|
30.7 Percentage of Participants
Interval 25.9 to 35.9
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Headache
|
21.2 Percentage of Participants
Interval 18.8 to 23.9
|
21.2 Percentage of Participants
Interval 17.0 to 25.9
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Muscle pain/myalgia
|
24.1 Percentage of Participants
Interval 21.6 to 26.9
|
25.5 Percentage of Participants
Interval 21.0 to 30.5
|
SECONDARY outcome
Timeframe: From Month 6 (before Vaccination 2) to Month 7Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=1036 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=345 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23
|
0.0 Percentage of Participants
Interval 0.0 to 0.3
|
0.3 Percentage of Participants
Interval 0.0 to 1.6
|
SECONDARY outcome
Timeframe: Day 30Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 1 (Shared)
|
3.56 µg/mL
Interval 3.29 to 3.85
|
4.59 µg/mL
Interval 4.0 to 5.26
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 3 (Shared)
|
0.77 µg/mL
Interval 0.72 to 0.83
|
0.63 µg/mL
Interval 0.57 to 0.71
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 4 (Shared)
|
1.53 µg/mL
Interval 1.4 to 1.66
|
2.71 µg/mL
Interval 2.34 to 3.13
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 5 (Shared)
|
3.43 µg/mL
Interval 3.14 to 3.75
|
4.48 µg/mL
Interval 3.77 to 5.32
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 6A (Shared)
|
11.84 µg/mL
Interval 10.71 to 13.1
|
10.87 µg/mL
Interval 9.06 to 13.05
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 6B (Shared)
|
17.90 µg/mL
Interval 16.21 to 19.76
|
11.36 µg/mL
Interval 9.45 to 13.66
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 7F (Shared)
|
5.18 µg/mL
Interval 4.77 to 5.62
|
6.88 µg/mL
Interval 5.95 to 7.95
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 9V (Shared)
|
4.44 µg/mL
Interval 4.11 to 4.8
|
5.31 µg/mL
Interval 4.62 to 6.1
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 14 (Shared)
|
15.91 µg/mL
Interval 14.46 to 17.51
|
17.35 µg/mL
Interval 14.93 to 20.16
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 18C (Shared)
|
14.57 µg/mL
Interval 13.42 to 15.81
|
9.32 µg/mL
Interval 8.06 to 10.79
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 19A (Shared)
|
19.41 µg/mL
Interval 18.0 to 20.93
|
21.79 µg/mL
Interval 18.85 to 25.19
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 19F (Shared)
|
13.98 µg/mL
Interval 12.9 to 15.14
|
13.35 µg/mL
Interval 11.52 to 15.47
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 23F (Shared)
|
13.57 µg/mL
Interval 12.44 to 14.8
|
10.98 µg/mL
Interval 9.34 to 12.91
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 22F (Unique to V114)
|
6.22 µg/mL
Interval 5.74 to 6.74
|
0.52 µg/mL
Interval 0.45 to 0.6
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Serotype 33F (Unique to V114)
|
7.79 µg/mL
Interval 7.16 to 8.48
|
0.88 µg/mL
Interval 0.78 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 18C (Shared)
|
20.4 Ratio
Interval 18.6 to 22.4
|
11.7 Ratio
Interval 10.1 to 13.6
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 1 (Shared)
|
22.8 Ratio
Interval 20.6 to 25.1
|
21.9 Ratio
Interval 18.4 to 26.2
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 3 (Shared)
|
5.8 Ratio
Interval 5.4 to 6.3
|
4.8 Ratio
Interval 4.3 to 5.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 4 (Shared)
|
17.9 Ratio
Interval 16.2 to 19.8
|
33.4 Ratio
Interval 28.1 to 39.7
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 5 (Shared)
|
17.3 Ratio
Interval 15.7 to 18.9
|
21.1 Ratio
Interval 18.0 to 24.7
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 19A (Shared)
|
12.5 Ratio
Interval 11.3 to 13.9
|
13.6 Ratio
Interval 11.4 to 16.2
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 19F (Shared)
|
7.5 Ratio
Interval 6.9 to 8.2
|
7.4 Ratio
Interval 6.4 to 8.6
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 6A (Shared)
|
21.7 Ratio
Interval 19.6 to 23.9
|
21.4 Ratio
Interval 18.0 to 25.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 6B (Shared)
|
32.2 Ratio
Interval 28.6 to 36.3
|
25.0 Ratio
Interval 20.6 to 30.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 7F (Shared)
|
7.3 Ratio
Interval 6.6 to 8.2
|
10.0 Ratio
Interval 8.3 to 12.0
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 9V (Shared)
|
4.9 Ratio
Interval 4.5 to 5.3
|
5.7 Ratio
Interval 5.0 to 6.6
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 14 (Shared)
|
8.2 Ratio
Interval 7.4 to 9.2
|
8.7 Ratio
Interval 7.2 to 10.6
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 23F (Shared)
|
22.5 Ratio
Interval 20.0 to 25.4
|
17.8 Ratio
Interval 14.6 to 21.7
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 22F (Unique to V114)
|
13.9 Ratio
Interval 11.8 to 16.3
|
1.3 Ratio
Interval 1.1 to 1.6
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 33F (Unique to V114)
|
5.4 Ratio
Interval 4.9 to 5.9
|
1.0 Ratio
Interval 0.8 to 1.1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 3 (Shared)
|
4.1 Ratio
Interval 3.8 to 4.3
|
3.6 Ratio
Interval 3.2 to 4.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 4 (Shared)
|
8.0 Ratio
Interval 7.4 to 8.6
|
16.2 Ratio
Interval 14.3 to 18.4
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 5 (Shared)
|
4.3 Ratio
Interval 4.0 to 4.7
|
5.2 Ratio
Interval 4.5 to 6.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 6A (Shared)
|
35.5 Ratio
Interval 32.5 to 38.8
|
31.3 Ratio
Interval 26.7 to 36.6
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 6B (Shared)
|
40.5 Ratio
Interval 37.1 to 44.2
|
28.0 Ratio
Interval 24.2 to 32.4
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 7F (Shared)
|
12.2 Ratio
Interval 11.3 to 13.2
|
16.9 Ratio
Interval 14.8 to 19.3
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 9V (Shared)
|
10.6 Ratio
Interval 9.8 to 11.4
|
12.8 Ratio
Interval 11.3 to 14.5
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 14 (Shared)
|
11.3 Ratio
Interval 10.3 to 12.5
|
11.5 Ratio
Interval 9.7 to 13.7
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 18C (Shared)
|
30.5 Ratio
Interval 28.0 to 33.1
|
20.0 Ratio
Interval 17.2 to 23.2
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 19A (Shared)
|
11.1 Ratio
Interval 10.2 to 12.0
|
14.0 Ratio
Interval 12.2 to 16.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 19F (Shared)
|
14.4 Ratio
Interval 13.2 to 15.7
|
15.3 Ratio
Interval 13.1 to 17.7
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 23F (Shared)
|
26.5 Ratio
Interval 24.2 to 29.0
|
22.0 Ratio
Interval 19.0 to 25.5
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 22F (Unique to V114)
|
11.4 Ratio
Interval 10.4 to 12.6
|
1.0 Ratio
Interval 1.0 to 1.1
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 33F (Unique to V114)
|
8.3 Ratio
Interval 7.7 to 8.9
|
1.0 Ratio
Interval 1.0 to 1.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 1 (Shared)
|
12.2 Ratio
Interval 11.3 to 13.2
|
15.7 Ratio
Interval 13.9 to 17.8
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 1 (Shared)
|
83.9 Percentage of Participants
Interval 81.5 to 86.1
|
81.4 Percentage of Participants
Interval 76.8 to 85.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 3 (Shared)
|
62.2 Percentage of Participants
Interval 59.1 to 65.3
|
56.8 Percentage of Participants
Interval 51.3 to 62.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 4 (Shared)
|
79.0 Percentage of Participants
Interval 76.4 to 81.5
|
87.8 Percentage of Participants
Interval 83.8 to 91.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 5 (Shared)
|
83.4 Percentage of Participants
Interval 81.0 to 85.7
|
84.9 Percentage of Participants
Interval 80.6 to 88.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 6A (Shared)
|
87.5 Percentage of Participants
Interval 85.1 to 89.6
|
85.2 Percentage of Participants
Interval 80.7 to 89.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 6B (Shared)
|
84.7 Percentage of Participants
Interval 82.3 to 86.9
|
83.8 Percentage of Participants
Interval 79.4 to 87.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 7F (Shared)
|
56.8 Percentage of Participants
Interval 53.6 to 60.0
|
64.5 Percentage of Participants
Interval 58.9 to 69.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 9V (Shared)
|
51.5 Percentage of Participants
Interval 48.3 to 54.7
|
55.4 Percentage of Participants
Interval 49.0 to 60.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 14 (Shared)
|
59.8 Percentage of Participants
Interval 56.7 to 62.9
|
60.4 Percentage of Participants
Interval 54.9 to 65.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 18C (Shared)
|
84.5 Percentage of Participants
Interval 82.1 to 86.7
|
75.8 Percentage of Participants
Interval 70.8 to 80.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 19A (Shared)
|
72.1 Percentage of Participants
Interval 69.2 to 74.9
|
75.2 Percentage of Participants
Interval 70.1 to 79.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 19F (Shared)
|
64.3 Percentage of Participants
Interval 61.2 to 67.3
|
65.7 Percentage of Participants
Interval 60.2 to 70.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 23F (Shared)
|
78.7 Percentage of Participants
Interval 76.0 to 81.3
|
77.7 Percentage of Participants
Interval 72.7 to 82.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 22F (Unique to V114)
|
58.9 Percentage of Participants
Interval 55.5 to 62.1
|
15.5 Percentage of Participants
Interval 11.5 to 20.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 33F (Unique to V114)
|
52.9 Percentage of Participants
Interval 49.7 to 56.1
|
3.1 Percentage of Participants
Interval 1.5 to 5.6
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 1 (Shared)
|
81.2 Percentage of Participants
Interval 78.7 to 83.6
|
86.4 Percentage of Participants
Interval 82.3 to 89.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 4 (Shared)
|
70.1 Percentage of Participants
Interval 67.2 to 73.0
|
86.1 Percentage of Participants
Interval 81.9 to 89.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 5 (Shared)
|
44.1 Percentage of Participants
Interval 41.0 to 47.2
|
50.4 Percentage of Participants
Interval 45.0 to 55.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 6A (Shared)
|
93.3 Percentage of Participants
Interval 91.6 to 94.8
|
88.2 Percentage of Participants
Interval 84.2 to 91.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 6B (Shared)
|
93.4 Percentage of Participants
Interval 91.7 to 94.9
|
90.5 Percentage of Participants
Interval 86.9 to 93.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 7F (Shared)
|
79.3 Percentage of Participants
Interval 76.7 to 81.8
|
86.4 Percentage of Participants
Interval 82.3 to 89.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 9V (Shared)
|
76.5 Percentage of Participants
Interval 73.8 to 79.1
|
84.0 Percentage of Participants
Interval 79.7 to 87.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 14 (Shared)
|
70.8 Percentage of Participants
Interval 67.9 to 73.6
|
68.6 Percentage of Participants
Interval 63.4 to 73.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 18C (Shared)
|
91.1 Percentage of Participants
Interval 89.1 to 92.8
|
87.3 Percentage of Participants
Interval 83.2 to 90.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 19A (Shared)
|
75.3 Percentage of Participants
Interval 72.5 to 77.9
|
82.0 Percentage of Participants
Interval 77.4 to 85.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 19F (Shared)
|
80.0 Percentage of Participants
Interval 77.4 to 82.4
|
80.8 Percentage of Participants
Interval 76.2 to 84.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 23F (Shared)
|
89.2 Percentage of Participants
Interval 87.1 to 91.0
|
87.6 Percentage of Participants
Interval 83.6 to 90.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 22F (Unique to V114)
|
73.1 Percentage of Participants
Interval 70.2 to 75.8
|
1.5 Percentage of Participants
Interval 0.5 to 3.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 33F (Unique to V114)
|
70.0 Percentage of Participants
Interval 67.1 to 72.8
|
0.3 Percentage of Participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Serotype 3 (Shared)
|
44.8 Percentage of Participants
Interval 41.7 to 48.0
|
41.1 Percentage of Participants
Interval 35.8 to 46.6
|
SECONDARY outcome
Timeframe: Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 1 (Shared)
|
266.6 Titers
Interval 243.6 to 291.8
|
214.4 Titers
Interval 180.7 to 254.5
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 3 (Shared)
|
211.0 Titers
Interval 195.2 to 228.1
|
208.0 Titers
Interval 179.7 to 240.7
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 4 (Shared)
|
1734.5 Titers
Interval 1620.7 to 1856.4
|
1980.6 Titers
Interval 1771.3 to 2214.6
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 5 (Shared)
|
595.1 Titers
Interval 544.5 to 650.5
|
626.7 Titers
Interval 531.7 to 738.7
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 6A (Shared)
|
5810.3 Titers
Interval 5366.9 to 6290.3
|
5739.9 Titers
Interval 4974.4 to 6623.1
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 6B (Shared)
|
5215.2 Titers
Interval 4863.6 to 5592.2
|
4412.4 Titers
Interval 3892.8 to 5001.5
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 7F (Shared)
|
6070.5 Titers
Interval 5699.7 to 6465.6
|
6223.9 Titers
Interval 5595.3 to 6923.0
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 9V (Shared)
|
3133.1 Titers
Interval 2918.4 to 3363.7
|
3364.1 Titers
Interval 2972.2 to 3807.6
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 14 (Shared)
|
5644.9 Titers
Interval 5262.5 to 6055.2
|
5317.6 Titers
Interval 4686.1 to 6034.1
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 18C (Shared)
|
3260.6 Titers
Interval 3057.3 to 3477.5
|
2294.4 Titers
Interval 2052.5 to 2564.8
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 19A (Shared)
|
4336.2 Titers
Interval 4038.6 to 4655.6
|
4286.4 Titers
Interval 3838.6 to 4786.4
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 33F (Unique to V114)
|
11356.6 Titers
Interval 10492.4 to 12291.9
|
16053.2 Titers
Interval 13688.1 to 18827.1
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 19F (Shared)
|
3198.6 Titers
Interval 3011.0 to 3397.8
|
3085.4 Titers
Interval 2770.7 to 3435.9
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 23F (Shared)
|
3057.3 Titers
Interval 2823.0 to 3311.0
|
2896.0 Titers
Interval 2494.1 to 3362.7
|
|
Geometric Mean Titer of Serotype-specific OPA at Month 7
Serotype 22F (Unique to V114)
|
3624.0 Titers
Interval 3384.5 to 3880.3
|
4060.2 Titers
Interval 3358.6 to 4908.4
|
SECONDARY outcome
Timeframe: Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 1 (Shared)
|
2.91 µg/mL
Interval 2.71 to 3.12
|
3.42 µg/mL
Interval 3.02 to 3.87
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 3 (Shared)
|
0.66 µg/mL
Interval 0.62 to 0.71
|
0.68 µg/mL
Interval 0.61 to 0.76
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 4 (Shared)
|
1.33 µg/mL
Interval 1.23 to 1.44
|
1.77 µg/mL
Interval 1.55 to 2.02
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 5 (Shared)
|
3.45 µg/mL
Interval 3.17 to 3.75
|
3.92 µg/mL
Interval 3.37 to 4.56
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 18C (Shared)
|
5.50 µg/mL
Interval 5.07 to 5.98
|
4.24 µg/mL
Interval 3.71 to 4.84
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 19A (Shared)
|
11.26 µg/mL
Interval 10.47 to 12.11
|
12.04 µg/mL
Interval 10.57 to 13.72
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 33F (Unique to V114)
|
5.98 µg/mL
Interval 5.5 to 6.5
|
8.66 µg/mL
Interval 7.31 to 10.26
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 6A (Shared)
|
4.25 µg/mL
Interval 3.84 to 4.69
|
4.88 µg/mL
Interval 4.08 to 5.85
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 6B (Shared)
|
6.79 µg/mL
Interval 6.15 to 7.49
|
6.04 µg/mL
Interval 5.08 to 7.19
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 7F (Shared)
|
3.46 µg/mL
Interval 3.36 to 3.94
|
4.07 µg/mL
Interval 3.54 to 4.68
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 9V (Shared)
|
3.18 µg/mL
Interval 2.96 to 3.43
|
3.61 µg/mL
Interval 3.17 to 4.12
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 14 (Shared)
|
14.28 µg/mL
Interval 13.13 to 15.53
|
14.59 µg/mL
Interval 12.64 to 16.85
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 19F (Shared)
|
9.07 µg/mL
Interval 8.45 to 9.74
|
8.81 µg/mL
Interval 7.74 to 10.02
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 23F (Shared)
|
5.42 µg/mL
Interval 4.98 to 5.89
|
4.96 µg/mL
Interval 4.25 to 5.81
|
|
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Serotype 22F (Unique to V114)
|
4.85 µg/mL
Interval 4.5 to 5.23
|
4.76 µg/mL
Interval 4.01 to 5.65
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 6A (Shared)
|
9.6 Ratio
Interval 8.7 to 10.5
|
11.0 Ratio
Interval 9.3 to 13.0
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 6B (Shared)
|
16.6 Ratio
Interval 14.7 to 18.7
|
15.7 Ratio
Interval 12.8 to 19.2
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 7F (Shared)
|
7.7 Ratio
Interval 6.9 to 8.6
|
8.2 Ratio
Interval 6.7 to 9.9
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 9V (Shared)
|
4.5 Ratio
Interval 4.2 to 4.9
|
4.9 Ratio
Interval 4.2 to 5.7
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 14 (Shared)
|
9.2 Ratio
Interval 8.2 to 10.3
|
8.0 Ratio
Interval 6.6 to 9.7
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 1 (Shared)
|
22.6 Ratio
Interval 20.6 to 24.8
|
17.4 Ratio
Interval 14.8 to 20.5
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 3 (Shared)
|
6.1 Ratio
Interval 5.6 to 6.6
|
6.4 Ratio
Interval 5.6 to 7.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 4 (Shared)
|
21.6 Ratio
Interval 19.5 to 23.9
|
25.6 Ratio
Interval 21.7 to 30.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 5 (Shared)
|
17.8 Ratio
Interval 16.3 to 19.3
|
18.3 Ratio
Interval 15.8 to 21.1
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 18C (Shared)
|
11.1 Ratio
Interval 10.2 to 12.2
|
9.1 Ratio
Interval 7.9 to 10.5
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 19A (Shared)
|
9.6 Ratio
Interval 8.6 to 10.6
|
9.7 Ratio
Interval 8.1 to 11.6
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 19F (Shared)
|
6.9 Ratio
Interval 6.3 to 7.6
|
7.1 Ratio
Interval 6.1 to 8.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 23F (Shared)
|
14.0 Ratio
Interval 12.4 to 15.7
|
12.6 Ratio
Interval 10.3 to 15.4
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 22F (Unique to V114)
|
12.1 Ratio
Interval 10.4 to 14.3
|
16.6 Ratio
Interval 12.2 to 22.6
|
|
GMFR in Serotype-specific OPA Day 1 to Month 7
Serotype 33F (Unique to V114)
|
5.1 Ratio
Interval 4.6 to 5.7
|
6.6 Ratio
Interval 5.5 to 8.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 1 (Shared)
|
10.1 Ratio
Interval 9.4 to 10.8
|
11.4 Ratio
Interval 10.1 to 12.8
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 3 (Shared)
|
3.5 Ratio
Interval 3.3 to 3.7
|
3.8 Ratio
Interval 3.4 to 4.2
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 4 (Shared)
|
7.1 Ratio
Interval 6.7 to 7.6
|
10.7 Ratio
Interval 9.5 to 12.0
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 5 (Shared)
|
4.3 Ratio
Interval 4.0 to 4.6
|
4.6 Ratio
Interval 4.1 to 5.2
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 6A (Shared)
|
12.3 Ratio
Interval 11.3 to 13.4
|
13.9 Ratio
Interval 12.0 to 16.1
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 6B (Shared)
|
15.3 Ratio
Interval 14.1 to 16.6
|
14.9 Ratio
Interval 13.0 to 17.0
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 7F (Shared)
|
8.7 Ratio
Interval 8.1 to 9.3
|
10.1 Ratio
Interval 9.0 to 11.3
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 9V (Shared)
|
7.6 Ratio
Interval 7.1 to 8.1
|
8.5 Ratio
Interval 7.6 to 9.5
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 14 (Shared)
|
10.3 Ratio
Interval 9.4 to 11.3
|
10.0 Ratio
Interval 8.5 to 11.8
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 18C (Shared)
|
11.5 Ratio
Interval 10.7 to 12.4
|
9.3 Ratio
Interval 8.2 to 10.4
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 19F (Shared)
|
9.0 Ratio
Interval 8.3 to 9.7
|
9.8 Ratio
Interval 8.6 to 11.2
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 23F (Shared)
|
10.8 Ratio
Interval 9.9 to 11.7
|
10.3 Ratio
Interval 9.0 to 11.7
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 22F (Unique to V114)
|
8.9 Ratio
Interval 8.1 to 9.7
|
8.9 Ratio
Interval 7.5 to 10.7
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 19A (Shared)
|
6.4 Ratio
Interval 6.0 to 6.9
|
7.5 Ratio
Interval 6.7 to 8.5
|
|
GMFR in Serotype-specific IgG Day 1 to Month 7
Serotype 33F (Unique to V114)
|
6.4 Ratio
Interval 6.0 to 6.9
|
9.6 Ratio
Interval 8.4 to 11.1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 1 (Shared)
|
87.7 Percentage of Participants
Interval 85.2 to 89.8
|
83.7 Percentage of Participants
Interval 78.8 to 87.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 3 (Shared)
|
66.5 Percentage of Participants
Interval 63.1 to 69.7
|
66.7 Percentage of Participants
Interval 60.7 to 72.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 4 (Shared)
|
84.3 Percentage of Participants
Interval 81.6 to 86.7
|
86.4 Percentage of Participants
Interval 81.8 to 90.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 5 (Shared)
|
86.8 Percentage of Participants
Interval 84.3 to 89.0
|
87.1 Percentage of Participants
Interval 82.6 to 90.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 6A (Shared)
|
73.5 Percentage of Participants
Interval 70.2 to 76.6
|
80.2 Percentage of Participants
Interval 74.6 to 84.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 6B (Shared)
|
75.8 Percentage of Participants
Interval 72.7 to 78.7
|
74.4 Percentage of Participants
Interval 68.7 to 79.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 7F (Shared)
|
59.8 Percentage of Participants
Interval 56.3 to 63.3
|
60.2 Percentage of Participants
Interval 54.0 to 66.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 14 (Shared)
|
64.9 Percentage of Participants
Interval 61.5 to 68.2
|
58.9 Percentage of Participants
Interval 52.8 to 64.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 18C (Shared)
|
77.5 Percentage of Participants
Interval 74.5 to 80.4
|
76.2 Percentage of Participants
Interval 70.7 to 81.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 19A (Shared)
|
68.2 Percentage of Participants
Interval 64.9 to 71.4
|
70.5 Percentage of Participants
Interval 64.7 to 75.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 19F (Shared)
|
61.0 Percentage of Participants
Interval 57.6 to 64.4
|
62.9 Percentage of Participants
Interval 56.8 to 68.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 23F (Shared)
|
73.5 Percentage of Participants
Interval 70.2 to 76.5
|
71.9 Percentage of Participants
Interval 66.0 to 77.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 22F (Unique to V114)
|
59.0 Percentage of Participants
Interval 55.4 to 62.6
|
65.4 Percentage of Participants
Interval 59.2 to 71.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 9V (Shared)
|
50.5 Percentage of Participants
Interval 47.0 to 54.0
|
52.4 Percentage of Participants
Interval 46.3 to 58.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Serotype 33F (Unique to V114)
|
53.3 Percentage of Participants
Interval 49.8 to 56.8
|
60.8 Percentage of Participants
Interval 54.7 to 66.6
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 3 (Shared)
|
40.7 Percentage of Participants
Interval 37.3 to 44.1
|
46.1 Percentage of Participants
Interval 40.1 to 52.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 4 (Shared)
|
71.2 Percentage of Participants
Interval 68.0 to 74.3
|
82.0 Percentage of Participants
Interval 77.0 to 86.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 5 (Shared)
|
48.7 Percentage of Participants
Interval 45.3 to 52.2
|
51.8 Percentage of Participants
Interval 45.8 to 57.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 6A (Shared)
|
81.6 Percentage of Participants
Interval 78.8 to 84.2
|
81.8 Percentage of Participants
Interval 76.8 to 86.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 6B (Shared)
|
86.4 Percentage of Participants
Interval 83.9 to 88.7
|
85.4 Percentage of Participants
Interval 80.7 to 89.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 9V (Shared)
|
71.8 Percentage of Participants
Interval 68.6 to 74.8
|
77.1 Percentage of Participants
Interval 71.8 to 81.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 14 (Shared)
|
76.7 Percentage of Participants
Interval 73.7 to 79.5
|
70.7 Percentage of Participants
Interval 65.0 to 76.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 18C (Shared)
|
82.7 Percentage of Participants
Interval 80.0 to 85.2
|
80.4 Percentage of Participants
Interval 75.2 to 84.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 19A (Shared)
|
65.8 Percentage of Participants
Interval 62.5 to 69.0
|
74.6 Percentage of Participants
Interval 69.1 to 79.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 19F (Shared)
|
74.5 Percentage of Participants
Interval 71.4 to 77.5
|
78.9 Percentage of Participants
Interval 73.7 to 83.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 23F (Shared)
|
77.8 Percentage of Participants
Interval 74.8 to 80.6
|
78.1 Percentage of Participants
Interval 72.8 to 82.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 22F (Unique to V114)
|
68.8 Percentage of Participants
Interval 65.5 to 71.9
|
65.7 Percentage of Participants
Interval 59.8 to 71.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 33F (Unique to V114)
|
68.2 Percentage of Participants
Interval 64.9 to 71.3
|
75.7 Percentage of Participants
Interval 70.3 to 80.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 1 (Shared)
|
81.4 Percentage of Participants
Interval 78.6 to 84.0
|
83.6 Percentage of Participants
Interval 78.7 to 87.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Serotype 7F (Shared)
|
77.4 Percentage of Participants
Interval 74.4 to 80.2
|
84.3 Percentage of Participants
Interval 79.5 to 88.3
|
SECONDARY outcome
Timeframe: Month 6 (Baseline before Vaccination 2) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 3 (Shared)
|
2.0 Ratio
Interval 1.9 to 2.1
|
2.4 Ratio
Interval 2.2 to 2.7
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 4 (Shared)
|
2.7 Ratio
Interval 2.5 to 2.9
|
1.7 Ratio
Interval 1.5 to 1.9
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 5 (Shared)
|
2.7 Ratio
Interval 2.5 to 2.9
|
2.1 Ratio
Interval 1.9 to 2.4
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 6A (Shared)
|
1.0 Ratio
Interval 1.0 to 1.1
|
1.1 Ratio
Interval 1.0 to 1.2
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 6B (Shared)
|
1.1 Ratio
Interval 1.1 to 1.2
|
1.2 Ratio
Interval 1.1 to 1.4
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 7F (Shared)
|
1.9 Ratio
Interval 1.8 to 2.0
|
1.4 Ratio
Interval 1.3 to 1.6
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 9V (Shared)
|
1.6 Ratio
Interval 1.5 to 1.7
|
1.5 Ratio
Interval 1.4 to 1.7
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 14 (Shared)
|
2.0 Ratio
Interval 1.8 to 2.1
|
1.5 Ratio
Interval 1.3 to 1.6
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 18C (Shared)
|
1.3 Ratio
Interval 1.3 to 1.4
|
1.6 Ratio
Interval 1.4 to 1.7
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 19A (Shared)
|
1.7 Ratio
Interval 1.6 to 1.8
|
1.5 Ratio
Interval 1.4 to 1.7
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 19F (Shared)
|
1.9 Ratio
Interval 1.8 to 2.0
|
1.6 Ratio
Interval 1.5 to 1.8
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 23F (Shared)
|
1.3 Ratio
Interval 1.2 to 1.4
|
1.4 Ratio
Interval 1.2 to 1.6
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 22F (Unique to V114)
|
1.8 Ratio
Interval 1.7 to 1.9
|
9.6 Ratio
Interval 7.1 to 13.0
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 33F (Unique to V114)
|
1.6 Ratio
Interval 1.5 to 1.8
|
6.5 Ratio
Interval 5.5 to 7.6
|
|
GMFR in Serotype-specific OPA Month 6 to Month 7
Serotype 1 (Shared)
|
3.2 Ratio
Interval 2.9 to 3.5
|
2.0 Ratio
Interval 1.7 to 2.2
|
SECONDARY outcome
Timeframe: Month 6 (Baseline before Vaccination 2) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
IgG for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 1 (Shared)
|
2.1 Ratio
Interval 2.0 to 2.2
|
1.5 Ratio
Interval 1.4 to 1.7
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 3 (Shared)
|
1.7 Ratio
Interval 1.6 to 1.7
|
2.0 Ratio
Interval 1.8 to 2.1
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 6B (Shared)
|
1.1 Ratio
Interval 1.0 to 1.1
|
1.2 Ratio
Interval 1.2 to 1.3
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 7F (Shared)
|
1.7 Ratio
Interval 1.6 to 1.8
|
1.4 Ratio
Interval 1.3 to 1.5
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 9V (Shared)
|
1.5 Ratio
Interval 1.5 to 1.6
|
1.4 Ratio
Interval 1.3 to 1.5
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 14 (Shared)
|
1.7 Ratio
Interval 1.6 to 1.8
|
1.4 Ratio
Interval 1.3 to 1.5
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 18C (Shared)
|
1.1 Ratio
Interval 1.0 to 1.1
|
1.1 Ratio
Interval 1.1 to 1.2
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 19A (Shared)
|
1.4 Ratio
Interval 1.3 to 1.4
|
1.4 Ratio
Interval 1.3 to 1.4
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 4 (Shared)
|
2.0 Ratio
Interval 1.9 to 2.1
|
1.6 Ratio
Interval 1.5 to 1.7
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 5 (Shared)
|
1.9 Ratio
Interval 1.8 to 1.9
|
1.5 Ratio
Interval 1.4 to 1.6
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 6A (Shared)
|
1.0 Ratio
Interval 1.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.1
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 19F (Shared)
|
1.6 Ratio
Interval 1.6 to 1.7
|
1.6 Ratio
Interval 1.5 to 1.7
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 23F (Shared)
|
1.1 Ratio
Interval 1.1 to 1.2
|
1.2 Ratio
Interval 1.1 to 1.2
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 22F (Unique to V114)
|
1.8 Ratio
Interval 1.7 to 1.9
|
8.8 Ratio
Interval 7.4 to 10.4
|
|
GMFR in Serotype-specific IgG Month 6 to Month 7
Serotype 33F (Unique to V114)
|
1.6 Ratio
Interval 1.6 to 1.7
|
9.9 Ratio
Interval 8.6 to 11.3
|
SECONDARY outcome
Timeframe: Month 6 (Baseline before Vaccination 2) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 1 (Shared)
|
40.2 Percentage of Participants
Interval 36.8 to 43.6
|
21.4 Percentage of Participants
Interval 16.8 to 26.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 3 (Shared)
|
19.2 Percentage of Participants
Interval 16.6 to 22.1
|
25.5 Percentage of Participants
Interval 20.5 to 31.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 4 (Shared)
|
30.8 Percentage of Participants
Interval 27.7 to 34.1
|
14.9 Percentage of Participants
Interval 11.0 to 19.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 5 (Shared)
|
32.5 Percentage of Participants
Interval 29.3 to 35.8
|
23.0 Percentage of Participants
Interval 18.3 to 28.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 6A (Shared)
|
3.9 Percentage of Participants
Interval 2.7 to 5.5
|
5.9 Percentage of Participants
Interval 3.4 to 9.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 6B (Shared)
|
4.6 Percentage of Participants
Interval 3.3 to 6.3
|
6.4 Percentage of Participants
Interval 3.9 to 10.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 7F (Shared)
|
14.6 Percentage of Participants
Interval 12.3 to 17.2
|
7.5 Percentage of Participants
Interval 4.7 to 11.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 9V (Shared)
|
11.9 Percentage of Participants
Interval 9.7 to 14.2
|
10.4 Percentage of Participants
Interval 7.1 to 14.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 14 (Shared)
|
17.8 Percentage of Participants
Interval 15.3 to 20.6
|
8.6 Percentage of Participants
Interval 5.6 to 12.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 18C (Shared)
|
5.4 Percentage of Participants
Interval 3.9 to 7.1
|
14.3 Percentage of Participants
Interval 10.4 to 19.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 19A (Shared)
|
15.9 Percentage of Participants
Interval 13.5 to 18.6
|
12.1 Percentage of Participants
Interval 8.5 to 16.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 19F (Shared)
|
17.7 Percentage of Participants
Interval 15.2 to 20.4
|
12.9 Percentage of Participants
Interval 9.2 to 17.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 23F (Shared)
|
9.2 Percentage of Participants
Interval 7.3 to 11.4
|
11.4 Percentage of Participants
Interval 7.9 to 15.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 22F (Unique to V114)
|
16.7 Percentage of Participants
Interval 14.2 to 19.4
|
52.6 Percentage of Participants
Interval 46.2 to 58.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
Serotype 33F (Unique to V114)
|
15.8 Percentage of Participants
Interval 13.4 to 18.5
|
62.6 Percentage of Participants
Interval 56.6 to 68.3
|
SECONDARY outcome
Timeframe: Month 6 (Baseline before Vaccination 2) and Month 7Population: The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=1133 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=379 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 1 (Shared)
|
16.4 Percentage of Participants
Interval 13.9 to 19.0
|
8.2 Percentage of Participants
Interval 5.2 to 12.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 3 (Shared)
|
6.3 Percentage of Participants
Interval 4.8 to 8.2
|
13.8 Percentage of Participants
Interval 10.0 to 18.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 4 (Shared)
|
15.2 Percentage of Participants
Interval 12.9 to 17.8
|
7.5 Percentage of Participants
Interval 4.7 to 11.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 5 (Shared)
|
12.1 Percentage of Participants
Interval 10.0 to 14.5
|
5.7 Percentage of Participants
Interval 3.3 to 9.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 6A (Shared)
|
0.6 Percentage of Participants
Interval 0.2 to 1.4
|
1.1 Percentage of Participants
Interval 0.2 to 3.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 6B (Shared)
|
0.7 Percentage of Participants
Interval 0.3 to 1.5
|
2.8 Percentage of Participants
Interval 1.2 to 5.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 7F (Shared)
|
8.4 Percentage of Participants
Interval 6.6 to 10.5
|
4.3 Percentage of Participants
Interval 2.2 to 7.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 9V (Shared)
|
6.3 Percentage of Participants
Interval 4.8 to 8.2
|
3.9 Percentage of Participants
Interval 2.0 to 6.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 14 (Shared)
|
9.8 Percentage of Participants
Interval 7.9 to 12.1
|
3.9 Percentage of Participants
Interval 2.0 to 6.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 18C (Shared)
|
0.6 Percentage of Participants
Interval 0.2 to 1.4
|
0.7 Percentage of Participants
Interval 0.1 to 2.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 19A (Shared)
|
3.4 Percentage of Participants
Interval 2.3 to 4.9
|
4.3 Percentage of Participants
Interval 2.2 to 7.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 19F (Shared)
|
8.1 Percentage of Participants
Interval 6.3 to 10.1
|
6.4 Percentage of Participants
Interval 3.8 to 9.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 23F (Shared)
|
0.5 Percentage of Participants
Interval 0.1 to 1.2
|
1.1 Percentage of Participants
Interval 0.2 to 3.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 22F (Unique to V114)
|
10.2 Percentage of Participants
Interval 8.2 to 12.4
|
64.9 Percentage of Participants
Interval 59.0 to 70.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
Serotype 33F (Unique to V114)
|
7.5 Percentage of Participants
Interval 5.8 to 9.5
|
75.9 Percentage of Participants
Interval 70.5 to 80.8
|
Adverse Events
V114
Serious events: 49 serious events
Other events: 934 other events
Deaths: 4 deaths
Prevnar 13™
Serious events: 12 serious events
Other events: 298 other events
Deaths: 2 deaths
V114 (Post-PNEUMOVAX™23)
Serious events: 3 serious events
Other events: 771 other events
Deaths: 0 deaths
Prevnar 13™ (Post-PNEUMOVAX™23)
Serious events: 3 serious events
Other events: 258 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=1134 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=378 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
V114 (Post-PNEUMOVAX™23)
n=1036 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™ (Post-PNEUMOVAX™23)
n=345 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Endocrine disorders
Diabetes insipidus
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Endocrine disorders
Goitre
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Gastrointestinal disorders
Ascites
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
General disorders
Chest pain
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.29%
1/345 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.18%
2/1134 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Immune system disorders
Anaphylactic reaction
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Groin abscess
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Haematoma infection
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Influenza
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Localised infection
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Meningitis
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Periorbital cellulitis
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Perirectal abscess
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Peritonsillitis
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Pyelonephritis
|
0.18%
2/1134 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
1/1134 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.18%
2/1134 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
Migraine
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.26%
3/1134 • Number of events 3 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.10%
1/1036 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Psychiatric disorders
Completed suicide
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.26%
1/378 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Psychiatric disorders
Suicide attempt
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.18%
2/1134 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
2/1134 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Social circumstances
Physical assault
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Vascular disorders
Hypertensive urgency
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Vascular disorders
Hypotension
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.10%
1/1036 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.29%
1/345 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.29%
1/345 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1134 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.10%
1/1036 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
|
Cardiac disorders
Cardiac Arrest
|
0.09%
1/1134 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/378 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/1036 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
0.00%
0/345 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
Other adverse events
| Measure |
V114
n=1134 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™
n=378 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
V114 (Post-PNEUMOVAX™23)
n=1036 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
|
Prevnar 13™ (Post-PNEUMOVAX™23)
n=345 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
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General disorders
Fatigue
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34.3%
389/1134 • Number of events 510 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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36.8%
139/378 • Number of events 186 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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30.1%
312/1036 • Number of events 366 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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30.7%
106/345 • Number of events 139 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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General disorders
Injection site erythema
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15.3%
174/1134 • Number of events 180 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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14.8%
56/378 • Number of events 57 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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22.7%
235/1036 • Number of events 237 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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25.5%
88/345 • Number of events 91 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
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General disorders
Injection site pain
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76.3%
865/1134 • Number of events 931 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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68.8%
260/378 • Number of events 292 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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68.9%
714/1036 • Number of events 762 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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67.0%
231/345 • Number of events 252 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
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General disorders
Injection site swelling
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22.1%
251/1134 • Number of events 257 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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22.2%
84/378 • Number of events 84 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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29.4%
305/1036 • Number of events 307 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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32.8%
113/345 • Number of events 113 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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Musculoskeletal and connective tissue disorders
Arthralgia
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12.7%
144/1134 • Number of events 180 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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11.6%
44/378 • Number of events 63 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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12.0%
124/1036 • Number of events 130 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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11.0%
38/345 • Number of events 47 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
|
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Musculoskeletal and connective tissue disorders
Myalgia
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28.8%
327/1134 • Number of events 377 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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26.5%
100/378 • Number of events 113 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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24.1%
250/1036 • Number of events 260 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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25.5%
88/345 • Number of events 99 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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Nervous system disorders
Headache
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26.5%
300/1134 • Number of events 425 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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24.9%
94/378 • Number of events 122 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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21.2%
220/1036 • Number of events 274 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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21.2%
73/345 • Number of events 93 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER