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Pneumovax 23 · 1 trial · 1 indication
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
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.
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.
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
| Arm | Type | Description |
|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | EXPERIMENTAL | Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 |
| Pneumovax™ 23: Participants >=50 Years | EXPERIMENTAL | Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 |
| Name | Type | Description |
|---|---|---|
| Pneumovax™ 23 | BIOLOGICAL | 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 |
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, chroni...
Pneumovax 23 is used for the prevention of pneumococcal disease, a serious infection caused by the bacterium Streptococcus pneumoniae. It is indicated for use in individuals aged 2 years and older to help protect against the strains of pneumococcus covered by the vaccine.
Pneumovax 23 is developed and manufactured by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is responsible for the research, clinical development, and commercialization of the vaccine.
Pneumovax 23 is in Phase 3 clinical development. It is an investigational vaccine for pneumococcal disease, and it is not yet approved for use. The Phase 3 trial has been completed, and the vaccine remains under regulatory review for potential approval.
Pneumovax 23 has one completed Phase 3 clinical trial registered under NCT01734239. This trial, titled 'A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)', enrolled 102 participants aged 2 years and older.
Yes, Pneumovax 23 is classified as a monoclonal antibody. However, it is important to note that it is a vaccine designed to stimulate an immune response against pneumococcal disease, rather than a therapeutic antibody used to treat an existing infection.
Yes, Pneumovax 23 is also known as V110. In clinical trial records, the vaccine is referred to by both names, with the trial NCT01734239 specifically studying the safety and immunogenicity of Pneumovax™ 23 (V110) in a Russian population.