Pneumococcal Infections
Conditions
Keywords
Pneumococcal vaccines
Brief summary
The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older. The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.
Interventions
BIOLOGICALPneumococcal Conjugate Vaccine (V114)
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
BIOLOGICALPNEUMOVAX® 23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.
BIOLOGICALPREVNAR 13®
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Without fever for 72 hours prior to vaccination
Exclusion criteria
* Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine * Known or suspected to be immunocompromised * Functional or anatomic asplenia * History of autoimmune disease * Evidence of dementia or cognitive impairment * Use of any immunosuppressive therapy * Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine * Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine * Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine * Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine * History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease * Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Up to Day 14 postvaccination | Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed. |
| Percentage of Participants With an Adverse Event | All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. |
| Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Up to Day 14 postvaccination | Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed. |
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | One month postvaccination | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay. |
| Percentage of Participants With a Serious Adverse Event | Up to 6 months postvaccination | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | Up to 6 months postvaccination | A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | One month postvaccination | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4) |
Participant flow
Recruitment details
This trial was conducted at 25 trial centers: 10 in the United States; 2 in Canada; 2 in Denmark; 2 in Israel; 2 in Norway, 3 in Poland, 2 in Spain and 2 in Sweden.
Participants by arm
| Arm | Count |
|---|---|
| V114 Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. | 230 |
| PNEUMOVAX® 23 Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1. | 231 |
| PREVNAR 13® Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1. | 230 |
| Total | 691 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 5 | 2 |
| Overall Study | Randomized but not vaccinated | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | V114 | PNEUMOVAX® 23 | PREVNAR 13® | Total |
|---|---|---|---|---|
| Age, Customized 50 to 64 years | 79 Participants | 80 Participants | 80 Participants | 239 Participants |
| Age, Customized 65 to 74 years | 75 Participants | 76 Participants | 74 Participants | 225 Participants |
| Age, Customized >= 75 years | 76 Participants | 75 Participants | 76 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 20 Participants | 14 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 216 Participants | 211 Participants | 215 Participants | 642 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 6 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 6 Participants | 12 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 212 Participants | 217 Participants | 212 Participants | 641 Participants |
| Sex: Female, Male Female | 122 Participants | 123 Participants | 122 Participants | 367 Participants |
| Sex: Female, Male Male | 108 Participants | 108 Participants | 108 Participants | 324 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 229 | 1 / 230 | 0 / 230 |
| other Total, other adverse events | 167 / 229 | 149 / 230 | 141 / 230 |
| serious Total, serious adverse events | 4 / 229 | 7 / 230 | 5 / 230 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.
Time frame: One month postvaccination
Population: The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 22F | 5.21 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 9V | 4.05 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 4 | 1.96 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 23F | 5.55 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 19F | 3.35 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 3 | 1.13 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 33F | 11.56 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 1 | 3.76 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 7F | 4.59 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 14 | 8.56 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 18C | 8.00 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 6B | 5.43 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 19A | 9.36 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 5 | 3.99 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 6A | 4.88 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 33F | 8.26 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 1 | 3.30 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 4 | 1.03 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 9V | 2.72 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 14 | 8.13 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 19A | 6.99 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 22F | 1.98 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 23F | 1.82 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 3 | 0.57 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 5 | 2.70 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 6A | 1.14 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 6B | 2.01 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 7F | 3.74 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 18C | 4.66 µg/mL |
| PNEUMOVAX® 23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 19F | 4.17 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 19A | 11.36 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 4 | 2.09 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 6A | 4.86 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 18C | 6.83 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 19F | 4.80 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 6B | 2.81 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 9V | 3.41 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 1 | 3.12 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 33F | 0.85 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 23F | 3.41 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 7F | 6.06 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 3 | 0.56 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 22F | 0.38 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 14 | 8.90 µg/mL |
| PREVNAR 13® | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Serotype 5 | 2.76 µg/mL |
Primary
Percentage of Participants With an Adverse Event
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Time frame: All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination
Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With an Adverse Event | 75.1 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With an Adverse Event | 68.3 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With an Adverse Event | 65.7 Percentage of Participants |
95% CI: [-1.4, 15]Miettinen & Nurminen
95% CI: [1.1, 17.7]Miettinen & Nurminen
Primary
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed.
Time frame: Up to Day 14 postvaccination
Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site induration | 14.8 Percentage of Participants |
| V114 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site warmth | 0.9 Percentage of Participants |
| V114 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site swelling | 20.1 Percentage of Participants |
| V114 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site pruritus | 3.1 Percentage of Participants |
| V114 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site erythema | 14.8 Percentage of Participants |
| V114 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site pain | 60.3 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site erythema | 14.8 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site induration | 10.4 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site pain | 51.3 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site swelling | 10.9 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site warmth | 0.0 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site pruritus | 1.3 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site pruritus | 2.2 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site warmth | 2.2 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site induration | 12.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site erythema | 13.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site swelling | 18.3 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection site pain | 53.0 Percentage of Participants |
Primary
Percentage of Participants With a Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Time frame: Up to 6 months postvaccination
Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Serious Adverse Event | 1.7 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With a Serious Adverse Event | 3.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With a Serious Adverse Event | 2.2 Percentage of Participants |
Primary
Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed.
Time frame: Up to Day 14 postvaccination
Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | 48.5 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | 43.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | 45.6 Percentage of Participants |
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event
A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.
Time frame: Up to 6 months postvaccination
Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 Percentage of Participants |
| PNEUMOVAX® 23 | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 Percentage of Participants |
Secondary
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)
Time frame: One month postvaccination
Population: The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 14 | 4352.27 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 18C | 4631.86 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 5 | 712.21 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 22F | 8329.52 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 19A | 3391.18 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 6A | 4216.34 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 19F | 1201.17 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 4 | 2875.79 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 3 | 595.16 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 6B | 6469.99 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 1 | 208.03 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 33F | 31116.90 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 7F | 5148.66 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 9V | 3024.34 Titer |
| V114 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 23F | 2217.18 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 6B | 1630.20 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 1 | 117.87 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 5 | 288.41 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 6A | 490.60 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 9V | 1674.44 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 18C | 2438.57 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 19A | 2682.65 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 19F | 1581.60 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 22F | 4382.78 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 23F | 378.41 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 3 | 313.83 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 4 | 1099.88 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 7F | 3665.62 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 14 | 3572.27 Titer |
| PNEUMOVAX® 23 | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 33F | 27560.15 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 23F | 1197.80 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 6B | 4207.86 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 6A | 5251.47 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 1 | 115.75 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 3 | 256.76 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 33F | 3129.94 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 4 | 3001.63 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 19A | 4186.28 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 5 | 372.35 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 19F | 1946.04 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 18C | 3358.41 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 14 | 4478.38 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 22F | 57.45 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 9V | 2471.10 Titer |
| PREVNAR 13® | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | Serotype 7F | 7816.74 Titer |