Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018) (NCT NCT03480802)
NCT ID: NCT03480802
Last Updated: 2022-05-05
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. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Up to 5 days after Vaccination 1 (Up to Day 5)
Results posted on
2022-05-05
Participant Flow
Adults 18 years of age or older infected with human immunodeficiency virus (HIV) who did not receive a pneumococcal vaccine prior to study entry were enrolled in this study.
Participant milestones
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
150
|
|
Overall Study
Week 8
|
150
|
148
|
|
Overall Study
COMPLETED
|
145
|
147
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Relocated
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)
Baseline characteristics by cohort
| Measure |
V114
n=152 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=150 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 Years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
41.3 Years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
41.9 Years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=93 Participants
|
118 Participants
n=4 Participants
|
238 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=93 Participants
|
104 Participants
n=4 Participants
|
206 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
36 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after Vaccination 1 (Up to Day 5)Population: All randomized participants who received at least 1 dose of the study vaccination they actually received.
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. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=152 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=150 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1
Injection site swelling
|
11.8 Percentage of Participants
Interval 7.2 to 18.1
|
4.0 Percentage of Participants
Interval 1.5 to 8.5
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1
Injection site erythema
|
4.6 Percentage of Participants
Interval 1.9 to 9.3
|
3.3 Percentage of Participants
Interval 1.1 to 7.6
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1
Injection site pain
|
57.2 Percentage of Participants
Interval 49.0 to 65.2
|
51.3 Percentage of Participants
Interval 43.0 to 59.6
|
PRIMARY outcome
Timeframe: Up to 14 days after Vaccination 1 (Up to Day 14)Population: All randomized participants who received at least 1 dose of the study vaccination they actually received.
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. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=152 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=150 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
Myalgia
|
12.5 Percentage of Participants
Interval 7.7 to 18.8
|
9.3 Percentage of Participants
Interval 5.2 to 15.2
|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
Arthralgia
|
3.3 Percentage of Participants
Interval 1.1 to 7.5
|
4.0 Percentage of Participants
Interval 1.5 to 8.5
|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
Fatigue
|
20.4 Percentage of Participants
Interval 14.3 to 27.7
|
13.3 Percentage of Participants
Interval 8.3 to 19.8
|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
Headache
|
13.2 Percentage of Participants
Interval 8.2 to 19.6
|
9.3 Percentage of Participants
Interval 5.2 to 15.2
|
PRIMARY outcome
Timeframe: Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)Population: All randomized participants who received at least 1 dose of the study vaccination they actually received.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=152 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=150 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1
|
0 Percentage of Participants
Interval 0.0 to 2.4
|
0 Percentage of Participants
Interval 0.0 to 2.4
|
PRIMARY outcome
Timeframe: Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results.
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). This assay reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V114
n=152 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=150 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 1
|
238.8 1/dil
Interval 173.1 to 329.3
|
200.9 1/dil
Interval 142.7 to 282.7
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 3
|
116.8 1/dil
Interval 94.9 to 143.7
|
72.3 1/dil
Interval 58.6 to 89.2
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 4
|
824.0 1/dil
Interval 618.8 to 1097.2
|
1465.5 1/dil
Interval 1154.5 to 1860.3
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 5
|
336.7 1/dil
Interval 242.4 to 467.7
|
276.7 1/dil
Interval 197.9 to 386.7
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 6A
|
6421.0 1/dil
Interval 4890.4 to 8430.7
|
5645.1 1/dil
Interval 4278.9 to 7447.4
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 19F
|
2438.6 1/dil
Interval 1972.7 to 3014.6
|
2042.0 1/dil
Interval 1618.9 to 2575.5
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 6B
|
4772.9 1/dil
Interval 3628.3 to 6278.7
|
3554.0 1/dil
Interval 2751.0 to 4591.4
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 7F
|
6085.8 1/dil
Interval 4871.6 to 7602.8
|
6144.3 1/dil
Interval 4982.8 to 7576.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 9V
|
2836.3 1/dil
Interval 2311.5 to 3480.4
|
2133.9 1/dil
Interval 1721.8 to 2644.5
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 14
|
3508.7 1/dil
Interval 2730.6 to 4508.5
|
3000.3 1/dil
Interval 2350.0 to 3830.5
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 18C
|
3002.2 1/dil
Interval 2435.5 to 3700.8
|
1560.3 1/dil
Interval 1213.8 to 2005.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 23F
|
1757.4 1/dil
Interval 1276.1 to 2420.2
|
1787.0 1/dil
Interval 1309.0 to 2437.9
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 22F
|
3943.7 1/dil
Interval 3049.2 to 5100.5
|
109.3 1/dil
Interval 66.2 to 180.3
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 33F
|
11342.4 1/dil
Interval 9184.3 to 14007.6
|
1807.6 1/dil
Interval 1357.3 to 2407.3
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Serotype 19A
|
4240.7 1/dil
Interval 3415.4 to 5265.3
|
3715.9 1/dil
Interval 2949.2 to 4681.8
|
PRIMARY outcome
Timeframe: Day 30Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V114
n=152 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=150 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 1
|
3.16 μg/mL
Interval 2.48 to 4.01
|
4.27 μg/mL
Interval 3.31 to 5.5
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 3
|
0.57 μg/mL
Interval 0.48 to 0.68
|
0.50 μg/mL
Interval 0.41 to 0.6
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 4
|
1.14 μg/mL
Interval 0.9 to 1.44
|
2.00 μg/mL
Interval 1.56 to 2.55
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 5
|
2.38 μg/mL
Interval 1.89 to 3.01
|
2.03 μg/mL
Interval 1.56 to 2.64
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 6A
|
5.13 μg/mL
Interval 3.73 to 7.04
|
4.91 μg/mL
Interval 3.49 to 6.91
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 6B
|
7.17 μg/mL
Interval 5.34 to 9.63
|
5.23 μg/mL
Interval 3.73 to 7.35
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 7F
|
2.61 μg/mL
Interval 2.0 to 3.41
|
3.74 μg/mL
Interval 2.91 to 4.81
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 9V
|
3.35 μg/mL
Interval 2.71 to 4.14
|
3.55 μg/mL
Interval 2.77 to 4.56
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 14
|
15.44 μg/mL
Interval 11.69 to 20.39
|
15.22 μg/mL
Interval 11.56 to 20.03
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 18C
|
5.58 μg/mL
Interval 4.33 to 7.18
|
5.07 μg/mL
Interval 3.97 to 6.48
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 19A
|
9.09 μg/mL
Interval 7.08 to 11.67
|
9.61 μg/mL
Interval 7.36 to 12.56
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 19F
|
6.41 μg/mL
Interval 4.89 to 8.39
|
6.21 μg/mL
Interval 4.73 to 8.15
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 23F
|
3.92 μg/mL
Interval 2.94 to 5.22
|
4.90 μg/mL
Interval 3.54 to 6.77
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 22F
|
3.97 μg/mL
Interval 3.06 to 5.15
|
0.20 μg/mL
Interval 0.17 to 0.25
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Serotype 33F
|
6.83 μg/mL
Interval 5.14 to 9.07
|
0.77 μg/mL
Interval 0.62 to 0.95
|
SECONDARY outcome
Timeframe: Up to 5 days after Vaccination 2 (Up to Day 61)Population: All randomized participants who received at least 1 dose of the study vaccination they actually received.
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. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=150 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=148 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2
Injection site erythema
|
10.0 Percentage of Participants
Interval 5.7 to 16.0
|
12.2 Percentage of Participants
Interval 7.4 to 18.5
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2
Injection site pain
|
53.3 Percentage of Participants
Interval 45.0 to 61.5
|
61.5 Percentage of Participants
Interval 53.1 to 69.4
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2
Injection site swelling
|
20.0 Percentage of Participants
Interval 13.9 to 27.3
|
29.1 Percentage of Participants
Interval 21.9 to 37.1
|
SECONDARY outcome
Timeframe: Up to 14 days after Vaccination 2 (Up to Day 70)Population: All randomized participants who received at least 1 dose of the study vaccination they actually received.
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. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=150 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=148 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2
Arthralgia
|
2.7 Percentage of Participants
Interval 0.7 to 6.7
|
1.4 Percentage of Participants
Interval 0.2 to 4.8
|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2
Fatigue
|
12.7 Percentage of Participants
Interval 7.8 to 19.1
|
10.8 Percentage of Participants
Interval 6.3 to 17.0
|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2
Headache
|
8.7 Percentage of Participants
Interval 4.7 to 14.4
|
8.8 Percentage of Participants
Interval 4.8 to 14.6
|
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2
Myalgia
|
11.3 Percentage of Participants
Interval 6.7 to 17.5
|
12.2 Percentage of Participants
Interval 7.4 to 18.5
|
SECONDARY outcome
Timeframe: From Week 8 up to Month 6Population: All randomized participants who received at least 1 dose of the study vaccination they actually received.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
V114
n=150 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=148 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2
|
0 Percentage of Participants
Interval 0.0 to 2.4
|
0 Percentage of Participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include not vaccinated at week 8, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results.
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA. The MOPA reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V114
n=150 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=148 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 3
|
102.8 1/dil
Interval 83.0 to 127.2
|
96.6 1/dil
Interval 79.5 to 117.4
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 5
|
418.1 1/dil
Interval 312.1 to 560.3
|
274.5 1/dil
Interval 199.9 to 376.8
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 9V
|
2454.8 1/dil
Interval 2008.7 to 3000.0
|
1929.9 1/dil
Interval 1567.7 to 2375.7
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 14
|
3634.0 1/dil
Interval 2935.6 to 4498.5
|
2539.3 1/dil
Interval 1960.6 to 3288.9
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 19F
|
2230.7 1/dil
Interval 1803.6 to 2759.0
|
1994.1 1/dil
Interval 1630.7 to 2438.4
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 1
|
212.0 1/dil
Interval 160.5 to 280.2
|
154.0 1/dil
Interval 111.6 to 212.4
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 4
|
915.4 1/dil
Interval 722.9 to 1159.1
|
984.7 1/dil
Interval 772.1 to 1255.7
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 6A
|
4065.4 1/dil
Interval 3052.1 to 5415.1
|
4593.2 1/dil
Interval 3543.0 to 5954.7
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 6B
|
3661.1 1/dil
Interval 2735.1 to 4900.6
|
2826.4 1/dil
Interval 2202.7 to 3626.8
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 7F
|
5983.5 1/dil
Interval 4788.9 to 7476.1
|
5516.5 1/dil
Interval 4522.2 to 6729.5
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 18C
|
2511.5 1/dil
Interval 1958.7 to 3220.3
|
1753.8 1/dil
Interval 1428.6 to 2153.1
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 19A
|
3358.1 1/dil
Interval 2679.6 to 4208.4
|
3300.3 1/dil
Interval 2638.7 to 4127.7
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 23F
|
1641.2 1/dil
Interval 1217.2 to 2212.9
|
1266.5 1/dil
Interval 944.3 to 1698.5
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 22F
|
3399.9 1/dil
Interval 2697.6 to 4285.0
|
2952.7 1/dil
Interval 2207.7 to 3949.1
|
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Serotype 33F
|
10576.3 1/dil
Interval 8383.1 to 13343.4
|
11926.3 1/dil
Interval 9085.9 to 15654.6
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include not vaccinated at week 8, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results.
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™ ; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex ECL using the PnECL v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V114
n=150 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
Prevnar 13™
n=148 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
|---|---|---|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 1
|
2.80 μg/mL
Interval 2.25 to 3.49
|
4.04 μg/mL
Interval 3.27 to 5.0
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 6B
|
4.69 μg/mL
Interval 3.52 to 6.25
|
4.35 μg/mL
Interval 3.23 to 5.86
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 7F
|
2.45 μg/mL
Interval 1.91 to 3.15
|
3.17 μg/mL
Interval 2.6 to 3.87
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 9V
|
2.92 μg/mL
Interval 2.39 to 3.57
|
3.24 μg/mL
Interval 2.62 to 4.01
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 19A
|
7.23 μg/mL
Interval 5.8 to 9.02
|
8.54 μg/mL
Interval 6.8 to 10.72
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 19F
|
5.19 μg/mL
Interval 4.06 to 6.62
|
5.84 μg/mL
Interval 4.67 to 7.3
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 3
|
0.51 μg/mL
Interval 0.43 to 0.61
|
0.59 μg/mL
Interval 0.5 to 0.7
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 4
|
1.26 μg/mL
Interval 1.1 to 1.57
|
1.61 μg/mL
Interval 1.31 to 1.98
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 5
|
2.61 μg/mL
Interval 2.08 to 3.28
|
2.13 μg/mL
Interval 1.69 to 2.68
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 6A
|
3.12 μg/mL
Interval 2.27 to 4.3
|
3.71 μg/mL
Interval 2.74 to 5.03
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 14
|
13.68 μg/mL
Interval 10.34 to 18.1
|
14.37 μg/mL
Interval 11.25 to 18.36
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 18C
|
3.96 μg/mL
Interval 3.08 to 5.09
|
3.96 μg/mL
Interval 3.18 to 4.95
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 23F
|
3.21 μg/mL
Interval 2.42 to 4.25
|
3.74 μg/mL
Interval 2.85 to 4.91
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 22F
|
3.94 μg/mL
Interval 3.07 to 5.05
|
3.50 μg/mL
Interval 2.75 to 4.45
|
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Serotype 33F
|
6.18 μg/mL
Interval 4.72 to 8.09
|
9.20 μg/mL
Interval 7.19 to 11.77
|
Adverse Events
V114
Serious events: 3 serious events
Other events: 103 other events
Deaths: 0 deaths
Prevnar 13™
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
V114 (Post-PPV23)
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
Prevnar 13™ (Post-PPV23)
Serious events: 6 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=152 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1).
|
Prevnar 13™
n=150 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1).
|
V114 (Post-PPV23)
n=150 participants at risk
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 (PPV23) at Week 8 (Vaccination 2).
|
Prevnar 13™ (Post-PPV23)
n=148 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PPV23 at Week 8 (Vaccination 2).
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.68%
1/148 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.67%
1/150 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/148 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
1.4%
2/148 • Number of events 2 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.68%
1/148 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.68%
1/148 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.68%
1/148 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.66%
1/152 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/148 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.66%
1/152 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/148 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Psychiatric disorders
Suicide attempt
|
0.66%
1/152 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/148 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.67%
1/150 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/148 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/152 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.00%
0/150 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
0.68%
1/148 • Number of events 1 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
Other adverse events
| Measure |
V114
n=152 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1).
|
Prevnar 13™
n=150 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1).
|
V114 (Post-PPV23)
n=150 participants at risk
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 (PPV23) at Week 8 (Vaccination 2).
|
Prevnar 13™ (Post-PPV23)
n=148 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PPV23 at Week 8 (Vaccination 2).
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
20.4%
31/152 • Number of events 34 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
13.3%
20/150 • Number of events 23 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
12.7%
19/150 • Number of events 20 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
10.8%
16/148 • Number of events 16 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
General disorders
Injection site erythema
|
5.3%
8/152 • Number of events 8 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
3.3%
5/150 • Number of events 5 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
10.0%
15/150 • Number of events 15 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
12.2%
18/148 • Number of events 18 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
General disorders
Injection site pain
|
57.9%
88/152 • Number of events 100 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
52.0%
78/150 • Number of events 86 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
53.3%
80/150 • Number of events 97 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
62.2%
92/148 • Number of events 101 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
General disorders
Injection site swelling
|
11.8%
18/152 • Number of events 18 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
4.0%
6/150 • Number of events 6 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
20.0%
30/150 • Number of events 30 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
29.1%
43/148 • Number of events 43 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
19/152 • Number of events 21 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
9.3%
14/150 • Number of events 15 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
11.3%
17/150 • Number of events 18 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
12.2%
18/148 • Number of events 18 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
|
Nervous system disorders
Headache
|
13.2%
20/152 • Number of events 23 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
9.3%
14/150 • Number of events 15 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
8.7%
13/150 • Number of events 14 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
8.8%
13/148 • Number of events 13 • V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.
The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER