Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
Conditions
Keywords
13-valent pneunococcal conjugate vaccine, pneumococcal disease prevention; safety and immunogenicity study
Brief summary
This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.
Interventions
BIOLOGICAL13-valent Pneumococcal conjugate vaccine
1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
PROCEDUREBlood sample collection
10 mL of blood will be collected just before and approximately 1 month after vaccination.
Sponsors
Pfizer
Study design
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.
Exclusion criteria
Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination | Within 1 month after 13vPnC vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Before 13vPnC vaccination | Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | 1 month after 13vPnC vaccination | Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. |
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Before 13vPnC vaccination, 1 month after 13vPnC vaccination | GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. |
| Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Before 13vPnC vaccination | Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. |
| Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | 1 month after 13vPnC vaccination | Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. |
Countries
India
Participant flow
Pre-assignment details
A total of 1200 (200 pediatric and 1000 adult) participants were randomized in the study. Out of the 1000 adult participants, 999 participants and all 200 pediatric participants received vaccination.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC (Pediatric Participants) Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly. | 200 |
| 13vPnC (Adult Participants) Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly. | 999 |
| Total | 1,199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | No Longer Willing to Participate | 0 | 3 |
Baseline characteristics
| Characteristic | 13vPnC (Pediatric Participants) | Total | 13vPnC (Adult Participants) |
|---|---|---|---|
| Age, Customized 12 to 17 years | 43 Participants | 43 Participants | 0 Participants |
| Age, Customized 50 to 64 years | 0 Participants | 997 Participants | 997 Participants |
| Age, Customized 65 to 84 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Customized 6 to 11 years | 157 Participants | 157 Participants | 0 Participants |
| Sex: Female, Male Female | 107 Participants | 521 Participants | 414 Participants |
| Sex: Female, Male Male | 93 Participants | 678 Participants | 585 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 200 | 70 / 999 |
| serious Total, serious adverse events | 0 / 200 | 0 / 999 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination
GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: Before 13vPnC vaccination, 1 month after 13vPnC vaccination
Population: Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 4 (n=175, 344) | 32.6 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 7F (n=160, 354) | 7.1 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 19F (n=194, 358) | 13.3 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 9V (n=180, 358) | 3.3 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 5 (n=199, 351) | 15.3 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 3 (n=197, 374) | 6.4 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 18C (n=153, 350) | 41.5 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 6A (n=169, 339) | 19.1 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 19A (n=192, 375) | 31.2 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 1 (n=185, 373) | 16.3 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 6B (n=160, 316) | 24.9 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 23F (n=183, 371) | 53.3 Fold rise |
| 13vPnC (Pediatric Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 14 (n=179, 372) | 5.5 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 23F (n=183, 371) | 102.7 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 1 (n=185, 373) | 24.0 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 3 (n=197, 374) | 14.4 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 4 (n=175, 344) | 27.6 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 5 (n=199, 351) | 36.9 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 6A (n=169, 339) | 23.1 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 6B (n=160, 316) | 24.2 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 7F (n=160, 354) | 9.5 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 9V (n=180, 358) | 6.6 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 14 (n=179, 372) | 7.8 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 18C (n=153, 350) | 36.6 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 19A (n=192, 375) | 36.3 Fold rise |
| 13vPnC (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | Serotype 19F (n=194, 358) | 29.2 Fold rise |
Primary
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: 1 month after 13vPnC vaccination
Population: Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 4 (n=199, 371) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 9V (n=197, 375) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 6A (n=199, 376) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 14 (n=197, 379) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 3 (n=200, 378) | 99.5 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 18C (n=198, 360) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 6B (n=195, 362) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 19A (n=197, 380) | 99.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 5 (n=200, 354) | 91.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 19F (n=200, 368) | 99.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 7F (n=199, 378) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 23F (n=199, 378) | 100.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 1 (n=191, 376) | 92.7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 23F (n=199, 378) | 98.9 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 1 (n=191, 376) | 94.9 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 3 (n=200, 378) | 95.8 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 4 (n=199, 371) | 100.0 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 5 (n=200, 354) | 93.8 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 6A (n=199, 376) | 100.0 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 6B (n=195, 362) | 99.7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 7F (n=199, 378) | 99.2 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 9V (n=197, 375) | 99.7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 14 (n=197, 379) | 98.7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 18C (n=198, 360) | 99.4 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 19A (n=197, 380) | 99.5 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Serotype 19F (n=200, 368) | 98.9 Percentage of participants |
Primary
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: Before 13vPnC vaccination
Population: Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 4 (n=176, 358) | 60.2 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 9V (n=183, 369) | 90.2 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 6A (n=170, 347) | 73.5 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 14 (n=182, 380) | 91.2 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 3 (n=197, 384) | 50.8 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 18C (n=154, 374) | 50.0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 6B (n=163, 339) | 55.8 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 19A (n=195, 383) | 62.1 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 5 (n=199, 383) | 12.1 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 19F (n=194, 375) | 66.5 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 7F (n=160, 363) | 78.1 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 23F (n=184, 379) | 53.3 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 1 (n=194, 385) | 6.7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 23F (n=184, 379) | 54.6 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 1 (n=194, 385) | 12.7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 3 (n=197, 384) | 25.8 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 4 (n=176, 358) | 65.6 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 5 (n=199, 383) | 13.1 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 6A (n=170, 347) | 77.8 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 6B (n=163, 339) | 68.7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 7F (n=160, 363) | 57.9 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 9V (n=183, 369) | 74.5 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 14 (n=182, 380) | 82.1 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 18C (n=154, 374) | 67.6 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 19A (n=195, 383) | 74.2 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Serotype 19F (n=194, 375) | 54.4 Percentage of participants |
Primary
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Within 1 month after 13vPnC vaccination
Population: Safety population included all participants who received 1 dose of 13vPnC vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Pediatric Participants) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination | AEs | 0 Percentage of participants |
| 13vPnC (Pediatric Participants) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination | SAEs | 0 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination | AEs | 7 Percentage of participants |
| 13vPnC (Adult Participants) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination | SAEs | 0 Percentage of participants |
Primary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination
Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: 1 month after 13vPnC vaccination
Population: Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 5 (n=200, 354) | 286 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 9V (n=197, 375) | 7028 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 1 (n=191, 376) | 176 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 14 (n=197, 379) | 7484 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 6A (n=199, 376) | 9247 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 18C (n=198, 360) | 8641 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 4 (n=199, 371) | 7860 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 19A (n=197, 380) | 1928 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 6B (n=195, 362) | 6755 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 19F (n=200, 368) | 3551 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 3 (n=200, 378) | 118 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 23F (n=199, 378) | 4419 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 7F (n=199, 378) | 5251 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 23F (n=199, 378) | 5766 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 3 (n=200, 378) | 143 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 4 (n=199, 371) | 6029 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 5 (n=200, 354) | 639 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 6A (n=199, 376) | 6653 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 6B (n=195, 362) | 7690 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 7F (n=199, 378) | 3211 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 9V (n=197, 375) | 5441 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 14 (n=197, 379) | 3182 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 18C (n=198, 360) | 7670 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 19A (n=197, 380) | 2371 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 19F (n=200, 368) | 3340 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Serotype 1 (n=191, 376) | 266 Titers |
Primary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination
Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: Before 13vPnC vaccination
Population: Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 4 (n=176, 358) | 230 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 9V (n=183, 369) | 2097 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 6A (n=170, 347) | 461 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 14 (n=182, 380) | 1387 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 3 (n=197, 384) | 18 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 18C (n=154, 374) | 216 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 6B (n=163, 339) | 263 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 19A (n=195, 383) | 62 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 5 (n=199, 383) | 19 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 19F (n=194, 375) | 265 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 7F (n=160, 363) | 742 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 23F (n=184, 379) | 84 Titers |
| 13vPnC (Pediatric Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 1 (n=194, 385) | 11 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 23F (n=184, 379) | 57 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 1 (n=194, 385) | 11 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 3 (n=197, 384) | 10 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 4 (n=176, 358) | 212 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 5 (n=199, 383) | 17 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 6A (n=170, 347) | 304 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 6B (n=163, 339) | 331 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 7F (n=160, 363) | 324 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 9V (n=183, 369) | 826 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 14 (n=182, 380) | 400 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 18C (n=154, 374) | 213 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 19A (n=195, 383) | 66 Titers |
| 13vPnC (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Serotype 19F (n=194, 375) | 115 Titers |