Trial Outcomes & Findings for Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020) (NCT NCT03950856)
NCT ID: NCT03950856
Last Updated: 2021-04-12
Results Overview
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2340 participants
Primary outcome timeframe
Up to Day 5
Results posted on
2021-04-12
Participant Flow
Healthy males or females ≥50 years of age without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine were enrolled in this study.
Participant milestones
| Measure |
V114 Lot 1
Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
702
|
704
|
701
|
233
|
|
Overall Study
Vaccinated
|
698
|
704
|
700
|
231
|
|
Overall Study
COMPLETED
|
683
|
689
|
683
|
227
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
18
|
6
|
Reasons for withdrawal
| Measure |
V114 Lot 1
Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
8
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
3
|
1
|
|
Overall Study
Unable to phone
|
7
|
6
|
7
|
2
|
Baseline Characteristics
Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)
Baseline characteristics by cohort
| Measure |
V114 Lot 1
n=702 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=701 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
n=233 Participants
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
Total
n=2340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.4 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
64.4 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
64.3 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
64.4 Years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
387 Participants
n=5 Participants
|
422 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
1346 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
315 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
994 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
131 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
464 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
560 Participants
n=5 Participants
|
540 Participants
n=7 Participants
|
558 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
1848 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
644 Participants
n=5 Participants
|
621 Participants
n=7 Participants
|
628 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
2096 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Day 5Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Outcome measures
| Measure |
V114 Lot 1
n=699 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots
Injection site erythema
|
10.2 Percentage of participants
Interval 8.0 to 12.6
|
11.5 Percentage of participants
Interval 9.2 to 14.1
|
11.0 Percentage of participants
Interval 8.8 to 13.6
|
—
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots
Injection site pain
|
66.1 Percentage of participants
Interval 62.5 to 69.6
|
67.0 Percentage of participants
Interval 63.4 to 70.5
|
67.3 Percentage of participants
Interval 63.7 to 70.8
|
—
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots
Injection site swelling
|
15.6 Percentage of participants
Interval 13.0 to 18.5
|
15.8 Percentage of participants
Interval 13.2 to 18.7
|
14.7 Percentage of participants
Interval 12.2 to 17.6
|
—
|
PRIMARY outcome
Timeframe: Up to Day 5Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated.
Outcome measures
| Measure |
V114 Lot 1
n=2103 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=230 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Injection site pain
|
66.8 Percentage of participants
|
52.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Injection site erythema
|
10.9 Percentage of participants
|
9.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Injection site swelling
|
15.4 Percentage of participants
|
14.3 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Outcome measures
| Measure |
V114 Lot 1
n=699 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
Arthralgia
|
7.6 Percentage of participants
Interval 5.7 to 9.8
|
7.0 Percentage of participants
Interval 5.2 to 9.1
|
8.4 Percentage of participants
Interval 6.5 to 10.7
|
—
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
Fatigue
|
22.0 Percentage of participants
Interval 19.0 to 25.3
|
20.9 Percentage of participants
Interval 17.9 to 24.1
|
21.6 Percentage of participants
Interval 18.6 to 24.8
|
—
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
Headache
|
18.2 Percentage of participants
Interval 15.4 to 21.2
|
19.9 Percentage of participants
Interval 17.0 to 23.0
|
18.6 Percentage of participants
Interval 15.8 to 21.7
|
—
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
Myalgia
|
28.0 Percentage of participants
Interval 24.7 to 31.5
|
24.3 Percentage of participants
Interval 21.2 to 27.6
|
28.4 Percentage of participants
Interval 25.1 to 31.9
|
—
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated.
Outcome measures
| Measure |
V114 Lot 1
n=2103 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=230 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Arthralgia
|
7.7 Percentage of participants
|
5.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Fatigue
|
21.5 Percentage of participants
|
22.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Headache
|
18.9 Percentage of participants
|
18.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Myalgia
|
26.9 Percentage of participants
|
21.7 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 6Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Outcome measures
| Measure |
V114 Lot 1
n=699 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
—
|
PRIMARY outcome
Timeframe: Up to Month 6Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated.
Outcome measures
| Measure |
V114 Lot 1
n=2103 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=230 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Outcome measures
| Measure |
V114 Lot 1
n=698 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 6A
|
5845.0 1/dil
|
6077.6 1/dil
|
6123.8 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 23F
|
2222.9 1/dil
|
2417.8 1/dil
|
2133.0 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 1
|
248.5 1/dil
|
251.6 1/dil
|
239.4 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 3
|
198.3 1/dil
|
232.2 1/dil
|
214.4 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 4
|
1073.1 1/dil
|
1303.7 1/dil
|
1074.4 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 5
|
389.8 1/dil
|
461.6 1/dil
|
391.3 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 6B
|
5160.6 1/dil
|
5362.7 1/dil
|
5109.5 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 7F
|
3757.7 1/dil
|
4590.5 1/dil
|
4202.0 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 9V
|
1708.4 1/dil
|
1690.6 1/dil
|
1749.9 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 14
|
2364.8 1/dil
|
2509.6 1/dil
|
2050.6 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 18C
|
3880.8 1/dil
|
3522.4 1/dil
|
3381.0 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 19A
|
3384.7 1/dil
|
3774.8 1/dil
|
3498.5 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 19F
|
1866.4 1/dil
|
2017.8 1/dil
|
1993.2 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 22F
|
2617.4 1/dil
|
2761.6 1/dil
|
2676.0 1/dil
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Serotype 33F
|
7758.1 1/dil
|
7736.9 1/dil
|
7365.6 1/dil
|
—
|
SECONDARY outcome
Timeframe: Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Outcome measures
| Measure |
V114 Lot 1
n=698 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 7F
|
5.71 μg/mL
|
7.11 μg/mL
|
5.94 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 9V
|
4.20 μg/mL
|
4.44 μg/mL
|
4.26 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 14
|
9.82 μg/mL
|
11.38 μg/mL
|
8.66 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 18C
|
14.07 μg/mL
|
11.81 μg/mL
|
10.66 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 19A
|
15.45 μg/mL
|
17.34 μg/mL
|
15.81 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 19F
|
9.78 μg/mL
|
11.22 μg/mL
|
10.65 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 23F
|
7.38 μg/mL
|
7.97 μg/mL
|
7.44 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 22F
|
4.12 μg/mL
|
4.41 μg/mL
|
3.80 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 33F
|
9.92 μg/mL
|
10.88 μg/mL
|
9.45 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 1
|
3.91 μg/mL
|
4.05 μg/mL
|
3.83 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 3
|
0.74 μg/mL
|
0.86 μg/mL
|
0.73 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 4
|
1.79 μg/mL
|
2.18 μg/mL
|
1.67 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 5
|
3.81 μg/mL
|
4.63 μg/mL
|
3.96 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 6A
|
8.09 μg/mL
|
8.84 μg/mL
|
8.16 μg/mL
|
—
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Serotype 6B
|
10.92 μg/mL
|
11.46 μg/mL
|
10.44 μg/mL
|
—
|
SECONDARY outcome
Timeframe: Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated,
Outcome measures
| Measure |
V114 Lot 1
n=2102 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=231 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 1
|
3.91 μg/mL
|
5.22 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 19F
|
10.52 μg/mL
|
10.25 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 23F
|
7.58 μg/mL
|
6.03 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 3
|
0.77 μg/mL
|
0.55 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 4
|
1.87 μg/mL
|
2.38 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 5
|
4.14 μg/mL
|
4.66 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 6A
|
8.38 μg/mL
|
7.20 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 6B
|
10.92 μg/mL
|
7.28 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 7F
|
6.19 μg/mL
|
7.12 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 9V
|
4.30 μg/mL
|
4.97 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 14
|
9.89 μg/mL
|
9.97 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 18C
|
12.08 μg/mL
|
9.58 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 19A
|
16.18 μg/mL
|
16.66 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 22F
|
4.10 μg/mL
|
0.34 μg/mL
|
—
|
—
|
|
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Serotype 33F
|
10.03 μg/mL
|
1.07 μg/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Outcome measures
| Measure |
V114 Lot 1
n=698 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 5
|
11.2 Ratio
Interval 9.9 to 12.8
|
13.3 Ratio
Interval 11.8 to 15.1
|
11.1 Ratio
Interval 9.8 to 12.7
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 1
|
15.9 Ratio
Interval 13.9 to 18.2
|
16.5 Ratio
Interval 14.6 to 18.8
|
15.4 Ratio
Interval 13.6 to 17.4
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 3
|
6.5 Ratio
Interval 5.9 to 7.2
|
7.6 Ratio
Interval 6.8 to 8.4
|
6.9 Ratio
Interval 6.2 to 7.6
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 4
|
17.4 Ratio
Interval 15.4 to 19.8
|
20.7 Ratio
Interval 18.3 to 23.4
|
16.5 Ratio
Interval 14.6 to 18.7
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 6A
|
13.7 Ratio
Interval 12.1 to 15.5
|
14.1 Ratio
Interval 12.5 to 16.0
|
14.6 Ratio
Interval 12.8 to 16.5
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 6B
|
33.4 Ratio
Interval 29.0 to 38.5
|
31.2 Ratio
Interval 27.0 to 36.1
|
34.9 Ratio
Interval 30.2 to 40.3
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 7F
|
11.9 Ratio
Interval 10.4 to 13.7
|
14.3 Ratio
Interval 12.4 to 16.5
|
12.9 Ratio
Interval 11.3 to 14.8
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 9V
|
4.8 Ratio
Interval 4.4 to 5.3
|
4.8 Ratio
Interval 4.3 to 5.3
|
5.0 Ratio
Interval 4.5 to 5.6
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 14
|
7.6 Ratio
Interval 6.6 to 8.6
|
7.6 Ratio
Interval 6.7 to 8.7
|
6.2 Ratio
Interval 5.4 to 7.0
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 18C
|
16.7 Ratio
Interval 14.9 to 18.8
|
15.0 Ratio
Interval 13.4 to 16.8
|
14.1 Ratio
Interval 12.6 to 15.8
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 19A
|
10.4 Ratio
Interval 9.2 to 11.8
|
11.0 Ratio
Interval 9.6 to 12.5
|
11.7 Ratio
Interval 10.3 to 13.4
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 19F
|
6.5 Ratio
Interval 5.9 to 7.3
|
6.8 Ratio
Interval 6.1 to 7.6
|
7.3 Ratio
Interval 6.5 to 8.1
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 23F
|
16.8 Ratio
Interval 14.6 to 19.4
|
17.4 Ratio
Interval 15.2 to 20.0
|
17.0 Ratio
Interval 14.8 to 19.4
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 22F
|
27.2 Ratio
Interval 22.3 to 33.1
|
31.1 Ratio
Interval 25.6 to 38.0
|
28.3 Ratio
Interval 23.4 to 34.3
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 33F
|
8.4 Ratio
Interval 7.2 to 9.7
|
7.7 Ratio
Interval 6.6 to 8.9
|
7.5 Ratio
Interval 6.5 to 8.7
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Outcome measures
| Measure |
V114 Lot 1
n=698 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 7F
|
11.7 Ratio
Interval 10.5 to 13.1
|
14.8 Ratio
Interval 13.2 to 16.6
|
12.0 Ratio
Interval 10.7 to 13.3
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 9V
|
9.5 Ratio
Interval 8.6 to 10.5
|
9.8 Ratio
Interval 8.9 to 10.9
|
9.6 Ratio
Interval 8.6 to 10.6
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 1
|
10.9 Ratio
Interval 9.8 to 12.2
|
11.2 Ratio
Interval 10.1 to 12.4
|
10.3 Ratio
Interval 9.2 to 11.5
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 3
|
5.4 Ratio
Interval 4.9 to 5.9
|
6.3 Ratio
Interval 5.7 to 6.9
|
5.2 Ratio
Interval 4.8 to 5.7
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 4
|
8.6 Ratio
Interval 7.8 to 9.5
|
10.5 Ratio
Interval 9.5 to 11.6
|
7.9 Ratio
Interval 7.1 to 8.7
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 5
|
4.5 Ratio
Interval 4.1 to 5.0
|
5.5 Ratio
Interval 4.9 to 6.0
|
4.7 Ratio
Interval 4.2 to 5.2
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 6A
|
22.6 Ratio
Interval 20.1 to 25.3
|
24.1 Ratio
Interval 21.5 to 27.1
|
22.9 Ratio
Interval 20.4 to 25.8
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 6B
|
23.5 Ratio
Interval 21.0 to 26.3
|
24.1 Ratio
Interval 21.5 to 27.0
|
22.1 Ratio
Interval 19.7 to 24.8
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 14
|
6.5 Ratio
Interval 5.8 to 7.3
|
6.8 Ratio
Interval 6.1 to 7.7
|
5.2 Ratio
Interval 4.7 to 5.8
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 18C
|
20.6 Ratio
Interval 18.3 to 23.1
|
17.0 Ratio
Interval 15.1 to 19.1
|
15.9 Ratio
Interval 14.2 to 17.9
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 19A
|
9.1 Ratio
Interval 8.2 to 10.0
|
10.6 Ratio
Interval 9.6 to 11.7
|
9.5 Ratio
Interval 8.6 to 10.5
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 19F
|
12.3 Ratio
Interval 11.1 to 13.7
|
13.8 Ratio
Interval 12.5 to 15.4
|
13.1 Ratio
Interval 11.8 to 14.5
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 23F
|
14.3 Ratio
Interval 12.7 to 16.1
|
16.2 Ratio
Interval 14.4 to 18.1
|
14.8 Ratio
Interval 13.2 to 16.6
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 22F
|
12.8 Ratio
Interval 11.4 to 14.4
|
13.4 Ratio
Interval 11.8 to 15.1
|
11.1 Ratio
Interval 9.9 to 12.5
|
—
|
|
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 33F
|
9.2 Ratio
Interval 8.3 to 10.3
|
9.5 Ratio
Interval 8.6 to 10.6
|
7.9 Ratio
Interval 7.1 to 8.8
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Outcome measures
| Measure |
V114 Lot 1
n=698 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 1
|
74.4 Percentage of participants
Interval 70.9 to 77.7
|
76.8 Percentage of participants
Interval 73.4 to 79.9
|
77.2 Percentage of participants
Interval 73.8 to 80.3
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 3
|
64.7 Percentage of participants
Interval 61.0 to 68.3
|
68.9 Percentage of participants
Interval 65.2 to 72.4
|
64.8 Percentage of participants
Interval 61.1 to 68.5
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 4
|
79.4 Percentage of participants
Interval 76.1 to 82.4
|
83.6 Percentage of participants
Interval 80.5 to 86.3
|
79.5 Percentage of participants
Interval 76.2 to 82.5
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 5
|
71.3 Percentage of participants
Interval 67.7 to 74.7
|
76.1 Percentage of participants
Interval 72.7 to 79.3
|
69.5 Percentage of participants
Interval 65.8 to 73.0
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 6A
|
78.5 Percentage of participants
Interval 75.1 to 81.7
|
77.8 Percentage of participants
Interval 74.3 to 81.0
|
76.9 Percentage of participants
Interval 73.4 to 80.2
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 6B
|
83.3 Percentage of participants
Interval 80.2 to 86.1
|
83.6 Percentage of participants
Interval 80.5 to 86.3
|
84.5 Percentage of participants
Interval 81.5 to 87.2
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 7F
|
69.4 Percentage of participants
Interval 65.7 to 73.0
|
71.6 Percentage of participants
Interval 68.0 to 75.1
|
70.4 Percentage of participants
Interval 66.7 to 73.9
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 9V
|
53.4 Percentage of participants
Interval 49.5 to 57.3
|
51.2 Percentage of participants
Interval 47.3 to 55.1
|
53.2 Percentage of participants
Interval 49.3 to 57.1
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 14
|
56.8 Percentage of participants
Interval 52.9 to 60.6
|
57.6 Percentage of participants
Interval 53.7 to 61.4
|
52.3 Percentage of participants
Interval 48.4 to 56.1
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 18C
|
80.1 Percentage of participants
Interval 76.9 to 83.1
|
79.0 Percentage of participants
Interval 75.7 to 82.0
|
78.3 Percentage of participants
Interval 75.0 to 81.4
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 19A
|
67.8 Percentage of participants
Interval 64.1 to 71.4
|
69.8 Percentage of participants
Interval 66.2 to 73.3
|
71.2 Percentage of participants
Interval 67.6 to 74.7
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 19F
|
60.8 Percentage of participants
Interval 57.0 to 64.5
|
61.9 Percentage of participants
Interval 58.1 to 65.6
|
63.0 Percentage of participants
Interval 59.2 to 66.7
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 23F
|
75.4 Percentage of participants
Interval 71.7 to 78.7
|
78.3 Percentage of participants
Interval 74.8 to 81.4
|
78.2 Percentage of participants
Interval 74.8 to 81.4
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 22F
|
71.1 Percentage of participants
Interval 67.4 to 74.7
|
73.4 Percentage of participants
Interval 69.6 to 76.9
|
72.8 Percentage of participants
Interval 69.0 to 76.3
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Serotype 33F
|
59.5 Percentage of participants
Interval 55.6 to 63.3
|
58.3 Percentage of participants
Interval 54.4 to 62.2
|
56.8 Percentage of participants
Interval 52.8 to 60.7
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Outcome measures
| Measure |
V114 Lot 1
n=698 Participants
Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 Participants
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 Participants
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar13™
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 14
|
54.4 Percentage of participants
Interval 50.6 to 58.2
|
57.9 Percentage of participants
Interval 54.0 to 61.6
|
48.3 Percentage of participants
Interval 44.5 to 52.2
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 19F
|
77.8 Percentage of participants
Interval 74.5 to 80.9
|
79.0 Percentage of participants
Interval 75.8 to 82.1
|
78.6 Percentage of participants
Interval 75.3 to 81.7
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 23F
|
76.1 Percentage of participants
Interval 72.7 to 79.2
|
80.7 Percentage of participants
Interval 77.5 to 83.6
|
76.7 Percentage of participants
Interval 73.3 to 79.9
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 33F
|
69.4 Percentage of participants
Interval 65.8 to 72.9
|
70.9 Percentage of participants
Interval 67.3 to 74.3
|
66.1 Percentage of participants
Interval 62.3 to 69.7
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 1
|
73.9 Percentage of participants
Interval 70.4 to 77.1
|
75.2 Percentage of participants
Interval 71.8 to 78.4
|
73.0 Percentage of participants
Interval 69.4 to 76.3
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 3
|
58.6 Percentage of participants
Interval 54.8 to 62.4
|
61.9 Percentage of participants
Interval 58.1 to 65.6
|
54.7 Percentage of participants
Interval 50.8 to 58.5
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 4
|
68.8 Percentage of participants
Interval 65.1 to 72.3
|
73.8 Percentage of participants
Interval 70.3 to 77.1
|
65.7 Percentage of participants
Interval 61.9 to 69.3
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 5
|
45.6 Percentage of participants
Interval 41.8 to 49.5
|
52.5 Percentage of participants
Interval 48.7 to 56.3
|
45.9 Percentage of participants
Interval 42.1 to 49.8
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 6A
|
86.6 Percentage of participants
Interval 83.8 to 89.0
|
87.2 Percentage of participants
Interval 84.5 to 89.7
|
83.8 Percentage of participants
Interval 80.8 to 86.5
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 6B
|
87.0 Percentage of participants
Interval 84.2 to 89.4
|
85.6 Percentage of participants
Interval 82.7 to 88.2
|
84.2 Percentage of participants
Interval 81.2 to 86.9
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 7F
|
75.3 Percentage of participants
Interval 71.9 to 78.5
|
78.8 Percentage of participants
Interval 75.5 to 81.8
|
74.8 Percentage of participants
Interval 71.3 to 78.0
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 9V
|
72.6 Percentage of participants
Interval 69.1 to 76.0
|
73.0 Percentage of participants
Interval 69.4 to 76.3
|
71.6 Percentage of participants
Interval 68.0 to 75.0
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 18C
|
84.6 Percentage of participants
Interval 81.7 to 87.3
|
78.6 Percentage of participants
Interval 75.3 to 81.7
|
76.7 Percentage of participants
Interval 73.3 to 79.9
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 19A
|
70.6 Percentage of participants
Interval 67.0 to 74.0
|
74.2 Percentage of participants
Interval 70.7 to 77.5
|
71.0 Percentage of participants
Interval 67.4 to 74.4
|
—
|
|
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Serotype 22F
|
75.3 Percentage of participants
Interval 71.9 to 78.5
|
75.4 Percentage of participants
Interval 71.9 to 78.6
|
72.1 Percentage of participants
Interval 68.5 to 75.5
|
—
|
Adverse Events
V114 Lot 1
Serious events: 12 serious events
Other events: 548 other events
Deaths: 1 deaths
V114 Lot 2
Serious events: 19 serious events
Other events: 534 other events
Deaths: 2 deaths
V114 Lot 3
Serious events: 7 serious events
Other events: 535 other events
Deaths: 0 deaths
Prevnar 13™
Serious events: 5 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114 Lot 1
n=699 participants at risk
Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 participants at risk
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 participants at risk
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar 13™
n=230 participants at risk
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.43%
1/230 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Eye disorders
Blindness
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
General disorders
Chest pain
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
General disorders
Death
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.43%
1/230 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.28%
2/704 • Number of events 2 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Bronchitis
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Cystitis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.43%
1/230 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Diverticulitis
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Pneumonia
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.43%
1/230 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.43%
1/230 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Nervous system disorders
Migraine
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Psychiatric disorders
Depression
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.14%
1/699 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.28%
2/704 • Number of events 2 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/704 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/700 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/699 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.14%
1/704 • Number of events 1 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/700 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
0.00%
0/230 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
Other adverse events
| Measure |
V114 Lot 1
n=699 participants at risk
Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 2
n=704 participants at risk
Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
V114 Lot 3
n=700 participants at risk
Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
|
Prevnar 13™
n=230 participants at risk
Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
22.0%
154/699 • Number of events 202 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
20.9%
147/704 • Number of events 182 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
21.6%
151/700 • Number of events 189 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
22.2%
51/230 • Number of events 74 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
General disorders
Injection site erythema
|
11.0%
77/699 • Number of events 82 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
12.2%
86/704 • Number of events 91 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
12.7%
89/700 • Number of events 91 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
9.6%
22/230 • Number of events 24 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
General disorders
Injection site pain
|
66.4%
464/699 • Number of events 518 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
67.5%
475/704 • Number of events 520 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
67.3%
471/700 • Number of events 514 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
53.0%
122/230 • Number of events 134 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
General disorders
Injection site swelling
|
15.9%
111/699 • Number of events 115 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
16.3%
115/704 • Number of events 117 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
15.1%
106/700 • Number of events 109 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
14.8%
34/230 • Number of events 34 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
53/699 • Number of events 68 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
7.0%
49/704 • Number of events 54 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
8.4%
59/700 • Number of events 75 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
5.7%
13/230 • Number of events 14 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.0%
196/699 • Number of events 226 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
24.3%
171/704 • Number of events 196 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
28.4%
199/700 • Number of events 226 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
21.7%
50/230 • Number of events 54 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
|
Nervous system disorders
Headache
|
18.2%
127/699 • Number of events 166 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
19.9%
140/704 • Number of events 170 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
18.6%
130/700 • Number of events 171 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
18.7%
43/230 • Number of events 53 • Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
|
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.
- Publication restrictions are in place
Restriction type: OTHER