Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02547649 | Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) | PHASE2 | COMPLETED | 690 | — | — | Oct 8, 2015 | Jan 20, 2016 | Apr 16, 2019 | - | — |
The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).
| Arm | Type | Description |
|---|---|---|
| V114 Formulation A | EXPERIMENTAL | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1 |
| V114 Formulation B | EXPERIMENTAL | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1 |
| Prevnar 13® | ACTIVE_COMPARATOR | Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1 |
| Name | Type | Description |
|---|---|---|
| V114-A | BIOLOGICAL | Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress). |
| V114-B | BIOLOGICAL | Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress). |
| Prevnar 13® | BIOLOGICAL | Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose. |
Inclusion Criteria: * Good health; any underlying chronic illness must be documented to be in stable condition * Highly unlikely to conceive through 6 weeks after administration of the study vaccine Exclusion Criteria: * Prior administration of any pneumococcal vaccine * History of invasive pneum...