Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028) (NCT NCT03848065)
NCT ID: NCT03848065
Last Updated: 2025-01-15
Results Overview
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 injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
133 participants
Primary outcome timeframe
Day 1 to Day 14 post each vaccination
Results posted on
2025-01-15
Participant Flow
Healthy male and female participants of 3 months of age were enrolled in this study.
Participant milestones
| Measure |
V114-SC
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
Infant participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
Infant participants received a single 0.5 mL SC injection of pneumococcal 13-valent conjugate vaccine (PCV13) at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
45
|
44
|
|
Overall Study
Vaccination 1
|
44
|
45
|
43
|
|
Overall Study
Vaccination 2
|
44
|
45
|
43
|
|
Overall Study
Vaccination 3
|
44
|
45
|
42
|
|
Overall Study
Vaccination 4
|
44
|
44
|
42
|
|
Overall Study
COMPLETED
|
44
|
44
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
V114-SC
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
Infant participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
Infant participants received a single 0.5 mL SC injection of pneumococcal 13-valent conjugate vaccine (PCV13) at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
Baseline characteristics by cohort
| Measure |
V114-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 Participants
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.7 Weeks
STANDARD_DEVIATION 0.8 • n=5 Participants
|
13.9 Weeks
STANDARD_DEVIATION 1.0 • n=7 Participants
|
13.8 Weeks
STANDARD_DEVIATION 1.1 • n=5 Participants
|
13.8 Weeks
STANDARD_DEVIATION 1.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
133 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14 post each vaccinationPopulation: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.
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 injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.
Outcome measures
| Measure |
V114-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 Participants
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 Participants
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Injection Site Erythema (Redness)
|
100.0 Percentage of Participants
|
82.2 Percentage of Participants
|
95.3 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Injection Site Induration (Hard Lump)
|
90.9 Percentage of Participants
|
77.8 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Injection Site Pain
|
38.6 Percentage of Participants
|
28.9 Percentage of Participants
|
41.9 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Injection Site Swelling
|
86.4 Percentage of Participants
|
73.3 Percentage of Participants
|
88.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14 post each vaccinationPopulation: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.
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 were decreased appetite (appetite loss), somnolence (drowsiness), irritability and urticaria (hives/welts).
Outcome measures
| Measure |
V114-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 Participants
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 Participants
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Decreased Appetite (Appetite Loss)
|
25.0 Percentage of Participants
|
35.6 Percentage of Participants
|
34.9 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Somnolence (Drowsiness)
|
70.5 Percentage of Participants
|
60.0 Percentage of Participants
|
74.4 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Irritability
|
81.8 Percentage of Participants
|
71.1 Percentage of Participants
|
74.4 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event
Urticaria (Hives/Welts)
|
9.1 Percentage of Participants
|
4.4 Percentage of Participants
|
7.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks post vaccination 4 (~14.5 months)Population: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.
An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator.
Outcome measures
| Measure |
V114-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 Participants
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 Participants
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: One month post vaccination 3 (~3 months after Vaccination 1)Population: Analysis population consisted of those participants who were not considered protocol violators.
Serotype-specific pneumococcal IgG antibody was measured using pneumococcal electrochemiluminescence (PnECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Outcome measures
| Measure |
V114-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 Participants
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 Participants
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 4
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
Serotype (ST) 1
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 3
|
100.0 Percentage of Participants
|
97.8 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 5
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 6A
|
97.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 6B
|
90.9 Percentage of Participants
|
93.3 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 7F
|
100.0 Percentage of Participants
|
97.8 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 9V
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 14
|
97.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 18C
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 19A
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 19F
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 23F
|
97.7 Percentage of Participants
|
100.0 Percentage of Participants
|
97.6 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 22F
|
95.5 Percentage of Participants
|
100.0 Percentage of Participants
|
4.8 Percentage of Participants
|
|
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
ST 33F
|
81.8 Percentage of Participants
|
88.9 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (~3 months after Vaccination 1)Population: Analysis population consisted of those participants who were not considered protocol violators.
The anti-pneumococcal polysaccharide (PnPs) serotype-specific IgG Geometric Mean Concentrations (GMCs) were determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 Participants
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 Participants
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 33F
|
1.15 μg/mL
Interval 0.81 to 1.62
|
1.56 μg/mL
Interval 1.11 to 2.19
|
0.05 μg/mL
Interval 0.03 to 0.06
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 1
|
4.03 μg/mL
Interval 3.33 to 4.88
|
4.55 μg/mL
Interval 3.76 to 5.5
|
5.30 μg/mL
Interval 4.36 to 6.45
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 3
|
3.95 μg/mL
Interval 3.2 to 4.89
|
4.52 μg/mL
Interval 3.66 to 5.57
|
3.04 μg/mL
Interval 2.44 to 3.78
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 4
|
5.40 μg/mL
Interval 4.63 to 6.29
|
6.02 μg/mL
Interval 5.17 to 7.01
|
7.48 μg/mL
Interval 6.39 to 8.75
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 5
|
3.51 μg/mL
Interval 2.8 to 4.4
|
3.98 μg/mL
Interval 3.19 to 4.98
|
4.20 μg/mL
Interval 3.33 to 5.29
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 6A
|
2.09 μg/mL
Interval 1.7 to 2.57
|
2.30 μg/mL
Interval 1.88 to 2.82
|
3.33 μg/mL
Interval 2.69 to 4.11
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 6B
|
1.51 μg/mL
Interval 1.14 to 1.99
|
1.72 μg/mL
Interval 1.31 to 2.27
|
2.85 μg/mL
Interval 2.14 to 3.78
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 7F
|
2.95 μg/mL
Interval 2.42 to 3.59
|
3.32 μg/mL
Interval 2.73 to 4.03
|
4.85 μg/mL
Interval 3.97 to 5.94
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 9V
|
4.18 μg/mL
Interval 3.45 to 5.06
|
4.75 μg/mL
Interval 3.93 to 5.74
|
5.54 μg/mL
Interval 4.55 to 6.74
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 14
|
11.43 μg/mL
Interval 8.99 to 14.53
|
13.79 μg/mL
Interval 10.87 to 17.48
|
13.54 μg/mL
Interval 10.59 to 17.31
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 18C
|
3.10 μg/mL
Interval 2.58 to 3.72
|
3.17 μg/mL
Interval 2.64 to 3.8
|
4.48 μg/mL
Interval 3.72 to 5.41
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 19A
|
6.27 μg/mL
Interval 5.15 to 7.63
|
5.25 μg/mL
Interval 4.33 to 6.38
|
7.22 μg/mL
Interval 5.9 to 8.83
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 19F
|
5.42 μg/mL
Interval 4.65 to 6.32
|
5.85 μg/mL
Interval 5.02 to 6.8
|
7.62 μg/mL
Interval 6.51 to 8.92
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 23F
|
2.56 μg/mL
Interval 2.04 to 3.2
|
2.57 μg/mL
Interval 2.06 to 3.21
|
3.24 μg/mL
Interval 2.57 to 4.07
|
|
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
ST 22F
|
6.82 μg/mL
Interval 5.1 to 9.13
|
10.35 μg/mL
Interval 7.76 to 13.8
|
0.05 μg/mL
Interval 0.04 to 0.07
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (~3 months after Vaccination 1)Population: Analysis population consisted of those participants who were not considered protocol violators.
DTaP-IPV antibody titers were measured by neutralization assay (diphtheria toxin and poliovirus 1/2/3), particle agglutination assay (tetanus toxin) and enzyme-linked immunosorbent assay (ELISA) methodology (pertussis PT and pertussis FHA) 1 month post vaccination 3. Threshold values were: Diphtheria toxin level ≥0.1 IU/mL, Pertussis PT level ≥10 EU/mL, Pertussis FHA level ≥10 EU/mL, Tetanus toxin level ≥0.01 IU/mL, Neutralizing antibody (NA) titers of Polio virus types 1/2/3 ≥1:8.
Outcome measures
| Measure |
V114-SC
n=44 Participants
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 Participants
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 Participants
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Diphtheria toxin
|
97.7 Percentage of Participants
|
95.6 Percentage of Participants
|
95.2 Percentage of Participants
|
|
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Tetanus toxin
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
97.6 Percentage of Participants
|
|
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Pertussis toxin
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Pertussis FHA
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Poliovirus Type 1
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Poliovirus Type 2
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Poliovirus Type 3
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
Adverse Events
V114-SC
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
V114-IM
Serious events: 3 serious events
Other events: 44 other events
Deaths: 1 deaths
PCV13-SC
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114-SC
n=44 participants at risk
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 participants at risk
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 participants at risk
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/44 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.2%
1/45 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
0.00%
0/43 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/44 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
0.00%
0/45 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.3%
1/43 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/44 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.2%
1/45 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
0.00%
0/43 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
2.3%
1/44 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.2%
1/45 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.3%
1/43 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
Other adverse events
| Measure |
V114-SC
n=44 participants at risk
Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
V114-IM
n=45 participants at risk
Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
PCV13-SC
n=43 participants at risk
Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Number of events 6 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
0.00%
0/45 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
7.0%
3/43 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
4/44 • Number of events 4 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
11.1%
5/45 • Number of events 8 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
14.0%
6/43 • Number of events 6 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
General disorders
Injection site erythema
|
100.0%
44/44 • Number of events 236 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
82.2%
37/45 • Number of events 145 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
95.3%
41/43 • Number of events 217 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
General disorders
Injection site induration
|
90.9%
40/44 • Number of events 215 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
77.8%
35/45 • Number of events 144 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
100.0%
43/43 • Number of events 229 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
General disorders
Injection site pain
|
38.6%
17/44 • Number of events 43 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
28.9%
13/45 • Number of events 30 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
41.9%
18/43 • Number of events 49 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
General disorders
Injection site swelling
|
86.4%
38/44 • Number of events 174 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
73.3%
33/45 • Number of events 87 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
88.4%
38/43 • Number of events 163 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
General disorders
Injection site warmth
|
6.8%
3/44 • Number of events 10 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
4.4%
2/45 • Number of events 4 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
14.0%
6/43 • Number of events 10 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
General disorders
Pyrexia
|
61.4%
27/44 • Number of events 63 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
55.6%
25/45 • Number of events 50 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
62.8%
27/43 • Number of events 53 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
5/44 • Number of events 5 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
6.7%
3/45 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
7.0%
3/43 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
11/44 • Number of events 19 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
35.6%
16/45 • Number of events 30 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
34.9%
15/43 • Number of events 32 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Nervous system disorders
Somnolence
|
70.5%
31/44 • Number of events 64 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
60.0%
27/45 • Number of events 75 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
74.4%
32/43 • Number of events 81 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Psychiatric disorders
Irritability
|
81.8%
36/44 • Number of events 90 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
71.1%
32/45 • Number of events 87 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
74.4%
32/43 • Number of events 102 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
15.9%
7/44 • Number of events 9 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
17.8%
8/45 • Number of events 8 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
20.9%
9/43 • Number of events 11 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/44 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
0.00%
0/45 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
7.0%
3/43 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
9.1%
4/44 • Number of events 5 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
4.4%
2/45 • Number of events 2 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
11.6%
5/43 • Number of events 5 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
13.6%
6/44 • Number of events 7 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.2%
1/45 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.3%
1/43 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
2.3%
1/44 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
6.7%
3/45 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
4.7%
2/43 • Number of events 2 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.8%
3/44 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
0.00%
0/45 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.3%
1/43 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
6.8%
3/44 • Number of events 4 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
2.2%
1/45 • Number of events 1 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
4.7%
2/43 • Number of events 2 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.8%
3/44 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
6.7%
3/45 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
7.0%
3/43 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.1%
4/44 • Number of events 5 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
4.4%
2/45 • Number of events 3 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
7.0%
3/43 • Number of events 5 • Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. The Sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER