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Pneumococcal Conjugate Vaccine · 1 trial · 1 indication
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.
Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed.
Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed.
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.
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.
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.
| Arm | Type | Description |
|---|---|---|
| V114 | EXPERIMENTAL | Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. |
| PNEUMOVAX® 23 | ACTIVE_COMPARATOR | Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1. |
| PREVNAR 13® | ACTIVE_COMPARATOR | Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1. |
| Name | Type | Description |
|---|---|---|
| Pneumococcal Conjugate Vaccine (V114) | BIOLOGICAL | 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. |
| PNEUMOVAX® 23 | BIOLOGICAL | 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. |
| PREVNAR 13® | BIOLOGICAL | 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. |
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 ...
Pneumococcal Conjugate Vaccine is used for the prevention of pneumococcal infections, which are caused by the bacterium Streptococcus pneumoniae. It is being developed for adults 50 years of age or older, as evaluated in a clinical trial assessing its safety, tolerability, and immunogenicity in this population.
Pneumococcal Conjugate Vaccine is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adults.
Pneumococcal Conjugate Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 2 trial has been completed to evaluate its safety, tolerability, and immunogenicity in adults aged 50 years and older.
Pneumococcal Conjugate Vaccine has one completed clinical trial, registered as NCT01513551. This Phase 2 study, titled V114-002, evaluated the safety, tolerability, and immunogenicity of a single dose of the vaccine compared with PNEUMOVAX 23 and PREVNAR 13 in adults 50 years of age or older. The trial enrolled 692 participants.
Pneumococcal Conjugate Vaccine is not the same as PNEUMOVAX 23 or PREVNAR 13. In the clinical trial NCT01513551, it was compared against these two existing pneumococcal vaccines as active controls. The study assessed the safety, tolerability, and immunogenicity of the investigational vaccine relative to these comparators.