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Also known as Pneumococcal Conjugate Vaccine (V114)
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 (V114) is being developed for the prevention of pneumococcal infections. It is an investigational vaccine candidate studied in adults 50 years of age or older. Merck is evaluating it as a vaccine against pneumococcal disease, the infections caused by Streptococcus pneumoniae bacteria.
Pneumococcal Conjugate Vaccine (V114) is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating this investigational pneumococcal conjugate vaccine candidate.
Pneumococcal Conjugate Vaccine (V114) is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 study of V114 has been completed, and no trials of this candidate are currently listed as active.
Pneumococcal Conjugate Vaccine (V114) has been studied in the Phase 2 trial NCT01513551, titled V114-002. That completed trial evaluated the safety, tolerability, and immunogenicity of a single dose of V114 compared with PNEUMOVAX 23 or PREVNAR 13 in adults 50 years of age or older.
The Phase 2 trial NCT01513551 was a randomized, double-blind study with active controls. It enrolled 692 participants aged 50 years and older, including healthy volunteers of any sex. Participants received a single dose of V114, PNEUMOVAX 23, or PREVNAR 13, and the study assessed safety, tolerability, and immunogenicity.
Yes. Pneumococcal Conjugate Vaccine (V114) is the same candidate referred to as Pneumococcal Conjugate Vaccine, with V114 serving as its development code name. Both names refer to the Merck investigational pneumococcal conjugate vaccine studied in the Phase 2 V114-002 trial.