Pneumococcal Disease
Conditions
Brief summary
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female adults ≥18 and \<50 years of age. 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. Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.
Exclusion criteria
1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. 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. 3. History of microbiologically proven invasive disease caused by S pneumoniae. 4. Pregnant female subjects or breastfeeding female subjects (known or suspected).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | 1 month after vaccination | OPA titers 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 GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
| Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination | Within 1 month after vaccination | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination | Within 6 month after vaccination | 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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | Within 6 months after vaccination | 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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Within 10 days after vaccination | 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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Within 7 days after vaccination | Systemic events fever, fatigue, headache, muscle pain, 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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | 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. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
| Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | 1 month after vaccination | The percentage of participants with OPA titers \>=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
| Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Before vaccination to 1 month after vaccination | Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. 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. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only. |
Countries
United States
Participant flow
Pre-assignment details
A total of 1718 participants were enrolled, out of which only 1710 were randomized. There were 8 participants who were enrolled (signed informed consent document) but were not randomized into the study as the randomization system had reached the pre-specified capacity.
Participants by arm
| Arm | Count |
|---|---|
| 20vPnC Lot 1 Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination. | 488 |
| 20vPnC Lot 2 Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination. | 489 |
| 20vPnC Lot 3 Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination. | 486 |
| 13vPnC Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination. | 245 |
| Total | 1,708 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 22 | 12 | 23 | 7 |
| Overall Study | No longer met eligibility criteria | 0 | 1 | 1 | 3 |
| Overall Study | Protocol Violation | 0 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | 20vPnC Lot 1 | 20vPnC Lot 2 | 20vPnC Lot 3 | 13vPnC | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 9.17 | 35.7 years STANDARD_DEVIATION 9.03 | 34.9 years STANDARD_DEVIATION 9.05 | 35.0 years STANDARD_DEVIATION 8.7 | 35.3 years STANDARD_DEVIATION 9.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 58 Participants | 56 Participants | 29 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 434 Participants | 427 Participants | 427 Participants | 215 Participants | 1503 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 4 Participants | 3 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 9 Participants | 5 Participants | 4 Participants | 23 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 17 Participants | 17 Participants | 12 Participants | 59 Participants |
| Race (NIH/OMB) Black or African American | 87 Participants | 88 Participants | 97 Participants | 44 Participants | 316 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 13 Participants | 13 Participants | 5 Participants | 37 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 10 Participants | 3 Participants | 5 Participants | 26 Participants |
| Race (NIH/OMB) White | 367 Participants | 351 Participants | 350 Participants | 173 Participants | 1241 Participants |
| Sex: Female, Male Female | 331 Participants | 316 Participants | 324 Participants | 144 Participants | 1115 Participants |
| Sex: Female, Male Male | 157 Participants | 173 Participants | 162 Participants | 101 Participants | 593 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,463 | 0 / 245 |
| other Total, other adverse events | 1,275 / 1,463 | 206 / 245 |
| serious Total, serious adverse events | 10 / 1,463 | 0 / 245 |
Outcome results
Primary
Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time frame: Within 1 month after vaccination
Population: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled 20vPnC | Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination | 6.8 percentage of participants |
| 13vPnC | Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination | 5.3 percentage of participants |
Primary
Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time frame: Within 6 months after vaccination
Population: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled 20vPnC | Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | 1.0 percentage of participants |
| 13vPnC | Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | 2.0 percentage of participants |
Primary
Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination
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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time frame: Within 6 month after vaccination
Population: Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled 20vPnC | Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 0.7 percentage of participants |
| 13vPnC | Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 0 percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time frame: Within 10 days after vaccination
Population: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Any | 7.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Mild | 3.9 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Moderate | 2.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Severe | 0.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Any | 8.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Mild | 5.4 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Moderate | 2.9 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Severe | 0.2 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Any | 78.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Mild | 50.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Moderate | 27.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Severe | 1.2 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Moderate | 27.6 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Any | 6.2 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Moderate | 3.3 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Mild | 3.3 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Mild | 46.5 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Moderate | 2.9 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Severe | 0 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Redness: Severe | 0 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Severe | 1.6 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Any | 8.6 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Pain at the injection site: Any | 75.7 percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Swelling: Mild | 5.3 percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events fever, fatigue, headache, muscle pain, 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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time frame: Within 7 days after vaccination
Population: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >=38.0 degree C (Any) | 1.2 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >=38.0 degree C to 38.4 degree C | 0.8 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.4 degree C to 38.9 degree C | 0.3 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.9 degree C to 40.0 degree C | 0.2 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >40.0 degree C | 0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Any | 47.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 24.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 21.2 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 1.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Any | 36.2 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 22.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 12.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 1.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Any | 62.1 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Mild | 38.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Moderate | 22.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Severe | 1.1 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Any | 16.8 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Mild | 10.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Moderate | 6.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Severe | 0.4 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 27.2 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >=38.0 degree C (Any) | 0.8 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Mild | 7.8 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >=38.0 degree C to 38.4 degree C | 0.4 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 9.9 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.4 degree C to 38.9 degree C | 0.4 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Severe | 2.1 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.9 degree C to 40.0 degree C | 0 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0.8 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >40.0 degree C | 0 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Severe | 0.8 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Any | 43.6 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Any | 60.5 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 24.3 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Any | 14.0 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 17.7 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Mild | 38.7 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 1.6 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Moderate | 5.3 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Any | 37.9 percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Moderate | 19.8 percentage of participants |
Primary
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
OPA titers 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 GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time frame: 1 month after vaccination
Population: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 10A | 6328.1 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 9V | 5120.4 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 33F | 10745.7 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 8 | 1595.0 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 14 | 2240.2 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 6B | 4403.3 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 23F | 1416.1 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 18C | 3903.7 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 5 | 125.8 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 19F | 524.5 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 19A | 1457.8 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 3 | 47.3 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 15B | 7342.8 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 6A | 4654.1 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 1 | 199.5 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 12F | 8563.0 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 22F | 12507.5 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 11A | 8656.2 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 7F | 1820.6 titer |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 4 | 1499.7 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 15B | 6356.9 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 1 | 175.1 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 3 | 46.8 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 4 | 1568.2 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 5 | 135.6 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 6A | 3748.3 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 6B | 4349.9 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 7F | 1865.6 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 9V | 4604.1 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 14 | 2091.2 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 18C | 4450.7 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 19A | 1528.1 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 19F | 529.2 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 23F | 1547.5 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 8 | 1345.9 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 10A | 5692.6 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 11A | 6728.5 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 12F | 7907.5 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 22F | 11213.4 titer |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 33F | 10328.2 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 3 | 43.1 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 8 | 1624.3 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 7F | 1875.7 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 33F | 10418.2 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 10A | 5962.2 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 6B | 3907.3 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 22F | 12728.6 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 11A | 8720.3 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 6A | 3330.4 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 1 | 164.6 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 12F | 7412.4 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 5 | 116.8 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 19A | 1434.4 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 18C | 4221.7 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 4 | 1505.6 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 19F | 549.0 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 14 | 2001.9 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 15B | 7018.9 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 23F | 1434.6 titer |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | Serotype 9V | 4921.7 titer |
Comparison: Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.75, 1.13]
Comparison: Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).95% CI: [0.95, 1.37]
Comparison: Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.88, 1.16]
Comparison: Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.78, 1.17]
Comparison: Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.77, 1.12]
Comparison: Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [1.03, 1.5]
Comparison: Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.85, 1.21]
Comparison: Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.82, 1.17]
Comparison: Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.93, 1.33]
Comparison: Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.9, 1.27]
Comparison: Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.72, 1.07]
Comparison: Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.81, 1.12]
Comparison: Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.81, 1.21]
Comparison: Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.72, 1.16]
Comparison: Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [1, 1.4]
Comparison: Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.91, 1.36]
Comparison: Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [1.03, 1.6]
Comparison: Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.88, 1.33]
Comparison: Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.91, 1.46]
Comparison: Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.87, 1.43]
Comparison: Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.95% CI: [0.83, 1.3]
Comparison: Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [1.01, 1.46]
Comparison: Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.96, 1.26]
Comparison: Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.82, 1.22]
Comparison: Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.89, 1.31]
Comparison: Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [1.16, 1.69]
Comparison: Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.94, 1.35]
Comparison: Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.81, 1.16]
Comparison: Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.87, 1.25]
Comparison: Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.94, 1.33]
Comparison: Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.86, 1.2]
Comparison: Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.78, 1.17]
Comparison: Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.78, 1.25]
Comparison: Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.83, 1.16]
Comparison: Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.87, 1.3]
Comparison: Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.8, 1.24]
Comparison: Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.94, 1.42]
Comparison: Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.82, 1.33]
Comparison: Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.77, 1.26]
Comparison: Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.95% CI: [0.82, 1.29]
Comparison: Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.89, 1.28]
Comparison: Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.95, 1.24]
Comparison: Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.85, 1.27]
Comparison: Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.96, 1.41]
Comparison: Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.93, 1.36]
Comparison: Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.93, 1.33]
Comparison: Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.83, 1.19]
Comparison: Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.78, 1.12]
Comparison: Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.88, 1.24]
Comparison: Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.86, 1.29]
Comparison: Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.91, 1.25]
Comparison: Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.79, 1.17]
Comparison: Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.85, 1.37]
Comparison: Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.7, 0.98]
Comparison: Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.78, 1.17]
Comparison: Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.62, 0.96]
Comparison: Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.87, 1.31]
Comparison: Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.71, 1.15]
Comparison: Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.69, 1.12]
Comparison: Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.95% CI: [0.79, 1.24]
Secondary
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From 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. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time frame: Before vaccination to 1 month after vaccination
Population: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 74.9 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 79.1 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 83.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 82.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 70.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 65.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 85.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 83.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 62.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 74.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 81.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 81.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 94.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 79.8 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 91.8 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 90.3 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 85.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 52.4 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 76.8 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 56.1 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 82.0 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 82.9 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 57.8 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 87.6 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 67.2 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 93.1 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 91.4 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 76.7 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 79.5 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 67.7 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 88.2 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 81.8 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 76.2 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 88.2 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 82.3 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 74.5 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 48.0 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 93.1 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 82.1 percentage of participants |
| 13vPnC | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 62.7 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 53.0 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 82.5 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 80.0 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 62.7 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 70.8 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 89.2 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 81.4 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 42.2 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 93.0 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 82.4 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 91.5 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 65.3 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 85.5 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 84.5 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 86.2 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 75.2 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 67.7 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 81.0 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 88.8 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 75.7 percentage of participants |
Secondary
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
The percentage of participants with OPA titers \>=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time frame: 1 month after vaccination
Population: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 10A | 99.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 9V | 98.5 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 1 | 91.8 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 8 | 98.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 14 | 98.9 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 5 | 80.3 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 23F | 94.3 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 18C | 96.9 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 33F | 99.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 19F | 91.2 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 19A | 99.3 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 15B | 99.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 6A | 99.1 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 22F | 99.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 12F | 99.0 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 6B | 97.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 4 | 97.6 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 11A | 99.2 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 7F | 94.7 percentage of participants |
| Pooled 20vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 3 | 89.7 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 15B | 98.6 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 1 | 92.8 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 3 | 89.6 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 4 | 97.0 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 5 | 84.3 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 6A | 98.1 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 6B | 99.6 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 7F | 94.0 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 9V | 98.9 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 14 | 99.4 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 18C | 98.1 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 19A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 19F | 91.0 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 23F | 95.8 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 8 | 99.1 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 10A | 99.0 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 11A | 99.5 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 12F | 99.3 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 22F | 99.2 percentage of participants |
| 13vPnC | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 33F | 98.8 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 3 | 88.9 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 8 | 99.1 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 7F | 96.6 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 33F | 98.5 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 10A | 99.3 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 6B | 98.9 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 22F | 99.5 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 11A | 99.5 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 6A | 98.2 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 1 | 91.0 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 12F | 99.0 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 5 | 81.3 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 19A | 99.3 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 18C | 98.7 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 4 | 97.1 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 19F | 90.7 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 14 | 97.8 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 15B | 99.3 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 23F | 94.9 percentage of participants |
| 20vPnC Lot 3 | Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination | Serotype 9V | 98.2 percentage of participants |
Secondary
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. 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. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time frame: Before vaccination to 1 month after vaccination
Population: EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, Number analyzed = participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 20.8 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 25.4 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 20.2 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 38.3 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 18.2 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 8.7 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 99.5 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 80.4 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 8.3 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 14.0 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 35.9 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 112.5 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 157.2 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 83.8 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 175.5 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 72.5 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 77.6 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 6.9 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 18.3 fold rise |
| Pooled 20vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 5.0 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 84.2 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 17.8 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 5.0 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 94.7 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 9.4 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 119.6 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 75.4 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 19.5 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 23.3 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 16.3 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 95.0 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 39.1 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 14.7 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 125.1 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 38.8 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 19.0 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 5.0 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 174.6 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 63.3 fold rise |
| 13vPnC | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 8.6 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 4.6 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 46.1 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 19.0 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 7.4 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 20.2 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 70.5 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 77.8 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 5.3 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 128.4 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 17.3 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 175.7 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 8.0 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 41.8 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 79.9 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 81.0 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 15.4 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 18.1 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 91.7 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 120.9 fold rise |
| 20vPnC Lot 3 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 21.6 fold rise |