Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE) (NCT NCT03731182)
NCT ID: NCT03731182
Last Updated: 2021-06-16
Results Overview
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
104 participants
Primary outcome timeframe
Up to 14 days post-vaccination
Results posted on
2021-06-16
Participant Flow
Participant milestones
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
34
|
|
Overall Study
V114 or Prevnar 13™ Vaccination (Day 1)
|
69
|
34
|
|
Overall Study
COMPLETED
|
65
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal By Parent/Guardian
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)
Baseline characteristics by cohort
| Measure |
V114
n=70 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
10.8 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
38 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 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 14 days post-vaccinationPopulation: All randomized participants who received at least 1 dose of study vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Outcome measures
| Measure |
V114
n=69 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection site erythema
|
4.3 Percentage of participants
95% Confidence Interval 0.9 • Interval 0.9 to 12.2
|
5.9 Percentage of participants
95% Confidence Interval 0.7 • Interval 0.7 to 19.7
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection site induration
|
8.7 Percentage of participants
95% Confidence Interval 3.3 • Interval 3.3 to 18.0
|
8.8 Percentage of participants
95% Confidence Interval 1.9 • Interval 1.9 to 23.7
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection site pain
|
60.9 Percentage of participants
95% Confidence Interval 48.4 • Interval 48.4 to 72.4
|
67.6 Percentage of participants
95% Confidence Interval 49.5 • Interval 49.5 to 82.6
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection site swelling
|
27.5 Percentage of participants
95% Confidence Interval 17.5 • Interval 17.5 to 39.6
|
35.3 Percentage of participants
95% Confidence Interval 19.7 • Interval 19.7 to 53.5
|
PRIMARY outcome
Timeframe: Up to 14 days post-vaccinationPopulation: All randomized participants who received at least 1 dose of study vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
Outcome measures
| Measure |
V114
n=69 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Arthralgia
|
2.9 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 10.1
|
8.8 Percentage of participants
95% Confidence Interval 1.9 • Interval 1.9 to 23.7
|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Fatigue
|
13.0 Percentage of participants
95% Confidence Interval 6.1 • Interval 6.1 to 23.3
|
20.6 Percentage of participants
95% Confidence Interval 8.7 • Interval 8.7 to 37.9
|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Headache
|
24.6 Percentage of participants
95% Confidence Interval 15.1 • Interval 15.1 to 36.5
|
17.6 Percentage of participants
95% Confidence Interval 6.8 • Interval 6.8 to 34.5
|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Myalgia
|
23.2 Percentage of participants
95% Confidence Interval 13.9 • Interval 13.9 to 34.9
|
11.8 Percentage of participants
95% Confidence Interval 3.3 • Interval 3.3 to 27.5
|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Urticaria
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 5.2
|
2.9 Percentage of participants
95% Confidence Interval 0.1 • Interval 0.1 to 15.3
|
PRIMARY outcome
Timeframe: Up to 6 months post-vaccinationPopulation: All randomized participants who received at least 1 dose of study vaccination
A serious adverse event (SAE) is an AE that results in death, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Outcome measures
| Measure |
V114
n=69 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 5.2
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 10.3
|
PRIMARY outcome
Timeframe: Day 30Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Outcome measures
| Measure |
V114
n=69 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 1
|
2.12 μg/mL
Interval 1.63 to 2.75
|
2.76 μg/mL
Interval 1.95 to 3.91
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 3
|
1.09 μg/mL
Interval 0.87 to 1.38
|
1.07 μg/mL
Interval 0.7 to 1.65
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 4
|
1.58 μg/mL
Interval 1.18 to 2.1
|
2.90 μg/mL
Interval 2.0 to 4.2
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 5
|
4.44 μg/mL
Interval 3.19 to 6.17
|
6.56 μg/mL
Interval 4.09 to 10.52
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 6A
|
23.29 μg/mL
Interval 17.22 to 31.52
|
15.97 μg/mL
Interval 8.82 to 28.91
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 6B
|
38.38 μg/mL
Interval 28.53 to 51.64
|
22.94 μg/mL
Interval 13.6 to 38.71
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 7F
|
5.81 μg/mL
Interval 4.42 to 7.64
|
4.65 μg/mL
Interval 3.06 to 7.06
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 9V
|
4.46 μg/mL
Interval 3.44 to 5.78
|
5.36 μg/mL
Interval 3.45 to 8.33
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 14
|
16.03 μg/mL
Interval 11.23 to 22.9
|
20.53 μg/mL
Interval 12.39 to 34.03
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 18C
|
6.11 μg/mL
Interval 4.47 to 8.35
|
4.20 μg/mL
Interval 2.66 to 6.62
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 19A
|
19.86 μg/mL
Interval 14.77 to 26.7
|
21.65 μg/mL
Interval 14.45 to 32.44
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 19F
|
13.88 μg/mL
Interval 9.96 to 19.35
|
12.80 μg/mL
Interval 9.1 to 18.01
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 23F
|
5.38 μg/mL
Interval 3.88 to 7.46
|
6.88 μg/mL
Interval 4.01 to 11.83
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 22F
|
7.30 μg/mL
Interval 5.68 to 9.36
|
0.49 μg/mL
Interval 0.33 to 0.73
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Serotype 33F
|
4.46 μg/mL
Interval 3.38 to 5.87
|
0.97 μg/mL
Interval 0.62 to 1.51
|
SECONDARY outcome
Timeframe: Day 30Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
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 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
Outcome measures
| Measure |
V114
n=69 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 1
|
484.0 1/dil
Interval 327.5 to 715.4
|
504.0 1/dil
Interval 254.8 to 997.0
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 3
|
264.8 1/dil
Interval 193.4 to 362.4
|
234.3 1/dil
Interval 133.0 to 412.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 4
|
4670.8 1/dil
Interval 2965.9 to 7355.6
|
7015.5 1/dil
Interval 3994.0 to 12322.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 5
|
1383.9 1/dil
Interval 957.1 to 2000.9
|
1198.2 1/dil
Interval 638.1 to 2250.0
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 6A
|
27305.7 1/dil
Interval 19797.6 to 37661.2
|
20277.1 1/dil
Interval 11740.2 to 35021.7
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 6B
|
31560.4 1/dil
Interval 24134.1 to 41272.1
|
18531.0 1/dil
Interval 11024.7 to 31148.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 7F
|
19411.5 1/dil
Interval 15195.9 to 24796.5
|
16928.1 1/dil
Interval 11107.4 to 25799.0
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 9V
|
4561.8 1/dil
Interval 3240.7 to 6421.4
|
3941.7 1/dil
Interval 2659.6 to 5841.7
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 14
|
6597.6 1/dil
Interval 4706.8 to 9248.0
|
8112.2 1/dil
Interval 4827.2 to 13632.8
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 18C
|
9684.6 1/dil
Interval 6642.1 to 14120.7
|
5685.1 1/dil
Interval 3329.4 to 9707.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 19A
|
14067.7 1/dil
Interval 9972.8 to 19843.9
|
9224.9 1/dil
Interval 5015.5 to 16967.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 19F
|
4931.8 1/dil
Interval 3387.8 to 7179.7
|
3313.3 1/dil
Interval 2039.4 to 5383.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 23F
|
17190.9 1/dil
Interval 12066.0 to 24492.4
|
19197.1 1/dil
Interval 10511.1 to 35061.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 22F
|
7257.5 1/dil
Interval 5278.5 to 9978.3
|
1013.2 1/dil
Interval 477.4 to 2150.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Serotype 33F
|
24013.6 1/dil
Interval 17612.4 to 32741.4
|
4824.8 1/dil
Interval 3216.3 to 7237.9
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: All randomized participants without protocol deviations that could have substantially impacted the results of these immunogenicity analyses and who had sufficient data to perform the analyses
IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Outcome measures
| Measure |
V114
n=69 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 1
|
6.2 Ratio
Interval 4.6 to 8.5
|
6.0 Ratio
Interval 3.7 to 9.9
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 3
|
4.8 Ratio
Interval 3.5 to 6.6
|
4.1 Ratio
Interval 2.6 to 6.7
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 4
|
6.0 Ratio
Interval 4.3 to 8.3
|
9.3 Ratio
Interval 5.4 to 16.2
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 5
|
5.3 Ratio
Interval 3.8 to 7.4
|
6.4 Ratio
Interval 3.8 to 10.8
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 6A
|
54.7 Ratio
Interval 37.9 to 78.9
|
40.6 Ratio
Interval 22.9 to 71.9
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 6B
|
37.2 Ratio
Interval 25.8 to 53.6
|
25.0 Ratio
Interval 13.8 to 45.3
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 7F
|
11.6 Ratio
Interval 8.3 to 16.0
|
9.8 Ratio
Interval 6.3 to 15.3
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 9V
|
7.4 Ratio
Interval 5.3 to 10.3
|
8.1 Ratio
Interval 4.9 to 13.2
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 14
|
10.8 Ratio
Interval 6.8 to 17.2
|
7.2 Ratio
Interval 3.5 to 14.8
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 18C
|
10.8 Ratio
Interval 7.7 to 15.1
|
7.6 Ratio
Interval 4.5 to 12.8
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 19A
|
8.2 Ratio
Interval 5.4 to 12.4
|
8.6 Ratio
Interval 5.0 to 14.9
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 19F
|
8.3 Ratio
Interval 5.6 to 12.3
|
7.6 Ratio
Interval 4.5 to 12.8
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 23F
|
9.3 Ratio
Interval 6.1 to 14.2
|
13.1 Ratio
Interval 7.4 to 23.4
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 22F
|
15.0 Ratio
Interval 10.1 to 22.1
|
1.1 Ratio
Interval 0.9 to 1.3
|
|
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Serotype 33F
|
9.0 Ratio
Interval 6.7 to 12.1
|
1.3 Ratio
Interval 1.0 to 1.7
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: All randomized participants without protocol deviations that could have substantially affected the results of these immunogenicity analyses and who had sufficient data to perform the analyses
Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Outcome measures
| Measure |
V114
n=69 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13™
n=34 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 1
|
24.1 Ratio
Interval 14.9 to 39.1
|
13.3 Ratio
Interval 5.1 to 34.2
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 3
|
4.9 Ratio
Interval 3.5 to 7.0
|
3.1 Ratio
Interval 1.8 to 5.6
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 4
|
10.2 Ratio
Interval 6.3 to 16.6
|
18.5 Ratio
Interval 8.8 to 38.9
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 5
|
23.7 Ratio
Interval 15.0 to 37.5
|
13.8 Ratio
Interval 6.6 to 28.6
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 6A
|
20.7 Ratio
Interval 13.3 to 32.1
|
11.2 Ratio
Interval 4.8 to 26.2
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 6B
|
21.7 Ratio
Interval 12.7 to 36.9
|
13.7 Ratio
Interval 6.8 to 27.7
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 7F
|
5.4 Ratio
Interval 3.8 to 7.7
|
5.4 Ratio
Interval 3.2 to 9.1
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 9V
|
4.4 Ratio
Interval 3.0 to 6.5
|
6.1 Ratio
Interval 3.6 to 10.4
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 14
|
6.9 Ratio
Interval 4.3 to 11.1
|
4.6 Ratio
Interval 2.1 to 10.2
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 18C
|
14.0 Ratio
Interval 8.9 to 22.0
|
4.8 Ratio
Interval 2.5 to 9.3
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 19A
|
9.0 Ratio
Interval 5.4 to 15.0
|
7.8 Ratio
Interval 4.4 to 14.0
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 19F
|
6.4 Ratio
Interval 4.3 to 9.7
|
6.6 Ratio
Interval 3.3 to 12.9
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 23F
|
10.4 Ratio
Interval 5.8 to 18.4
|
18.1 Ratio
Interval 8.8 to 37.1
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 22F
|
6.5 Ratio
Interval 3.7 to 11.3
|
0.9 Ratio
Interval 0.7 to 1.2
|
|
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Serotype 33F
|
3.8 Ratio
Interval 2.7 to 5.2
|
0.8 Ratio
Interval 0.7 to 1.0
|
Adverse Events
V114
Serious events: 13 serious events
Other events: 52 other events
Deaths: 0 deaths
Prevnar 13
Serious events: 8 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=69 participants at risk
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13
n=34 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
10.1%
7/69 • Number of events 9 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
17.6%
6/34 • Number of events 7 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
2.9%
1/34 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Pyelonephritis
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/34 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/34 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/34 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Viral infection
|
0.00%
0/69 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
2.9%
1/34 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/34 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Investigations
Medical observation
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/34 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/34 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
1.4%
1/69 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/34 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
Other adverse events
| Measure |
V114
n=69 participants at risk
Participants received a single 0.5 mL IM injection of V114 on Day 1.
|
Prevnar 13
n=34 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
General disorders
Fatigue
|
13.0%
9/69 • Number of events 9 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
20.6%
7/34 • Number of events 7 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
General disorders
Injection site erythema
|
4.3%
3/69 • Number of events 3 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
5.9%
2/34 • Number of events 2 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
General disorders
Injection site induration
|
8.7%
6/69 • Number of events 6 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
8.8%
3/34 • Number of events 3 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
General disorders
Injection site pain
|
60.9%
42/69 • Number of events 48 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
67.6%
23/34 • Number of events 25 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
General disorders
Injection site swelling
|
27.5%
19/69 • Number of events 21 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
35.3%
12/34 • Number of events 14 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
General disorders
Pyrexia
|
5.8%
4/69 • Number of events 4 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
2.9%
1/34 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
2/69 • Number of events 3 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
8.8%
3/34 • Number of events 4 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
4/69 • Number of events 4 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
2.9%
1/34 • Number of events 1 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.2%
16/69 • Number of events 20 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
11.8%
4/34 • Number of events 7 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Nervous system disorders
Headache
|
24.6%
17/69 • Number of events 25 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
17.6%
6/34 • Number of events 10 • Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination
The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER