A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

Study Overview
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Brief Summary
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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

Official Title
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A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Biological: Pneumovax™ 23


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumovax™ 23: Participants Between 2 and 49 Years<br>Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 | Biological: Pneumovax™ 23<br>* 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<br>* Other names: V110;|
| Experimental: Pneumovax™ 23: Participants >=50 Years<br>Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 | Biological: Pneumovax™ 23<br>* 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<br>* Other names: V110;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays | Prevaccination and Day 28 after vaccination | 
| 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. | Day 28 postvaccination | 
| 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 | 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. | Up to Day 14 postvaccination | 
| 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 | Up to Day 28 postvaccination |