Pneumococcal Disease
Conditions
Brief summary
The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India. This study is seeking participants who: * are generally healthy adults of 18 years or older. * have not received pneumococcal vaccine. The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older. Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month. The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.
Interventions
One dose of 20vPnC will be administered intramuscularly.
Sponsors
Study design
Intervention model description
Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.
Eligibility
Inclusion criteria
\- Generally healthy participants ≥18 years of age at the time of consent.
Exclusion criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 20vPnC, or to any other diphtheria toxoid-containing vaccine. * Known or suspected immune deficiency or suppression. * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Day 1 to Day 7 after vaccination | Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than \[\>\]2.0 to 5.0 cm), moderate (\>5.0 to 10.0cm) and severe (\>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Day 1 to Day 7 after vaccination | Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (\>=)38.0 degree Celsius (C) and was classified as \>=38.0 degree C, \>=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, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination | From vaccination on Day 1 up to 1 Month after vaccination | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination | From vaccination on Day 1 up to 1 Month after vaccination | An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | From before vaccination to 1 Month after vaccination | GMFRs and 2-sided 95% confidence interval (CIs) were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ in the analysis. Evaluable immunogenicity population: Eligible participants in the immunogenicity subset who received 1 dose of the intervention with at least 1 valid immunogenicity result from the blood sample collection within 27 to 49 days after vaccination, had no other major protocol deviations as determined by the clinician. |
Countries
India
Participant flow
Recruitment details
A total of 405 participants signed the informed consent form. Two participants were screen failures and 3 were not assigned to receive study treatment and 400 participants received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: 18 to 49 Years Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1). | 200 |
| Cohort 2: >= 50 Years Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1). | 200 |
| Total | 400 |
Baseline characteristics
| Characteristic | Cohort 2: >= 50 Years | Total | Cohort 1: 18 to 49 Years |
|---|---|---|---|
| Age, Continuous | 58.8 Years STANDARD_DEVIATION 7.22 | 46.7 Years STANDARD_DEVIATION 14.31 | 34.7 Years STANDARD_DEVIATION 8.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 200 Participants | 400 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 200 Participants | 400 Participants | 200 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 52 Participants | 116 Participants | 64 Participants |
| Sex: Female, Male Male | 148 Participants | 284 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 400 |
| other Total, other adverse events | 171 / 400 |
| serious Total, serious adverse events | 0 / 400 |
Outcome results
Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Time frame: From vaccination on Day 1 up to 1 Month after vaccination
Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: 18 to 49 Years | Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination | 1.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination | 3.0 Percentage of participants |
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than \[\>\]2.0 to 5.0 cm), moderate (\>5.0 to 10.0cm) and severe (\>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Time frame: Day 1 to Day 7 after vaccination
Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 33.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Any | 1.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 9.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Any | 1.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Any | 43.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 0.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 4.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Any | 32.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 27.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Any | 1.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 1.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Any | 1.0 Percentage of participants |
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination
An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event.
Time frame: From vaccination on Day 1 up to 1 Month after vaccination
Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: 18 to 49 Years | Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination | 0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination | 0 Percentage of participants |
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (\>=)38.0 degree Celsius (C) and was classified as \>=38.0 degree C, \>=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, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Time frame: Day 1 to Day 7 after vaccination
Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Severe | 0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >=38.0 to 38.4 degree C | 1.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.4 to 38.9 degree C | 0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.9 to 40.0 degree C | 1.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >40.0 degree C | 0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Any | 12.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 7.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 4.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 9.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 2.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Any | 5.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Mild | 3.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Moderate | 2.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >= 38.0 degree C | 3.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Any | 14.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Mild | 10.0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Moderate | 4.5 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Severe | 0 Percentage of participants |
| Cohort 1: 18 to 49 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Any | 12.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Mild | 7.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >= 38.0 degree C | 1.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 1.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >=38.0 to 38.4 degree C | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Severe | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.4 to 38.9 degree C | 1.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >38.9 to 40.0 degree C | 0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Severe | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: >40.0 degree C | 0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Any | 4.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Any | 12.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Any | 9.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 8.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Mild | 2.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 3.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle pain: Moderate | 1.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 0.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Any | 11.5 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint pain: Moderate | 1.0 Percentage of participants |
| Cohort 2: >= 50 Years | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 9.5 Percentage of participants |
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
GMFRs and 2-sided 95% confidence interval (CIs) were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ in the analysis. Evaluable immunogenicity population: Eligible participants in the immunogenicity subset who received 1 dose of the intervention with at least 1 valid immunogenicity result from the blood sample collection within 27 to 49 days after vaccination, had no other major protocol deviations as determined by the clinician.
Time frame: From before vaccination to 1 Month after vaccination
Population: Evaluable immunogenicity population evaluated. Number of participants analyzed= Number of participants in evaluable immunogenicity population. Number Analyzed = Number of evaluable participants with valid OPA titers for the specified serotype both before and after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 24.3 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 8.9 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 15.2 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 14.9 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 29.8 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 8.6 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 16.0 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 4.8 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 5.8 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 21.4 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 15.0 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 13.1 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 46.2 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 18.4 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 8.4 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 3.3 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 76.1 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 48.8 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 12.6 Fold rise |
| Cohort 1: 18 to 49 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 8.4 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 15B | 86.2 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 1 | 17.1 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19A | 30.9 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 11A | 9.5 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 4 | 42.6 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 19F | 19.1 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 5 | 24.3 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 33F | 11.7 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 3 | 8.8 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6A | 30.9 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 23F | 53.6 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 6B | 11.6 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 12F | 75.2 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 7F | 24.1 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 8 | 38.2 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 9V | 9.5 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 22F | 30.8 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 14 | 6.0 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 10A | 31.1 Fold rise |
| Cohort 2: >= 50 Years | Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination | Serotype 18C | 42.0 Fold rise |