Pneumococcal Infections
Conditions
Brief summary
This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).
Interventions
BIOLOGICALMultivalent
Pneumococcal conjugate vaccine
BIOLOGICALPrevnar 13
Pneumococcal conjugate vaccine
BIOLOGICALPPSV23
Pneumococcal polysaccharide vaccine
OTHERSaline
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female adults \>/= 60 to \</=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment. 2. Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator. 3. Female subjects who are not of childbearing potential.
Exclusion criteria
1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. History of microbiologically proven invasive disease caused by S pneumoniae. 3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1 | within 12 months after Vaccination 1 (up to 378 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported. |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | within 10 days after Vaccination 1 | Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | within 7 days after Vaccination 1 | Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees Celsius (C), \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity. |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | within 1 month after Vaccination 1 (up to 35 days) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1 | within 6 months after Vaccination 1 (up to 196 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group | Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. |
| Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | before Vaccination 1 to one month after Vaccination 1 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. |
| Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group | GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | 1 month after Vaccination 1 | Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ in the analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 20vPnC Followed by Saline Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. | 221 |
| 13vPnC Followed by PPSV23 Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. | 222 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 8 |
| Overall Study | No longer meets eligibility criteria | 1 | 7 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Randomized but not treated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | 13vPnC Followed by PPSV23 | Total | 20vPnC Followed by Saline |
|---|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 1.41 | 62.0 years STANDARD_DEVIATION 1.41 | 62.0 years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 52 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants | 387 Participants | 192 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 83 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 165 Participants | 334 Participants | 169 Participants |
| Sex: Female, Male Female | 133 Participants | 248 Participants | 115 Participants |
| Sex: Female, Male Male | 89 Participants | 195 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 221 | 0 / 222 |
| other Total, other adverse events | 162 / 221 | 164 / 222 |
| serious Total, serious adverse events | 9 / 221 | 11 / 222 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: within 1 month after Vaccination 1 (up to 35 days)
Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20vPnC Followed by Saline | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 12.2 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 13.1 percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time frame: within 10 days after Vaccination 1
Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Redness: Mild | 7.3 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Redness: Moderate | 3.6 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Pain at injection site: Mild | 46.8 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Pain at injection site: Moderate | 10.9 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Redness: Severe | 0.5 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Swelling: Mild | 7.7 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Swelling: Moderate | 5.5 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Pain at injection site: Severe | 0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Pain at injection site: Moderate | 9.5 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Swelling: Mild | 7.7 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Pain at injection site: Severe | 0.5 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Swelling: Moderate | 3.6 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Redness: Mild | 3.6 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Redness: Moderate | 3.2 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Pain at injection site: Mild | 43.7 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Time frame: within 12 months after Vaccination 1 (up to 378 days)
Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20vPnC Followed by Saline | Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1 | 10.0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1 | 6.3 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Time frame: within 6 months after Vaccination 1 (up to 196 days)
Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20vPnC Followed by Saline | Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1 | 5.4 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1 | 4.5 percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees Celsius (C), \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.
Time frame: within 7 days after Vaccination 1
Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 to 38.4 degree C | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.4 to 38.9 degree C | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.9 to 40.0 degree C | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >40.0 degree C | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Mild | 19.1 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Moderate | 11.4 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Severe | 0.5 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Mild | 16.8 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Severe | 0.5 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Muscle pain: Mild | 32.7 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Muscle pain: Severe | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Joint pain: Mild | 9.5 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Joint pain: Severe | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Moderate | 3.6 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Muscle pain: Moderate | 10.5 percentage of participants |
| 20vPnC Followed by Saline | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Joint pain: Moderate | 5.5 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Severe | 0.9 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 to 38.4 degree C | 0.5 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 degree C | 0.5 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.4 to 38.9 degree C | 0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Muscle pain: Mild | 27.0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.9 to 40.0 degree C | 0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Muscle pain: Moderate | 9.5 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >40.0 degree C | 0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Joint pain: Severe | 0.5 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Mild | 18.0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Muscle pain: Severe | 0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Moderate | 10.4 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Moderate | 5.4 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Severe | 1.8 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Joint pain: Mild | 8.1 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Mild | 18.0 percentage of participants |
| 13vPnC Followed by PPSV23 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Joint pain: Moderate | 5.9 percentage of participants |
Secondary
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group
Population: EIP: participants with no protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Number of Participants with non-missing OPA results at both time points at specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 8 | 37.1 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 10A | 49.3 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 11A | 11.2 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 15B | 57.1 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 22F | 55.4 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 33F | 14.0 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 12F | 113.4 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 15B | 21.3 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 8 | 56.9 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 33F | 8.9 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 10A | 17.1 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 22F | 20.3 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 11A | 9.8 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 12F | 77.0 fold rise |
Secondary
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: before Vaccination 1 to one month after Vaccination 1
Population: EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Number of participants with non-missing OPA results at both time points at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 18C | 26.8 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 3 | 6.0 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 4 | 37.8 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6A | 58.6 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6B | 29.6 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 7F | 12.2 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 9V | 7.7 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 14 | 8.5 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19A | 23.3 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19F | 11.8 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 23F | 33.6 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 5 | 8.3 fold rise |
| 20vPnC Followed by Saline | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 1 | 21.2 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 5 | 11.6 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 1 | 33.5 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 14 | 9.6 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 3 | 7.1 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 18C | 35.2 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 23F | 39.8 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6A | 68.6 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19A | 30.9 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6B | 38.8 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 4 | 51.0 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 7F | 15.8 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19F | 18.4 fold rise |
| 13vPnC Followed by PPSV23 | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 9V | 10.1 fold rise |
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Time frame: 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group
Population: EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 11A | 3210 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 15B | 1889 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 10A | 2604 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 22F | 6286 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 12F | 6571 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 33F | 5584 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 8 | 740 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 33F | 3940 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 8 | 1150 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 10A | 988 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 11A | 3007 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 12F | 4290 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 15B | 720 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Serotype 22F | 3513 Titer (1/dilution) |
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ in the analysis.
Time frame: 1 month after Vaccination 1
Population: EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 1 | 302 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 3 | 51 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 4 | 876 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 5 | 144 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6A | 1907 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6B | 2006 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 7F | 1581 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 9V | 1164 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 14 | 1114 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 18C | 1322 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 23F | 408 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19A | 943 Titer (1/dilution) |
| 20vPnC Followed by Saline | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19F | 455 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 7F | 1936 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 1 | 454 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19F | 738 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 3 | 64 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 9V | 1612 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 4 | 1153 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 19A | 1137 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 5 | 215 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 14 | 1282 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6A | 2440 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 23F | 509 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 6B | 2218 Titer (1/dilution) |
| 13vPnC Followed by PPSV23 | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Serotype 18C | 1660 Titer (1/dilution) |