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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02037984 | Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004) | PHASE1 | COMPLETED | 341 | — | — | Jan 28, 2014 | Jul 1, 2016 | Jun 24, 2019 | - | — |
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...