Streptococcus Pneumoniae Infection, Pneumococcal Infections
Conditions
Brief 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.
Interventions
BIOLOGICALV114 0.5x:0.5x:2x
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.
BIOLOGICALPrevnar 13®
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.
BIOLOGICALV114 1x:1x:1x
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).
BIOLOGICALV114 2x:2x:2x
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.
BIOLOGICALV114 2x:1x:2x
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.
BIOLOGICALV114 1x:1x:2x
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Month 7 (1 month PD3) | 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. |
| Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE) | Up to 14 days | 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. |
| Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | Up to 14 days | 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. |
| Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) | Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age) | 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. |
| Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age) | 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. |
| 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® | Month 7 (1 month PD3) | 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. |
| 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® | Month 7 (1 month PD3) | 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. |
| 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® | Month 7 (1 month PD3) | 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. |
| 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® | Month 7 (1 month PD3) | 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. |
| 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® | Month 7 (1 month PD3) | 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. |
| 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) | Month 7 (1 month PD3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Month 7 (1 month PD3) | The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 1x APA and varying pneumococcal polysaccharide. |
| 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® | One month following the 4th vaccination (approximately 13 to 16 months of age). | The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation. |
| 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® | One month following the 4th vaccination (approximately 13 to 16 months of age). | The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation. |
| 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® | One month following the 4th vaccination (approximately 13 to 16 months of age). | The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation. |
| 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® | One month following the 4th vaccination (approximately 13 to 16 months of age). | The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation. |
| 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® | One month following the 4th vaccination (approximately 13 to 16 months of age). | The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation. |
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | One month following the 4th vaccination (approximately 13 to 16 months of age) | The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD4 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. |
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | Month 2 (1 month after a single vaccination) | The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype. |
| Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | Month 2 (1 month after a single vaccination) | The percentage of participants with ≥4-fold-rise from baseline in each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. |
| 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) | Month 7 (1 month PD3) | The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 2x APA and varying pneumococcal polysaccharide. |
Participant flow
Recruitment details
Healthy adults and infants were recruited and enrolled at 26 study sites in the United States. Each of the adult participants completed the study prior to enrollment of the infant participants.
Participants by arm
| Arm | Count |
|---|---|
| Adult V114: 1x:1x:1x On Day 1, adults receive a single vaccination of V114 1x:1x:1x (containing 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 APA). | 20 |
| Adult V114: 2x.2x.2x On Day 1, adults receive a single vaccination of V114 2x:2x:2x (containing 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). | 20 |
| Infant V114: 1x:1x:1x Infants receive 4 total V114: 1x:1x:1x (containing 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 APA) vaccinations given at 2, 4, 6, and 12 to 15 months of age. | 50 |
| Infant V114: 2x:1x:2x Infants receive 4 total V114: 2x:1x:2x (containing 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) vaccinations given at 2, 4, 6, and 12 to 15 months of age. | 51 |
| Infant V114: 2x:2x:2x Infants receive 4 total V114: 2x:2x:2x (containing 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) vaccinations given at 2, 4, 6, and 12 to 15 months of age. | 50 |
| Infant V114: 0.5x:0.5x:2x Infants receive 4 total V114 0.5x:0.5x:2x (containing 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) vaccinations given at 2, 4, 6, and 12 to 15 months of age. | 48 |
| Infant V114: 1x:1x:2x Infants receive 4 total V114 1x:1x:2x (containing 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) total vaccinations given at 2, 4, 6, and 12 to 15 months of age. | 50 |
| Infant Prevnar 13® Infants receive 4 total Prevnar 13® (containing 2.2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 4.4 µg of serotype 6B) vaccinations given at 2, 4, 6, and 12 to 15 months of age. | 51 |
| Total | 340 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 3 | 10 | 2 | 2 | 4 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 | 3 | 5 | 2 | 2 | 2 | 4 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 |
| Overall Study | Technical Problems | 0 | 0 | 3 | 3 | 2 | 3 | 4 | 2 |
| Overall Study | Withdrawal by Parent/Guardian | 0 | 0 | 3 | 2 | 5 | 1 | 4 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | Infant Prevnar 13® | Total | Infant V114: 0.5x:0.5x:2x | Infant V114: 2x:2x:2x | Infant V114: 2x:1x:2x | Infant V114: 1x:1x:1x | Adult V114: 2x.2x.2x | Adult V114: 1x:1x:1x | Infant V114: 1x:1x:2x |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 8.4 Weeks STANDARD_DEVIATION 1 | 31.4 Years STANDARD_DEVIATION 8.4 | 8.5 Weeks STANDARD_DEVIATION 1.5 | 8.9 Weeks STANDARD_DEVIATION 1.3 | 8.7 Weeks STANDARD_DEVIATION 1.2 | 8.9 Weeks STANDARD_DEVIATION 1.4 | 31.6 Years STANDARD_DEVIATION 8.1 | 31.3 Years STANDARD_DEVIATION 8.9 | 8.6 Weeks STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 33 Participants | 8 Participants | 4 Participants | 5 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 23 Participants | 5 Participants | 4 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 280 Participants | 35 Participants | 41 Participants | 44 Participants | 42 Participants | 15 Participants | 15 Participants | 46 Participants |
| Sex: Female, Male Female | 30 Participants | 182 Participants | 18 Participants | 23 Participants | 26 Participants | 30 Participants | 12 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 21 Participants | 158 Participants | 30 Participants | 27 Participants | 25 Participants | 20 Participants | 8 Participants | 5 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 50 | 0 / 51 | 0 / 50 | 0 / 48 | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 20 / 20 | 20 / 20 | 49 / 50 | 51 / 51 | 48 / 50 | 46 / 48 | 49 / 50 | 50 / 51 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 1 / 50 | 4 / 51 | 3 / 50 | 3 / 48 | 0 / 50 | 5 / 51 |
Outcome results
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)
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.
Time frame: Month 7 (1 month PD3)
Population: All randomized and treated infants with results available for the outcome measure and no protocol violations in the V114 arms are included. Results are pooled across arms to determine the impact of increased polysaccharide concentration on antibody concentrations across V114 formulations.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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) | PT1 | 1.19 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT3 | 1.13 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT4 | 1.44 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT5 | 1.29 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT6A | 1.09 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT6B | 0.73 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT7F | 1.40 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT9V | 1.15 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT14 | 1.47 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT18C | 1.45 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT19A | 1.30 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT19F | 1.47 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | PT22F | 1.64 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | non-PT23F | 1.20 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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) | non-PT33F | 0.94 Estimated Fold-rise per-unit Change |
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
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.
Time frame: Month 7 (1 month PD3)
Population: All randomized and treated infants with results available for the outcome measure and no protocol violations in the V114 arms are included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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 | PT1 | 0.84 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT3 | 0.84 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT4 | 0.77 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT5 | 0.76 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT6A | 0.89 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT6B | 0.74 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT7F | 1.01 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT9V | 0.83 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT14 | 1.48 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT18C | 0.75 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT19A | 0.77 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT19F | 1.01 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | PT22F | 1.37 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | non-PT23F | 0.73 Estimated Fold-rise per-unit Change |
| Adult V114: 1x:1x:1x | 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 | non-PT33F | 1.00 Estimated Fold-rise per-unit Change |
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®
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.
Time frame: Month 7 (1 month PD3)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 1.35 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT14 | 3.71 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT3 | 0.95 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT18C | 0.94 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT6B | 0.80 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19A | 1.01 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT5 | 0.87 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19F | 1.67 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT7F | 1.73 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT23F | 0.78 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT4 | 0.95 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 3.41 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT9V | 1.07 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 1.47 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT1 | 1.01 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 0.06 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT1 | 1.48 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT3 | 0.43 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT4 | 0.98 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT5 | 1.63 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6A | 2.75 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6B | 2.24 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT7F | 2.90 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT9V | 1.35 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT14 | 5.01 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT18C | 1.41 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19A | 1.45 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19F | 1.89 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT23F | 1.13 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 0.06 µg/mL |
95% CI: [0.5, 0.93]
95% CI: [1.62, 3.02]
95% CI: [0.71, 1.31]
95% CI: [0.36, 0.79]
95% CI: [0.26, 0.94]
95% CI: [0.17, 0.77]
95% CI: [0.42, 0.85]
95% CI: [0.54, 1.16]
95% CI: [0.48, 1.14]
95% CI: [0.46, 0.95]
95% CI: [0.48, 1.02]
95% CI: [0.6, 1.29]
95% CI: [0.43, 1.12]
95% CI: [37.66, 83.52]
95% CI: [14.18, 46.78]
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®
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.
Time frame: Month 7 (1 month PD3)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 1.64 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT14 | 2.96 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT3 | 0.96 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT18C | 1.29 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT6B | 0.77 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19A | 1.27 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT5 | 1.16 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19F | 2.31 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT7F | 2.09 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT23F | 1.02 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT4 | 1.33 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 4.10 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT9V | 1.00 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 1.37 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT1 | 1.20 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 0.06 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT1 | 1.48 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT3 | 0.43 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT4 | 0.98 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT5 | 1.63 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6A | 2.75 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6B | 2.24 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT7F | 2.90 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT9V | 1.35 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT14 | 5.01 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT18C | 1.41 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19A | 1.45 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19F | 1.89 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT23F | 1.13 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 0.06 µg/mL |
95% CI: [0.6, 1.1]
95% CI: [1.64, 3.02]
95% CI: [1.01, 1.84]
95% CI: [0.48, 1.05]
95% CI: [0.32, 1.13]
95% CI: [0.16, 0.73]
95% CI: [0.51, 1.02]
95% CI: [0.51, 1.08]
95% CI: [0.39, 0.9]
95% CI: [0.64, 1.31]
95% CI: [0.61, 1.27]
95% CI: [0.83, 1.78]
95% CI: [0.57, 1.45]
95% CI: [45.58, 99.97]
95% CI: [13.21, 43.24]
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®
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.
Time frame: Month 7 (1 month PD3)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 0.92 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT14 | 3.94 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT3 | 1.10 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT18C | 1.02 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT6B | 0.39 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19A | 0.79 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT5 | 0.83 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19F | 1.84 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT7F | 1.71 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT23F | 0.89 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT4 | 1.05 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 4.17 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT9V | 0.92 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 1.15 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT1 | 1.18 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 0.06 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT1 | 1.48 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT3 | 0.43 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT4 | 0.98 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT5 | 1.63 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6A | 2.75 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6B | 2.24 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT7F | 2.90 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT9V | 1.35 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT14 | 5.01 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT18C | 1.41 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19A | 1.45 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19F | 1.89 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT23F | 1.13 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 0.06 µg/mL |
95% CI: [0.58, 1.09]
95% CI: [1.86, 3.49]
95% CI: [0.79, 1.46]
95% CI: [0.34, 0.76]
95% CI: [0.17, 0.65]
95% CI: [0.08, 0.38]
95% CI: [0.41, 0.84]
95% CI: [0.46, 1.01]
95% CI: [0.51, 1.22]
95% CI: [0.5, 1.05]
95% CI: [0.37, 0.8]
95% CI: [0.66, 1.44]
95% CI: [0.49, 1.28]
95% CI: [45.81, 102.84]
95% CI: [10.88, 36.88]
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®
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.
Time frame: Month 7 (1 month PD3)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 0.85 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT14 | 3.20 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT3 | 0.77 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT18C | 1.20 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT6B | 0.36 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19A | 0.96 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT5 | 0.83 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19F | 2.10 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT7F | 1.39 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT23F | 0.76 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT4 | 0.85 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 2.71 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT 9V | 0.76 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 0.88 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT1 | 0.77 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 0.06 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT1 | 1.48 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT3 | 0.43 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT4 | 0.98 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT5 | 1.63 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6A | 2.75 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6B | 2.24 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT7F | 2.90 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT 9V | 1.35 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT14 | 5.01 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT18C | 1.41 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19A | 1.45 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19F | 1.89 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT23F | 1.13 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 0.06 µg/mL |
95% CI: [0.39, 0.7]
95% CI: [1.33, 2.41]
95% CI: [0.65, 1.16]
95% CI: [0.35, 0.74]
95% CI: [0.17, 0.58]
95% CI: [0.08, 0.34]
95% CI: [0.34, 0.67]
95% CI: [0.39, 0.82]
95% CI: [0.42, 0.97]
95% CI: [0.6, 1.21]
95% CI: [0.46, 0.95]
95% CI: [0.77, 1.6]
95% CI: [0.43, 1.07]
95% CI: [30.42, 65.43]
95% CI: [8.58, 27.26]
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®
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.
Time frame: Month 7 (1 month PD3)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 0.91 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT14 | 5.17 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT3 | 1.15 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT18C | 1.35 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT6B | 0.24 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19A | 1.37 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT5 | 1.11 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT19F | 2.35 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT7F | 2.12 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT23F | 0.85 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT4 | 1.48 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 4.72 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT9V | 1.18 µg/mL |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 0.90 µg/mL |
| Adult V114: 1x:1x:1x | 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® | PT1 | 1.16 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 0.06 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT1 | 1.48 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT3 | 0.43 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT4 | 0.98 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT5 | 1.63 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6A | 2.75 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT6B | 2.24 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT7F | 2.90 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT9V | 1.35 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT14 | 5.01 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT18C | 1.41 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19A | 1.45 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT19F | 1.89 µg/mL |
| Adult V114: 2x.2x.2x | 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® | PT23F | 1.13 µg/mL |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 0.06 µg/mL |
95% CI: [0.57, 1.07]
95% CI: [1.95, 3.68]
95% CI: [1.11, 2.07]
95% CI: [0.46, 1.02]
95% CI: [0.17, 0.64]
95% CI: [0.05, 0.23]
95% CI: [0.51, 1.04]
95% CI: [0.59, 1.3]
95% CI: [0.66, 1.6]
95% CI: [0.66, 1.39]
95% CI: [0.64, 1.39]
95% CI: [0.84, 1.84]
95% CI: [0.46, 1.23]
95% CI: [51.6, 116.6]
95% CI: [8.46, 28.98]
Primary
Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
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.
Time frame: Up to 14 days
Population: Adult participants who received V114 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult V114: 1x:1x:1x | Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
Primary
Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)
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.
Time frame: Up to 14 days
Population: Adult participants who received V114 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult V114: 1x:1x:1x | Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE) | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE) | 100.0 Percentage of Participants |
Primary
Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
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.
Time frame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
Population: Infant participants who received V114 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult V114: 1x:1x:1x | Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
| Infant V114: 2x:2x:2x | Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
| Infant V114: 1x:1x:2x | Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
| Infant Prevnar 13® | Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE) | 0.0 Percentage of Participants |
Primary
Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)
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.
Time frame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
Population: Infant participants who received V114 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult V114: 1x:1x:1x | Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) | 98.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) | 100.0 Percentage of Participants |
| Infant V114: 2x:2x:2x | Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) | 96.0 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) | 97.9 Percentage of Participants |
| Infant V114: 1x:1x:2x | Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) | 98.0 Percentage of Participants |
| Infant Prevnar 13® | Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE) | 98.0 Percentage of Participants |
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Time frame: Month 2 (1 month after a single vaccination)
Population: Randomized and treated adults with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6A | 8.23 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT14 | 16.24 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT3 | 0.84 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT18C | 4.56 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6B | 8.96 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19A | 9.71 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT5 | 2.63 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19F | 3.39 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT7F | 4.88 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT22F | 6.05 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT4 | 2.28 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT23F | 4.78 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT9V | 4.96 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT33F | 3.41 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT1 | 3.19 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT33F | 4.69 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT1 | 5.82 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT3 | 1.12 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT4 | 1.80 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT5 | 1.90 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6A | 3.52 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6B | 4.08 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT7F | 2.20 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT9V | 2.96 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT14 | 18.45 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT18C | 2.63 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19A | 4.39 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19F | 3.71 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT22F | 7.81 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT23F | 3.32 µg/mL |
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD4 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT23F | 2.01 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19F | 6.07 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19A | 3.65 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6B | 7.35 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6A | 6.93 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT14 | 8.68 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT9V | 2.96 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT5 | 2.31 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT4 | 1.71 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT3 | 1.10 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT1 | 1.67 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT18C | 2.06 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT7F | 4.69 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT33F | 6.44 µg/mL |
| Adult V114: 1x:1x:1x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT22F | 7.21 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT9V | 2.20 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT14 | 7.83 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT18C | 2.82 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19A | 5.34 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19F | 9.72 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT23F | 2.60 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT22F | 5.05 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT33F | 3.93 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT1 | 1.85 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT3 | 0.96 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT4 | 1.60 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT5 | 2.46 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6A | 9.62 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6B | 8.89 µg/mL |
| Adult V114: 2x.2x.2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT7F | 3.00 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT4 | 2.46 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT7F | 5.24 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT3 | 1.69 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT23F | 2.95 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT1 | 2.25 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19A | 6.54 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT9V | 3.18 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT22F | 10.66 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19F | 9.11 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6A | 6.16 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT5 | 3.61 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT18C | 2.95 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT14 | 9.40 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT33F | 8.03 µg/mL |
| Infant V114: 2x:2x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6B | 6.31 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT33F | 6.85 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT23F | 2.00 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT18C | 2.21 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT22F | 6.78 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6B | 7.27 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT9V | 2.83 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT1 | 1.62 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT3 | 1.06 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT14 | 8.48 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT4 | 1.21 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT7F | 4.65 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT5 | 2.38 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6A | 7.88 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19A | 3.46 µg/mL |
| Infant V114: 0.5x:0.5x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19F | 4.38 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6A | 6.58 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT33F | 5.07 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT9V | 2.27 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT18C | 1.82 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6B | 6.53 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT5 | 2.50 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19A | 5.86 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT4 | 1.39 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT14 | 7.15 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT1 | 1.67 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT23F | 2.02 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT7F | 4.39 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT3 | 1.09 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT22F | 7.88 µg/mL |
| Infant V114: 1x:1x:2x | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19F | 5.86 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT18C | 2.84 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT23F | 3.91 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT4 | 1.78 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6B | 11.55 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT22F | 0.08 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT5 | 4.72 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT9V | 3.25 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT6A | 10.31 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT7F | 5.65 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19F | 5.11 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT1 | 2.33 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT14 | 7.48 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT19A | 5.11 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | PT3 | 0.62 µg/mL |
| Infant Prevnar 13® | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants | non-PT33F | 0.07 µg/mL |
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®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT3 | 94.1 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT23F | 94.1 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT4 | 82.4 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT1 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 2.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT1 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT3 | 75.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT4 | 97.3 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 10.8 Percentage of Participants |
95% CI: [-10.3, 9.5]
95% CI: [1.7, 35.5]
95% CI: [-31.4, -1.2]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-10.3, 9.5]
95% CI: [-19.2, 3.9]
95% CI: [75.2, 95.7]
95% CI: [85.9, 99.5]
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®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT3 | 90.3 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT4 | 90.3 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT1 | 96.8 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 2.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT1 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT3 | 75.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT4 | 97.3 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 10.8 Percentage of Participants |
95% CI: [-4.1, 32.5]
95% CI: [-16.3, 6.5]
95% CI: [-22.8, 5.7]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [-11.2, 9.5]
95% CI: [75.2, 95.7]
95% CI: [85.1, 99.5]
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®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT3 | 89.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT18C | 96.6 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19A | 93.1 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT5 | 96.6 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19F | 96.6 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT4 | 89.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT9V | 96.6 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 96.6 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT1 | 96.6 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 2.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT1 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT3 | 75.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT4 | 97.3 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 10.8 Percentage of Participants |
95% CI: [-17.3, 6.3]
95% CI: [-5.5, 32]
95% CI: [-24.2, 5.2]
95% CI: [-17.3, 6.3]
95% CI: [-11.9, 9.5]
95% CI: [-11.9, 9.5]
95% CI: [-11.9, 9.5]
95% CI: [-17.3, 6.3]
95% CI: [-11.9, 9.5]
95% CI: [-17.3, 6.3]
95% CI: [-22.1, 3]
95% CI: [-17.3, 6.3]
95% CI: [-11.9, 9.5]
95% CI: [75.2, 95.7]
95% CI: [78.5, 98.3]
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®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT3 | 87.5 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT4 | 95.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 95.8 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 95.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT1 | 95.8 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 2.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT1 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT3 | 75.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT4 | 97.3 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 10.8 Percentage of Participants |
95% CI: [-14.5, 9.6]
95% CI: [-20.4, 5.6]
95% CI: [-10, 30.6]
95% CI: [-18.8, 10.3]
95% CI: [-14, 9.6]
95% CI: [-14.5, 9.6]
95% CI: [-14, 9.6]
95% CI: [-14, 9.6]
95% CI: [-14, 9.6]
95% CI: [-14.5, 9.6]
95% CI: [-14, 9.6]
95% CI: [-14, 9.6]
95% CI: [-14, 9.6]
95% CI: [65.8, 93.6]
95% CI: [75.1, 98.1]
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®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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® | PT1 | 97.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT4 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT6B | 97.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT3 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT23F | 97.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT22F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | non-PT33F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT33F | 2.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT1 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT3 | 75.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT4 | 97.3 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT5 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT6B | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT7F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT9V | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT14 | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT18C | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19A | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT19F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | PT23F | 100.0 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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® | non-PT22F | 10.8 Percentage of Participants |
95% CI: [-15.5, 6.7]
95% CI: [12.6, 40.2]
95% CI: [-8, 14]
95% CI: [-10.6, 9.5]
95% CI: [-10.6, 9.5]
95% CI: [-15.5, 6.7]
95% CI: [-10.6, 9.5]
95% CI: [-10.6, 9.5]
95% CI: [-10.6, 9.5]
95% CI: [-10.6, 9.5]
95% CI: [-10.6, 9.5]
95% CI: [-10.6, 9.5]
95% CI: [-15.5, 6.7]
95% CI: [75.2, 95.7]
95% CI: [85.7, 99.5]
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)
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 1x APA and varying pneumococcal polysaccharide.
Time frame: Month 7 (1 month PD3)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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) | PT1 | 97.4 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT3 | 89.5 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT4 | 97.4 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT5 | 94.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT6A | 86.8 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT6B | 65.8 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT7F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT9V | 86.8 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT14 | 92.1 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT18C | 97.4 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT19A | 97.4 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT19F | 100.0 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT23F | 89.5 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | non-PT22F | 94.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | non-PT33F | 86.8 Percentage of Participants |
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)
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 2x APA and varying pneumococcal polysaccharide.
Time frame: Month 7 (1 month PD3)
Population: Randomized and treated infants with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | 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) | PT1 | 94.6 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT19F | 97.3 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT14 | 94.6 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT4 | 91.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT18C | 91.9 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT19A | 91.9 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT5 | 88.9 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT3 | 91.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | non-PT22F | 100.00 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT6A | 91.7 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT6B | 69.4 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT23F | 83.3 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT7F | 97.2 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | non-PT33F | 91.9 Percentage of Participants |
| Adult V114: 1x:1x:1x | 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) | PT9V | 94.4 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT9V | 78.6 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT19F | 95.2 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT6A | 66.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT14 | 97.6 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT3 | 85.7 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT19A | 88.1 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT23F | 78.6 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT18C | 90.5 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT4 | 95.2 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT7F | 100.00 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | non-PT33F | 76.2 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | non-PT22F | 97.6 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT6B | 47.6 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT5 | 78.6 Percentage of Participants |
| Adult V114: 2x.2x.2x | 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) | PT1 | 85.7 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT9V | 87.9 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT1 | 97.0 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT3 | 100.0 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT4 | 97.0 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT5 | 93.9 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT6A | 72.7 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT6B | 33.3 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT7F | 93.9 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT14 | 100.00 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT18C | 93.9 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT19A | 93.9 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT19F | 97.0 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | PT23F | 84.8 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | non-PT22F | 97.0 Percentage of Participants |
| Infant V114: 2x:2x:2x | 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) | non-PT33F | 72.7 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT7F | 97.1 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT3 | 88.2 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT19F | 94.1 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT6B | 52.9 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT6A | 76.5 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT1 | 97.1 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT23F | 85.3 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT5 | 88.2 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT4 | 88.2 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | non-PT33F | 82.4 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT18C | 94.1 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT14 | 100.0 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | non-PT22F | 100.0 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT19A | 88.2 Percentage of Participants |
| Infant V114: 0.5x:0.5x:2x | 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) | PT9V | 85.3 Percentage of Participants |
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
The percentage of participants with ≥4-fold-rise from baseline in each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.
Time frame: Month 2 (1 month after a single vaccination)
Population: Randomized and treated adults with results available for the outcome measure and no protocol violations are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6A | 81.25 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT14 | 87.50 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT3 | 56.25 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT18C | 87.50 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6B | 100.00 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19A | 81.25 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT5 | 50.00 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19F | 81.25 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT7F | 81.25 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT22F | 93.75 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT4 | 93.75 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT23F | 87.50 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT9V | 100.00 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT33F | 62.50 Percentage of Participants |
| Adult V114: 1x:1x:1x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT1 | 93.75 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT33F | 66.67 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT1 | 100.00 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT3 | 66.67 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT4 | 88.89 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT5 | 61.11 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6A | 72.22 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT6B | 83.33 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT7F | 44.44 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT9V | 88.89 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT14 | 83.33 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT18C | 72.22 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19A | 55.56 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT19F | 83.33 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | PT22F | 83.33 Percentage of Participants |
| Adult V114: 2x.2x.2x | Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults | non-PT23F | 77.78 Percentage of Participants |