Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02573181

Enrollment

253

Registered

2015-10-09

Start date

2015-10-30

Completion date

2016-01-28

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

Brief summary

This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

Interventions

BIOLOGICALV114

V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.

BIOLOGICALPrevnar 13™

Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Is in good health (any underlying chronic illness must be documented to be in stable condition) * Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry * Is a male or postmenopausal female

Exclusion criteria

* Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine * Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease * Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine * Is known or suspected impairment of immune function * Has received systemic corticosteroids for \>=14 consecutive days and has not completed treatment \<=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination * Has a coagulation disorder contraindicating intramuscular vaccination * Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease * Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion * Has participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study * Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Baseline (Day 1) and Day 30 after vaccination	The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Up to Day 14 after vaccination	Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Baseline (Day 1) and Day 30 after vaccination	The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Baseline (Day 1) and Day 30 after vaccination	The GMFR (Day 30 geometric mean concentration \[GMC\] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Percentage of Participants With an Adverse Event (AE)	Up to Day 44 after vaccination	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Up to Day 5 after vaccination	Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.

Secondary

Measure	Time frame	Description
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Baseline (Day 1) and Day 30 after vaccination	The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Baseline (Day 1) and Day 30 after vaccination	The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Baseline (Day 1) and Day 30 after vaccination	The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4).

Participant flow

Recruitment details

Participants were recruited at 17 study centers in the United States.

Participants by arm

Arm	Count
V114 Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.	127
Prevnar 13™ Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.	126
Total	253

Baseline characteristics

Characteristic	Prevnar 13™	Total	V114
Age, Continuous	72.7 Years STANDARD_DEVIATION 5.7	72.7 Years STANDARD_DEVIATION 5.8	72.7 Years STANDARD_DEVIATION 5.8
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants	39 Participants	20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants	214 Participants	107 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	8 Participants	15 Participants	7 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	118 Participants	238 Participants	120 Participants
Sex: Female, Male Female	75 Participants	151 Participants	76 Participants
Sex: Female, Male Male	51 Participants	102 Participants	51 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 127	0 / 126
other Total, other adverse events	86 / 127	74 / 126
serious Total, serious adverse events	0 / 127	2 / 126

Outcome results

Primary

Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.

Time frame: Baseline (Day 1) and Day 30 after vaccination

Population: Randomized and vaccinated participants with no protocol violations are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F Day 30	4.01 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1 Day 1	1.11 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1 Day 30	3.31 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3 Day 1	0.19 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3 Day 30	0.72 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4 Day 1	0.32 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4 Day 30	1.13 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5 Day 1	1.31 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5 Day 30	2.69 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A Day 1	0.48 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A Day 30	3.85 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B Day 1	0.64 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B Day 30	3.74 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F Day 1	1.25 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F Day 30	3.85 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V Day 1	1.26 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V Day 30	3.79 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14 Day 1	2.84 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14 Day 30	5.46 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C Day 1	1.69 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C Day 30	6.85 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A Day 1	3.28 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A Day 30	9.3 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F Day 1	1.46 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F Day 30	5.06 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F Day 1	0.74 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F Day 30	2.57 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F Day 1	0.71 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F Day 1	2.98 µg/mL
V114	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F Day 30	6.57 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V Day 1	1.04 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F Day 1	1.45 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1 Day 1	1.27 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V Day 30	2.72 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1 Day 30	3.42 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F Day 1	0.73 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3 Day 1	0.19 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14 Day 1	4.10 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3 Day 30	0.46 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F Day 30	4.35 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4 Day 1	0.33 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14 Day 30	6.45 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4 Day 30	1.15 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F Day 30	3.35 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5 Day 1	1.48 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C Day 1	1.76 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5 Day 30	3.67 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F Day 1	0.68 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A Day 1	0.47 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C Day 30	5.30 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A Day 30	4.34 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F Day 30	3.11 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B Day 1	0.67 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A Day 1	3.29 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B Day 30	3.70 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F Day 30	0.60 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F Day 1	1.01 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A Day 30	9.41 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F Day 30	3.24 µg/mL
Prevnar 13™	Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F Day 1	3.30 µg/mL

Primary

Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

The GMFR (Day 30 geometric mean concentration \[GMC\] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.

Time frame: Baseline (Day 1) and Day 30 after vaccination

Population: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5	2.14 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V	2.98 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1	2.98 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14	1.90 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A	7.09 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C	4.06 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4	3.37 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F	3.37 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B	5.20 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F	3.27 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3	3.14 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F	5.26 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F	2.97 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F	2.22 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A	2.85 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F	0.91 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A	2.81 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1	2.70 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3	2.03 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4	3.28 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5	2.39 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A	8.24 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B	4.92 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F	3.03 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V	2.57 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14	1.48 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C	2.93 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F	2.86 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F	0.90 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F	4.24 GMFR

Primary

Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.

Time frame: Baseline (Day 1) and Day 30 after vaccination

Population: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.

Arm	Measure	Group	Value (NUMBER)
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A	64.7 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14	18.5 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3	36.1 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C	46.2 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B	54.6 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A	31.1 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5	19.3 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F	35.3 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F	31.1 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F	31.9 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4	36.1 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F	52.9 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V	35.3 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F	24.4 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1	32.8 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 33F	0.0 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 1	26.5 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 3	17.1 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 4	35.9 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 5	23.9 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6A	65.0 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 6B	46.2 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 7F	33.3 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 9V	23.9 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 14	9.4 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 18C	30.8 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19A	35.0 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 19F	33.3 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 22F	0.0 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)	Serotype 23F	45.3 Percentage of Participants

Primary

Percentage of Participants With an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Time frame: Up to Day 44 after vaccination

Population: All participants who received study vaccination are included.

Arm	Measure	Value (NUMBER)
V114	Percentage of Participants With an Adverse Event (AE)	68.5 Percentage of Participants
Prevnar 13™	Percentage of Participants With an Adverse Event (AE)	64.3 Percentage of Participants

95% CI: [-7.4, 15.8]

Primary

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.

Time frame: Up to Day 5 after vaccination

Population: All participants who received study vaccination are included.

Arm	Measure	Group	Value (NUMBER)
V114	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Erythema/Redness	7.9 Percentage of Participants
V114	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Swelling	14.2 Percentage of Participants
V114	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Tenderness/Pain	55.1 Percentage of Participants
Prevnar 13™	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Erythema/Redness	7.1 Percentage of Participants
Prevnar 13™	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Swelling	6.3 Percentage of Participants
Prevnar 13™	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Tenderness/Pain	44.4 Percentage of Participants

Primary

Percentage of Participants With a Solicited Systemic Adverse Event (AE)

Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.

Time frame: Up to Day 14 after vaccination

Population: All participants who received study vaccination are included.

Arm	Measure	Group	Value (NUMBER)
V114	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Fatigue	18.1 Percentage of Participants
V114	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Arthralgia	5.5 Percentage of Participants
V114	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Myalgia	15.7 Percentage of Participants
V114	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Headache	13.4 Percentage of Participants
Prevnar 13™	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Headache	15.9 Percentage of Participants
Prevnar 13™	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Fatigue	19.0 Percentage of Participants
Prevnar 13™	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Myalgia	11.1 Percentage of Participants
Prevnar 13™	Percentage of Participants With a Solicited Systemic Adverse Event (AE)	Arthralgia	8.7 Percentage of Participants

95% CI: [-10.7, 8.8]

95% CI: [-10.2, 3.4]

95% CI: [-3.9, 13.3]

95% CI: [-11.4, 6.4]

Secondary

Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)

The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).

Time frame: Baseline (Day 1) and Day 30 after vaccination

Population: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F	5.55 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1	4.16 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3	5.06 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4	6.59 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5	3.94 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A	25.19 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B	11.83 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F	4.77 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V	5.79 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14	2.52 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C	8.14 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A	4.14 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F	8.88 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F	10.41 GMFR
V114	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F	3.91 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C	4.93 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F	4.02 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F	9.58 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F	7.59 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1	3.33 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F	0.85 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3	3.24 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V	5.79 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4	7.94 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A	3.83 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5	4.95 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14	1.89 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A	43.85 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F	1.03 GMFR
Prevnar 13™	Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B	14.74 GMFR

Secondary

Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)

The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4).

Time frame: Baseline (Day 1) and Day 30 after vaccination

Population: Randomized and vaccinated participants with no protocol violations are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V Day 1	320.81 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C Day 30	1550.65 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V Day 30	1962.51 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5 Day 30	183.10 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14 Day 1	451.24 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3 Day 30	145.24 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14 Day 30	1228.80 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A Day 1	71.43 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C Day 1	180.26 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1 Day 30	109.25 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A Day 1	498.71 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A Day 30	2321.06 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A Day 30	2078.60 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4 Day 1	114.78 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F Day 1	145.50 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B Day 1	175.69 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F Day 30	919.31 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1 Day 1	20.30 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F Day 1	173.09 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B Day 30	2389.20 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F Day 30	1761.25 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4 Day 30	881.94 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F Day 1	69.60 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F Day 1	228.75 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F Day 30	846.33 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3 Day 1	23.37 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F Day 1	1950.86 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F Day 30	1232.86 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F Day 30	7856.78 Titers
V114	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5 Day 1	41.89 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F Day 30	2572.78 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1 Day 1	24.24 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1 Day 30	91.53 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3 Day 1	26.71 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3 Day 30	103.77 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4 Day 1	96.28 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4 Day 30	924.82 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5 Day 1	39.52 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5 Day 30	222.18 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A Day 1	46.57 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A Day 30	2798.09 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B Day 1	132.41 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B Day 30	2423.27 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F Day 1	205.76 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F Day 30	1664.85 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V Day 1	222.07 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V Day 30	1387.45 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14 Day 1	475.62 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14 Day 30	899.66 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C Day 30	1009.16 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A Day 1	480.66 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A Day 30	1861.84 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F Day 1	234.63 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F Day 30	961.71 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F Day 1	120.52 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F Day 30	107.83 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F Day 1	48.74 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F Day 30	572.82 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F Day 1	2093.00 Titers
Prevnar 13™	Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C Day 1	205.56 Titers

Secondary

Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)

The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).

Time frame: Baseline (Day 1) and Day 30 after vaccination

Population: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.

Arm	Measure	Group	Value (NUMBER)
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5	44.9 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14	18.6 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1	40.7 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C	54.2 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A	71.8 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A	37.3 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B	62.7 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F	40.2 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4	44.1 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F	50.4 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F	41.0 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F	61.0 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3	53.8 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F	38.1 Percentage of Participants
V114	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V	47.9 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 33F	6.3 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 1	33.6 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 3	39.3 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 4	54.9 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 5	50.4 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6B	67.0 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 7F	50.0 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 9V	44.6 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 14	15.9 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 18C	43.4 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19A	37.2 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 19F	38.1 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 22F	9.8 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 23F	52.2 Percentage of Participants
Prevnar 13™	Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)	Serotype 6A	77.0 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026

Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

Percentage of Participants With an Adverse Event (AE)

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Percentage of Participants With a Solicited Systemic Adverse Event (AE)

Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)

Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)

Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)