Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033) (NCT NCT04384107)

Last Updated: 2023-07-28

Results Overview

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

694 participants

Primary outcome timeframe

Day 1 to Day 14 post any vaccination, up to a total of 13.5 months

Results posted on

2023-07-28

Participant Flow

This study enrolled healthy Japanese infants at 2 to 6 months of age.

694 infants were randomized in a 1:1 ratio with stratification into 3 categories by age category (2 months, 3 months and 4 to 6 months of age), to receive either V114 or Pneumococcal 13-valent Conjugate Vaccine (PCV13).

Participant milestones

Participant milestones
Measure	V114 Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Overall Study STARTED	347	347
Overall Study Dose 1	347	346
Overall Study Dose 2	344	346
Overall Study Dose 3	343	346
Overall Study Dose 4	340	342
Overall Study COMPLETED	338	341
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	V114 Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Overall Study Withdrawal By Parent/Guardian	8	6
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months

Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.

Outcome measures

Outcome measures
Measure	V114 n=347 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=346 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Percentage of Participants With Solicited Injection-Site Adverse Events Injection site erythema	88.2 Percentage of Participants	89.3 Percentage of Participants
Percentage of Participants With Solicited Injection-Site Adverse Events Injection site induration	81.0 Percentage of Participants	81.2 Percentage of Participants
Percentage of Participants With Solicited Injection-Site Adverse Events Injection site pain	31.1 Percentage of Participants	24.0 Percentage of Participants
Percentage of Participants With Solicited Injection-Site Adverse Events Injection site swelling	75.8 Percentage of Participants	79.8 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months

Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.

Outcome measures

Outcome measures
Measure	V114 n=347 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=346 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Percentage of Participants With Solicited Systemic Adverse Events Decreased appetite	23.9 Percentage of Participants	24.3 Percentage of Participants
Percentage of Participants With Solicited Systemic Adverse Events Irritability	66.6 Percentage of Participants	60.7 Percentage of Participants
Percentage of Participants With Solicited Systemic Adverse Events Somnolence	55.9 Percentage of Participants	54.9 Percentage of Participants
Percentage of Participants With Solicited Systemic Adverse Events Urticaria	4.0 Percentage of Participants	4.3 Percentage of Participants

PRIMARY outcome

Timeframe: ~1 month after Dose 4, up to a total of 14 months

Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.

Outcome measures

Outcome measures
Measure	V114 n=347 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=346 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Percentage of Participants With Vaccine-Related Serious Adverse Events	0.3 Percentage of Participants	0.3 Percentage of Participants

PRIMARY outcome

Timeframe: 30 Days after Dose 3, up to a total of 11 months

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed.

The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 n=339 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=343 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 1 (Shared)	99.7 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 3 (Shared)	100.0 Percentage of Participants	97.7 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 4 (Shared)	100.0 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 5 (Shared)	98.8 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 6A (Shared)	99.1 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 6B (Shared)	95.0 Percentage of Participants	98.8 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 7F (Shared)	99.7 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 9V (Shared)	99.7 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 14 (Shared)	99.4 Percentage of Participants	99.7 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 18C (Shared)	98.8 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 19A (Shared)	99.7 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 19F (Shared)	100.0 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 23F (Shared)	97.9 Percentage of Participants	99.7 Percentage of Participants
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 22F (Unique to V114)	99.7 Percentage of Participants	NA Percentage of Participants This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 3 at 97.7) in recipients of PCV13 for shared serotypes.
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 Serotype 33F (Unique to V114)	90.9 Percentage of Participants	NA Percentage of Participants This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 3 at 97.7) in recipients of PCV13 for shared serotypes.

PRIMARY outcome

Timeframe: 30 Days after Dose 3, up to a total of 11 months

The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 n=339 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=343 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 1 (Shared)	2.39 μg/mL Interval 2.19 to 2.62	3.95 μg/mL Interval 3.61 to 4.32
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 3 (Shared)	2.63 μg/mL Interval 2.39 to 2.89	1.42 μg/mL Interval 1.29 to 1.56
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 4 (Shared)	2.98 μg/mL Interval 2.71 to 3.27	3.54 μg/mL Interval 3.23 to 3.89
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 5 (Shared)	2.59 μg/mL Interval 2.32 to 2.89	3.35 μg/mL Interval 3.0 to 3.74
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 6A (Shared)	2.51 μg/mL Interval 2.26 to 2.79	4.45 μg/mL Interval 4.0 to 4.94
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 6B (Shared)	2.46 μg/mL Interval 2.14 to 2.82	4.17 μg/mL Interval 3.63 to 4.79
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 7F (Shared)	4.38 μg/mL Interval 3.95 to 4.85	5.22 μg/mL Interval 4.71 to 5.78
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 9V (Shared)	3.09 μg/mL Interval 2.8 to 3.41	3.55 μg/mL Interval 3.22 to 3.92
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 14 (Shared)	8.99 μg/mL Interval 7.96 to 10.14	12.03 μg/mL Interval 10.66 to 13.57
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 18C (Shared)	2.85 μg/mL Interval 2.58 to 3.14	3.85 μg/mL Interval 3.49 to 4.25
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 19A (Shared)	3.44 μg/mL Interval 3.14 to 3.77	5.28 μg/mL Interval 4.82 to 5.79
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 19F (Shared)	4.24 μg/mL Interval 3.93 to 4.58	5.65 μg/mL Interval 5.24 to 6.1
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 Serotype 23F (Shared)	2.42 μg/mL Interval 2.15 to 2.72	2.95 μg/mL Interval 2.62 to 3.32

SECONDARY outcome

Timeframe: 30 days after Dose 3, up to a total of 11 months

The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 n=339 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=343 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 Serotype 22F (Unique to V114)	6.59 μg/mL Interval 5.95 to 7.3	0.06 μg/mL Interval 0.06 to 0.07
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 Serotype 33F (Unique to V114)	1.85 μg/mL Interval 1.6 to 2.14	0.06 μg/mL Interval 0.05 to 0.07

SECONDARY outcome

Timeframe: 30 Days after Dose 4, up to a total of 14 months

The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.

Outcome measures

SECONDARY outcome

Timeframe: 30 Days after Dose 4, up to a total of 14 months

The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 n=333 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=334 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 1 (Shared)	2.74 μg/mL Interval 2.47 to 3.04	5.19 μg/mL Interval 4.68 to 5.77
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 3 (Shared)	2.18 μg/mL Interval 1.97 to 2.41	1.28 μg/mL Interval 1.15 to 1.41
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 4 (Shared)	2.91 μg/mL Interval 2.57 to 3.3	3.18 μg/mL Interval 2.81 to 3.59
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 5 (Shared)	4.43 μg/mL Interval 3.96 to 4.95	6.65 μg/mL Interval 5.95 to 7.43
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 6A (Shared)	6.05 μg/mL Interval 5.36 to 6.81	9.41 μg/mL Interval 8.35 to 10.6
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 6B (Shared)	8.03 μg/mL Interval 7.12 to 9.05	10.88 μg/mL Interval 9.66 to 12.26
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 7F (Shared)	5.80 μg/mL Interval 5.15 to 6.54	7.15 μg/mL Interval 6.35 to 8.05
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 9V (Shared)	4.27 μg/mL Interval 3.79 to 4.81	5.18 μg/mL Interval 4.6 to 5.83
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 14 (Shared)	9.51 μg/mL Interval 8.45 to 10.69	11.26 μg/mL Interval 10.02 to 12.66
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 18C (Shared)	5.21 μg/mL Interval 4.6 to 5.89	5.21 μg/mL Interval 4.61 to 5.9
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 19A (Shared)	6.88 μg/mL Interval 6.2 to 7.63	8.37 μg/mL Interval 7.55 to 9.28
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 19F (Shared)	6.53 μg/mL Interval 5.89 to 7.22	7.76 μg/mL Interval 7.01 to 8.58
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 23F (Shared)	3.75 μg/mL Interval 3.26 to 4.31	6.22 μg/mL Interval 5.42 to 7.15
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 22F (Unique to V114)	11.42 μg/mL Interval 10.31 to 12.66	0.13 μg/mL Interval 0.12 to 0.15
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 Serotype 33F (Unique to V114)	6.14 μg/mL Interval 5.48 to 6.89	0.14 μg/mL Interval 0.12 to 0.15

SECONDARY outcome

Timeframe: 30 Days after Dose 3, up to a total of 11 months

The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.

Outcome measures

Outcome measures
Measure	V114 n=337 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=340 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 9V (Shared)	2725.29 Titer Interval 2399.27 to 3095.62	3338.40 Titer Interval 2939.75 to 3791.11
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 5 (Shared)	1241.69 Titer Interval 1098.82 to 1403.14	1358.43 Titer Interval 1202.35 to 1534.79
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 6A (Shared)	9124.96 Titer Interval 7894.53 to 10547.16	11956.64 Titer Interval 10340.85 to 13824.91
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 6B (Shared)	8416.19 Titer Interval 7243.92 to 9778.18	10421.94 Titer Interval 8972.87 to 12105.02
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 7F (Shared)	22324.41 Titer Interval 19365.68 to 25735.19	27396.28 Titer Interval 23771.84 to 31573.33
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 1 (Shared)	211.51 Titer Interval 180.48 to 247.86	322.44 Titer Interval 275.23 to 377.76
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 3 (Shared)	660.68 Titer Interval 586.6 to 744.11	471.43 Titer Interval 418.48 to 531.08
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 4 (Shared)	3984.87 Titer Interval 3537.66 to 4488.62	4118.16 Titer Interval 3656.82 to 4637.7
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 14 (Shared)	14175.13 Titer Interval 12024.73 to 16710.08	12288.35 Titer Interval 10433.9 to 14472.4
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 18C (Shared)	3698.24 Titer Interval 3346.73 to 4086.66	3705.21 Titer Interval 3353.84 to 4093.39
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 19A (Shared)	2709.90 Titer Interval 2418.02 to 3037.02	3961.10 Titer Interval 3535.23 to 4438.26
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 19F (Shared)	2371.39 Titer Interval 2141.38 to 2624.87	2541.27 Titer Interval 2297.18 to 2811.29
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 23F (Shared)	11861.63 Titer Interval 10118.3 to 13905.32	18957.26 Titer Interval 16186.86 to 22201.82
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 22F (Unique to V114)	5575.08 Titer Interval 4769.68 to 6516.47	9.95 Titer Interval 8.51 to 11.63
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 Serotype 33F (Unique to V114)	23888.79 Titer Interval 17632.59 to 32364.75	121.79 Titer Interval 89.73 to 165.32

SECONDARY outcome

Timeframe: 30 Days after Dose 4, up to a total of 14 months

Population: The first 50% of all participants with sufficient serum volume after dose 3 to evaluate OPA responses were analyzed.

Outcome measures

Outcome measures
Measure	V114 n=157 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=156 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 1 (Shared)	453.42 Titer Interval 327.21 to 628.32	854.50 Titer Interval 616.64 to 1184.1
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 3 (Shared)	1444.00 Titer Interval 1166.36 to 1787.72	893.97 Titer Interval 720.25 to 1109.58
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 4 (Shared)	4531.52 Titer Interval 3592.99 to 5715.21	6264.94 Titer Interval 4957.63 to 7916.97
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 5 (Shared)	1853.08 Titer Interval 1439.01 to 2386.3	2151.95 Titer Interval 1669.81 to 2773.3
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 6A (Shared)	12553.06 Titer Interval 10072.11 to 15645.13	17476.24 Titer Interval 13999.28 to 21816.75
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 6B (Shared)	9218.64 Titer Interval 7346.96 to 11567.14	14041.53 Titer Interval 11171.79 to 17648.42
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 7F (Shared)	15451.96 Titer Interval 12500.49 to 19100.31	18039.04 Titer Interval 14593.41 to 22298.22
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 9V (Shared)	3259.24 Titer Interval 2548.05 to 4168.93	5050.89 Titer Interval 3957.89 to 6445.73
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 14 (Shared)	8486.72 Titer Interval 6720.27 to 10717.49	5719.04 Titer Interval 4521.91 to 7233.08
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 18C (Shared)	7027.62 Titer Interval 5704.7 to 8657.32	5903.86 Titer Interval 4785.06 to 7284.24
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 19A (Shared)	8441.43 Titer Interval 6620.55 to 10763.11	10834.58 Titer Interval 8499.57 to 13811.07
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 19F (Shared)	4716.70 Titer Interval 3863.66 to 5758.07	3829.62 Titer Interval 3138.93 to 4672.28
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 23F (Shared)	11319.82 Titer Interval 8635.69 to 14838.22	30686.58 Titer Interval 23314.4 to 40389.89
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 22F (Unique to V114)	5561.71 Titer Interval 3730.3 to 8292.26	35.68 Titer Interval 23.67 to 53.79
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 Serotype 33F (Unique to V114)	19899.34 Titer Interval 14204.44 to 27877.46	1183.52 Titer Interval 844.22 to 1659.18

Adverse Events

V114

Serious events: 24 serious events

Other events: 340 other events

Deaths: 0 deaths

PCV13

Serious events: 23 serious events

Other events: 340 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	V114 n=347 Participants Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=347 Participants Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	Total n=694 Participants Total of all reporting groups
Age, Continuous	2.4 months STANDARD_DEVIATION 0.4 • n=5 Participants	2.4 months STANDARD_DEVIATION 0.4 • n=7 Participants	2.4 months STANDARD_DEVIATION 0.4 • n=5 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	347 Participants n=5 Participants	347 Participants n=7 Participants	694 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	173 Participants n=7 Participants	339 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants	174 Participants n=7 Participants	355 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	347 Participants n=5 Participants	347 Participants n=7 Participants	694 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	347 Participants n=5 Participants	347 Participants n=7 Participants	694 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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

Measure	V114 n=347 participants at risk Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.	PCV13 n=346 participants at risk Participants received a single 0.5 ml subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Gastrointestinal disorders Diarrhoea	10.1% 35/347 • Number of events 43 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	5.8% 20/346 • Number of events 22 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
General disorders Injection site erythema	88.2% 306/347 • Number of events 878 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	89.3% 309/346 • Number of events 929 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
General disorders Injection site induration	81.0% 281/347 • Number of events 813 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	81.2% 281/346 • Number of events 787 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
General disorders Injection site pain	31.1% 108/347 • Number of events 178 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	24.0% 83/346 • Number of events 134 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
General disorders Injection site swelling	75.8% 263/347 • Number of events 670 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	79.8% 276/346 • Number of events 688 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
General disorders Pyrexia	65.4% 227/347 • Number of events 544 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	72.8% 252/346 • Number of events 610 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Infections and infestations Nasopharyngitis	9.2% 32/347 • Number of events 34 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	10.7% 37/346 • Number of events 39 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Infections and infestations Upper respiratory tract infection	5.8% 20/347 • Number of events 23 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	6.4% 22/346 • Number of events 29 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Metabolism and nutrition disorders Decreased appetite	23.9% 83/347 • Number of events 132 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	24.3% 84/346 • Number of events 117 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Nervous system disorders Somnolence	55.9% 194/347 • Number of events 430 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	54.9% 190/346 • Number of events 399 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Psychiatric disorders Irritability	66.6% 231/347 • Number of events 522 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	60.7% 210/346 • Number of events 500 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.9% 10/347 • Number of events 12 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	6.1% 21/346 • Number of events 23 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Skin and subcutaneous tissue disorders Eczema infantile	5.2% 18/347 • Number of events 19 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	4.6% 16/346 • Number of events 16 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Skin and subcutaneous tissue disorders Erythema	9.5% 33/347 • Number of events 44 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	9.0% 31/346 • Number of events 42 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Skin and subcutaneous tissue disorders Rash	4.9% 17/347 • Number of events 21 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	5.2% 18/346 • Number of events 22 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
Skin and subcutaneous tissue disorders Skin induration	6.6% 23/347 • Number of events 29 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.	5.2% 18/346 • Number of events 22 • Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.