Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) (NCT NCT03565900)
NCT ID: NCT03565900
Last Updated: 2023-07-28
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
277 participants
Primary outcome timeframe
Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
Results posted on
2023-07-28
Participant Flow
This study recruited male and female participants at least 3 years of age who have received allogeneic hematopoietic stem cell transplant (allo-HSCT) 90 to 180 days prior to randomization.
263 adult participants and 14 pediatric participants (3 to 18 years of age) were randomized in a 1:1 ratio to receive either V114 or Prevnar 13™ on Day 1.
Participant milestones
| Measure |
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
138
|
|
Overall Study
Vaccination 1 With V114 or Prevnar 13™ (PCV) (Day 1)
|
139
|
135
|
|
Overall Study
Vaccination 2 With PCV (Day 30)
|
135
|
128
|
|
Overall Study
Vaccination 3 With PCV (Day 60)
|
130
|
124
|
|
Overall Study
Vaccination 4 With PNEUMOVAX™23 (PPV23) (12 Months After Allo-HSCT, Without Chronic GVHD)
|
89
|
75
|
|
Overall Study
Vaccination 4 With PCV (12 Months After Allo-HSCT, With Chronic GVHD)
|
29
|
37
|
|
Overall Study
COMPLETED
|
115
|
111
|
|
Overall Study
NOT COMPLETED
|
24
|
27
|
Reasons for withdrawal
| Measure |
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|
|
Overall Study
Disposition Unknown
|
4
|
1
|
|
Overall Study
Withdrawal By Parent/Guardian
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Randomized By Mistake
|
0
|
2
|
|
Overall Study
Physician Decision
|
7
|
11
|
|
Overall Study
Death
|
9
|
7
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
Baseline characteristics by cohort
| Measure |
V114
n=139 Participants
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™
n=138 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 18.3 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Children (2-11 years)
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
108 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Age, Customized
From 65-84 years
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Outcome measures
| Measure |
V114 (Adult)
n=131 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=129 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Injection site erythema
|
20.6 Percentage of Participants
Interval 14.0 to 28.6
|
14.0 Percentage of Participants
Interval 8.5 to 21.2
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Injection site pain
|
88.5 Percentage of Participants
Interval 81.8 to 93.4
|
74.4 Percentage of Participants
Interval 66.0 to 81.7
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Injection site swelling
|
32.1 Percentage of Participants
Interval 24.2 to 40.8
|
17.8 Percentage of Participants
Interval 11.7 to 25.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Outcome measures
| Measure |
V114 (Adult)
n=8 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=6 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Injection site erythema
|
0.0 Percentage of Participants
Interval 0.0 to 36.9
|
33.3 Percentage of Participants
Interval 4.3 to 77.7
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Injection site induration
|
12.5 Percentage of Participants
Interval 0.0 to 52.7
|
33.3 Percentage of Participants
Interval 4.3 to 77.0
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Injection site pain
|
75.0 Percentage of Participants
Interval 34.9 to 96.8
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Injection site swelling
|
25.0 Percentage of Participants
Interval 3.2 to 65.1
|
50.0 Percentage of Participants
Interval 11.8 to 88.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia.
Outcome measures
| Measure |
V114 (Adult)
n=131 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=129 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Arthralgia
|
16.0 Percentage of Participants
Interval 10.2 to 23.5
|
18.6 Percentage of Participants
Interval 12.3 to 26.4
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Fatigue
|
45.0 Percentage of Participants
Interval 36.3 to 54.0
|
40.3 Percentage of Participants
Interval 31.8 to 49.3
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Headache
|
29.0 Percentage of Participants
Interval 21.4 to 37.6
|
31.0 Percentage of Participants
Interval 23.2 to 39.7
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Myalgia
|
48.9 Percentage of Participants
Interval 40.0 to 57.7
|
34.9 Percentage of Participants
Interval 26.7 to 43.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, myalgia, and hives or welts.
Outcome measures
| Measure |
V114 (Adult)
n=8 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=6 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Arthralgia
|
12.5 Percentage of Participants
Interval 0.3 to 52.7
|
0.0 Percentage of Participants
Interval 0.0 to 45.9
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Fatigue
|
25.0 Percentage of Participants
Interval 3.2 to 65.1
|
16.7 Percentage of Participants
Interval 0.4 to 64.1
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Headache
|
12.5 Percentage of Participants
Interval 0.3 to 52.7
|
16.7 Percentage of Participants
Interval 0.4 to 64.1
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Myalgia
|
50.0 Percentage of Participants
Interval 15.7 to 84.3
|
16.7 Percentage of Participants
Interval 0.4 to 64.1
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
Hives or welts
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or Prevnar 13™) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 up to 12 months post-HSCT, which could be up to 9 months post-vaccine dose 1.
Outcome measures
| Measure |
V114 (Adult)
n=131 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=129 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
n=8 Participants
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
n=6 Participants
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT
|
0.8 Percentage of Participants
Interval 0.0 to 4.2
|
0.0 Percentage of Participants
Interval 0.0 to 2.8
|
0.0 Percentage of Participants
Interval 0.0 to 36.9
|
0.0 Percentage of Participants
Interval 0.0 to 45.9
|
PRIMARY outcome
Timeframe: Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114 (Adult)
n=105 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=88 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 1 (Shared)
|
2.97 µg/mL
Interval 2.22 to 3.99
|
1.90 µg/mL
Interval 1.34 to 2.69
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 3 (Shared)
|
0.80 µg/mL
Interval 0.63 to 1.02
|
0.52 µg/mL
Interval 0.38 to 0.71
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 4 (Shared)
|
1.61 µg/mL
Interval 1.23 to 2.11
|
1.52 µg/mL
Interval 1.04 to 2.2
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 5 (Shared)
|
2.85 µg/mL
Interval 2.13 to 3.81
|
1.91 µg/mL
Interval 1.32 to 2.77
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6A (Shared)
|
3.40 µg/mL
Interval 2.42 to 4.76
|
2.79 µg/mL
Interval 1.78 to 4.38
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6B (Shared)
|
3.49 µg/mL
Interval 2.45 to 4.98
|
2.86 µg/mL
Interval 1.82 to 4.49
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 7F (Shared)
|
3.20 µg/mL
Interval 2.38 to 4.3
|
3.01 µg/mL
Interval 2.07 to 4.36
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 9V (Shared)
|
2.56 µg/mL
Interval 1.94 to 3.38
|
1.83 µg/mL
Interval 1.26 to 2.65
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 14 (Shared)
|
6.50 µg/mL
Interval 4.94 to 8.57
|
4.61 µg/mL
Interval 3.17 to 6.69
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 18C (Shared)
|
3.84 µg/mL
Interval 2.83 to 5.22
|
2.58 µg/mL
Interval 1.76 to 3.79
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19A (Shared)
|
5.03 µg/mL
Interval 3.88 to 6.53
|
4.31 µg/mL
Interval 3.0 to 6.2
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19F (Shared)
|
5.03 µg/mL
Interval 3.72 to 6.79
|
3.67 µg/mL
Interval 2.53 to 5.33
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 23F (Shared)
|
3.59 µg/mL
Interval 2.64 to 4.88
|
2.62 µg/mL
Interval 1.66 to 4.15
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 22F (Unique to V114)
|
4.09 µg/mL
Interval 3.02 to 5.54
|
0.15 µg/mL
Interval 0.11 to 0.2
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 33F (Unique to V114)
|
3.40 µg/mL
Interval 2.58 to 4.48
|
0.39 µg/mL
Interval 0.29 to 0.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Outcome measures
| Measure |
V114 (Adult)
n=84 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=71 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site erythema
|
17.9 Percentage of Participants
Interval 10.4 to 27.7
|
22.5 Percentage of Participants
Interval 13.5 to 34.0
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site pain
|
67.9 Percentage of Participants
Interval 56.8 to 77.6
|
57.7 Percentage of Participants
Interval 45.4 to 69.4
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site swelling
|
21.4 Percentage of Participants
Interval 13.2 to 31.7
|
23.9 Percentage of Participants
Interval 14.6 to 35.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were induration, pain, swelling, and erythema.
Outcome measures
| Measure |
V114 (Adult)
n=5 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=4 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site induration
|
0.0 Percentage of Participants
Interval 0.0 to 52.2
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site pain
|
60.0 Percentage of Participants
Interval 14.7 to 94.7
|
50.0 Percentage of Participants
Interval 6.8 to 93.2
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site swelling
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site erythema
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
Outcome measures
| Measure |
V114 (Adult)
n=84 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=71 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Arthralgia
|
7.1 Percentage of Participants
Interval 2.7 to 14.9
|
8.5 Percentage of Participants
Interval 3.2 to 17.5
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Fatigue
|
22.6 Percentage of Participants
Interval 14.2 to 33.0
|
16.9 Percentage of Participants
Interval 9.0 to 27.7
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Headache
|
21.4 Percentage of Participants
Interval 13.2 to 31.7
|
19.7 Percentage of Participants
Interval 11.2 to 30.9
|
—
|
—
|
|
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Myalgia
|
32.1 Percentage of Participants
Interval 22.4 to 43.2
|
26.8 Percentage of Participants
Interval 16.9 to 38.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, hives or welts, and arthralgia.
Outcome measures
| Measure |
V114 (Adult)
n=5 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=4 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Fatigue
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Headache
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Myalgia
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Hives or welts
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
|
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Arthralgia
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 month after PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 10 months after Day 1)Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following a single dose vaccination with PNEUMOVAX™23 was reported.
Outcome measures
| Measure |
V114 (Adult)
n=84 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=71 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
n=5 Participants
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
n=4 Participants
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23
|
1.2 Percentage of Participants
Interval 0.0 to 6.5
|
0.0 Percentage of Participants
Interval 0.0 to 5.1
|
0.0 Percentage of Participants
Interval 0.0 to 52.2
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
SECONDARY outcome
Timeframe: Up to 5 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Outcome measures
| Measure |
V114 (Adult)
n=27 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=36 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
Injection site erythema
|
3.7 Percentage of Participants
Interval 0.1 to 19.0
|
8.3 Percentage of Participants
Interval 1.8 to 22.5
|
—
|
—
|
|
Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
Injection site pain
|
77.8 Percentage of Participants
Interval 57.7 to 91.4
|
61.1 Percentage of Participants
Interval 43.5 to 76.9
|
—
|
—
|
|
Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
Injection site swelling
|
22.2 Percentage of Participants
Interval 8.6 to 42.3
|
13.9 Percentage of Participants
Interval 4.7 to 29.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AE assessed were pain, erythema, swelling, and induration.
Outcome measures
| Measure |
V114 (Adult)
n=2 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=1 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
Injection site pain
|
50.0 Percentage of Participants
Interval 1.3 to 98.7
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
—
|
—
|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
Injection site erythema
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
Injection site swelling
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
Injection site induration
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
Outcome measures
| Measure |
V114 (Adult)
n=27 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=36 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Arthralgia
|
11.1 Percentage of Participants
Interval 2.4 to 29.2
|
8.3 Percentage of Participants
Interval 1.8 to 22.5
|
—
|
—
|
|
Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Fatigue
|
29.6 Percentage of Participants
Interval 13.8 to 50.2
|
16.7 Percentage of Participants
Interval 6.4 to 32.8
|
—
|
—
|
|
Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Headache
|
22.2 Percentage of Participants
Interval 8.6 to 42.3
|
11.1 Percentage of Participants
Interval 3.1 to 26.1
|
—
|
—
|
|
Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Myalgia
|
29.6 Percentage of Participants
Interval 13.8 to 50.2
|
22.2 Percentage of Participants
Interval 10.1 to 39.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed myalgia, arthralgia, headache, fatigue, and hives or welts.
Outcome measures
| Measure |
V114 (Adult)
n=2 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=1 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Myalgia
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Arthralgia
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Headache
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Fatigue
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
|
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
Hives or welts
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
0.0 Percentage of Participants
95% Confidence Interval could not be calculated, because 0 events were observed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 months after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 15 months after Day 1)Population: All randomized participants who received at least 1 dose of relevant study vaccination for the timepoint of interest were analyzed.
This end point applies to participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as vaccine dose 4. An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 4 with V114 or Prevnar 13™ through completion of study was reported.
Outcome measures
| Measure |
V114 (Adult)
n=27 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=36 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
n=2 Participants
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
n=1 Participants
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
0.0 Percentage of Participants
Interval 0.0 to 9.7
|
0.0 Percentage of Participants
Interval 0.0 to 84.2
|
0.0 Percentage of Participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Up to Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Outcome measures
| Measure |
V114 (Adult)
n=92 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=68 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 1 (Shared)
|
90.9 Titers
Interval 60.8 to 135.9
|
59.3 Titers
Interval 37.8 to 93.1
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 3 (Shared)
|
152.1 Titers
Interval 114.6 to 201.7
|
128.5 Titers
Interval 89.6 to 184.4
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 4 (Shared)
|
1008.4 Titers
Interval 684.3 to 1486.2
|
1357.7 Titers
Interval 786.7 to 2343.1
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 5 (Shared)
|
317.6 Titers
Interval 206.7 to 487.9
|
169.1 Titers
Interval 106.1 to 269.6
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6A (Shared)
|
2494.5 Titers
Interval 1731.4 to 3593.8
|
2295.0 Titers
Interval 1463.8 to 3598.4
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6B (Shared)
|
2280.2 Titers
Interval 1500.8 to 3464.3
|
3000.4 Titers
Interval 1800.0 to 5001.3
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 7F (Shared)
|
1945.3 Titers
Interval 1278.5 to 2960.0
|
3076.9 Titers
Interval 1958.1 to 4834.7
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 9V (Shared)
|
1059.4 Titers
Interval 743.0 to 1510.5
|
1050.0 Titers
Interval 659.5 to 1671.6
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 14 (Shared)
|
1953.6 Titers
Interval 1296.9 to 2942.9
|
1689.2 Titers
Interval 995.0 to 2867.6
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 18C (Shared)
|
1146.6 Titers
Interval 833.6 to 1577.2
|
714.6 Titers
Interval 439.3 to 1162.3
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19A (Shared)
|
1365.6 Titers
Interval 960.4 to 1941.8
|
1201.6 Titers
Interval 724.0 to 1994.2
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19F (Shared)
|
965.6 Titers
Interval 675.3 to 1380.8
|
1065.6 Titers
Interval 707.8 to 1604.3
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 23F (Shared)
|
1158.3 Titers
Interval 784.1 to 1711.1
|
2065.2 Titers
Interval 1144.3 to 3727.4
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 22F (Unique to V114)
|
1127.5 Titers
Interval 717.9 to 1770.7
|
19.0 Titers
Interval 11.9 to 30.2
|
—
|
—
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 33F (Unique to V114)
|
4441.7 Titers
Interval 2966.6 to 6650.2
|
173.6 Titers
Interval 97.0 to 310.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
The GMFR of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114 (Adult)
n=103 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=84 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 1 (Shared)
|
69.9 Percentage of Participants
Interval 60.1 to 78.5
|
64.3 Percentage of Participants
Interval 53.1 to 74.4
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 3 (Shared)
|
62.1 Percentage of Participants
Interval 52.0 to 71.5
|
48.8 Percentage of Participants
Interval 37.7 to 60.0
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 4 (Shared)
|
73.8 Percentage of Participants
Interval 64.2 to 82.0
|
70.2 Percentage of Participants
Interval 59.3 to 79.7
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 5 (Shared)
|
60.2 Percentage of Participants
Interval 50.1 to 69.7
|
60.7 Percentage of Participants
Interval 49.5 to 71.2
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6A (Shared)
|
73.8 Percentage of Participants
Interval 64.2 to 82.0
|
69.0 Percentage of Participants
Interval 58.0 to 78.7
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6B (Shared)
|
71.8 Percentage of Participants
Interval 62.1 to 80.3
|
69.0 Percentage of Participants
Interval 58.0 to 78.7
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 7F (Shared)
|
69.9 Percentage of Participants
Interval 60.1 to 78.5
|
70.2 Percentage of Participants
Interval 59.3 to 79.7
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 9V (Shared)
|
65.0 Percentage of Participants
Interval 55.0 to 74.2
|
63.1 Percentage of Participants
Interval 51.9 to 73.4
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 14 (Shared)
|
51.5 Percentage of Participants
Interval 41.4 to 61.4
|
50.6 Percentage of Participants
Interval 39.4 to 61.8
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 18C (Shared)
|
67.0 Percentage of Participants
Interval 57.0 to 75.9
|
61.9 Percentage of Participants
Interval 50.7 to 72.3
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19A (Shared)
|
55.3 Percentage of Participants
Interval 45.2 to 65.1
|
48.8 Percentage of Participants
Interval 37.7 to 60.0
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19F (Shared)
|
63.1 Percentage of Participants
Interval 53.0 to 72.4
|
61.9 Percentage of Participants
Interval 50.7 to 72.3
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 23F (Shared)
|
61.2 Percentage of Participants
Interval 51.1 to 70.6
|
61.9 Percentage of Participants
Interval 50.7 to 72.3
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 22F (Unique to V114)
|
74.8 Percentage of Participants
Interval 65.2 to 82.8
|
1.2 Percentage of Participants
Interval 0.0 to 6.5
|
—
|
—
|
|
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 33F (Unique to V114)
|
54.4 Percentage of Participants
Interval 44.3 to 64.2
|
4.8 Percentage of Participants
Interval 1.3 to 11.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Time Frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Activity for the 15 serotypes contained in V114 vaccine were determined using a Multiplex Opsonophagocytic Assay. The GMFR of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using multiplexed opsonophagocytic assay.
Outcome measures
| Measure |
V114 (Adult)
n=88 Participants
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Adult)
n=62 Participants
Adult participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 1 (Shared)
|
65.9 Percentage of Participants
Interval 55.0 to 75.7
|
54.1 Percentage of Participants
Interval 40.8 to 66.9
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 3 (Shared)
|
58.0 Percentage of Participants
Interval 47.0 to 68.4
|
55.7 Percentage of Participants
Interval 42.4 to 68.5
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 4 (Shared)
|
71.3 Percentage of Participants
Interval 60.6 to 80.5
|
78.0 Percentage of Participants
Interval 65.3 to 87.7
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 5 (Shared)
|
70.5 Percentage of Participants
Interval 59.8 to 79.7
|
53.2 Percentage of Participants
Interval 40.1 to 66.0
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6A (Shared)
|
64.4 Percentage of Participants
Interval 53.4 to 74.4
|
68.9 Percentage of Participants
Interval 55.7 to 80.1
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 6B (Shared)
|
69.4 Percentage of Participants
Interval 58.5 to 79.0
|
73.3 Percentage of Participants
Interval 60.3 to 83.9
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 7F (Shared)
|
68.6 Percentage of Participants
Interval 57.7 to 78.2
|
71.7 Percentage of Participants
Interval 58.6 to 82.5
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 9V (Shared)
|
54.5 Percentage of Participants
Interval 43.6 to 65.2
|
53.3 Percentage of Participants
Interval 40.0 to 66.3
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 14 (Shared)
|
54.7 Percentage of Participants
Interval 43.5 to 65.4
|
58.1 Percentage of Participants
Interval 44.8 to 70.5
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 18C (Shared)
|
69.3 Percentage of Participants
Interval 58.6 to 78.7
|
46.7 Percentage of Participants
Interval 33.7 to 60.0
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19A (Shared)
|
64.0 Percentage of Participants
Interval 52.9 to 74.0
|
59.0 Percentage of Participants
Interval 45.7 to 71.7
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 19F (Shared)
|
61.4 Percentage of Participants
Interval 50.4 to 71.6
|
68.9 Percentage of Participants
Interval 55.7 to 80.1
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 23F (Shared)
|
63.5 Percentage of Participants
Interval 52.4 to 73.7
|
69.1 Percentage of Participants
Interval 55.2 to 80.9
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 22F (Unique to V114)
|
70.2 Percentage of Participants
Interval 59.3 to 79.7
|
3.4 Percentage of Participants
Interval 0.4 to 11.9
|
—
|
—
|
|
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Serotype 33F (Unique to V114)
|
61.6 Percentage of Participants
Interval 50.5 to 71.9
|
11.3 Percentage of Participants
Interval 4.7 to 21.9
|
—
|
—
|
Adverse Events
V114 (Following Any of the First 3 Doses of PCV) Adults
Serious events: 38 serious events
Other events: 125 other events
Deaths: 6 deaths
Prevnar 13™ (Following Any of the First 3 Doses of PCV) Adults
Serious events: 48 serious events
Other events: 108 other events
Deaths: 9 deaths
V114 (Following PPV23) Adults
Serious events: 2 serious events
Other events: 65 other events
Deaths: 1 deaths
Prevnar 13™ (Following PPV23) Adults
Serious events: 4 serious events
Other events: 53 other events
Deaths: 0 deaths
V114 (Following Dose 4 of PCV) Adults
Serious events: 6 serious events
Other events: 22 other events
Deaths: 2 deaths
Prevnar 13™ (Following Dose 4 of PCV) Adults
Serious events: 7 serious events
Other events: 26 other events
Deaths: 1 deaths
V114 (Following Any of the First 3 Doses of PCV) Pediatric
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Prevnar 13™ (Following Any of the First 3 Doses of PCV) Pediatric
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
V114 (Following PPV23) Pediatric
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Prevnar 13™ (Following PPV23) Pediatric
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
V114 (Following Dose 4 of PCV) Pediatric
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Prevnar 13™ (Following Dose 4 of PCV) Pediatric
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114 (Following Any of the First 3 Doses of PCV) Adults
n=131 participants at risk
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Any of the First 3 Doses of PCV) Adults
n=129 participants at risk
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following PPV23) Adults
n=84 participants at risk
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following PPV23) Adults
n=71 participants at risk
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following Dose 4 of PCV) Adults
n=27 participants at risk
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Dose 4 of PCV) Adults
n=36 participants at risk
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following Any of the First 3 Doses of PCV) Pediatric
n=8 participants at risk
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Any of the First 3 Doses of PCV) Pediatric
n=6 participants at risk
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following PPV23) Pediatric
n=5 participants at risk
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following PPV23) Pediatric
n=4 participants at risk
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following Dose 4 of PCV) Pediatric
n=2 participants at risk
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Dose 4 of PCV) Pediatric
n=1 participants at risk
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
2/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.76%
1/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Cardiac disorders
Myocarditis
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Cardiac disorders
Pericarditis
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
3/131 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.2%
1/84 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Disease progression
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Malaise
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Mucosal inflammation
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Polyserositis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Pyrexia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.3%
3/129 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.2%
1/84 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Acute graft versus host disease
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Chronic graft versus host disease
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Graft versus host disease
|
3.1%
4/131 • Number of events 4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.9%
5/129 • Number of events 5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
5.6%
2/36 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
1.5%
2/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Graft versus host disease in liver
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Graft versus host disease in lung
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
COVID-19
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Erysipelas
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Infected skin ulcer
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Infection
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Influenza
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Nocardia sepsis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.5%
2/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pneumonia
|
2.3%
3/131 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
4.7%
6/129 • Number of events 9 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pulmonary sepsis
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Sepsis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Septic shock
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Sinusitis fungal
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Transfusion microchimerism
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.76%
1/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
1.5%
2/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
5.4%
7/129 • Number of events 7 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
7.4%
2/27 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
1.5%
2/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.3%
3/129 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia recurrent
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Nervous system disorders
Headache
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Psychiatric disorders
Depression
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.8%
1/36 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Vascular disorders
Hypotension
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
Other adverse events
| Measure |
V114 (Following Any of the First 3 Doses of PCV) Adults
n=131 participants at risk
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Any of the First 3 Doses of PCV) Adults
n=129 participants at risk
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following PPV23) Adults
n=84 participants at risk
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following PPV23) Adults
n=71 participants at risk
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following Dose 4 of PCV) Adults
n=27 participants at risk
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Dose 4 of PCV) Adults
n=36 participants at risk
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following Any of the First 3 Doses of PCV) Pediatric
n=8 participants at risk
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Any of the First 3 Doses of PCV) Pediatric
n=6 participants at risk
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following PPV23) Pediatric
n=5 participants at risk
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following PPV23) Pediatric
n=4 participants at risk
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
V114 (Following Dose 4 of PCV) Pediatric
n=2 participants at risk
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
|
Prevnar 13™ (Following Dose 4 of PCV) Pediatric
n=1 participants at risk
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.76%
1/131 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
25.0%
1/4 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
2/131 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
4.7%
6/129 • Number of events 6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
12/131 • Number of events 15 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.9%
5/129 • Number of events 6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.4%
2/84 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
4/131 • Number of events 4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.3%
3/129 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Fatigue
|
45.0%
59/131 • Number of events 105 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
40.3%
52/129 • Number of events 111 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
22.6%
19/84 • Number of events 21 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.9%
12/71 • Number of events 16 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
29.6%
8/27 • Number of events 9 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
6/36 • Number of events 6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
25.0%
2/8 • Number of events 5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
20.0%
1/5 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site erythema
|
20.6%
27/131 • Number of events 37 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
14.0%
18/129 • Number of events 22 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
17.9%
15/84 • Number of events 15 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
22.5%
16/71 • Number of events 16 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
8.3%
3/36 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
33.3%
2/6 • Number of events 5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site induration
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
33.3%
2/6 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
25.0%
1/4 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site pain
|
88.5%
116/131 • Number of events 284 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
75.2%
97/129 • Number of events 237 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
67.9%
57/84 • Number of events 57 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
57.7%
41/71 • Number of events 42 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
77.8%
21/27 • Number of events 21 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
61.1%
22/36 • Number of events 23 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
75.0%
6/8 • Number of events 13 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
83.3%
5/6 • Number of events 8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
60.0%
3/5 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
50.0%
2/4 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
50.0%
1/2 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site swelling
|
32.1%
42/131 • Number of events 64 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
17.8%
23/129 • Number of events 35 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
21.4%
18/84 • Number of events 18 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
23.9%
17/71 • Number of events 17 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
22.2%
6/27 • Number of events 7 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
13.9%
5/36 • Number of events 5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
25.0%
2/8 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
50.0%
3/6 • Number of events 5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
20.0%
1/5 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
25.0%
1/4 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
General disorders
Pyrexia
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
6.0%
5/84 • Number of events 5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.7%
1/27 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
5.6%
2/36 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
25.0%
1/4 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
50.0%
1/2 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Graft versus host disease in eye
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
3.1%
4/129 • Number of events 4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
2.3%
3/129 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.6%
2/129 • Number of events 5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
25.0%
2/8 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
21/131 • Number of events 33 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
18.6%
24/129 • Number of events 38 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
7.1%
6/84 • Number of events 6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
8.5%
6/71 • Number of events 6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
11.1%
3/27 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
8.3%
3/36 • Number of events 3 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
48.9%
64/131 • Number of events 111 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
34.9%
45/129 • Number of events 77 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
32.1%
27/84 • Number of events 30 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
26.8%
19/71 • Number of events 20 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
29.6%
8/27 • Number of events 8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
22.2%
8/36 • Number of events 8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
50.0%
4/8 • Number of events 8 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
40.0%
2/5 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Nervous system disorders
Headache
|
29.0%
38/131 • Number of events 73 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
31.0%
40/129 • Number of events 67 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
21.4%
18/84 • Number of events 20 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
19.7%
14/71 • Number of events 16 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
22.2%
6/27 • Number of events 7 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
11.1%
4/36 • Number of events 4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
16.7%
1/6 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
20.0%
1/5 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Psychiatric disorders
Depression
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.76%
1/131 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.78%
1/129 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
1.4%
1/71 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/131 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/129 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/84 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/71 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/27 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/36 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
12.5%
1/8 • Number of events 1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/6 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/5 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/4 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/2 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
0.00%
0/1 • Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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