Phase 2
N=341
Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)
Streptococcus Pneumoniae Infection · Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT02037984 ↗Enrolled (actual)
341
Serious AEs
4.7%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE) — 100.0; 100.0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prevnar 13® (Biological); V114 1x:1x:1x (Biological); V114 2x:2x:2x (Biological); V114 2x:1x:2x (Biological); V114 1x:1x:2x (Biological); V114 0.5x:0.5x:2x (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE) |
100.0; 100.0 | — |
| PRIMARY Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) |
0.0; 0.0 | — |
| PRIMARY Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) |
98.0; 100.0; 96.0; 97.9; 98.0; 98.0 | — |
| PRIMARY Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13® |
1.20; 1.48; 0.96; 0.43; 1.33; 0.98 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13® |
0.77; 1.48; 0.77; 0.43; 0.85; 0.98 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13® |
1.16; 1.48; 1.15; 0.43; 1.48; 0.98 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13® |
1.01; 1.48; 0.95; 0.43; 0.95; 0.98 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13® |
1.18; 1.48; 1.10; 0.43; 1.05; 0.98 | — |
| PRIMARY Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3) |
1.19; 1.13; 1.44; 1.29; 1.09; 0.73 | — |
| PRIMARY Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants |
0.84; 0.84; 0.77; 0.76; 0.89; 0.74 | — |
| SECONDARY Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA) |
94.6; 85.7; 97.0; 97.1; 91.7; 85.7 | — |
| SECONDARY Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA) |
97.4; 89.5; 97.4; 94.7; 86.8; 65.8 | — |
| SECONDARY Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13® |
96.8; 100.0; 90.3; 75.7; 90.3; 97.3 | — |
| SECONDARY Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13® |
95.8; 100.0; 87.5; 75.7; 95.7; 97.3 | — |
| SECONDARY Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13® |
97.0; 100.0; 100.0; 75.7; 100.0; 97.3 | — |
| SECONDARY Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13® |
100.0; 100.0; 94.1; 75.7; 82.4; 97.3 | — |
| SECONDARY Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13® |
96.6; 100.0; 89.7; 75.7; 89.7; 97.3 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants |
1.67; 1.85; 2.25; 1.62; 1.67; 2.33 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults |
3.19; 5.82; 0.84; 1.12; 2.28; 1.80 | — |
| SECONDARY Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults |
93.75; 100.00; 56.25; 66.67; 93.75; 88.89 | — |
Summary
This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.
Eligibility Criteria
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 vaccine within 14 days, or any live vaccine within 30 days.
- History of invasive pneumococcal disease.
- Known hypersensitivity to any vaccine component.
- Received systemic corticosteroids within 14 days of first vaccination.
- Known or suspected impairment of immune function.
- Febrile illness within 72 hours before vaccination.
- Received blood transfusion or blood products within 30 days. Infants
- Mother has documented human immunodeficiency virus or is hepatitis B surface antigen positive.
- Has asplenia or failure to thrive.
Adults:
- Is breastfeeding.
Data sourced from ClinicalTrials.gov (NCT02037984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.