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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult V114: 1x:1x:1x | Experimental | Adults receive a single vaccination on Day 1. |
|
| Adult V114: 2x:2x:2x | Experimental | Adults receive a single vaccination on Day 1. |
|
| Infant V114: 1x:1x:1x | Experimental | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
|
| Infant V114: 2x:1x:2x | Experimental | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
|
| Infant V114: 2x:2x:2x | Experimental | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
|
| Infant V114: 0.5x:0.5x:2x | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevnar 13® | Biological | Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 days |
| 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. | Up to 14 days |
| 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. | Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age) |
| 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. | Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Adults:
- Is breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30689507 | Result | Rupp R, Hurley D, Grayson S, Li J, Nolan K, McFetridge RD, Hartzel J, Abeygunawardana C, Winters M, Pujar H, Benner P, Musey L. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Aluminum Phosphate Adjuvant [APA]). |
| FG001 | 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). |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized and treated participants are included. One participant in the Infant V114: 0.5x:0.5x:2x arm was enrolled and randomized but did not receive any study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Adult V114: 2x.2x.2x |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean (SD) age in years is shown for adults. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Adult participants who received V114 are included. | Posted | Number | Percentage of Participants | Up to 14 days |
|
Up to 14 days after each dose of study drug.
All adult and infant participants who received ≥1 dose of study drug are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary valve stenosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
|
| Infant V114: 1x:1x:2x | Experimental | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
|
| Infant Prevnar 13® | Active Comparator | Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. |
|
| V114 1x:1x:1x | Biological | V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA). |
|
| V114 2x:2x:2x | Biological | V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
|
| V114 2x:1x:2x | Biological | V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
|
| V114 1x:1x:2x | Biological | V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
|
| V114 0.5x:0.5x:2x | Biological | V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
|
| Month 7 (1 month PD3) |
| 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. | Month 7 (1 month PD3) |
| 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. | Month 7 (1 month PD3) |
| 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. | Month 7 (1 month PD3) |
| 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. | Month 7 (1 month PD3) |
| 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. | Month 7 (1 month PD3) |
| 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. | Month 7 (1 month PD3) |
| Month 7 (1 month PD3) |
| 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. | Month 7 (1 month PD3) |
| 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. | One month following the 4th vaccination (approximately 13 to 16 months of age). |
| 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. | One month following the 4th vaccination (approximately 13 to 16 months of age). |
| 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. | One month following the 4th vaccination (approximately 13 to 16 months of age). |
| 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. | One month following the 4th vaccination (approximately 13 to 16 months of age). |
| 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. | One month following the 4th vaccination (approximately 13 to 16 months of age). |
| 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. | One month following the 4th vaccination (approximately 13 to 16 months of age) |
| 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. | Month 2 (1 month after a single vaccination) |
| 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. | Month 2 (1 month after a single vaccination) |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Technical Problems |
|
| Withdrawal by Parent/Guardian |
|
| Withdrawal by Subject |
|
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). |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
Adult participants only are included.
| Mean |
| Standard Deviation |
| Years |
|
| Age, Continuous | Mean (SD) age in weeks is shown for infants. | Infant participants only are included. | Mean | Standard Deviation | Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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).
|
|
| 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. | Adult participants who received V114 are included. | Posted | Number | Percentage of Participants | Up to 14 days |
|
|
|
| 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. | Infant participants who received V114 are included. | Posted | Number | Percentage of Participants | Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age) |
|
|
|
| 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. | Infant participants who received V114 are included. | Posted | Number | Percentage of Participants | Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age) |
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 7 (1 month PD3) |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 7 (1 month PD3) |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 7 (1 month PD3) |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 7 (1 month PD3) |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 7 (1 month PD3) |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Estimated Fold-rise per-unit Change | Month 7 (1 month PD3) |
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|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 7 (1 month PD3) |
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 7 (1 month PD3) |
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Number | Percentage of Participants | One month following the 4th vaccination (approximately 13 to 16 months of age). |
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|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Number | Percentage of Participants | One month following the 4th vaccination (approximately 13 to 16 months of age). |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Number | Percentage of Participants | One month following the 4th vaccination (approximately 13 to 16 months of age). |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Number | Percentage of Participants | One month following the 4th vaccination (approximately 13 to 16 months of age). |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Number | Percentage of Participants | One month following the 4th vaccination (approximately 13 to 16 months of age). |
|
|
|
|
| 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. | Randomized and treated infants with results available for the outcome measure and no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month following the 4th vaccination (approximately 13 to 16 months of age) |
|
|
|
| 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. | Randomized and treated adults with results available for the outcome measure and no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 2 (1 month after a single vaccination) |
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|
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| 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. | Randomized and treated adults with results available for the outcome measure and no protocol violations are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 2 (1 month after a single vaccination) |
|
|
|
| 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. | All randomized and treated infants with results available for the outcome measure and no protocol violations in the V114 arms are included. | Posted | Mean | 95% Confidence Interval | Estimated Fold-rise per-unit Change | Month 7 (1 month PD3) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| EG001 | 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). | 0 | 20 | 0 | 20 | 20 | 20 |
| EG002 | 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. | 0 | 50 | 1 | 50 | 49 | 50 |
| EG003 | 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. | 0 | 51 | 4 | 51 | 51 | 51 |
| EG004 | 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. | 0 | 50 | 3 | 50 | 48 | 50 |
| EG005 | 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. | 0 | 48 | 3 | 48 | 46 | 48 |
| EG006 | 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. | 0 | 50 | 0 | 50 | 49 | 50 |
| EG007 | 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. | 0 | 51 | 5 | 51 | 50 | 51 |
| Abdominal wall abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Oral viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Plagiocephaly | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Infantile spitting up | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site granuloma | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site joint pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site lymphadenopathy | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site macule | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sluggishness | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Injection site abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Metapneumovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Roseola | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Stool pH decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cow's milk intolerance | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Lordosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Developmental coordination disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Stereotypy | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Genital rash | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Acne infantile | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Macule | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| D007239 | Infections |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 GMC Ratio |
| 2.22 |
| 2-Sided |
| 95 |
| 1.64 |
| 3.02 |
| Other |
PT3 GMC Ratio (V114/Prevnar 13®) |
| PT4 GMG Ratio | 1.37 | 2-Sided | 95 | 1.01 | 1.84 | Other | PT4 GMC Ratio (V114/Prevnar 13®) |
| PT5 GMC Ratio | 0.71 | 2-Sided | 95 | 0.48 | 1.05 | Other | PT5 GMC Ratio (V114/Prevnar 13®) |
| PT6A GMC Ratio | 0.60 | 2-Sided | 95 | 0.32 | 1.13 | Other | PT6A GMC Ratio (V114/Prevnar 13®) |
| PT6B GMG Ratio | 0.34 | 2-Sided | 95 | 0.16 | 0.73 | Other | PT6B GMC Ratio (V114/Prevnar 13®) |
| PT7F GMC Ratio | 0.72 | 2-Sided | 95 | 0.51 | 1.02 | Other | PT7F GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.74 | 2-Sided | 95 | 0.51 | 1.08 | Other | PT9V GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.59 | 2-Sided | 95 | 0.39 | 0.90 | Other | PT14 GMC Ratio (V114/Prevnar®) |
| PT18C GMC Ratio | 0.92 | 2-Sided | 95 | 0.64 | 1.31 | Other | PT18C GMC Ratio (V114/Prevnar 13®) |
| PT19A GMC Ratio | 0.88 | 2-Sided | 95 | 0.61 | 1.27 | Other | PT19A GMC Ratio (V114/Prevnar 13®) |
| PT19F GMC Ratio | 1.22 | 2-Sided | 95 | 0.83 | 1.78 | Other | PT19F GMC Ratio (V114/Prevnar 13®) |
| PT23F GMC Ratio | 0.91 | 2-Sided | 95 | 0.57 | 1.45 | Other | PT23F GMC Ratio (V114/Prevnar 13®) |
| non-PT22F GMC Ratio | 67.50 | 2-Sided | 95 | 45.58 | 99.97 | Other | non-PT22F GMC Ratio (V114/Prevnar 13®) |
| non-PT33F GMC Ratio | 23.90 | 2-Sided | 95 | 13.21 | 43.24 | Other | non-PT33F GMC Ratio (V114/Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT 9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 GMC Ratio |
| 1.79 |
| 2-Sided |
| 95 |
| 1.33 |
| 2.41 |
| Other |
PT3 GMC Ratio (V114/Prevnar 13®) |
| PT4 GMG Ratio | 0.87 | 2-Sided | 95 | 0.65 | 1.16 | Other | PT4 GMC Ratio (V114/Prevnar 13®) |
| PT5 GMC Ratio | 0.51 | 2-Sided | 95 | 0.35 | 0.74 | Other | PT5 GMC Ratio (V114/Prevnar 13®) |
| PT6A GMC Ratio | 0.31 | 2-Sided | 95 | 0.17 | 0.58 | Other | PT6A GMC Ratio (V114/Prevnar 13®) |
| PT6B GMG Ratio | 0.16 | 2-Sided | 95 | 0.08 | 0.34 | Other | PT6B GMC Ratio (V114/Prevnar 13®) |
| PT7F GMC Ratio | 0.48 | 2-Sided | 95 | 0.34 | 0.67 | Other | PT7F GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.56 | 2-Sided | 95 | 0.39 | 0.82 | Other | PT9V GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.64 | 2-Sided | 95 | 0.42 | 0.97 | Other | PT14 GMC Ratio (V114/Prevnar®) |
| PT18C GMC Ratio | 0.85 | 2-Sided | 95 | 0.60 | 1.21 | Other | PT18C GMC Ratio (V114/Prevnar 13®) |
| PT19A GMC Ratio | 0.66 | 2-Sided | 95 | 0.46 | 0.95 | Other | PT19A GMC Ratio (V114/Prevnar 13®) |
| PT19F GMC Ratio | 1.11 | 2-Sided | 95 | 0.77 | 1.60 | Other | PT19F GMC Ratio (V114/Prevnar 13®) |
| PT23F GMC Ratio | 0.68 | 2-Sided | 95 | 0.43 | 1.07 | Other | PT23F GMC Ratio (V114/Prevnar 13®) |
| non-PT22F GMC Ratio | 44.61 | 2-Sided | 95 | 30.42 | 65.43 | Other | non-PT22F GMC Ratio (V114/Prevnar 13®) |
| non-PT33F GMC Ratio | 15.29 | 2-Sided | 95 | 8.58 | 27.26 | Other | non-PT33F GMC Ratio (V114/Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 GMC Ratio |
| 2.68 |
| 2-Sided |
| 95 |
| 1.95 |
| 3.68 |
| Other |
PT3 GMC Ratio (V114/Prevnar 13®) |
| PT4 GMG Ratio | 1.52 | 2-Sided | 95 | 1.11 | 2.07 | Other | PT4 GMC Ratio (V114/Prevnar 13®) |
| PT5 GMC Ratio | 0.68 | 2-Sided | 95 | 0.46 | 1.02 | Other | PT5 GMC Ratio (V114/Prevnar 13®) |
| PT6A GMC Ratio | 0.33 | 2-Sided | 95 | 0.17 | 0.64 | Other | PT6A GMC Ratio (V114/Prevnar 13®) |
| PT6B GMG Ratio | 0.11 | 2-Sided | 95 | 0.05 | 0.23 | Other | PT6B GMC Ratio (V114/Prevnar 13®) |
| PT7F GMC Ratio | 0.73 | 2-Sided | 95 | 0.51 | 1.04 | Other | PT7F GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.88 | 2-Sided | 95 | 0.59 | 1.30 | Other | PT9V GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 1.03 | 2-Sided | 95 | 0.66 | 1.60 | Other | PT14 GMC Ratio (V114/Prevnar®) |
| PT18C GMC Ratio | 0.96 | 2-Sided | 95 | 0.66 | 1.39 | Other | PT18C GMC Ratio (V114/Prevnar 13®) |
| PT19A GMC Ratio | 0.95 | 2-Sided | 95 | 0.64 | 1.39 | Other | PT19A GMC Ratio (V114/Prevnar 13®) |
| PT19F GMC Ratio | 1.24 | 2-Sided | 95 | 0.84 | 1.84 | Other | PT19F GMC Ratio (V114/Prevnar 13®) |
| PT23F GMC Ratio | 0.75 | 2-Sided | 95 | 0.46 | 1.23 | Other | PT23F GMC Ratio (V114/Prevnar 13®) |
| non-PT22F GMC Ratio | 77.57 | 2-Sided | 95 | 51.60 | 116.60 | Other | non-PT22F GMC Ratio (V114/Prevnar 13®) |
| non-PT33F GMC Ratio | 15.66 | 2-Sided | 95 | 8.46 | 28.98 | Other | non-PT33F GMC Ratio (V114/Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 GMC Ratio |
| 2.21 |
| 2-Sided |
| 95 |
| 1.62 |
| 3.02 |
| Other |
PT3 GMC Ratio (V114/Prevnar 13®) |
| PT4 GMG Ratio | 0.97 | 2-Sided | 95 | 0.71 | 1.31 | Other | PT4 GMC Ratio (V114/Prevnar 13®) |
| PT5 GMC Ratio | 0.53 | 2-Sided | 95 | 0.36 | 0.79 | Other | PT5 GMC Ratio (V114/Prevnar 13®) |
| PT6A GMC Ratio | 0.49 | 2-Sided | 95 | 0.26 | 0.94 | Other | PT6A GMC Ratio (V114/Prevnar 13®) |
| PT6B GMG Ratio | 0.36 | 2-Sided | 95 | 0.17 | 0.77 | Other | PT6B GMC Ratio (V114/Prevnar 13®) |
| PT7F GMC Ratio | 0.60 | 2-Sided | 95 | 0.42 | 0.85 | Other | PT7F GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.79 | 2-Sided | 95 | 0.54 | 1.16 | Other | PT9V GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.74 | 2-Sided | 95 | 0.48 | 1.14 | Other | PT14 GMC Ratio (V114/Prevnar®) |
| PT18C GMC Ratio | 0.66 | 2-Sided | 95 | 0.46 | 0.95 | Other | PT18C GMC Ratio (V114/Prevnar 13®) |
| PT19A GMC Ratio | 0.70 | 2-Sided | 95 | 0.48 | 1.02 | Other | PT19A GMC Ratio (V114/Prevnar 13®) |
| PT19F GMC Ratio | 0.88 | 2-Sided | 95 | 0.60 | 1.29 | Other | PT19F GMC Ratio (V114/Prevnar 13®) |
| PT23F GMC Ratio | 0.69 | 2-Sided | 95 | 0.43 | 1.12 | Other | PT23F GMC Ratio (V114/Prevnar 13®) |
| non-PT22F GMC Ratio | 56.08 | 2-Sided | 95 | 37.66 | 83.52 | Other | non-PT22F GMC Ratio (V114/Prevnar 13®) |
| non-PT33F GMC Ratio | 25.75 | 2-Sided | 95 | 14.18 | 46.78 | Other | non-PT33F GMC Ratio (V114/Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 GMC Ratio |
| 2.55 |
| 2-Sided |
| 95 |
| 1.86 |
| 3.49 |
| Other |
PT3 GMC Ratio (V114/Prevnar 13®) |
| PT4 GMG Ratio | 1.07 | 2-Sided | 95 | 0.79 | 1.46 | Other | PT4 GMC Ratio (V114/Prevnar 13®) |
| PT5 GMC Ratio | 0.51 | 2-Sided | 95 | 0.34 | 0.76 | Other | PT5 GMC Ratio (V114/Prevnar 13®) |
| PT6A GMC Ratio | 0.34 | 2-Sided | 95 | 0.17 | 0.65 | Other | PT6A GMC Ratio (V114/Prevnar 13®) |
| PT6B GMG Ratio | 0.18 | 2-Sided | 95 | 0.08 | 0.38 | Other | PT6B GMC Ratio (V114/Prevnar 13®) |
| PT7F GMC Ratio | 0.59 | 2-Sided | 95 | 0.41 | 0.84 | Other | PT7F GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.68 | 2-Sided | 95 | 0.46 | 1.01 | Other | PT9V GMC Ratio (V114/Prevnar 13®) |
| PT9V GMC Ratio | 0.79 | 2-Sided | 95 | 0.51 | 1.22 | Other | PT14 GMC Ratio (V114/Prevnar®) |
| PT18C GMC Ratio | 0.72 | 2-Sided | 95 | 0.50 | 1.05 | Other | PT18C GMC Ratio (V114/Prevnar 13®) |
| PT19A GMC Ratio | 0.55 | 2-Sided | 95 | 0.37 | 0.80 | Other | PT19A GMC Ratio (V114/Prevnar 13®) |
| PT19F GMC Ratio | 0.97 | 2-Sided | 95 | 0.66 | 1.44 | Other | PT19F GMC Ratio (V114/Prevnar 13®) |
| PT23F GMC Ratio | 0.79 | 2-Sided | 95 | 0.49 | 1.28 | Other | PT23F GMC Ratio (V114/Prevnar 13®) |
| non-PT22F GMC Ratio | 68.64 | 2-Sided | 95 | 45.81 | 102.84 | Other | non-PT22F GMC Ratio (V114/Prevnar 13®) |
| non-PT33F GMC Ratio | 20.03 | 2-Sided | 95 | 10.88 | 36.88 | Other | non-PT33F GMC Ratio (V114/Prevnar 13®) |
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT22F |
|
|
| non-PT23F |
|
|
| non-PT33F |
|
|
|
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 Percentage Point Difference |
| 14.6 |
| 2-Sided |
| 95 |
| -4.1 |
| 32.5 |
Estimated difference and 95% CI are based on the Miettinen and Nurminen method. |
| Other |
PT3 Percentage Point Difference (V114 - Prevnar 13®) |
| PT4 Percentage Point Difference | -7.0 | 2-Sided | 95 | -22.8 | 5.7 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT4 Percentage Point Difference (V114 - Prevnar 13®) |
| PT5 Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT5 Percentage Point Difference (V114 - Prevnar 13®) |
| PT6A Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6A Percentage Point Difference (V114 - Prevnar 13®) |
| PT6B Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6B Percentage Point Difference (V114 - Prevnar 13®) |
| PT7F Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT7F Percentage Point Difference (V114 - Prevnar 13®) |
| PT9V Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT9V Percentage Point Difference (V114 - Prevnar 13®) |
| PT14 Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT14 Percentage Point Difference (V114 - Prevnar 13®) |
| PT18C Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT18C Percentage Point Difference (V114 - Prevnar 13®) |
| PT19A Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19A Percentage Point Difference (V114 - Prevnar 13®) |
| PT19F Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19F Percentage Point Difference (V114 - Prevnar 13®) |
| PT23F Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.2 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT23F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT22F Percentage Point Difference | 89.2 | 2-Sided | 95 | 75.2 | 95.7 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT22F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT33F Percentage Point Difference | 97.3 | 2-Sided | 95 | 85.1 | 99.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT33F Percentage Point Difference (V114 - Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 Percentage Point Difference |
| 11.8 |
| 2-Sided |
| 95 |
| -10.0 |
| 30.6 |
Estimated difference and 95% CI are based on the Miettinen and Nurminen method. |
| Other |
PT3 Percentage Point Difference (V114 - Prevnar 13®) |
| PT4 Percentage Point Difference | -1.6 | 2-Sided | 95 | -18.8 | 10.3 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT4 Percentage Point Difference (V114 - Prevnar 13®) |
| PT5 Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.0 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT5 Percentage Point Difference (V114 - Prevnar 13®) |
| PT6A Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.5 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6A Percentage Point Difference (V114 - Prevnar 13®) |
| PT6B Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.5 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6B Percentage Point Difference (V114 - Prevnar 13®) |
| PT7F Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.0 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT7F Percentage Point Difference (V114 - Prevnar 13®) |
| PT9V Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.0 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT9V Percentage Point Difference (V114 - Prevnar 13®) |
| PT14 Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.0 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT14 Percentage Point Difference (V114 - Prevnar 13®) |
| PT18C Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.5 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT18C Percentage Point Difference (V114 - Prevnar 13®) |
| PT19A Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.0 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19A Percentage Point Difference (V114 - Prevnar 13®) |
| PT19F Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.0 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19F Percentage Point Difference (V114 - Prevnar 13®) |
| PT23F Percentage Point Difference | 0.0 | 2-Sided | 95 | -14.0 | 9.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT23F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT22F Percentage Point Difference | 85.0 | 2-Sided | 95 | 65.8 | 93.6 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT22F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT33F Percentage Point Difference | 92.9 | 2-Sided | 95 | 75.1 | 98.1 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT33F Percentage Point Difference (V114 - Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 Percentage Point Difference |
| 24.3 |
| 2-Sided |
| 95 |
| 12.6 |
| 40.2 |
Estimated difference and 95% CI are based on the Miettinen and Nurminen method. |
| Other |
PT3 Percentage Point Difference (V114 - Prevnar 13®) |
| PT4 Percentage Point Difference | 2.7 | 2-Sided | 95 | -8.0 | 14.0 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT4 Percentage Point Difference (V114 - Prevnar 13®) |
| PT5 Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT5 Percentage Point Difference (V114 - Prevnar 13®) |
| PT6A Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6A Percentage Point Difference (V114 - Prevnar 13®) |
| PT6B Percentage Point Difference | -3.0 | 2-Sided | 95 | -15.5 | 6.7 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6B Percentage Point Difference (V114 - Prevnar 13®) |
| PT7F Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT7F Percentage Point Difference (V114 - Prevnar 13®) |
| PT9V Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT9V Percentage Point Difference (V114 - Prevnar 13®) |
| PT14 Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT14 Percentage Point Difference (V114 - Prevnar 13®) |
| PT18C Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT18C Percentage Point Difference (V114 - Prevnar 13®) |
| PT19A Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19A Percentage Point Difference (V114 - Prevnar 13®) |
| PT19F Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.6 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19F Percentage Point Difference (V114 - Prevnar 13®) |
| PT23F Percentage Point Difference | -3.0 | 2-Sided | 95 | -15.5 | 6.7 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT23F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT22F Percentage Point Difference | 89.2 | 2-Sided | 95 | 75.2 | 95.7 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT22F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT33F Percentage Point Difference | 97.3 | 2-Sided | 95 | 85.7 | 99.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT33F Percentage Point Difference (V114 - Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 Percentage Point Difference |
| 18.4 |
| 2-Sided |
| 95 |
| 1.7 |
| 35.5 |
Estimated difference and 95% CI are based on the Miettinen and Nurminen method. |
| Other |
PT3 Percentage Point Difference (V114 - Prevnar 13®) |
| PT4 Percentage Point Difference | -14.9 | 2-Sided | 95 | -31.4 | -1.2 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT4 Percentage Point Difference (V114 - Prevnar 13®) |
| PT5 Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT5 Percentage Point Difference (V114 - Prevnar 13®) |
| PT6A Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6A Percentage Point Difference (V114 - Prevnar 13®) |
| PT6B Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6B Percentage Point Difference (V114 - Prevnar 13®) |
| PT7F Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT7F Percentage Point Difference (V114 - Prevnar 13®) |
| PT9V Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT9V Percentage Point Difference (V114 - Prevnar 13®) |
| PT14 Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT14 Percentage Point Difference (V114 - Prevnar 13®) |
| PT18C Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT18C Percentage Point Difference (V114 - Prevnar 13®) |
| PT19A Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19A Percentage Point Difference (V114 - Prevnar 13®) |
| PT19F Percentage Point Difference | 0.0 | 2-Sided | 95 | -10.3 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19F Percentage Point Difference (V114 - Prevnar 13®) |
| PT23F Percentage Point Difference | -5.9 | 2-Sided | 95 | -19.2 | 3.9 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT23F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT22F Percentage Point Difference | 89.2 | 2-Sided | 95 | 75.2 | 95.7 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT22F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT33F Percentage Point Difference | 97.3 | 2-Sided | 95 | 85.9 | 99.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT33F Percentage Point Difference (V114 - Prevnar 13®) |
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 Percentage Point Difference |
| 14.0 |
| 2-Sided |
| 95 |
| -5.5 |
| 32.0 |
Estimated difference and 95% CI are based on the Miettinen and Nurminen method. |
| Other |
PT3 Percentage Point Difference (V114 - Prevnar 13®) |
| PT4 Percentage Point Difference | -7.6 | 2-Sided | 95 | -24.2 | 5.2 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT4 Percentage Point Difference (V114 - Prevnar 13®) |
| PT5 Percentage Point Difference | -3.4 | 2-Sided | 95 | -17.3 | 6.3 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT5 Percentage Point Difference (V114 - Prevnar 13®) |
| PT6A Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.9 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6A Percentage Point Difference (V114 - Prevnar 13®) |
| PT6B Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.9 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT6B Percentage Point Difference (V114 - Prevnar 13®) |
| PT7F Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.9 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT7F Percentage Point Difference (V114 - Prevnar 13®) |
| PT9V Percentage Point Difference | -3.4 | 2-Sided | 95 | -17.3 | 6.3 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT9V Percentage Point Difference (V114 - Prevnar 13®) |
| PT14 Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.9 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT14 Percentage Point Difference (V114 - Prevnar 13®) |
| PT18C Percentage Point Difference | -3.4 | 2-Sided | 95 | -17.3 | 6.3 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT18C Percentage Point Difference (V114 - Prevnar 13®) |
| PT19A Percentage Point Difference | -6.9 | 2-Sided | 95 | -22.1 | 3.0 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19A Percentage Point Difference (V114 - Prevnar 13®) |
| PT19F Percentage Point Difference | -3.4 | 2-Sided | 95 | -17.3 | 6.3 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT19F Percentage Point Difference (V114 - Prevnar 13®) |
| PT23F Percentage Point Difference | 0.0 | 2-Sided | 95 | -11.9 | 9.5 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | PT23F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT22F Percentage Point Difference | 89.2 | 2-Sided | 95 | 75.2 | 95.7 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT22F Percentage Point Difference (V114 - Prevnar 13®) |
| non-PT33F Percentage Point Difference | 93.8 | 2-Sided | 95 | 78.5 | 98.3 | Estimated difference and 95% CI are based on the Miettinen and Nurminen method. | Other | non-PT33F Percentage Point Difference (V114 - Prevnar 13®) |
|
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT23F |
|
|
| non-PT22F |
|
|
| non-PT33F |
|
|
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT22F |
|
|
| non-PT23F |
|
|
| non-PT33F |
|
|
| PT3 |
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT22F |
|
|
| non-PT23F |
|
|
| non-PT33F |
|
|
|
| PT4 |
|
|
| PT5 |
|
|
| PT6A |
|
|
| PT6B |
|
|
| PT7F |
|
|
| PT9V |
|
|
| PT14 |
|
|
| PT18C |
|
|
| PT19A |
|
|
| PT19F |
|
|
| PT22F |
|
|
| non-PT23F |
|
|
| non-PT33F |
|
|