Pneumococcal Disease
Conditions
Brief summary
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female adults \>/= 18 years of age (from the 18th birthday) at enrollment and older. 2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. 3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.
Exclusion criteria
1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. History of microbiologically proven invasive disease caused by S pneumoniae. 3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study. 4. Pregnant female subjects or breastfeeding female subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Within 10 days after 20vPnC or 13vPnC | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Within 7 days after 20vPnC or 13vPnC | Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts | Within 1 month after 20vPnC or 13vPnC | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. |
| Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts | Within 6 months after 20vPnC or 13vPnC | An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts | Within 6 months after 20vPnC or 13vPnC | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. |
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | 1 month after Vaccination 1 | OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated. |
| Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | 1 month after Vaccination 1 in Cohort 1: 20vPnC/Saline; 1 month after Vaccination 2 in Cohort 1: 13vPnC/PPSV23 | OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Before vaccination to 1 month after vaccination | Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. |
| Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | 1 month after Vaccination 1 | The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | 1 month after vaccination | OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated. |
| Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | 1 month after vaccination | The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure were planned to be analyzed for the 20vPnC groups of Cohorts 2 and 3 only. |
| Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | 1 month after Vaccination 1 in Cohort 1: 20vPnC/Saline or 1 month after Vaccination 2 in Cohort 1: 13vPnC/PPSV23 | The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F. |
| Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | 1 month after vaccination | OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated. |
| Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Before Vaccination 1 to 1 month after Vaccination 1 | OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | From before Vaccination 1 to 1 month after Vaccination 1 in Cohort 1: 20vPnC/Saline or From before Vaccination 1 to 1 month after Vaccination 2 in Cohort 1: 13vPnC/PPSV23 | OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F. |
| Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Before vaccination to 1 month after vaccination | OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. |
| Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Before Vaccination 1 to 1 month after Vaccination 1 | Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Before Vaccination 1 to 1 month after Vaccination 1 for Cohort 1: 20vPnC/Saline; Before Vaccination 1 to 1 month after Vaccination 2 for Cohort 1: 13vPnC/PPSV23 | Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F. |
Countries
Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: 20vPnC/Saline Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). | 1,507 |
| Cohort 1: 13vPnC/PPSV23 Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). | 1,490 |
| Cohort 2: 20vPnC Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). | 334 |
| Cohort 2: 13vPnC Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). | 111 |
| Cohort 3: 20vPnC Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). | 335 |
| Cohort 3: 13vPnC Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). | 112 |
| Total | 3,889 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 8 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 41 | 28 | 9 | 2 | 14 | 8 |
| Overall Study | No longer met eligibility criteria | 3 | 9 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 21 | 13 | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 19 | 20 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: 20vPnC/Saline | Cohort 1: 13vPnC/PPSV23 | Cohort 2: 20vPnC | Cohort 2: 13vPnC | Cohort 3: 20vPnC | Cohort 3: 13vPnC | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 4.82 | 64.6 Years STANDARD_DEVIATION 4.81 | 54.9 Years STANDARD_DEVIATION 2.77 | 55.0 Years STANDARD_DEVIATION 3.11 | 34.0 Years STANDARD_DEVIATION 8.77 | 33.9 Years STANDARD_DEVIATION 8.03 | 60.0 Years STANDARD_DEVIATION 11.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 167 Participants | 169 Participants | 12 Participants | 8 Participants | 24 Participants | 7 Participants | 387 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1324 Participants | 1308 Participants | 319 Participants | 101 Participants | 300 Participants | 102 Participants | 3454 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 13 Participants | 3 Participants | 2 Participants | 11 Participants | 3 Participants | 48 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 9 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 20 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 15 Participants | 10 Participants | 2 Participants | 11 Participants | 1 Participants | 58 Participants |
| Race (NIH/OMB) Black or African American | 177 Participants | 212 Participants | 35 Participants | 15 Participants | 34 Participants | 7 Participants | 480 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 9 Participants | 6 Participants | 1 Participants | 8 Participants | 1 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 5 Participants | 0 Participants | 4 Participants | 0 Participants | 18 Participants |
| Race (NIH/OMB) White | 1295 Participants | 1237 Participants | 278 Participants | 90 Participants | 274 Participants | 101 Participants | 3275 Participants |
| Sex: Female, Male Female | 897 Participants | 879 Participants | 195 Participants | 69 Participants | 214 Participants | 77 Participants | 2331 Participants |
| Sex: Female, Male Male | 610 Participants | 611 Participants | 139 Participants | 42 Participants | 121 Participants | 35 Participants | 1558 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,507 | 0 / 1,490 | 0 / 334 | 0 / 111 | 0 / 335 | 0 / 112 |
| other Total, other adverse events | 1,074 / 1,507 | 1,063 / 1,490 | 281 / 334 | 91 / 111 | 302 / 335 | 107 / 112 |
| serious Total, serious adverse events | 36 / 1,507 | 29 / 1,490 | 1 / 334 | 1 / 111 | 2 / 335 | 1 / 112 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time frame: Within 1 month after 20vPnC or 13vPnC
Population: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts | 9.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts | 11.1 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts | 10.2 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts | 8.1 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts | 15.2 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts | 11.6 percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time frame: Within 10 days after 20vPnC or 13vPnC
Population: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination. Here, Overall Number of Participants Analyzed =number of participants with any electronic diary data after 20vPnC or 13vPnC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Any | 55.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Any | 7.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Severe | 0.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Severe | 0.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Moderate | 2.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Moderate | 9.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Severe | 0.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Any | 7.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Mild | 45.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Mild | 4.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Mild | 3.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Moderate | 2.4 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Mild | 4.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Moderate | 2.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Any | 54.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Mild | 3.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Any | 8.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Severe | 0.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Any | 6.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Severe | 0.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Moderate | 9.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Moderate | 2.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Severe | 0.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Mild | 44.6 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Moderate | 17.8 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Moderate | 2.7 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Any | 72.5 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Severe | 0.3 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Severe | 1.2 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Mild | 53.5 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Moderate | 3.0 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Severe | 0 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Any | 8.8 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Mild | 5.1 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Any | 8.2 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Mild | 5.7 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Severe | 0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Any | 5.4 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Mild | 2.7 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Moderate | 2.7 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Severe | 0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Any | 10.8 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Mild | 7.2 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Moderate | 3.6 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Any | 69.4 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Mild | 52.3 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Moderate | 16.2 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Severe | 0.9 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Any | 11.6 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Moderate | 5.4 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Any | 9.0 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Severe | 0.3 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Moderate | 38.2 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Severe | 0.6 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Mild | 3.0 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Any | 81.2 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Mild | 42.7 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Moderate | 4.5 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Severe | 0 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Mild | 7.2 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Severe | 0 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Any | 12.5 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Any | 82.1 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Severe | 0 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Severe | 0.9 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Mild | 52.7 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Moderate | 4.5 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Mild | 5.4 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Pain at the injection site: Moderate | 28.6 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Redness: Any | 9.8 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Moderate | 3.6 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts | Swelling: Mild | 8.9 percentage of participants |
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Time frame: Within 6 months after 20vPnC or 13vPnC
Population: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts | 2.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts | 2.3 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts | 1.5 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts | 0.9 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts | 1.5 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts | 1.8 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Time frame: Within 6 months after 20vPnC or 13vPnC
Population: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts | 2.4 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts | 1.9 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts | 0.3 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts | 0.9 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts | 0.6 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts | 0.9 percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Time frame: Within 7 days after 20vPnC or 13vPnC
Population: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination. Here, Overall Number of Participants Analyzed =number of participants with any electronic diary data after 20vPnC or 13vPnC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C | 0.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C to 38.4 degree C | 0.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.4 degree C to 38.9 degree C | 0.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.9 degree C to 40.0 degree C | 0.0 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >40.0 degree C | 0.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Any | 30.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Mild | 16.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Moderate | 12.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Severe | 1.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Any | 21.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Mild | 15.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Moderate | 5.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Severe | 0.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Any | 39.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Mild | 28.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Moderate | 9.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Severe | 0.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Any | 12.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Mild | 6.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Moderate | 5.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Severe | 0.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Mild | 17.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Moderate | 11.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.9 degree C to 40.0 degree C | 0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Moderate | 6.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Any | 23.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Severe | 1.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C to 38.4 degree C | 0.4 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C | 0.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Any | 13.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.4 degree C to 38.9 degree C | 0.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Any | 30.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Mild | 7.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Severe | 0.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Severe | 0.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Moderate | 10.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Mild | 26.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Mild | 17.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >40.0 degree C | 0.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Any | 37.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Severe | 0.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Moderate | 5.9 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.9 degree C to 40.0 degree C | 0.3 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >40.0 degree C | 0.3 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Mild | 10.6 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Any | 39.3 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Mild | 21.1 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Moderate | 17.2 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Severe | 0.9 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Any | 32.3 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Mild | 20.5 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Moderate | 4.8 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Moderate | 10.9 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Severe | 0.9 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Any | 49.8 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Mild | 33.8 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Moderate | 15.4 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Severe | 0.6 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Severe | 0 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Any | 15.4 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C | 1.5 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C to 38.4 degree C | 0.6 percentage of participants |
| Cohort 2: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.4 degree C to 38.9 degree C | 0.3 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Any | 20.7 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Mild | 12.6 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Severe | 0.9 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Mild | 31.5 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Any | 36.0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.4 degree C to 38.9 degree C | 0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Any | 36.0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Moderate | 17.1 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.9 degree C to 40.0 degree C | 0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Moderate | 7.2 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Moderate | 15.3 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >40.0 degree C | 0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Severe | 0.9 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Mild | 21.6 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Severe | 2.7 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Moderate | 13.5 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Mild | 18.0 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C | 0.9 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Any | 49.5 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C to 38.4 degree C | 0.9 percentage of participants |
| Cohort 2: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Severe | 0.9 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.9 degree C to 40.0 degree C | 0.3 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Mild | 21.5 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C to 38.4 degree C | 0.6 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Moderate | 14.6 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Mild | 18.8 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Severe | 2.7 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Moderate | 7.2 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Any | 66.6 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Mild | 36.4 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Moderate | 29.0 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Any | 42.7 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Severe | 1.2 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.4 degree C to 38.9 degree C | 0.3 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >40.0 degree C | 0 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C | 1.2 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Any | 13.4 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Severe | 1.8 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Severe | 0 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Moderate | 22.1 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Any | 38.8 percentage of participants |
| Cohort 3: 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Mild | 6.3 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Moderate | 8.0 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Mild | 20.5 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Any | 74.1 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Any | 17.9 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C to 38.4 degree C | 0 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >=38.0 degree C | 1.8 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Mild | 8.9 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Moderate | 19.6 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Moderate | 17.0 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Any | 43.8 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Severe | 0.9 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Moderate | 31.3 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Mild | 16.1 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Joint pain: Severe | 0.9 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Mild | 42.0 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.9 degree C to 40.0 degree C | 1.8 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fatigue: Severe | 3.6 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Muscle pain: Severe | 0.9 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Headache: Any | 33.9 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >40.0 degree C | 0 percentage of participants |
| Cohort 3: 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts | Fever: >38.4 degree C to 38.9 degree C | 0 percentage of participants |
Primary
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Time frame: 1 month after Vaccination 1 in Cohort 1: 20vPnC/Saline; 1 month after Vaccination 2 in Cohort 1: 13vPnC/PPSV23
Population: Evaluable 7-additional immunogenicity population: participants who were enrolled in the appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 11A | 4426.8 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 15B | 2398.2 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 10A | 2007.6 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 22F | 3666.2 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 12F | 2538.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 33F | 5125.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 8 | 465.6 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 33F | 3720.6 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 8 | 848.1 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 10A | 1079.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 11A | 2534.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 12F | 1716.6 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 15B | 768.5 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) | Serotype 22F | 1846.2 titer |
Comparison: Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.49, 0.62]
Comparison: Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [1.63, 2.12]
Comparison: Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [1.52, 2.01]
Comparison: Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [1.27, 1.72]
Comparison: Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [2.62, 3.71]
Comparison: Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [1.7, 2.32]
Comparison: Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [1.21, 1.57]
Primary
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Time frame: 1 month after Vaccination 1
Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 508.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 1455.5 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 889.0 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 746.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 40.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 1252.6 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 1115.2 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 517.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 91.6 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 265.8 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 968.8 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 276.5 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 123.4 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 335.1 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 153.8 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 47.8 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 626.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 109.7 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 1165.1 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 1341.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 1129.2 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 1567.8 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 746.7 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 1482.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 645.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 333.3 titer |
Comparison: Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.71, 0.9]
Comparison: Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.78, 0.93]
Comparison: Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.71, 0.93]
Comparison: Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.74, 0.94]
Comparison: Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.66, 0.88]
Comparison: Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.73, 0.95]
Comparison: Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.77, 0.96]
Comparison: Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.82, 1.05]
Comparison: Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.89, 1.13]
Comparison: Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.74, 0.97]
Comparison: Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.71, 0.9]
Comparison: Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.7, 0.91]
Comparison: Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI95% CI: [0.7, 0.97]
Secondary
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: Before vaccination to 1 month after vaccination
Population: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed =participants evaluable at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 4 | 84.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19A | 80.0 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6B | 78.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19F | 64.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 23F | 81.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 3 | 59.0 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 8 | 79.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 7F | 73.0 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 10A | 78.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 5 | 54.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 11A | 61.0 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 9V | 73.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 12F | 93.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 1 | 74.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 15B | 82.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 14 | 62.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 22 F | 80.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6A | 85.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 33F | 63.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 18C | 82.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 33F | 60.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 1 | 86.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 3 | 56.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 4 | 91.4 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 5 | 64.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6A | 96.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6B | 89.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 7F | 76.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 9V | 84.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 14 | 62.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 18C | 87.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19A | 82.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 23F | 87.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 8 | 83.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 10A | 78.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 11A | 47.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 12F | 93.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 15B | 73.4 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 22 F | 83.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19F | 78.4 percentage of participants |
Secondary
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: Before Vaccination 1 to 1 month after Vaccination 1 for Cohort 1: 20vPnC/Saline; Before Vaccination 1 to 1 month after Vaccination 2 for Cohort 1: 13vPnC/PPSV23
Population: E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed= participants evaluable at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 11A | 59.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 15B | 77.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 10A | 75.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 22F | 82.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 12F | 87.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 33F | 60.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 8 | 77.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 33F | 55.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 8 | 86.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 10A | 65.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 11A | 51.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 12F | 80.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 15B | 63.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP | Serotype 22F | 76.8 percentage of participants |
Secondary
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: Before Vaccination 1 to 1 month after Vaccination 1
Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 75.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 67.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 80.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 58.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 56.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 77.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 75.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 73.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 55.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 63.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 71.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 70.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 72.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 74.4 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 74.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 61.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 79.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 60.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 84.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 77.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 72.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 69.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 54.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 79.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 77.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 66.9 percentage of participants |
Secondary
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure were planned to be analyzed for the 20vPnC groups of Cohorts 2 and 3 only.
Time frame: 1 month after vaccination
Population: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed =participants evaluable at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 1 | 87.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 3 | 87.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 4 | 94.0 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 5 | 72.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6A | 91.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6B | 95.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 7F | 92.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 9V | 92.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 14 | 94.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 18C | 97.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19A | 98.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19F | 81.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 23F | 89.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 8 | 92.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 10A | 98.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 11A | 97.0 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 12F | 97.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 15B | 95.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 22F | 98.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 33F | 95.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 15B | 96.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 1 | 92.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19A | 99.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 3 | 89.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 11A | 99.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 4 | 98.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19F | 95.2 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 5 | 81.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 33F | 99.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6A | 99.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 23F | 96.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6B | 99.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 12F | 98.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 7F | 93.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 8 | 95.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 9V | 99.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 22F | 99.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 14 | 99.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 10A | 100.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 18C | 98.1 percentage of participants |
Secondary
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: 1 month after Vaccination 1 in Cohort 1: 20vPnC/Saline or 1 month after Vaccination 2 in Cohort 1: 13vPnC/PPSV23
Population: E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed= participants evaluable at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 11A | 97.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 15B | 94.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 10A | 95.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 22F | 98.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 12F | 95.7 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 33F | 96.4 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 8 | 92.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 33F | 92.8 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 8 | 96.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 10A | 88.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 11A | 95.4 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 12F | 89.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 15B | 83.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 22F | 94.5 percentage of participants |
Secondary
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month after Vaccination 1
Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed =participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 91.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 89.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 88.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 91.6 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 84.2 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 93.8 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 90.5 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 96.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 71.9 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 80.3 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 89.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 82.1 percentage of participants |
| Cohort 1: 20vPnC/Saline | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 85.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 83.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 87.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 87.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 92.1 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 76.0 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 90.9 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 91.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 91.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 90.3 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 93.5 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 94.7 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 96.6 percentage of participants |
| Cohort 1: 13vPnC/PPSV23 | Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 81.5 percentage of participants |
Secondary
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: Before Vaccination 1 to 1 month after Vaccination 1
Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at the specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 31.2 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 11.0 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 34.3 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 9.3 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 4.8 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 33.8 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 23.8 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 21.0 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 6.1 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 8.6 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 12.2 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 24.9 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 12.6 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 23F | 30.7 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 1 | 15.4 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 3 | 5.8 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 4 | 39.3 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 5 | 7.2 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6A | 42.6 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 6B | 26.5 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 7F | 13.5 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 9V | 12.5 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 14 | 8.3 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 18C | 37.7 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19A | 25.9 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population | Serotype 19F | 10.8 fold rise |
Secondary
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: Before vaccination to 1 month after vaccination
Population: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at the specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 1 | 14.4 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 3 | 5.1 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 4 | 43.4 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 5 | 5.9 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6A | 50.3 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6B | 31.7 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 7F | 12.8 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 9V | 12.1 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 14 | 10.4 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 18C | 48.3 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19A | 23.6 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19F | 9.2 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 23F | 47.8 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 8 | 23.9 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 10A | 17.9 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 11A | 10.4 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 12F | 107.3 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 15B | 72.1 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 22F | 63.5 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 33F | 9.1 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 15B | 65.0 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 1 | 18.6 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19A | 39.1 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 3 | 4.8 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 11A | 5.2 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 4 | 131.8 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 19F | 17.8 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 5 | 7.9 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 33F | 7.5 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6A | 146.5 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 23F | 118.2 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 6B | 70.3 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 12F | 171.1 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 7F | 19.7 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 8 | 34.6 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 9V | 35.1 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 22F | 69.3 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 14 | 14.6 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 10A | 22.7 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population | Serotype 18C | 111.8 fold rise |
Secondary
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: From before Vaccination 1 to 1 month after Vaccination 1 in Cohort 1: 20vPnC/Saline or From before Vaccination 1 to 1 month after Vaccination 2 in Cohort 1: 13vPnC/PPSV23
Population: E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 11A | 9.3 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 15B | 55.4 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 10A | 18.5 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 22F | 78.5 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 12F | 72.4 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 33F | 7.5 fold rise |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 8 | 22.1 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 33F | 5.7 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 8 | 40.4 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 10A | 10.1 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 11A | 6.0 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 12F | 47.3 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 15B | 18.2 fold rise |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population | Serotype 22F | 37.9 fold rise |
Secondary
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Time frame: 1 month after vaccination
Population: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 1 | 135.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 3 | 43.3 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 4 | 633.3 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 5 | 84.6 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6A | 1203.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6B | 1502.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 7F | 1047.0 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 9V | 1725.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 14 | 926.2 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 18C | 1805.0 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19A | 618.4 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19F | 286.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 23F | 549.1 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 8 | 486.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 10A | 2520.4 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 11A | 6416.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 12F | 3445.1 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 15B | 3355.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 22F | 3808.1 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 33F | 5571.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 15B | 2873.7 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 1 | 131.8 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19A | 600.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 3 | 40.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 11A | 5248.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 4 | 577.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19F | 290.4 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 5 | 96.5 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 33F | 5445.2 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6A | 997.1 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 23F | 327.5 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6B | 1199.0 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 12F | 3105.2 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 7F | 1173.0 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 8 | 502.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 9V | 1687.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 22F | 4228.4 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 14 | 742.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 10A | 2437.0 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 18C | 1355.2 titer |
Comparison: Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.84, 1.26]
Comparison: Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.92, 1.22]
Comparison: Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.87, 1.38]
Comparison: Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.72, 1.07]
Comparison: Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.95, 1.53]
Comparison: Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1, 1.56]
Comparison: Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.74, 1.07]
Comparison: Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.83, 1.26]
Comparison: Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.01, 1.54]
Comparison: Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.06, 1.68]
Comparison: Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.85, 1.25]
Comparison: Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.8, 1.22]
Comparison: Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.27, 2.22]
Comparison: Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.78, 1.2]
Comparison: Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.84, 1.28]
Comparison: Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.96, 1.56]
Comparison: Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.88, 1.39]
Comparison: Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.88, 1.56]
Comparison: Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.69, 1.17]
Comparison: Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.81, 1.3]
Secondary
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Time frame: 1 month after vaccination
Population: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 1 | 162.6 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 3 | 42.1 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 4 | 1966.7 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 5 | 107.9 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6A | 3930.5 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6B | 4260.0 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 7F | 1872.8 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 9V | 6041.4 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 14 | 1848.4 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 18C | 4460.5 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19A | 1415.0 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19F | 654.8 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 23F | 1559.2 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 8 | 867.0 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 10A | 4157.3 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 11A | 7169.3 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 12F | 5875.4 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 15B | 4601.0 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 22F | 7568.2 titer |
| Cohort 1: 20vPnC/Saline | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 33F | 7976.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 15B | 3019.0 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 1 | 132.0 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19A | 611.3 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 3 | 42.0 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 11A | 5419.7 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 4 | 594.5 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 19F | 301.2 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 5 | 96.9 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 33F | 5693.2 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6A | 1022.8 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 23F | 324.5 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 6B | 1250.4 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 12F | 3074.5 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 7F | 1187.2 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 8 | 508.1 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 9V | 1726.7 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 22F | 4482.5 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 14 | 772.8 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 10A | 2569.7 titer |
| Cohort 1: 13vPnC/PPSV23 | Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population | Serotype 18C | 1395.3 titer |
Comparison: Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.01, 1.5]
Comparison: Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.87, 1.16]
Comparison: Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [2.65, 4.13]
Comparison: Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [0.91, 1.36]
Comparison: Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [3.06, 4.83]
Comparison: Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [2.73, 4.26]
Comparison: Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.3, 1.91]
Comparison: Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [2.83, 4.33]
Comparison: Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.93, 2.96]
Comparison: Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [2.53, 4.04]
Comparison: Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.91, 2.81]
Comparison: Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.76, 2.68]
Comparison: Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [3.65, 6.32]
Comparison: Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.38, 2.12]
Comparison: Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.31, 2]
Comparison: Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.04, 1.68]
Comparison: Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.51, 2.41]
Comparison: Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.13, 2.05]
Comparison: Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.3, 2.2]
Comparison: Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI95% CI: [1.1, 1.79]