| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01513551 | The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002) | PHASE2 | COMPLETED | 692 | — | — | Mar 13, 2012 | Feb 15, 2013 | Dec 13, 2018 | - | — |
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 ...