Pneumococcal Infections
Conditions
Brief summary
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
Interventions
BIOLOGICAL13 valent Pneumococcal Conjugate Vaccine
0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
BIOLOGICAL23vPS
0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female aged 70 years or older. * Documented vaccination with 1 dose of 23vPS at least 5 years previous. * Healthy.
Exclusion criteria
* Receipt of more than one dose of 23vPS prior to enrollment. * History of severe adverse reaction to a vaccine. * Immunodeficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | 1 month after Vax 1 / Year 0 | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Baseline, 1 month after Vax 1 / Year 0 | OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | 1 month after Vax 1 / Year 0 | Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer. |
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 | Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 | Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 | Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 | Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain). |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 | Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain). |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Days 1 through 14 / Year 0 | Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder) |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 | Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain). |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Days 1 through 14 / Year 1 | Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain). |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 | Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder) |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 | Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder) |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Days 1 through 14 / Year 1 | Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder) |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 | Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder) |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Days 1 through 14 / Year 0 | Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain). |
Countries
Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC 13vPnC 0.5 mL dose IM at Year 0 (Vax 1) | 463 |
| 23vPS 23vPS 0.5 mL dose IM at Year 0 (Vax 1) | 473 |
| Total | 936 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Vax 1 / Year 0 | 6-Month Contact; withdraw before Vax 2 | 64 | 59 |
| Vax 1 / Year 0 | Adverse Event | 0 | 1 |
| Vax 1 / Year 0 | Death | 2 | 2 |
| Vax 1 / Year 0 | Lost to Follow-up | 0 | 1 |
| Vax 1 / Year 0 | Protocol Violation | 3 | 4 |
| Vax 1 / Year 0 | Randomized, not treated | 1 | 1 |
| Vax 1 / Year 0 | Withdrawal by Subject | 3 | 2 |
| Vax 2 / Year 1 | Adverse Event | 1 | 0 |
| Vax 2 / Year 1 | Other | 1 | 1 |
| Vax 2 / Year 1 | Vax 2; withdraw before 6-Month Contact | 2 | 1 |
Baseline characteristics
| Characteristic | 13vPnC | 23vPS | Total |
|---|---|---|---|
| Age Continuous | 76.7 years STANDARD_DEVIATION 4.6 | 76.7 years STANDARD_DEVIATION 4.5 | 76.7 years STANDARD_DEVIATION 4.6 |
| Sex: Female, Male Female | 221 Participants | 235 Participants | 456 Participants |
| Sex: Female, Male Male | 242 Participants | 238 Participants | 480 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 | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 234 / 463 | 275 / 473 | 60 / 463 | 59 / 473 | 191 / 391 | 189 / 404 | 29 / 391 | 30 / 404 |
| serious Total, serious adverse events | 3 / 463 | 8 / 473 | 27 / 463 | 26 / 473 | 4 / 391 | 7 / 404 | 17 / 391 | 21 / 404 |
Outcome results
Primary
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.
Time frame: Baseline, 1 month after Vax 1 / Year 0
Population: Evaluable Immunogenicity population. N=number of participants with a determinate antibody titer to the given serotype.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC | Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | 71.1 observed percentage of participants |
| 23vPS | Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | 27.3 observed percentage of participants |
Comparison: Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.~Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC - 23vPS) was \> 0.95% CI: [37.4, 49.9]
Primary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after Vax 1 / Year 0
Population: Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 1 | 81 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 3 | 55 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 4 | 545 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 5 | 72 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 6B | 1261 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 7F | 245 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 9V | 181 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 14 | 280 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 18C | 907 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 19A | 354 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 19F | 333 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 23F | 158 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 19F | 214 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 1 | 55 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 9V | 90 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 3 | 49 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 19A | 200 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 4 | 203 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 14 | 285 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 5 | 36 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 23F | 43 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 6B | 417 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 18C | 481 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | Serotype 7F | 160 geometric mean titer |
Comparison: Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.17, 1.88]
Comparison: Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.91, 1.35]
Comparison: Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.93, 3.74]
Comparison: Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.55, 2.63]
Comparison: Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [2.21, 4.13]
Comparison: Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.07, 2.18]
Comparison: Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.95% CI: [1.36, 2.97]
Comparison: Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.73, 1.33]
Comparison: Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.42, 2.5]
Comparison: Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.43, 2.2]
Comparison: Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.17, 2.06]
Comparison: Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [2.69, 5.09]
Secondary
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | 1134 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | 94 geometric mean titer |
Comparison: Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2.95% CI: [8.92, 16.44]
Secondary
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.
Time frame: 1 month after Vax 1 / Year 0
Population: Evaluable Immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | 903 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0) | 94 geometric mean titer |
Comparison: Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2.95% CI: [7, 13.26]
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 1 | 76 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 3 | 55 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 4 | 472 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 5 | 56 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 6B | 1565 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 7F | 185 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 9V | 158 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 14 | 238 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 18C | 975 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 19A | 339 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 19F | 311 geometric mean titers |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 23F | 310 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 19F | 214 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 1 | 55 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 9V | 90 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 3 | 49 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 19A | 200 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 4 | 203 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 14 | 285 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 5 | 36 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 23F | 43 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 6B | 417 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 18C | 481 geometric mean titers |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) | Serotype 7F | 160 geometric mean titers |
Comparison: Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.1, 1.76]
Comparison: Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.91, 1.34]
Comparison: Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.66, 3.25]
Comparison: Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.21, 2.06]
Comparison: Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [2.78, 5.07]
Comparison: Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.8, 1.67]
Comparison: Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.18, 2.62]
Comparison: Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.62, 1.13]
Comparison: Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.53, 2.69]
Comparison: Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.37, 2.1]
Comparison: Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.09, 1.93]
Comparison: Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.95% CI: [5.36, 9.82]
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype at both the postvaccination 1 and postvaccination 2 blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 3 | 55 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 7F | 222 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 5 | 69 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 9V | 187 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 1 | 79 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 14 | 265 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 6A | 971 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 18C | 918 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 4 | 614 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 19A | 349 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 6B | 1358 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 23F | 167 geometric mean titer |
| 13vPnC | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 19F | 329 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 23F | 309 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 19F | 322 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 1 | 76 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 3 | 55 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 4 | 487 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 5 | 57 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 6A | 1169 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 6B | 1590 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 7F | 180 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 9V | 166 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 14 | 241 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 18C | 1003 geometric mean titer |
| 23vPS | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) | Serotype 19A | 341 geometric mean titer |
Comparison: Serotype 1: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.85, 1.1]
Comparison: Serotype 3: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.91, 1.11]
Comparison: Serotype 4: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.68, 0.92]
Comparison: Serotype 5: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.73, 0.94]
Comparison: Serotype 6A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [1.03, 1.4]
Comparison: Serotype 6B: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [1.02, 1.35]
Comparison: Serotype 7F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.65, 1.01]
Comparison: Serotype 9V: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.69, 1.15]
Comparison: Serotype 14: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.79, 1.05]
Comparison: Serotype 18C: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.97, 1.23]
Comparison: Serotype 19A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.89, 1.07]
Comparison: Serotype 19F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.83, 1.15]
Comparison: Serotype 23F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [1.6, 2.14]
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Time frame: Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Severe (n=228, 222) | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Any (n=236, 241) | 12.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Moderate (n=229, 229) | 3.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Mild (n=234, 236) | 10.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Any (n=236, 228) | 12.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Severe (n=227, 222) | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Severe (n=226, 221) | 0.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Any (n=297, 302) | 58.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Mild (n=233, 226) | 6.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Mild (n=291, 297) | 54.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Mild (n=245, 249) | 15.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Moderate (n=239, 236) | 13.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Any (n=247, 251) | 16.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Severe (n=227, 222) | 1.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Moderate (n=228, 222) | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Moderate (n=231, 223) | 6.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Moderate (n=228, 222) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Mild (n=234, 236) | 11.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Moderate (n=239, 236) | 13.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Mild (n=245, 249) | 18.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Severe (n=228, 222) | 1.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Any (n=236, 228) | 10.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Mild (n=233, 226) | 8.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Moderate (n=231, 223) | 3.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Redness: Severe (n=227, 222) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Any (n=236, 241) | 14.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Moderate (n=229, 229) | 4.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Swelling: Severe (n=227, 222) | 0.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Any (n=297, 302) | 56.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Mild (n=291, 297) | 53.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Pain: Severe (n=226, 221) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) | Limitation of arm movement: Any (n=247, 251) | 19.9 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Time frame: Days 1 through 14 / Year 0
Population: Safety population is all participants who receive at least 1 dose of study vaccine. N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Vax 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Mild (n=304, 311) | 9.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Mild (n=305, 315) | 8.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Severe (n=299, 310) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Moderate (n=299, 323) | 4.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Moderate (n=306, 330) | 7.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Severe (n=297, 310) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Mild (n=359, 377) | 50.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Moderate (n=297, 303) | 0.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Severe (n=299, 306) | 1.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Moderate (n=301, 314) | 4.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Any (n=313, 326) | 10.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Any (n=306, 324) | 10.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Mild (n=312, 322) | 10.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Any (n=362, 383) | 51.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Any (n=307, 333) | 10.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Severe (n=298, 305) | 0.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Any (n=307, 333) | 23.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Mild (n=304, 311) | 13.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Moderate (n=301, 314) | 11.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Severe (n=297, 310) | 4.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Any (n=362, 383) | 58.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Mild (n=359, 377) | 54.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Severe (n=298, 305) | 3.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Severe (n=299, 310) | 4.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Redness: Any (n=306, 324) | 22.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Mild (n=305, 315) | 14.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Swelling: Moderate (n=299, 323) | 13.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Moderate (n=306, 330) | 23.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Pain: Severe (n=299, 306) | 2.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Any (n=313, 326) | 27.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Mild (n=312, 322) | 25.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Limitation of arm movement: Moderate (n=297, 303) | 2.6 percentage of participants |
Comparison: Redness: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: <0.00195% CI: [-17.3, -5.6]Chan & Zhang
Comparison: Redness: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.12995% CI: [-9.1, 1.1]Chan & Zhang
Comparison: Redness: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.00295% CI: [-11.3, -2.3]Chan & Zhang
Comparison: Redness: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.02895% CI: [-6.3, -0.3]Chan & Zhang
Comparison: Swelling: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: <0.00195% CI: [-18.5, -7]Chan & Zhang
Comparison: Swelling: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.04895% CI: [-10.2, -0.1]Chan & Zhang
Comparison: Swelling: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: <0.00195% CI: [-14.2, -5.1]Chan & Zhang
Comparison: Swelling: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: <0.00195% CI: [-7.9, -2.7]Chan & Zhang
Comparison: Pain: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.06295% CI: [-14, 0.4]Chan & Zhang
Comparison: Pain: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.28495% CI: [-11.3, 3.3]Chan & Zhang
Comparison: Pain: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: <0.00195% CI: [-21.7, -10.6]Chan & Zhang
Comparison: Pain: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.53995% CI: [-3.5, 1.4]Chan & Zhang
Comparison: Limitation of arm movement: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: <0.00195% CI: [-23.1, -11.1]Chan & Zhang
Comparison: Limitation of arm movement: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: <0.00195% CI: [-20.8, -9]Chan & Zhang
Comparison: Limitation of arm movement: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.0295% CI: [-4.8, -0.4]Chan & Zhang
Comparison: Limitation of arm movement: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.04295% CI: [-4.9, -0.1]Limitation of arm movement: any; differe
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Time frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Any (n=185, 185) | 9.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Severe (n=177, 177) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Mild (n=251, 251) | 53.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Moderate (n=187, 187) | 8.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Mild (n=194, 194) | 9.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Moderate (n=178, 178) | 0.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Severe (n=178, 178) | 0.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Mild (n=182, 182) | 8.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Moderate (n=182, 182) | 4.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Severe (n=179, 179) | 1.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Any (n=185, 185) | 9.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Mild (n=182, 182) | 6.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Moderate (n=179, 179) | 3.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Any (n=258, 258) | 55.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Severe (n=179, 179) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Any (n=195, 195) | 9.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Moderate (n=187, 187) | 11.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Any (n=185, 185) | 12.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Any (n=185, 185) | 10.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Severe (n=179, 179) | 1.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Severe (n=177, 177) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Any (n=258, 258) | 57.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Moderate (n=178, 178) | 0.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Severe (n=179, 179) | 0.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Any (n=195, 195) | 13.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Mild (n=182, 182) | 8.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Severe (n=178, 178) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Moderate (n=179, 179) | 2.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Mild (n=194, 194) | 13.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Mild (n=182, 182) | 6.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Mild (n=251, 251) | 54.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Moderate (n=182, 182) | 7.1 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Time frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Moderate (n=301, 223) | 4.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Moderate (n=299, 229) | 4.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Severe (n=299, 221) | 1.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Severe (n=297, 222) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Any (n=307, 241) | 10.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Any (n=362, 302) | 51.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Mild (n=359, 297) | 50.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Severe (n=299, 222) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Moderate (n=306, 236) | 7.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Severe (n=298, 222) | 0.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Any (n=313, 251) | 10.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Mild (n=305, 236) | 8.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Mild (n=312, 249) | 10.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Moderate (n=297, 222) | 0.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Mild (n=304, 226) | 9.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Any (n=306, 228) | 10.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Severe (n=298, 222) | 1.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Mild (n=304, 226) | 8.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Moderate (n=301, 223) | 3.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Severe (n=299, 222) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Any (n=307, 241) | 14.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Any (n=362, 302) | 56.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Severe (n=299, 221) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Mild (n=312, 249) | 18.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Redness: Any (n=306, 228) | 10.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Mild (n=305, 236) | 11.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Moderate (n=299, 229) | 4.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Swelling: Severe (n=297, 222) | 0.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Mild (n=359, 297) | 53.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Pain: Moderate (n=306, 236) | 13.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Any (n=313, 251) | 19.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Moderate (n=297, 222) | 0.9 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Time frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Severe (n=310, 227) | 4.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Any (n=383, 297) | 58.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Severe (n=306, 226) | 2.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Mild (n=377, 291) | 54.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Moderate (n=330, 239) | 23.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Any (n=326, 247) | 27.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Mild (n=322, 245) | 25.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Moderate (n=303, 228) | 2.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Severe (n=305, 228) | 3.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Any (n=324, 236) | 22.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Mild (n=311, 233) | 13.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Moderate (n=314, 231) | 11.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Any (n=333, 236) | 23.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Mild (n=315, 234) | 14.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Moderate (n=323, 229) | 13.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Severe (n=310, 227) | 4.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Moderate (n=303, 228) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Moderate (n=323, 229) | 3.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Severe (n=310, 227) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Moderate (n=314, 231) | 6.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Moderate (n=330, 239) | 13.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Severe (n=305, 228) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Any (n=383, 297) | 58.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Severe (n=310, 227) | 1.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Mild (n=377, 291) | 54.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Any (n=324, 236) | 12.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Pain: Severe (n=306, 226) | 0.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Mild (n=315, 234) | 10.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Any (n=326, 247) | 16.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Redness: Mild (n=311, 233) | 6.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Limitation of arm movement: Mild (n=322, 245) | 15.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Swelling: Any (n=333, 236) | 12.3 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Time frame: Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=227, 221) | 1.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Rash (n=232, 226) | 6.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=227, 224) | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Vomiting (n=226, 226) | 0.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fatigue (n=255, 265) | 28.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=237, 230) | 8.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=226, 222) | 0.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=260, 263) | 34.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Headache (n=246, 248) | 19.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=245, 248) | 18.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=227,221) | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | New joint pain (n=238, 234) | 10.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Chills (n=234, 233) | 7.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=239, 231) | 12.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=229, 224) | 3.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=239, 231) | 11.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=229, 224) | 2.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=227, 224) | 1.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=227,221) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=226, 222) | 0.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=227, 221) | 0.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Fatigue (n=255, 265) | 34.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Headache (n=246, 248) | 22.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Chills (n=234, 233) | 9.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Rash (n=232, 226) | 7.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Vomiting (n=226, 226) | 3.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=237, 230) | 7.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=260, 263) | 35.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=245, 248) | 21.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) | New joint pain (n=238, 234) | 12.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Time frame: Days 1 through 14 / Year 0
Population: Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Year 0). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Potentially life-threatening >40C (n=297, 307) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Rash (n=303, 323) | 7.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Mild ≥38 but <38.5 degrees C (n=299, 303) | 1.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Vomiting (n=300, 304) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fatigue (n=350, 367) | 34.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Decreased appetite (n=317, 313) | 10.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Severe ≥39 but ≤40 degrees C (n=297, 301) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | New muscle pain (n=345, 358) | 36.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Headache (n=329, 331) | 23.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Aggravated muscle pain (n=320, 334) | 20.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Moderate ≥38.5 but <39 degrees C(n=297,301) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | New joint pain (n=310, 323) | 12.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Chills (n=305, 312) | 7.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Aggravated joint pain (n=310, 322) | 11.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Any ≥38 degrees C (n=299, 309) | 1.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Aggravated joint pain (n=310, 322) | 16.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Any ≥38 degrees C (n=299, 309) | 4.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Mild ≥38 but <38.5 degrees C (n=299, 303) | 2.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Moderate ≥38.5 but <39 degrees C(n=297,301) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fever: Severe ≥39 but ≤40 degrees C (n=297, 301) | 0.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Potentially life-threatening >40C (n=297, 307) | 2.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Fatigue (n=350, 367) | 43.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Headache (n=329, 331) | 26.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Chills (n=305, 312) | 11.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Rash (n=303, 323) | 16.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Vomiting (n=300, 304) | 1.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Decreased appetite (n=317, 313) | 11.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | New muscle pain (n=345, 358) | 44.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | Aggravated muscle pain (n=320, 334) | 27.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) | New joint pain (n=310, 323) | 14.9 percentage of participants |
Comparison: New generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.03495% CI: [-15.2, -0.6]Chan & Zhang
Comparison: Aggravated generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.p-value: 0.03995% CI: [-13.6, -0.3]Chan & Zhang
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Time frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=219, 219) | 37.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=177, 177) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Chills (n=182, 182) | 9.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Rash (n=183, 183) | 8.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Vomiting (n=178, 178) | 1.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=190, 190) | 8.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=198, 198) | 20.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New joint pain (n=187, 187) | 11.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=188, 188) | 11.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=179, 179) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=179, 179) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=177,177) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=177, 177) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fatigue (n=215, 215) | 33.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Headache (n=200, 200) | 23.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=179, 179) | 0.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New joint pain (n=187, 187) | 7.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=177, 177) | 0.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Headache (n=200, 200) | 19.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=177,177) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Chills (n=182, 182) | 4.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=188, 188) | 10.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Rash (n=183, 183) | 6.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fatigue (n=215, 215) | 28.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Vomiting (n=178, 178) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=179, 179) | 2.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=190, 190) | 7.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=219, 219) | 35.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=177, 177) | 1.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=198, 198) | 16.2 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Time frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=317, 230) | 10.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=297,221) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=297, 222) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=297, 221) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fatigue (n=350, 265) | 34.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Headache (n=329, 248) | 23.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Chills (n=305, 233) | 7.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Rash (n=303, 226) | 7.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Vomiting (n=300, 226) | 1.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=345, 263) | 36.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=320, 248) | 20.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | New joint pain (n=310, 234) | 12.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=310, 231) | 11.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=299, 224) | 1.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=299, 224) | 1.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | New joint pain (n=310, 234) | 12.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=299, 224) | 2.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=299, 224) | 1.8 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Rash (n=303, 226) | 7.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=297,221) | 0.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=320, 248) | 21.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=297, 222) | 0.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Vomiting (n=300, 226) | 3.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=297, 221) | 0.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=317, 230) | 7.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Fatigue (n=350, 265) | 34.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=310, 231) | 11.7 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Headache (n=329, 248) | 22.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=345, 263) | 35.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) | Chills (n=305, 233) | 9.9 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Time frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Population: Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Headache (n=331, 246) | 26.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=303, 227) | 2.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=301,227) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=301, 226) | 0.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=307, 227) | 2.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fatigue (n=367, 255) | 43.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Chills (n=312, 234) | 11.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Rash (n=323, 232) | 16.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Vomiting (n=304, 226) | 1.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=313, 237) | 11.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=358, 260) | 44.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=334, 245) | 27.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New joint pain (n=323, 238) | 14.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=322, 239) | 16.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=309, 229) | 4.2 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New muscle pain (n=358, 260) | 34.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Any ≥38 degrees C (n=309, 229) | 3.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Rash (n=323, 232) | 6.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Mild ≥38 but <38.5 degrees C (n=303, 227) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | New joint pain (n=323, 238) | 10.5 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Moderate ≥38.5 but <39 degrees C(n=301,227) | 0.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Vomiting (n=304, 226) | 0.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fever: Severe ≥39 but ≤40 degrees C (n=301, 226) | 0.4 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated muscle pain (n=334, 245) | 18.0 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Potentially life-threatening >40C (n=307, 227) | 1.3 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Decreased appetite (n=313, 237) | 8.9 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Fatigue (n=367, 255) | 28.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Headache (n=331, 246) | 19.1 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Aggravated joint pain (n=322, 239) | 12.6 percentage of participants |
| 23vPS | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) | Chills (n=312, 234) | 7.3 percentage of participants |