HIV Infections, Pneumococcal Infections
Conditions
Keywords
vaccine, 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, human immunodeficiency virus
Brief summary
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.
Interventions
13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
PROCEDUREBlood draw
Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older * Viral load \< 50,000 copies/mL and CD4+ T cell count \>= 200/uL within 6 months before study vaccination * Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy * No previous vaccination with a pneumococcal vaccine * Subject or parent/legal guardian able to complete an electronic diary
Exclusion criteria
* Acquired immune deficiency syndrome (AIDS) at time of enrollment * Current illicit substance and/or alcohol abuse * History of active chronic viral hepatitis * Previous anaphylactic reaction to a vaccine or vaccine-related component * Serious chronic disorders including metastatic malignancy and end-stage renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 | Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. |
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose | Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws. |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Within 14 days after 13vPnC Dose 1 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged greater than (\>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error. |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Within 14 days after 13vPnC Dose 3 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged \>12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Within 14 days after 13vPnC Dose 1 | Specific systemic events (fever \>=38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours). All reporting of fever \>40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors. |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Within 14 days after 13vPnC Dose 2 | Specific systemic events (fever \>=38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours). All reporting of fever \>40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors. |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Within 14 days after 13vPnC Dose 3 | Specific systemic events (fever \>=38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours). All reporting of fever \>40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors. |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Within 14 days after 13vPnC Dose 2 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged \>12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). |
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 13vPnC Dose and after 13vPnC Dose 1 blood draws. |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 | Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 13vPnC Dose and after 13vPnC Dose 1 blood draws. |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
Countries
Romania, South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC, 23vPS (Pediatric Participants) Participants older than or equal to \[\>=\] 6 to less than \[\<\] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose). | 150 |
| 13vPnC, 23vPS (Adult Participants) Participants \>=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose). | 151 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Protocol Violation | 9 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 8 |
Baseline characteristics
| Characteristic | 13vPnC, 23vPS (Pediatric Participants) | 13vPnC, 23vPS (Adult Participants) | Total |
|---|---|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 3.04 | 41.2 years STANDARD_DEVIATION 8.45 | 25.8 years STANDARD_DEVIATION 16.72 |
| Sex: Female, Male Female | 76 Participants | 88 Participants | 164 Participants |
| Sex: Female, Male Male | 74 Participants | 63 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 301 | 216 / 301 | 171 / 290 | 137 / 286 | 31 / 282 | 2 / 282 |
| serious Total, serious adverse events | 1 / 301 | 1 / 301 | 4 / 290 | 1 / 286 | 0 / 282 | 1 / 282 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Time frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Population: Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 1 (n = 248) | 1.03 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 3 (n = 238) | 1.05 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 4 (n = 257) | 1.09 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 5 (n = 257) | 1.01 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 6A (n = 249) | 1.02 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 6B (n = 257) | 1.04 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 7F (n = 259) | 1.10 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 9V (n = 259) | 1.05 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 14 (n = 259) | 1.04 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 18C (n = 259) | 0.99 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 19A (n = 259) | 0.99 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 19F (n = 252) | 1.06 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 23F (n = 258) | 1.09 fold rise |
Secondary
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies all participants who were evaluable for this measure and n signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 2 (n = 126, 131, 257) | 4.52 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 3 (n = 120, 128, 248) | 4.14 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 2 (n = 118, 120, 238) | 1.47 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 3 (n = 118, 120, 238) | 1.49 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 2 (n = 127, 130, 257) | 3.06 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 3 (n = 127, 130, 257) | 3.36 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 2 (n = 120, 128, 248) | 3.88 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 3 (n = 126, 131, 257) | 4.84 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 2 (n = 119, 130, 249) | 7.66 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 3 (n = 119, 130, 249) | 7.97 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 2 (n = 127, 130, 257) | 11.43 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 3 (n = 127, 130, 257) | 11.94 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 2 (n = 128, 131, 259) | 4.25 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 3 (n = 128, 131, 259) | 5.05 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 2 (n = 128, 131, 259) | 4.81 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 3 (n = 128, 131, 259) | 4.98 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 2 (n = 128, 131, 259) | 11.60 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 3 (n = 128, 131, 259) | 12.62 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 2 (n = 128, 131, 259) | 3.79 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 3 (n = 128, 131, 259) | 3.83 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 2 (n = 128, 131, 259) | 14.38 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 3 (n = 128, 131, 259) | 14.19 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 2 (n = 124, 128, 252) | 5.78 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 3 (n = 124, 128, 252) | 6.09 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 2 (n = 127, 131, 258) | 6.45 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 3 (n = 127, 131, 258) | 6.64 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 2 (n = 119, 130, 249) | 7.03 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 2 (n = 128, 131, 259) | 13.19 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 3 (n = 119, 130, 249) | 7.04 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 2 (n = 127, 130, 257) | 7.93 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 2 (n = 127, 131, 258) | 6.10 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 3 (n = 127, 130, 257) | 8.28 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 3 (n = 128, 131, 259) | 13.18 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 2 (n = 128, 131, 259) | 5.78 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 3 (n = 128, 131, 259) | 5.90 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 2 (n = 128, 131, 259) | 5.14 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 2 (n = 124, 128, 252) | 5.34 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 3 (n = 128, 131, 259) | 5.48 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 2 (n = 128, 131, 259) | 15.14 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 3 (n = 128, 131, 259) | 15.13 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 2 (n = 120, 128, 248) | 3.95 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 3 (n = 120, 128, 248) | 3.92 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 3 (n = 124, 128, 252) | 5.67 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 2 (n = 118, 120, 238) | 0.97 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 2 (n = 128, 131, 259) | 5.33 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 3 (n = 118, 120, 238) | 1.06 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 2 (n = 127, 130, 257) | 2.97 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 3 (n = 127, 130, 257) | 3.19 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 3 (n = 128, 131, 259) | 5.18 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 2 (n = 126, 131, 257) | 5.77 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 3 (n = 126, 131, 257) | 5.53 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 3 (n = 127, 131, 258) | 7.06 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 2 (n = 126, 131, 257) | 5.12 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 2 (n = 127, 130, 257) | 3.01 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 2 (n = 120, 128, 248) | 3.92 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 3 (n = 119, 130, 249) | 7.47 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 2 (n = 128, 131, 259) | 13.77 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 3 (n = 128, 131, 259) | 13.83 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 2 (n = 127, 130, 257) | 9.50 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 3 (n = 124, 128, 252) | 5.87 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 3 (n = 120, 128, 248) | 4.03 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 3 (n = 127, 130, 257) | 9.92 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 3 (n = 128, 131, 259) | 4.46 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 3 (n = 127, 130, 257) | 3.27 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 2 (n = 128, 131, 259) | 4.96 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 3 (n = 128, 131, 259) | 13.67 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 2 (n = 118, 120, 238) | 1.19 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 3 (n = 128, 131, 259) | 5.46 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 2 (n = 127, 131, 258) | 6.27 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 2 (n = 119, 130, 249) | 7.33 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 2 (n = 128, 131, 259) | 4.98 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 3 (n = 126, 131, 257) | 5.18 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 3 (n = 118, 120, 238) | 1.25 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 3 (n = 128, 131, 259) | 5.23 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 2 (n = 124, 128, 252) | 5.55 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 2 (n = 128, 131, 259) | 4.50 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 2 (n = 128, 131, 259) | 13.27 microgram per milliliter (mcg/mL) |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 3 (n = 127, 131, 258) | 6.85 microgram per milliliter (mcg/mL) |
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Time frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 4 (n = 127, 130) | 1.10 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 9V (n = 128, 131) | 1.03 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 6A (n = 119, 130) | 1.04 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 14 (n = 128, 131) | 1.09 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 3 (n = 118, 120) | 1.01 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 18C (n = 128, 131) | 1.01 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 6B (n = 127, 130) | 1.04 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 19A (n = 128, 131) | 0.99 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 5 (n = 126, 131) | 1.07 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 19F (n = 124, 128) | 1.05 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 7F (n = 128, 131) | 1.19 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 23F (n = 127, 131) | 1.03 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 1 (n = 120, 128) | 1.07 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 23F (n = 127, 131) | 1.16 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 1 (n = 120, 128) | 0.99 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 3 (n = 118, 120) | 1.09 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 4 (n = 127, 130) | 1.07 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 5 (n = 126, 131) | 0.96 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 6A (n = 119, 130) | 1.00 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 6B (n = 127, 130) | 1.04 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 7F (n = 128, 131) | 1.02 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 9V (n = 128, 131) | 1.07 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 14 (n = 128, 131) | 1.00 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 18C (n = 128, 131) | 0.97 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 19A (n = 128, 131) | 1.00 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 19F (n = 124, 128) | 1.06 fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Time frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 19F (n = 122, 118, 240) | 1.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 14 (n = 117, 127, 244) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 6B (n = 121, 128, 249) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 4 (n = 117, 126, 243) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 9V (n = 118, 127, 245) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 7F (n = 125, 127, 252) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 1 (n = 126, 127, 253) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 3 (n = 127, 129, 256) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 19A (n = 125, 127, 252) | 1.5 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 5 (n = 122, 124, 246) | 1.7 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 23F (n = 120, 126, 246) | 1.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 18C (n = 117, 121, 238) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 6A (n = 125, 124, 249) | 1.4 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 7F (n = 125, 127, 252) | 1.2 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 1 (n = 126, 127, 253) | 1.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 3 (n = 127, 129, 256) | 1.6 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 4 (n = 117, 126, 243) | 1.2 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 5 (n = 122, 124, 246) | 1.4 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 6A (n = 125, 124, 249) | 1.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 6B (n = 121, 128, 249) | 1.4 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 9V (n = 118, 127, 245) | 1.4 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 14 (n = 117, 127, 244) | 1.1 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 18C (n = 117, 121, 238) | 1.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 19A (n = 125, 127, 252) | 1.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 19F (n = 122, 118, 240) | 1.9 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 23F (n = 120, 126, 246) | 1.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 14 (n = 117, 127, 244) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 5 (n = 122, 124, 246) | 1.5 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 19F (n = 122, 118, 240) | 1.7 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 18C (n = 117, 121, 238) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 4 (n = 117, 126, 243) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 1 (n = 126, 127, 253) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 19A (n = 125, 127, 252) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 7F (n = 125, 127, 252) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 6B (n = 121, 128, 249) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 3 (n = 127, 129, 256) | 1.5 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 9V (n = 118, 127, 245) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 6A (n = 125, 124, 249) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Serotype 23F (n = 120, 126, 246) | 1.6 fold rise |
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 2 (n = 122, 124, 246) | 159 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 3 (n = 126, 127, 253) | 69 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 2 (n = 127, 129, 256) | 81 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 3 (n = 127, 129, 256) | 114 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 2 (n = 117, 126, 243) | 2509 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 3 (n = 117, 126, 243) | 3246 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 2 (n = 126, 127, 253) | 51 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 3 (n = 122, 124, 246) | 267 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 2 (n = 125, 124, 249) | 5560 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 3 (n = 125, 124, 249) | 7758 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 2 (n = 121, 128, 249) | 5449 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 3 (n = 121, 128, 249) | 7151 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 2 (n = 125, 127, 252) | 3494 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 3 (n = 125, 127, 252) | 4638 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 2 (n = 118, 127, 245) | 3339 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 3 (n = 118, 127, 245) | 4714 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 2 (n = 117, 127, 244) | 3704 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 3 (n = 117, 127, 244) | 3963 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 2 (n = 117, 121, 238) | 4635 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 3 (n = 117, 121, 238) | 5579 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 2 (n = 125, 127, 252) | 684 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 3 (n = 125, 127, 252) | 1002 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 2 (n = 122, 118, 240) | 717 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 3 (n = 122, 118, 240) | 1152 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 2 (n = 120, 126, 246) | 1477 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 3 (n = 120, 126, 246) | 2327 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 2 (n = 125, 124, 249) | 2425 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 2 (n = 125, 127, 252) | 458 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 3 (n = 125, 124, 249) | 3239 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 2 (n = 121, 128, 249) | 2724 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 2 (n = 120, 126, 246) | 409 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 3 (n = 121, 128, 249) | 3723 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 3 (n = 125, 127, 252) | 613 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 2 (n = 125, 127, 252) | 2255 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 3 (n = 125, 127, 252) | 2702 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 2 (n = 118, 127, 245) | 1432 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 2 (n = 122, 118, 240) | 315 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 3 (n = 118, 127, 245) | 2004 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 2 (n = 117, 127, 244) | 1342 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 3 (n = 117, 127, 244) | 1480 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 2 (n = 126, 127, 253) | 54 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 3 (n = 126, 127, 253) | 69 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 3 (n = 122, 118, 240) | 597 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 2 (n = 127, 129, 256) | 48 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 2 (n = 117, 121, 238) | 1349 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 3 (n = 127, 129, 256) | 79 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 2 (n = 117, 126, 243) | 1620 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 3 (n = 117, 126, 243) | 1944 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 3 (n = 117, 121, 238) | 1787 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 2 (n = 122, 124, 246) | 104 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 3 (n = 122, 124, 246) | 142 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 3 (n = 120, 126, 246) | 671 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 2 (n = 122, 124, 246) | 129 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 2 (n = 117, 126, 243) | 2000 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 2 (n = 126, 127, 253) | 52 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 3 (n = 125, 124, 249) | 5022 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 2 (n = 125, 127, 252) | 559 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 3 (n = 117, 127, 244) | 2373 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 2 (n = 121, 128, 249) | 3815 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 3 (n = 122, 118, 240) | 834 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 1: 13vPnC Dose 3 (n = 126, 127, 253) | 69 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6B: 13vPnC Dose 3 (n = 121, 128, 249) | 5113 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 3 (n = 117, 121, 238) | 3127 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 4: 13vPnC Dose 3 (n = 117, 126, 243) | 2488 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 2 (n = 125, 127, 252) | 2802 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19A: 13vPnC Dose 3 (n = 125, 127, 252) | 782 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 2 (n = 127, 129, 256) | 62 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 7F: 13vPnC Dose 3 (n = 125, 127, 252) | 3533 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 2 (n = 120, 126, 246) | 765 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 6A: 13vPnC Dose 2 (n = 125, 124, 249) | 3678 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 2 (n = 118, 127, 245) | 2153 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 5: 13vPnC Dose 3 (n = 122, 124, 246) | 194 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 3: 13vPnC Dose 3 (n = 127, 129, 256) | 95 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 9V: 13vPnC Dose 3 (n = 118, 127, 245) | 3026 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 19F: 13vPnC Dose 2 (n = 122, 118, 240) | 479 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 18C: 13vPnC Dose 2 (n = 117, 121, 238) | 2475 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 14: 13vPnC Dose 2 (n = 117, 127, 244) | 2183 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants | Serotype 23F: 13vPnC Dose 3 (n = 120, 126, 246) | 1231 titers |
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 3 (n=132,130,262) | 4.73 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 23vPS Dose (n=128,127,255) | 4.42 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 3 (n=124,118,242) | 1.49 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 23vPS Dose (n=124,118,242) | 1.65 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 3 (n=133,128,261) | 3.29 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 23vPS Dose (n=133,128,261) | 3.28 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 3 (n=128,127,255) | 4.08 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 23vPS Dose (n=132,130,262) | 5.08 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 3 (n=122,129,251) | 8.20 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 23vPS Dose (n=122,129,251) | 7.98 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 3 (n=133,129,262) | 12.25 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 23vPS Dose (n=133,129,262) | 11.10 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 3 (n=133,130,263) | 5.05 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 23vPS Dose (n=133,130,263) | 5.15 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 3 (n=133,130,263) | 5.02 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 23vPS Dose (n=133,130,263) | 5.27 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 3 (n=133,130,263) | 13.18 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 23vPS Dose (n=133,130,263) | 12.98 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 3 (n=132,130,262) | 3.84 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 23vPS Dose (n=132,130,262) | 3.54 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 3 (n=133,130,263) | 14.16 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 23vPS Dose (n=133,130,263) | 13.16 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 3 (n=130,127,257) | 6.15 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 23vPS Dose (n=130,127,257) | 6.78 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 3 (n=132,129,261) | 6.69 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 23vPS Dose (n=132,129,261) | 5.99 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 3 (n=122,129,251) | 7.07 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 3 (n=133,130,263) | 13.21 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 23vPS Dose (n=122,129,251) | 6.71 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 3 (n=133,129,262) | 8.29 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 3 (n=132,129,261) | 7.30 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 23vPS Dose (n=133,129,262) | 8.25 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 23vPS Dose (n=133,130,263) | 13.28 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 3 (n=133,130,263) | 5.88 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 23vPS Dose (n=133,130,263) | 5.93 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 3 (n=133,130,263) | 5.49 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 3 (n=130,127,257) | 5.67 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 23vPS Dose (n=133,130,263) | 5.83 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 3 (n=133,130,263) | 15.35 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 23vPS Dose (n=133,130,263) | 16.24 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 3 (n=128,127,255) | 3.94 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 23vPS Dose (n=128,127,255) | 4.02 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 23vPS Dose (n=130,127,257) | 5.84 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 3 (n=124,118,242) | 1.04 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 3 (n=132,130,262) | 5.17 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 23vPS Dose (n=124,118,242) | 0.98 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 3 (n=133,128,261) | 3.19 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 23vPS Dose (n=133,128,261) | 3.01 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 23vPS Dose (n=132,130,262) | 4.80 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 3 (n=132,130,262) | 5.54 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 23vPS Dose (n=132,130,262) | 6.20 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 23vPS Dose (n=132,129,261) | 7.03 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 3 (n=132,130,262) | 5.12 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 3 (n=133,128,261) | 3.24 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 3 (n=128,127,255) | 4.01 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 23vPS Dose (n=122,129,251) | 7.30 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 3 (n=133,130,263) | 13.68 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 23vPS Dose (n=133,130,263) | 14.50 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 3 (n=133,129,262) | 10.10 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 23vPS Dose (n=130,127,257) | 6.30 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 23vPS Dose (n=128,127,255) | 4.21 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 23vPS Dose (n=133,129,262) | 9.59 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 23vPS Dose (n=132,130,262) | 4.12 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 23vPS Dose (n=133,128,261) | 3.15 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 3 (n=133,130,263) | 5.44 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 23vPS Dose (n=133,130,263) | 13.22 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 3 (n=124,118,242) | 1.25 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 23vPS Dose (n=133,130,263) | 5.52 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 3 (n=132,129,261) | 6.98 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 3 (n=122,129,251) | 7.60 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 3 (n=133,130,263) | 5.25 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 23vPS Dose (n=132,130,262) | 5.61 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 23vPS Dose (n=124,118,242) | 1.28 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 23vPS Dose (n=133,130,263) | 5.54 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 3 (n=130,127,257) | 5.91 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 3 (n=132,130,262) | 4.45 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 3 (n=133,130,263) | 14.21 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 23vPS Dose (n=132,129,261) | 6.49 mcg/mL |
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: Before 13vPnC Dose 1 (n=122,137,259) | 4.18 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 1 (n=78,122,200) | 3.78 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: Before 13vPnC Dose 1 (n=99,127,226) | 0.83 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 1 (n=99,127,226) | 1.25 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: Before 13vPnC Dose 1 (n=95,127,222) | 0.19 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 1 (n=95,127,222) | 2.62 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: Before 13vPnC Dose 1 (n=78,122,200) | 1.03 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 1 (n=122,137,259) | 4.81 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: Before 13vPnC Dose 1 (n=99,136,235) | 6.22 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 1 (n=99,136,235) | 7.31 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: Before 13vPnC Dose 1 (n=131,134,265) | 5.52 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 1 (n=131,134,265) | 10.26 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: Before 13vPnC Dose 1 (n=111,134,245) | 0.85 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 1 (n=111,134,245) | 4.34 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: Before 13vPnC Dose 1 (n=129,137,266) | 2.10 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 1 (n=129,137,266) | 4.77 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: Before 13vPnC Dose 1 (n=113,136,249) | 0.76 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 1 (n=113,136,249) | 12.04 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: Before 13vPnC Dose 1 (n=127,134,261) | 0.66 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 1 (n=127,134,261) | 3.92 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: Before 13vPnC Dose 1 (n=133,137,270) | 7.51 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 1 (n=133,137,270) | 13.28 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: Before 13vPnC Dose 1 (n=93,126,219) | 1.36 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 1 (n=93,126,219) | 4.62 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: Before 13vPnC Dose 1 (n=126,137,263) | 2.29 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 1 (n=126,137,263) | 5.65 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: Before 13vPnC Dose 1 (n=99,136,235) | 2.67 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: Before 13vPnC Dose 1 (n=133,137,270) | 4.78 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 1 (n=99,136,235) | 6.77 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: Before 13vPnC Dose 1 (n=131,134,265) | 3.23 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: Before 13vPnC Dose 1 (n=126,137,263) | 1.61 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 1 (n=131,134,265) | 7.29 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 1 (n=133,137,270) | 13.03 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: Before 13vPnC Dose 1 (n=111,134,245) | 1.14 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 1 (n=111,134,245) | 5.57 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: Before 13vPnC Dose 1 (n=129,137,266) | 1.56 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: Before 13vPnC Dose 1 (n=93,126,219) | 1.36 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 1 (n=129,137,266) | 5.16 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: Before 13vPnC Dose 1 (n=113,136,249) | 2.45 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 1 (n=113,136,249) | 16.46 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: Before 13vPnC Dose 1 (n=78,122,200) | 0.82 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 1 (n=78,122,200) | 4.00 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 1 (n=93,126,219) | 4.98 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: Before 13vPnC Dose 1 (n=99,127,226) | 0.47 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: Before 13vPnC Dose 1 (n=127,134,261) | 0.85 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 1 (n=99,127,226) | 0.75 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: Before 13vPnC Dose 1 (n=95,127,222) | 0.35 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 1 (n=95,127,222) | 2.91 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 1 (n=127,134,261) | 5.55 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: Before 13vPnC Dose 1 (n=122,137,259) | 3.38 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 1 (n=122,137,259) | 5.53 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 1 (n=126,137,263) | 5.30 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: Before 13vPnC Dose 1 (n=122,137,259) | 3.74 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: Before 13vPnC Dose 1 (n=95,127,222) | 0.27 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: Before 13vPnC Dose 1 (n=78,122,200) | 0.90 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 1 (n=99,136,235) | 6.99 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: Before 13vPnC Dose 1 (n=133,137,270) | 5.97 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 1 (n=113,136,249) | 14.28 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: Before 13vPnC Dose 1 (n=131,134,265) | 4.21 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 1 (n=93,126,219) | 4.82 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 1 (n=78,122,200) | 3.91 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 1 (n=131,134,265) | 8.63 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 1 (n=127,134,261) | 4.69 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 1 (n=95,127,222) | 2.79 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: Before 13vPnC Dose 1 (n=111,134,245) | 1.00 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 1 (n=133,137,270) | 13.15 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: Before 13vPnC Dose 1 (n=99,127,226) | 0.60 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 1 (n=111,134,245) | 4.97 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: Before 13vPnC Dose 1 (n=126,137,263) | 1.90 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: Before 13vPnC Dose 1 (n=99,136,235) | 3.81 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: Before 13vPnC Dose 1 (n=129,137,266) | 1.80 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 1 (n=122,137,259) | 5.18 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 1 (n=99,127,226) | 0.94 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 1 (n=129,137,266) | 4.97 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: Before 13vPnC Dose 1 (n=93,126,219) | 1.36 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: Before 13vPnC Dose 1 (n=127,134,261) | 0.75 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: Before 13vPnC Dose 1 (n=113,136,249) | 1.44 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 1 (n=126,137,263) | 5.47 mcg/mL |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Time frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F (n = 130, 127, 257) | 1.10 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14 (n = 133, 130, 263) | 0.98 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B (n = 133, 129, 262) | 0.91 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4 (n = 133, 128, 261) | 1.00 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V (n = 133, 130, 263) | 1.05 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F (n = 133, 130, 263) | 1.02 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1 (n = 128, 127, 255) | 1.08 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3 (n = 124, 118, 242) | 1.11 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A (n = 133, 130, 263) | 0.93 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5 (n = 132, 130, 262) | 1.07 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F (n = 132, 129, 261) | 0.90 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C (n = 132, 130, 262) | 0.92 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A (n = 122, 129, 251) | 0.97 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F (n = 133, 130, 263) | 1.01 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1 (n = 128, 127, 255) | 1.02 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3 (n = 124, 118, 242) | 0.94 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4 (n = 133, 128, 261) | 0.94 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5 (n = 132, 130, 262) | 1.12 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A (n = 122, 129, 251) | 0.95 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B (n = 133, 129, 262) | 1.00 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V (n = 133, 130, 263) | 1.06 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14 (n = 133, 130, 263) | 1.06 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C (n = 132, 130, 262) | 0.93 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A (n = 133, 130, 263) | 1.01 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F (n = 130, 127, 257) | 1.03 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F (n = 132, 129, 261) | 0.96 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14 (n = 133, 130, 263) | 1.02 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5 (n = 132, 130, 262) | 1.09 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F (n = 130, 127, 257) | 1.07 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C (n = 132, 130, 262) | 0.92 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4 (n = 133, 128, 261) | 0.97 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1 (n = 128, 127, 255) | 1.05 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A (n = 133, 130, 263) | 0.97 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F (n = 133, 130, 263) | 1.01 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B (n = 133, 129, 262) | 0.95 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3 (n = 124, 118, 242) | 1.02 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V (n = 133, 130, 263) | 1.06 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A (n = 122, 129, 251) | 0.96 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F (n = 132, 129, 261) | 0.93 fold rise |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F (n = 93, 126, 219) | 3.39 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14 (n = 113, 136, 249) | 15.79 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B (n = 131, 134, 265) | 1.86 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4 (n = 95, 127, 222) | 14.02 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V (n = 129, 137, 266) | 2.27 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F (n = 111, 134, 245) | 5.11 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1 (n = 78, 122, 200) | 3.67 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3 (n = 99, 127, 226) | 1.51 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A (n = 133, 137, 270) | 1.77 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5 (n = 122, 137, 259) | 1.15 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F (n = 126, 137, 263) | 2.47 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C (n = 127, 134, 261) | 5.92 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A (n = 99, 136, 235) | 1.18 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F (n = 111, 134, 245) | 4.90 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1 (n = 78, 122, 200) | 4.88 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3 (n = 99, 127, 226) | 1.62 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4 (n = 95, 127, 222) | 8.29 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5 (n = 122, 137, 259) | 1.64 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A (n = 99, 136, 235) | 2.54 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B (n = 131, 134, 265) | 2.26 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V (n = 129, 137, 266) | 3.32 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14 (n = 113, 136, 249) | 6.73 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C (n = 127, 134, 261) | 6.55 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A (n = 133, 137, 270) | 2.73 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F (n = 93, 126, 219) | 3.66 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F (n = 126, 137, 263) | 3.30 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14 (n = 113, 136, 249) | 9.91 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5 (n = 122, 137, 259) | 1.38 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F (n = 93, 126, 219) | 3.54 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C (n = 127, 134, 261) | 6.23 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4 (n = 95, 127, 222) | 10.38 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1 (n = 78, 122, 200) | 4.37 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A (n = 133, 137, 270) | 2.20 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F (n = 111, 134, 245) | 4.99 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B (n = 131, 134, 265) | 2.05 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3 (n = 99, 127, 226) | 1.57 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V (n = 129, 137, 266) | 2.76 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A (n = 99, 136, 235) | 1.83 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F (n = 126, 137, 263) | 2.87 fold rise |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F (n = 123, 123, 246) | 39.0 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14 (n = 107, 126, 233) | 10.9 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B (n = 101, 120, 221) | 13.8 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4 (n = 108, 119, 227) | 89.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V (n = 109, 117, 226) | 16.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F (n = 110, 113, 223) | 9.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1 (n = 129, 127, 256) | 9.8 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3 (n = 126, 128, 254) | 4.8 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A (n = 129, 128, 257) | 18.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5 (n = 125, 122, 247) | 14.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F (n = 118, 125, 243) | 41.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C (n = 95, 120, 215) | 67.9 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A (n = 99, 98, 197) | 22.2 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F (n = 110, 113, 223) | 52.2 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1 (n = 129, 127, 256) | 12.2 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3 (n = 126, 128, 254) | 4.1 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4 (n = 108, 119, 227) | 51.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5 (n = 125, 122, 247) | 21.7 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A (n = 99, 98, 197) | 25.2 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B (n = 101, 120, 221) | 9.1 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V (n = 109, 117, 226) | 17.8 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14 (n = 107, 126, 233) | 10.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C (n = 95, 120, 215) | 41.6 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A (n = 129, 128, 257) | 16.7 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F (n = 123, 123, 246) | 15.5 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F (n = 118, 125, 243) | 20.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14 (n = 107, 126, 233) | 10.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5 (n = 125, 122, 247) | 17.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F (n = 123, 123, 246) | 24.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C (n = 95, 120, 215) | 51.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4 (n = 108, 119, 227) | 66.8 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1 (n = 129, 127, 256) | 10.9 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A (n = 129, 128, 257) | 17.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F (n = 110, 113, 223) | 22.0 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B (n = 101, 120, 221) | 11.0 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3 (n = 126, 128, 254) | 4.5 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V (n = 109, 117, 226) | 17.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A (n = 99, 98, 197) | 23.6 fold rise |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F (n = 118, 125, 243) | 28.6 fold rise |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged greater than (\>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.
Time frame: Within 14 days after 13vPnC Dose 1
Population: Safety population. Here N (number of participants analyzed) signifies participants with known values for any local reaction and n signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Any (n = 92, 88, 180) | 20.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Mild (n = 91, 88, 179) | 19.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Moderate (n = 85, 88, 173) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Severe (n = 84, 88, 172) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Any (n = 97, 94, 191) | 29.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Mild (n = 91, 93, 184) | 17.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Moderate (n = 92, 89, 181) | 16.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Severe (n = 84, 88, 172) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Any (n = 117, 121, 238) | 68.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Mild (n = 112, 116, 228) | 55.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Moderate (n = 94, 94, 188) | 28.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Severe (n = 86, 89, 175) | 8.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Severe (n = 86, 89, 175) | 2.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Any (n = 92, 88, 180) | 2.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Moderate (n = 92, 89, 181) | 1.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Any (n = 117, 121, 238) | 62.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Mild (n = 91, 88, 179) | 2.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Mild (n = 91, 93, 184) | 8.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Moderate (n = 94, 94, 188) | 18.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Moderate (n = 85, 88, 173) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Severe (n = 84, 88, 172) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Any (n = 97, 94, 191) | 9.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Severe (n = 84, 88, 172) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Mild (n = 112, 116, 228) | 56.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Severe (n = 84, 88, 172) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Any (n = 97, 94, 191) | 19.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Mild (n = 112, 116, 228) | 55.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Mild (n = 91, 93, 184) | 13.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Moderate (n = 92, 89, 181) | 8.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Swelling: Severe (n = 84, 88, 172) | 0.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Moderate (n = 94, 94, 188) | 23.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Any (n = 92, 88, 180) | 11.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Mild (n = 91, 88, 179) | 11.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Any (n = 117, 121, 238) | 65.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Redness: Moderate (n = 85, 88, 173) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 | Pain at Injection Site: Severe (n = 86, 89, 175) | 5.1 percentage of participants |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged \>12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Time frame: Within 14 days after 13vPnC Dose 2
Population: Safety population. Here N (number of participants analyzed) signifies participants with known values for any local reaction and n signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Any (n = 101, 86, 187) | 13.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Mild (n = 100, 86, 186) | 10.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Moderate (n = 95, 85, 180) | 4.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Severe (n = 93, 85, 178) | 1.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Any (n = 103, 88, 191) | 25.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Mild (n = 102, 88, 190) | 18.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Moderate (n = 99, 85, 184) | 12.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Severe (n = 93, 85, 178) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Any (n = 117, 119, 236) | 60.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Mild (n = 110, 117, 227) | 49.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Moderate (n= 103, 96, 199) | 24.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Severe (n = 93, 86, 179) | 5.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Severe (n = 93, 86, 179) | 3.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Any (n = 101, 86, 187) | 2.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Moderate (n = 99, 85, 184) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Any (n = 117, 119, 236) | 79.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Mild (n = 100, 86, 186) | 2.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Mild (n = 102, 88, 190) | 8.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Moderate (n= 103, 96, 199) | 27.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Moderate (n = 95, 85, 180) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Severe (n = 93, 85, 178) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Any (n = 103, 88, 191) | 8.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Severe (n = 93, 85, 178) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Mild (n = 110, 117, 227) | 72.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Severe (n = 93, 85, 178) | 0.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Any (n = 103, 88, 191) | 17.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Mild (n = 110, 117, 227) | 61.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Mild (n = 102, 88, 190) | 13.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Moderate (n = 99, 85, 184) | 6.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Swelling: Severe (n = 93, 85, 178) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Moderate (n= 103, 96, 199) | 25.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Any (n = 101, 86, 187) | 8.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Mild (n = 100, 86, 186) | 6.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Any (n = 117, 119, 236) | 70.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Redness: Moderate (n = 95, 85, 180) | 2.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 | Pain at Injection Site: Severe (n = 93, 86, 179) | 4.5 percentage of participants |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to \<12 years and 2.5 to 5.0 cm for participants aged \>12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to \<12 years and 5.1 to 10.0 cm for participants aged \>12 years); Severe (\>7 cm for participants aged 6 to \<12 years and \>10 cm for participants aged \>12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Time frame: Within 14 days after 13vPnC Dose 3
Population: Safety population. Here N (number of participants analyzed) signifies participants with known values for any local reaction and n signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Any (n = 84, 70, 154) | 8.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Mild (n = 83, 70, 153) | 7.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Moderate (n = 82, 70, 152) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Severe (n = 80, 70, 150) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Any (n = 89, 71, 160) | 18.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Mild (n = 86, 71, 157) | 10.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Moderate (n = 84, 70, 154) | 9.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Severe (n = 80, 70, 150) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Any (n = 104, 109, 213) | 52.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Mild (n = 96, 105, 201) | 41.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Moderate (n = 89, 78, 167) | 19.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Severe (n = 83, 73, 156) | 4.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Severe (n = 83, 73, 156) | 5.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Any (n = 84, 70, 154) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Moderate (n = 84, 70, 154) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Any (n = 104, 109, 213) | 69.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Mild (n = 83, 70, 153) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Mild (n = 86, 71, 157) | 4.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Moderate (n = 89, 78, 167) | 24.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Moderate (n = 82, 70, 152) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Severe (n = 80, 70, 150) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Any (n = 89, 71, 160) | 4.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Severe (n = 80, 70, 150) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Mild (n = 96, 105, 201) | 63.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Severe (n = 80, 70, 150) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Any (n = 89, 71, 160) | 11.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Mild (n = 96, 105, 201) | 53.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Mild (n = 86, 71, 157) | 7.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Moderate (n = 84, 70, 154) | 5.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Swelling: Severe (n = 80, 70, 150) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Moderate (n = 89, 78, 167) | 21.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Any (n = 84, 70, 154) | 4.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Mild (n = 83, 70, 153) | 3.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Any (n = 104, 109, 213) | 61.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Redness: Moderate (n = 82, 70, 152) | 1.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 | Pain at Injection Site: Severe (n = 83, 73, 156) | 5.1 percentage of participants |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Specific systemic events (fever \>=38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours). All reporting of fever \>40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.
Time frame: Within 14 days after 13vPnC Dose 1
Population: Safety population. Here N (number of participants analyzed) signifies participants with known values for any systemic event and n signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Moderate (n = 89, 95, 184) | 12.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Any (n = 108, 118, 226) | 48.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Moderate (n = 94, 97, 191) | 18.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >40 degrees C (n = 88, 93, 181) | 6.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Severe (n = 85, 88, 173) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Severe (n = 87, 89, 176) | 6.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Use of Medication to Treat Pain (n = 101, 96, 197) | 33.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Moderate (n = 86, 91, 177) | 8.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Any (n = 89, 91, 180) | 18.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Mild (n = 98, 101, 199) | 26.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Mild (n = 92, 104, 196) | 19.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Mild (n = 89, 91, 180) | 14.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Any (n = 111, 119, 230) | 47.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Any (n = 94, 105, 199) | 25.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Moderate (n = 84, 88, 172) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38.5, <39 degrees C (n = 85, 89, 174) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Severe (n = 85, 88, 173) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Any (n = 100, 105, 205) | 34.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Mild (n = 105, 113, 218) | 33.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38, <38.5 degrees C (n = 87, 92, 179) | 8.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Severe (n = 86, 91, 177) | 5.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Moderate (n = 96, 99, 195) | 26.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Severe (n = 84, 91, 175) | 4.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38 degrees C (n= 94, 95, 189) | 19.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Severe (n = 86, 92, 178) | 9.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=39, =<40 degrees C (n = 86, 88, 174) | 4.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Moderate (n = 89, 98, 187) | 19.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Any (n = 107, 113, 220) | 39.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Use of Medication to Treat Fever (n=112, 107, 219) | 44.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Mild (n = 103, 110, 213) | 36.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Mild (n = 100, 109, 209) | 33.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Moderate (n = 89, 98, 187) | 19.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38 degrees C (n= 94, 95, 189) | 17.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38, <38.5 degrees C (n = 87, 92, 179) | 8.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38.5, <39 degrees C (n = 85, 89, 174) | 3.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=39, =<40 degrees C (n = 86, 88, 174) | 2.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >40 degrees C (n = 88, 93, 181) | 8.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Any (n = 111, 119, 230) | 58.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Mild (n = 105, 113, 218) | 51.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Moderate (n = 96, 99, 195) | 28.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Severe (n = 86, 92, 178) | 8.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Any (n = 107, 113, 220) | 61.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Mild (n = 100, 109, 209) | 57.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Moderate (n = 94, 97, 191) | 22.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Severe (n = 87, 89, 176) | 9.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Any (n = 89, 91, 180) | 7.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Mild (n = 89, 91, 180) | 7.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Moderate (n = 84, 88, 172) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Severe (n = 85, 88, 173) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Any (n = 94, 105, 199) | 34.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Mild (n = 92, 104, 196) | 29.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Moderate (n = 86, 91, 177) | 7.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Severe (n = 85, 88, 173) | 1.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Any (n = 108, 118, 226) | 62.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Mild (n = 103, 110, 213) | 56.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Severe (n = 86, 91, 177) | 5.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Any (n = 100, 105, 205) | 42.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Mild (n = 98, 101, 199) | 36.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Moderate (n = 89, 95, 184) | 17.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Severe (n = 84, 91, 175) | 4.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Use of Medication to Treat Pain (n = 101, 96, 197) | 24.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Use of Medication to Treat Fever (n=112, 107, 219) | 39.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Severe (n = 85, 88, 173) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Mild (n = 100, 109, 209) | 45.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38.5, <39 degrees C (n = 85, 89, 174) | 2.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Any (n = 108, 118, 226) | 55.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Any (n = 107, 113, 220) | 50.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38 degrees C (n= 94, 95, 189) | 18.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Mild (n = 103, 110, 213) | 46.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Severe (n = 86, 92, 178) | 9.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Moderate (n = 96, 99, 195) | 27.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Moderate (n = 89, 98, 187) | 19.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Mild (n = 105, 113, 218) | 42.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Severe (n = 84, 91, 175) | 4.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Severe (n = 86, 91, 177) | 5.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fatigue: Any (n = 111, 119, 230) | 53.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=38, <38.5 degrees C (n = 87, 92, 179) | 8.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Any (n = 100, 105, 205) | 38.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >40 degrees C (n = 88, 93, 181) | 7.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Moderate (n = 84, 88, 172) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Use of Medication to Treat Fever (n=112, 107, 219) | 42.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Severe (n = 85, 88, 173) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Mild (n = 89, 91, 180) | 11.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Mild (n = 98, 101, 199) | 31.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Any (n = 94, 105, 199) | 30.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Vomiting: Any (n = 89, 91, 180) | 12.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Fever: >=39, =<40 degrees C (n = 86, 88, 174) | 3.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Mild (n = 92, 104, 196) | 25.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Severe (n = 87, 89, 176) | 8.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Use of Medication to Treat Pain (n = 101, 96, 197) | 28.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Diarrhea: Moderate (n = 86, 91, 177) | 7.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Headache: Moderate (n = 94, 97, 191) | 20.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Moderate (n = 89, 95, 184) | 15.2 percentage of participants |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Specific systemic events (fever \>=38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours). All reporting of fever \>40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.
Time frame: Within 14 days after 13vPnC Dose 2
Population: Safety population. Here N (number of participants analyzed) signifies participants with known values for any systemic event and n signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Moderate (n = 99, 89, 188) | 11.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Any (n = 112, 104, 216) | 37.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Moderate (n = 97, 93, 190) | 13.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >40 degrees C (n = 95, 85, 180) | 1.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Severe (n = 94, 85, 179) | 4.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Severe (n = 94, 88, 182) | 2.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Use of Medication to Treat Pain (n = 100, 91, 191) | 20.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Moderate (n = 93, 87, 180) | 3.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Any (n = 96, 89, 185) | 10.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Mild (n = 100, 93, 193) | 16.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Mild (n = 94, 93, 187) | 7.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Mild (n = 94, 89, 183) | 6.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Any (n = 106, 105, 211) | 33.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Any (n = 95, 95, 190) | 10.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Moderate (n = 94, 85, 179) | 3.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38.5, <39 degrees C (n = 98, 85, 183) | 6.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Severe (n = 94, 85, 179) | 3.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Any (n = 106, 95, 201) | 26.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Mild (n = 104, 103, 207) | 24.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38, <38.5 degrees C (n = 96, 87, 183) | 7.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Severe (n = 95, 85, 180) | 5.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Moderate (n = 96, 88, 184) | 10.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Severe (n = 94, 85, 179) | 4.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38 degrees C (n= 102, 88, 190) | 16.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Severe (n = 95, 88, 183) | 7.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=39, =<40 degrees C (n = 97, 87, 184) | 7.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Moderate (n = 100, 91, 191) | 15.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Any (n = 101, 106, 207) | 28.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Use of Medication to Treat Fever (n=102, 96, 198) | 28.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Mild (n = 105, 103, 208) | 25.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Mild (n = 97, 102, 199) | 18.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Moderate (n = 100, 91, 191) | 20.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38 degrees C (n= 102, 88, 190) | 11.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38, <38.5 degrees C (n = 96, 87, 183) | 9.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38.5, <39 degrees C (n = 98, 85, 183) | 1.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=39, =<40 degrees C (n = 97, 87, 184) | 3.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >40 degrees C (n = 95, 85, 180) | 1.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Any (n = 106, 105, 211) | 48.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Mild (n = 104, 103, 207) | 42.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Moderate (n = 96, 88, 184) | 21.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Severe (n = 95, 88, 183) | 5.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Any (n = 101, 106, 207) | 49.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Mild (n = 97, 102, 199) | 40.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Moderate (n = 97, 93, 190) | 28.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Severe (n = 94, 88, 182) | 3.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Any (n = 96, 89, 185) | 10.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Mild (n = 94, 89, 183) | 9.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Moderate (n = 94, 85, 179) | 1.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Severe (n = 94, 85, 179) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Any (n = 95, 95, 190) | 26.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Mild (n = 94, 93, 187) | 24.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Moderate (n = 93, 87, 180) | 8.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Severe (n = 94, 85, 179) | 1.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Any (n = 112, 104, 216) | 52.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Mild (n = 105, 103, 208) | 46.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Severe (n = 95, 85, 180) | 2.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Any (n = 106, 95, 201) | 34.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Mild (n = 100, 93, 193) | 29.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Moderate (n = 99, 89, 188) | 12.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Severe (n = 94, 85, 179) | 2.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Use of Medication to Treat Pain (n = 100, 91, 191) | 17.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Use of Medication to Treat Fever (n=102, 96, 198) | 26.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Severe (n = 94, 85, 179) | 2.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Mild (n = 97, 102, 199) | 29.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38.5, <39 degrees C (n = 98, 85, 183) | 3.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Any (n = 112, 104, 216) | 44.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Any (n = 101, 106, 207) | 39.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Severe (n = 94, 85, 179) | 3.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Mild (n = 105, 103, 208) | 36.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Severe (n = 95, 88, 183) | 6.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Moderate (n = 96, 88, 184) | 15.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Moderate (n = 100, 91, 191) | 17.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Mild (n = 104, 103, 207) | 33.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38, <38.5 degrees C (n = 96, 87, 183) | 8.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Severe (n = 95, 85, 180) | 3.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fatigue: Any (n = 106, 105, 211) | 40.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Use of Medication to Treat Fever (n=102, 96, 198) | 27.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Any (n = 106, 95, 201) | 30.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >40 degrees C (n = 95, 85, 180) | 1.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Moderate (n = 94, 85, 179) | 2.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Use of Medication to Treat Pain (n = 100, 91, 191) | 18.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Severe (n = 94, 85, 179) | 1.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Mild (n = 94, 89, 183) | 7.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Mild (n = 100, 93, 193) | 22.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Any (n = 95, 95, 190) | 18.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Vomiting: Any (n = 96, 89, 185) | 10.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=39, =<40 degrees C (n = 97, 87, 184) | 5.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Mild (n = 94, 93, 187) | 16.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Severe (n = 94, 88, 182) | 2.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Fever: >=38 degrees C (n= 102, 88, 190) | 14.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Diarrhea: Moderate (n = 93, 87, 180) | 5.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Headache: Moderate (n = 97, 93, 190) | 20.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Moderate (n = 99, 89, 188) | 11.7 percentage of participants |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Specific systemic events (fever \>=38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (\>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (\>=6 loose stools in 24 hours). All reporting of fever \>40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.
Time frame: Within 14 days after 13vPnC Dose 3
Population: Safety population. Here N (number of participants analyzed) signifies participants with known values for any systemic event and n signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Moderate (n = 82, 77, 159) | 7.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Any (n = 99, 92, 191) | 37.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Moderate (n = 83, 77, 160) | 8.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >40 degrees C (n = 83, 70, 153) | 3.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Severe (n = 81, 73, 154) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Severe (n = 82, 72, 154) | 3.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Use of Medication to Treat Pain (n = 90, 79, 169) | 17.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Moderate (n = 80, 73, 153) | 1.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Any (n = 85, 74, 159) | 8.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Mild (n = 88, 82, 170) | 15.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Mild (n = 81, 79, 160) | 4.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Mild (n = 84, 72, 156) | 7.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Any (n = 92, 91, 183) | 25.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Any (n = 81, 81, 162) | 4.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Moderate (n = 82, 73, 155) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38.5, <39 degrees C (n = 81, 72, 153) | 2.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Severe (n = 81, 72, 153) | 1.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Any (n = 91, 83, 174) | 24.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Mild (n = 89, 88, 177) | 20.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38, <38.5 degrees C (n = 82, 73, 155) | 6.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Severe (n = 84, 72, 156) | 8.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Moderate (n = 83, 80, 163) | 6.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Severe (n = 81, 71, 152) | 2.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38 degrees C (n= 85, 73, 158) | 10.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Severe (n = 83, 73, 156) | 4.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=39, =<40 degrees C (n = 82, 70, 152) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Moderate (n = 85, 78, 163) | 12.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Any (n = 88, 89, 177) | 18.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Use of Medication to Treat Fever (n = 89, 75, 164) | 20.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Mild (n = 93, 89, 182) | 25.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Mild (n = 84, 87, 171) | 10.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Moderate (n = 85, 78, 163) | 24.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38 degrees C (n= 85, 73, 158) | 11.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38, <38.5 degrees C (n = 82, 73, 155) | 5.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38.5, <39 degrees C (n = 81, 72, 153) | 5.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=39, =<40 degrees C (n = 82, 70, 152) | 2.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >40 degrees C (n = 83, 70, 153) | 1.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Any (n = 92, 91, 183) | 47.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Mild (n = 89, 88, 177) | 39.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Moderate (n = 83, 80, 163) | 25.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Severe (n = 83, 73, 156) | 8.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Any (n = 88, 89, 177) | 46.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Mild (n = 84, 87, 171) | 41.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Moderate (n = 83, 77, 160) | 19.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Severe (n = 82, 72, 154) | 6.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Any (n = 85, 74, 159) | 9.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Mild (n = 84, 72, 156) | 5.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Moderate (n = 82, 73, 155) | 5.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Severe (n = 81, 72, 153) | 2.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Any (n = 81, 81, 162) | 28.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Mild (n = 81, 79, 160) | 25.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Moderate (n = 80, 73, 153) | 6.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Severe (n = 81, 73, 154) | 4.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Any (n = 99, 92, 191) | 47.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Mild (n = 93, 89, 182) | 37.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Severe (n = 84, 72, 156) | 5.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Any (n = 91, 83, 174) | 32.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Mild (n = 88, 82, 170) | 28.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Moderate (n = 82, 77, 159) | 15.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Severe (n = 81, 71, 152) | 2.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Use of Medication to Treat Pain (n = 90, 79, 169) | 21.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Use of Medication to Treat Fever (n = 89, 75, 164) | 20.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Severe (n = 81, 73, 154) | 2.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Mild (n = 84, 87, 171) | 26.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38.5, <39 degrees C (n = 81, 72, 153) | 3.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Any (n = 99, 92, 191) | 42.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Any (n = 88, 89, 177) | 32.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38 degrees C (n= 85, 73, 158) | 10.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Mild (n = 93, 89, 182) | 31.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Severe (n = 83, 73, 156) | 6.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Moderate (n = 83, 80, 163) | 15.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Moderate (n = 85, 78, 163) | 18.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Mild (n = 89, 88, 177) | 29.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Severe (n = 81, 71, 152) | 2.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Severe (n = 84, 72, 156) | 7.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fatigue: Any (n = 92, 91, 183) | 36.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=38, <38.5 degrees C (n = 82, 73, 155) | 5.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Any (n = 91, 83, 174) | 28.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >40 degrees C (n = 83, 70, 153) | 2.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Moderate (n = 82, 73, 155) | 3.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Use of Medication to Treat Fever (n = 89, 75, 164) | 20.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Severe (n = 81, 72, 153) | 2.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Mild (n = 84, 72, 156) | 6.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Mild (n = 88, 82, 170) | 21.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Any (n = 81, 81, 162) | 16.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Vomiting: Any (n = 85, 74, 159) | 8.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Fever: >=39, =<40 degrees C (n = 82, 70, 152) | 2.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Mild (n = 81, 79, 160) | 15.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Severe (n = 82, 72, 154) | 5.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Use of Medication to Treat Pain (n = 90, 79, 169) | 19.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Diarrhea: Moderate (n = 80, 73, 153) | 3.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Headache: Moderate (n = 83, 77, 160) | 13.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Moderate (n = 82, 77, 159) | 11.3 percentage of participants |
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR 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 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Time frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F (n = 126, 117, 243) | 1.5 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14 (n = 127, 126, 253) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B (n = 130, 126, 256) | 0.9 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4 (n = 127, 126, 253) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V (n = 127, 125, 252) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F (n = 131, 125, 256) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1 (n = 131, 125, 256) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3 (n = 132, 128, 260) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A (n = 131, 125, 256) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5 (n = 129, 124, 253) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F (n = 128, 126, 254) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C (n = 129, 121, 250) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A (n = 132, 127, 259) | 0.9 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F (n = 131, 125, 256) | 1.1 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1 (n = 131, 125, 256) | 1.0 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3 (n = 132, 128, 260) | 1.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4 (n = 127, 126, 253) | 1.0 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5 (n = 129, 124, 253) | 1.3 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A (n = 132, 127, 259) | 0.9 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B (n = 130, 126, 256) | 0.9 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V (n = 127, 125, 252) | 1.0 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14 (n = 127, 126, 253) | 1.1 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C (n = 129, 121, 250) | 1.1 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A (n = 131, 125, 256) | 1.1 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F (n = 126, 117, 243) | 1.4 fold rise |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F (n = 128, 126, 254) | 0.9 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14 (n = 127, 126, 253) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5 (n = 129, 124, 253) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F (n = 126, 117, 243) | 1.4 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C (n = 129, 121, 250) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4 (n = 127, 126, 253) | 1.0 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1 (n = 131, 125, 256) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A (n = 131, 125, 256) | 1.2 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F (n = 131, 125, 256) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B (n = 130, 126, 256) | 0.9 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3 (n = 132, 128, 260) | 1.3 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V (n = 127, 125, 252) | 1.1 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A (n = 132, 127, 259) | 0.9 fold rise |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F (n = 128, 126, 254) | 1.0 fold rise |
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 3 (n=129,124,253) | 270 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 23vPS Dose (n=131,125,256) | 100 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 3 (n=132,128,260) | 114 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 23vPS Dose (n=132,128,260) | 148 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 3 (n=127,126,253) | 3213 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 23vPS Dose (n=127,126,253) | 3553 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 3 (n=131,125,256) | 70 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 23vPS Dose (n=129,124,253) | 378 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 3 (n=132,127,259) | 8011 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 23vPS Dose (n=132,127,259) | 7236 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 3 (n=130,126,256) | 7102 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 23vPS Dose (n=130,126,256) | 6652 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 3 (n=131,125,256) | 4640 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 23vPS Dose (n=131,125,256) | 5260 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 3 (n=127,125,252) | 4501 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 23vPS Dose (n=127,125,252) | 5114 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 3 (n=127,126,253) | 4023 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 23vPS Dose (n=127,126,253) | 4718 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 3 (n=129,121,250) | 5455 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 23vPS Dose (n=129,121,250) | 6468 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 3 (n=131,125,256) | 1021 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 23vPS Dose (n=131,125,256) | 1244 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 3 (n=126,117,243) | 1166 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 23vPS Dose (n=126,117,243) | 1696 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 3 (n=128,126,254) | 2346 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 23vPS Dose (n=128,126,254) | 2595 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 3 (n=132,127,259) | 2956 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 3 (n=131,125,256) | 603 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 23vPS Dose (n=132,127,259) | 2707 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 3 (n=130,126,256) | 3666 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 3 (n=128,126,254) | 650 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 23vPS Dose (n=130,126,256) | 3324 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 23vPS Dose (n=131,125,256) | 691 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 3 (n=131,125,256) | 2821 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 23vPS Dose (n=131,125,256) | 3027 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 3 (n=127,125,252) | 1980 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 3 (n=126,117,243) | 564 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 23vPS Dose (n=127,125,252) | 2037 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 3 (n=127,126,253) | 1431 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 23vPS Dose (n=127,126,253) | 1620 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 3 (n=131,125,256) | 67 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 23vPS Dose (n=131,125,256) | 66 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 23vPS Dose (n=126,117,243) | 790 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 3 (n=132,128,260) | 78 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 3 (n=129,121,250) | 1667 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 23vPS Dose (n=132,128,260) | 103 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 3 (n=127,126,253) | 1888 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 23vPS Dose (n=127,126,253) | 1831 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 23vPS Dose (n=129,121,250) | 1835 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 3 (n=129,124,253) | 143 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 23vPS Dose (n=129,124,253) | 186 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 23vPS Dose (n=128,126,254) | 580 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 3 (n=129,124,253) | 198 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 3 (n=127,126,253) | 2466 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 3 (n=131,125,256) | 69 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 23vPS Dose (n=132,127,259) | 4468 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 3 (n=131,125,256) | 790 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 23vPS Dose (n=127,126,253) | 2771 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 3 (n=130,126,256) | 5129 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 23vPS Dose (n=126,117,243) | 1174 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 1: After 23vPS Dose (n=131,125,256) | 82 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6B: After 23vPS Dose (n=130,126,256) | 4728 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 23vPS Dose (n=129,121,250) | 3515 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 4: After 23vPS Dose (n=127,126,253) | 2554 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 3 (n=131,125,256) | 3639 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19A: After 23vPS Dose (n=131,125,256) | 933 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 3 (n=132,128,260) | 94 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 7F: After 23vPS Dose (n=131,125,256) | 4016 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 3 (n=128,126,254) | 1241 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 3 (n=132,127,259) | 4913 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 3 (n=127,125,252) | 2995 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 5: After 23vPS Dose (n=129,124,253) | 267 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 3: After 23vPS Dose (n=132,128,260) | 124 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 9V: After 23vPS Dose (n=127,125,252) | 3240 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 3 (n=126,117,243) | 822 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 3 (n=129,121,250) | 3074 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 3 (n=127,126,253) | 2405 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants | Serotype 23F: After 23vPS Dose (n=128,126,254) | 1234 titers |
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Population: Evaluable immunogenicity population. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: Before 13vPnC Dose 1 (n=125,122,247) | 5 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 1 (n=129,127,256) | 49 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: Before 13vPnC Dose 1 (n=126,128,254) | 8 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 1 (n=126,128,254) | 41 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: Before 13vPnC Dose 1 (n=108,119,227) | 25 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 1 (n=108,119,227) | 2247 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: Before 13vPnC Dose 1 (n=129,127,256) | 5 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 1 (n=125,122,247) | 79 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: Before 13vPnC Dose 1 (n=99,98,197) | 157 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 1 (n=99,98,197) | 3480 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: Before 13vPnC Dose 1 (n=101,120,221) | 279 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 1 (n=101,120,221) | 3852 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: Before 13vPnC Dose 1 (n=110,113,223) | 416 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 1 (n=110,113,223) | 3775 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: Before 13vPnC Dose 1 (n=109,117,226) | 152 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 1 (n=109,117,226) | 2533 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: Before 13vPnC Dose 1 (n=107,126,233) | 328 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 1 (n=107,126,233) | 3571 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: Before 13vPnC Dose 1 (n=95,120,215) | 42 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 1 (n=95,120,215) | 2821 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: Before 13vPnC Dose 1 (n=129,128,257) | 28 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 1 (n=129,128,257) | 506 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: Before 13vPnC Dose 1 (n=123,123,246) | 11 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 1 (n=123,123,246) | 425 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: Before 13vPnC Dose 1 (n=118,125,243) | 14 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 1 (n=118,125,243) | 587 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: Before 13vPnC Dose 1 (n=99,98,197) | 61 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: Before 13vPnC Dose 1 (n=129,128,257) | 23 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 1 (n=99,98,197) | 1543 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: Before 13vPnC Dose 1 (n=101,120,221) | 231 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: Before 13vPnC Dose 1 (n=118,125,243) | 7 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 1 (n=101,120,221) | 2099 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 1 (n=129,128,257) | 390 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: Before 13vPnC Dose 1 (n=110,113,223) | 38 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 1 (n=110,113,223) | 2005 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: Before 13vPnC Dose 1 (n=109,117,226) | 69 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: Before 13vPnC Dose 1 (n=123,123,246) | 14 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 1 (n=109,117,226) | 1231 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: Before 13vPnC Dose 1 (n=107,126,233) | 123 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 1 (n=107,126,233) | 1277 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: Before 13vPnC Dose 1 (n=129,127,256) | 5 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 1 (n=129,127,256) | 57 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 1 (n=123,123,246) | 214 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: Before 13vPnC Dose 1 (n=126,128,254) | 5 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: Before 13vPnC Dose 1 (n=95,120,215) | 25 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 1 (n=126,128,254) | 21 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: Before 13vPnC Dose 1 (n=108,119,227) | 27 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 1 (n=108,119,227) | 1372 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 1 (n=95,120,215) | 1031 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: Before 13vPnC Dose 1 (n=125,122,247) | 6 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 1 (n=125,122,247) | 123 titers |
| 13vPnC, 23vPS (Adult Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 1 (n=118,125,243) | 140 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: Before 13vPnC Dose 1 (n=125,122,247) | 6 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: Before 13vPnC Dose 1 (n=108,119,227) | 26 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: Before 13vPnC Dose 1 (n=129,127,256) | 5 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: After 13vPnC Dose 1 (n=99,98,197) | 2322 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: Before 13vPnC Dose 1 (n=129,128,257) | 26 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: After 13vPnC Dose 1 (n=107,126,233) | 2048 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: Before 13vPnC Dose 1 (n=101,120,221) | 252 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: After 13vPnC Dose 1 (n=123,123,246) | 302 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 1: After 13vPnC Dose 1 (n=129,127,256) | 53 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6B: After 13vPnC Dose 1 (n=101,120,221) | 2771 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: After 13vPnC Dose 1 (n=95,120,215) | 1609 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 4: After 13vPnC Dose 1 (n=108,119,227) | 1735 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: Before 13vPnC Dose 1 (n=110,113,223) | 124 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19A: After 13vPnC Dose 1 (n=129,128,257) | 445 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: Before 13vPnC Dose 1 (n=126,128,254) | 7 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 7F: After 13vPnC Dose 1 (n=110,113,223) | 2739 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: Before 13vPnC Dose 1 (n=118,125,243) | 10 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 6A: Before 13vPnC Dose 1 (n=99,98,197) | 98 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: Before 13vPnC Dose 1 (n=109,117,226) | 101 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 5: After 13vPnC Dose 1 (n=125,122,247) | 98 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 3: After 13vPnC Dose 1 (n=126,128,254) | 29 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 9V: After 13vPnC Dose 1 (n=109,117,226) | 1743 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 19F: Before 13vPnC Dose 1 (n=123,123,246) | 12 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 18C: Before 13vPnC Dose 1 (n=95,120,215) | 31 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 14: Before 13vPnC Dose 1 (n=107,126,233) | 193 titers |
| 13vPnC, 23vPS (All Participants) | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants | Serotype 23F: After 13vPnC Dose 1 (n=118,125,243) | 281 titers |