Pneumococcal Disease
Conditions
Brief summary
The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease
Interventions
BIOLOGICALPneumovax™ 23
Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* For participants 50 years of age or older: any underlying chronic illness must be in stable condition * For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities * Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination
Exclusion criteria
* Received prior vaccination with pneumococcal vaccine * Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids * Has history of autoimmune disease * Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination * Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination * Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine) * Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination * Hospitalized for acute illness within 3 months before study vaccination * Is a pregnant woman or nursing mother * History of invasive pneumococcal disease or of other culture-positive pneumococcal disease * History of fever illness within 3 days before study vaccination * Received antibiotic therapy for any acute illness within 7 days before study vaccination * Hypersensitivity to any components of the vaccine, including phenol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Prevaccination and Day 28 after vaccination | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays |
| Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Day 28 postvaccination | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A \>=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults. |
| Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) | Up to 5 days postvaccination | — |
| Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants | Up to Day 14 postvaccination | 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 of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in \>=4 participants were reported for this endpoint. |
| Number of Participants Reporting Serious Adverse Experiences | Up to Day 28 postvaccination | A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years Participants received a single 0.5 mL intramuscular injection on Day 1 | 52 |
| Pneumovax™ 23: Participants >=50 Years Participants received a single 0.5 mL intramuscular injection on Day 1 | 50 |
| Total | 102 |
Baseline characteristics
| Characteristic | Pneumovax™ 23: Participants Between 2 and 49 Years | Pneumovax™ 23: Participants >=50 Years | Total |
|---|---|---|---|
| Age, Continuous | 21.2 Years STANDARD_DEVIATION 15.3 | 60.4 Years STANDARD_DEVIATION 7.7 | 40.4 Years STANDARD_DEVIATION 23.1 |
| Sex: Female, Male Female | 16 Participants | 21 Participants | 37 Participants |
| Sex: Female, Male Male | 36 Participants | 29 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
Time frame: Prevaccination and Day 28 after vaccination
Population: The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 6B prevaccination | 0.5 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 14 Day 28 postvaccination | 13.2 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 1 Day 28 postvaccination | 4.1 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 6B Day 28 postvaccination | 2.7 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 19F Day 28 postvaccination | 12.6 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 1 prevaccination | 0.2 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 23F prevaccination | 0.6 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 14 prevaccination | 1.3 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 23F Day 28 postvaccination | 5.3 ug/mL |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 19F prevaccination | 1.5 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 23F Day 28 postvaccination | 8.1 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 1 prevaccination | 0.2 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 1 Day 28 postvaccination | 2.5 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 6B prevaccination | 0.6 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 6B Day 28 postvaccination | 5.3 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 14 prevaccination | 3.6 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 14 Day 28 postvaccination | 32.7 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 19F prevaccination | 1.5 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 19F Day 28 postvaccination | 9.9 ug/mL |
| Pneumovax™ 23: Participants >=50 Years | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 23F prevaccination | 1.1 ug/mL |
Primary
Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
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 of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in \>=4 participants were reported for this endpoint.
Time frame: Up to Day 14 postvaccination
Population: The All Subjects as Treated population included all enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants | 16 Number of participants |
| Pneumovax™ 23: Participants >=50 Years | Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants | 5 Number of participants |
Primary
Number of Participants Reporting Serious Adverse Experiences
A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention
Time frame: Up to Day 28 postvaccination
Population: The All Subjects as Treated population included all enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | Number of Participants Reporting Serious Adverse Experiences | 0 Number of participants |
| Pneumovax™ 23: Participants >=50 Years | Number of Participants Reporting Serious Adverse Experiences | 0 Number of participants |
Primary
Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
Time frame: Up to 5 days postvaccination
Population: The All Subjects as Treated population included all enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) | 1 Number of participants |
| Pneumovax™ 23: Participants >=50 Years | Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) | 0 Number of participants |
Primary
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A \>=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.
Time frame: Day 28 postvaccination
Population: The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 6B | 76.9 Percentage of participants |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 19F | 82.7 Percentage of participants |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 14 | 88.5 Percentage of participants |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 23F | 80.8 Percentage of participants |
| Pneumovax™ 23: Participants Between 2 and 49 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 1 | 96.2 Percentage of participants |
| Pneumovax™ 23: Participants >=50 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 23F | 87.5 Percentage of participants |
| Pneumovax™ 23: Participants >=50 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 1 | 87.5 Percentage of participants |
| Pneumovax™ 23: Participants >=50 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 6B | 89.6 Percentage of participants |
| Pneumovax™ 23: Participants >=50 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 14 | 89.6 Percentage of participants |
| Pneumovax™ 23: Participants >=50 Years | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serotype 19F | 79.2 Percentage of participants |