Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PREVNAR 20™, PREVNAR 20
Prevnar 13 · 1 trial · 2 indications
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
A mulitvariate regression model was used to evaluate the impact of increasing polysaccharide concentration from 1x to 2x on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase from 1x to 2x in polysaccharide concentration. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values \>1.0 show an increase in antibody concentration whereas values \<1.0 show a decrease in antibody concentration.
A mulitvariate regression model was used to evaluate the impact of increasing APA concentration on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase in APA. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values \>1.0 show an increase in antibody concentration whereas values \<1.0 show a decrease in antibody concentration.
| Arm | Type | Description |
|---|---|---|
| Adult V114: 1x:1x:1x | EXPERIMENTAL | Adults receive a single vaccination on Day 1. |
| Adult V114: 2x:2x:2x | EXPERIMENTAL | Adults receive a single vaccination on Day 1. |
| Infant V114: 1x:1x:1x | EXPERIMENTAL | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
| Infant V114: 2x:1x:2x | EXPERIMENTAL | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
| Infant V114: 2x:2x:2x | EXPERIMENTAL | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
| Infant V114: 0.5x:0.5x:2x | EXPERIMENTAL | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
| Infant V114: 1x:1x:2x | EXPERIMENTAL | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
| Infant Prevnar 13® | ACTIVE_COMPARATOR | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
| Name | Type | Description |
|---|---|---|
| Prevnar 13® | BIOLOGICAL | Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose. |
| V114 1x:1x:1x | BIOLOGICAL | V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA). |
| V114 2x:2x:2x | BIOLOGICAL | V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
| V114 2x:1x:2x | BIOLOGICAL | V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
| V114 1x:1x:2x | BIOLOGICAL | V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
| V114 0.5x:0.5x:2x | BIOLOGICAL | V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
Inclusion Criteria Infants: \- Healthy and able to attend all scheduled visits. Adults: \- Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine. Exclusion Criteria Infants and Adults: * Prior administration of any pneumococcal vaccine, any non-live vacci...
Prevnar is a pneumococcal conjugate vaccine used for the prevention of pneumococcal infections, including those caused by Streptococcus pneumoniae. It is being studied in healthy adults, infants, and older adults to evaluate its safety, tolerability, and immunogenicity against these bacterial infections.
Prevnar is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in various populations, including healthy infants, adults, and older individuals.
Prevnar is in Phase 3 clinical development. While some early-phase trials have been completed, the most advanced studies are Phase 3 trials evaluating the vaccine's safety and immunogenicity, including a study in healthy infants and another in adults aged 50 years and older.
Prevnar has been studied in several clinical trials, including NCT01215175, NCT02037984, NCT02225587, and NCT03620162. These trials evaluated the vaccine's safety, tolerability, and immunogenicity in healthy adults, infants, and older adults, with all trials completed.
Prevnar is also known as PREVNAR 20™ or PREVNAR 20. These names refer to the same pneumococcal conjugate vaccine being developed by Merck & Company, Inc. for the prevention of pneumococcal infections.
Prevnar is a pneumococcal conjugate vaccine that works by stimulating the immune system to produce antibodies against Streptococcus pneumoniae, the bacteria that cause pneumococcal infections. This helps protect against diseases such as pneumonia and other invasive pneumococcal infections.