Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V114 Aluminum-adjuvanted · 1 trial · 1 indication
Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
An 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 \> 0% of participants in one or more vaccination groups were assessed.
Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
An 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.
An 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.
| Arm | Type | Description |
|---|---|---|
| V114 Aluminum-adjuvanted | EXPERIMENTAL | Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
| V114 Non-adjuvanted | EXPERIMENTAL | Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
| Prevnar 13® | ACTIVE_COMPARATOR | Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age. |
| Name | Type | Description |
|---|---|---|
| V114 Aluminum-adjuvanted | BIOLOGICAL | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose. |
| V114 Non-adjuvanted | 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), and serotype 6B (4 mcg) 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 (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose. |
Inclusion criteria: * Healthy infants ≥ 42 days to ≤ 89 days. * Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent. * Afeb...
V114 Aluminum-adjuvanted is an investigational pneumococcal conjugate vaccine being studied for the prevention of pneumococcal infections. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
V114 Aluminum-adjuvanted is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK.
V114 Aluminum-adjuvanted is in Phase 2 clinical development. It is an investigational vaccine and has not been approved for commercial use.
V114 Aluminum-adjuvanted has one completed Phase 2 clinical trial, NCT01215188, which enrolled 1,152 participants. The study compared V114 to a marketed pneumococcal conjugate vaccine in healthy infants aged 6 weeks and older.
No, V114 Aluminum-adjuvanted is classified as a monoclonal antibody in the development database, but it is being studied as a pneumococcal conjugate vaccine for the prevention of pneumococcal infections.