Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Brief summary
People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.
Interventions
BIOLOGICAL13vPnC
0.5mL 13vPnC dose will be administered intramuscularly into the left limb at visits 1,2,3 and 5. Starting 3-6 months after HSCT 3 doses given at monthly intervals. 4th dose given 6 months after 3rd dose.
BIOLOGICAL23vPS
0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject \>=2 years of age. * Allogeneic HSCT for hematologic disorder. * Allogeneic HSCT with full myeloablative conditioning or reduced intensity conditioning. * Allogeneic HSCT approximately 3 to 6 months (91 days to 203 days) before enrollment. * Stable engraftment (absolute neutrophil count (ANC) \>1000/µL; platelet count \>50,000/µL). * Complete hematologic remission of underlying disease with very good partial remission (VGPR) acceptable in the case of lymphoma and myeloma. * Subject or parent/legal guardian expected to be available for the entire study and can be contacted by telephone. * Subject or parent/legal guardian must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation. * Hematological recovery as defined by ANC \>1000/µL; platelet count \>50,000/µL. * All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control from signing of the ICF until for 3 months after the last vaccination. * Negative urine pregnancy test for all female subjects of child bearing potential.
Exclusion criteria
* Autologous HSCT. * Receipt of donor lymphocyte infusions during the 28 days preceding enrollment. * Uncontrolled GVHD that in the opinion of the investigator would prevent the subject from participating in the study. * Lansky/Karnofsky Score \<=60%. * Receipt of plasma products or immunoglobulins during the 60 days preceding enrollment. * Receipt of rituximab since HSCT. * Receipt of chemotherapy for relapse of underlying malignant disease since HSCT. * Human immunodeficiency virus (HIV) infection. * Lymphoproliferative disorder since HSCT. * Chronic illnesses with cardiac, pulmonary, renal, or liver failure that in the opinion of the investigator would prevent the subject participating in the study. * Vaccination with any licensed or experimental pneumococcal vaccine since HSCT. * Previous anaphylactic reaction to any vaccine or vaccine-related component. * Bleeding diathesis or condition associated with prolonged bleeding time that would in the opinion of the investigator contraindicate intramuscular injection. * Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study. * Participation in another study with ongoing use of a licensed investigational product that in the opinion of the investigator would interfere with the evaluation of the study objectives. * Permanent residence in a nursing home or other residential care facility. * Pregnant or breastfeeding female subject. * Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or is a member of the study personnel. * Receipt of advanced therapy medicinal products (ATMP) including gene therapy products, somatic cell therapy products, and tissue engineered products at any time before enrollment. * If information is available, - previous allergic or anaphylactic reaction to any vaccine or vaccine-related component in a stem cell donor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants | Before 13vPnC Dose 1 (pre-vaccination), 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 before 13vPnC Dose 1 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 before 13vPnC Dose 1 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 in Pediatric, Adult and All Participants | 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 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 4 | 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 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Before 13vPnC Dose 1 (pre-vaccination), 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 before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. 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 1 and after 13vPnC Dose 3 blood draws. |
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4 | 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 4 were computed using the logarithmically transformed assay results. 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 1 and after 13vPnC Dose 4 blood draws. |
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | 1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4 | 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 13vPnC Dose 4 were computed using the logarithmically transformed assay results. 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 after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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 4 | Within 14 days after 13vPnC Dose 4 | 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). |
| 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 centimeters \[cm\] for participants aged 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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 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 centimeters \[cm\] for participants aged 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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 Local Reactions: 13vPnC Dose 4 | Within 14 days after 13vPnC Dose 4 | 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 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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). |
| 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). |
Countries
Belgium, Canada, Czechia, France, Germany, Netherlands, Poland, Spain, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC, 23vPS (Pediatric Participants) Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. | 59 |
| 13vPnC, 23vPS (Adult Participants) Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. | 188 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 31 |
| Overall Study | Death | 0 | 7 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Parent/legal guardian request | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 7 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | 13vPnC, 23vPS (Pediatric Participants) | 13vPnC, 23vPS (Adult Participants) | Total |
|---|---|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 4.41 | 47.3 years STANDARD_DEVIATION 12.39 | 38.4 years STANDARD_DEVIATION 19.26 |
| Sex: Female, Male Female | 26 Participants | 74 Participants | 100 Participants |
| Sex: Female, Male Male | 33 Participants | 114 Participants | 147 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 203 / 247 | 89 / 221 | 127 / 192 | 93 / 184 | 19 / 247 |
| serious Total, serious adverse events | 58 / 247 | 42 / 221 | 11 / 192 | 11 / 184 | 28 / 247 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 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 before 13vPnC Dose 1 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 before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.
Time frame: Before 13vPnC Dose 1 (pre-vaccination), 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 Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants | Serotype 5 (n=194) | 2.99 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 3 in All Participants | Serotype 6A (n=195) | 5.35 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 3 in All Participants | Serotype 6B (n=192) | 5.18 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 3 in All Participants | Serotype 7F (n=195) | 10.28 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 3 in All Participants | Serotype 9V (n=196) | 5.76 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 3 in All Participants | Serotype 14 (n=197) | 4.95 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 3 in All Participants | Serotype 18C (n=196) | 8.22 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 3 in All Participants | Serotype 19A (n=196) | 3.90 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 3 in All Participants | Serotype 19F (n=195) | 6.73 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 3 in All Participants | Serotype 23F (n=197) | 8.01 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 3 in All Participants | Serotype 1 (n=191) | 17.96 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 3 in All Participants | Serotype 3 (n=192) | 5.07 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 3 in All Participants | Serotype 4 (n=193) | 23.85 fold rise |
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 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 1 month after 13vPnC Dose 3 blood draw. CI for GMC are 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
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 in Pediatric, Adult and All Participants | Serotype 19F (n=49, 148, 197) | 5.80 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 in Pediatric, Adult and All Participants | Serotype 14 (n=49, 149, 198) | 6.22 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 in Pediatric, Adult and All Participants | Serotype 6B (n=48, 147, 195) | 6.29 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 in Pediatric, Adult and All Participants | Serotype 4 (n=49, 147, 196) | 4.13 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 in Pediatric, Adult and All Participants | Serotype 9V (n=49, 149, 198) | 4.17 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 in Pediatric, Adult and All Participants | Serotype 7F (n=48, 149, 197) | 7.34 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 in Pediatric, Adult and All Participants | Serotype 1 (n=49, 147, 196) | 3.52 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 in Pediatric, Adult and All Participants | Serotype 3 (n=49, 147, 196) | 1.60 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 in Pediatric, Adult and All Participants | Serotype 19A (n=49, 148, 197) | 8.26 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 in Pediatric, Adult and All Participants | Serotype 5 (n=48, 149, 197) | 4.18 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 in Pediatric, Adult and All Participants | Serotype 23F (n=49, 149, 198) | 6.74 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 in Pediatric, Adult and All Participants | Serotype 18C (n=49, 148, 197) | 4.17 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 in Pediatric, Adult and All Participants | Serotype 6A (n=49, 148, 197) | 7.61 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 in Pediatric, Adult and All Participants | Serotype 7F (n=48, 149, 197) | 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 in Pediatric, Adult and All Participants | Serotype 1 (n=49, 147, 196) | 2.05 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 in Pediatric, Adult and All Participants | Serotype 3 (n=49, 147, 196) | 0.62 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 in Pediatric, Adult and All Participants | Serotype 4 (n=49, 147, 196) | 1.78 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 in Pediatric, Adult and All Participants | Serotype 5 (n=48, 149, 197) | 2.00 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 in Pediatric, Adult and All Participants | Serotype 6A (n=49, 148, 197) | 3.31 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 in Pediatric, Adult and All Participants | Serotype 6B (n=48, 147, 195) | 3.00 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 in Pediatric, Adult and All Participants | Serotype 9V (n=49, 149, 198) | 2.44 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 in Pediatric, Adult and All Participants | Serotype 14 (n=49, 149, 198) | 5.99 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 in Pediatric, Adult and All Participants | Serotype 18C (n=49, 148, 197) | 3.04 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 in Pediatric, Adult and All Participants | Serotype 19A (n=49, 148, 197) | 4.77 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 in Pediatric, Adult and All Participants | Serotype 19F (n=49, 148, 197) | 3.48 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 in Pediatric, Adult and All Participants | Serotype 23F (n=49, 149, 198) | 3.87 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 in Pediatric, Adult and All Participants | Serotype 14 (n=49, 149, 198) | 6.05 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 in Pediatric, Adult and All Participants | Serotype 5 (n=48, 149, 197) | 2.39 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 in Pediatric, Adult and All Participants | Serotype 19F (n=49, 148, 197) | 3.95 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 in Pediatric, Adult and All Participants | Serotype 18C (n=49, 148, 197) | 3.29 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 in Pediatric, Adult and All Participants | Serotype 4 (n=49, 147, 196) | 2.20 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 in Pediatric, Adult and All Participants | Serotype 1 (n=49, 147, 196) | 2.35 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 in Pediatric, Adult and All Participants | Serotype 19A (n=49, 148, 197) | 5.47 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 in Pediatric, Adult and All Participants | Serotype 7F (n=48, 149, 197) | 4.57 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 in Pediatric, Adult and All Participants | Serotype 6B (n=48, 147, 195) | 3.60 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 in Pediatric, Adult and All Participants | Serotype 3 (n=49, 147, 196) | 0.79 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 in Pediatric, Adult and All Participants | Serotype 9V (n=49, 149, 198) | 2.79 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 in Pediatric, Adult and All Participants | Serotype 6A (n=49, 148, 197) | 4.07 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 in Pediatric, Adult and All Participants | Serotype 23F (n=49, 149, 198) | 4.44 microgram per milliliter (mcg/mL) |
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 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 1 month after 13vPnC Dose 4 blood draw. CI for GMC are 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 4
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 4 in Pediatric, Adult and All Participants | Serotype 19F (n=38, 123, 161) | 19.96 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 14 (n=37, 124, 161) | 16.04 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6B (n=38, 124, 162) | 18.13 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 4 (n=36, 124, 160) | 8.41 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 9V (n=37, 124, 161) | 7.78 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 7F (n=38, 124, 162) | 10.37 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 1 (n=38, 123, 161) | 8.75 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 3 (n=38, 123, 161) | 1.23 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19A (n=37, 124, 161) | 16.94 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 5 (n=38, 122, 160) | 8.43 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 23F (n=38, 123, 161) | 16.65 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 18C (n=38, 122, 160) | 6.54 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6A (n=37, 122, 159) | 16.33 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 7F (n=38, 124, 162) | 8.26 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 1 (n=38, 123, 161) | 4.67 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 3 (n=38, 123, 161) | 0.91 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 4 (n=36, 124, 160) | 4.56 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 5 (n=38, 122, 160) | 5.57 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6A (n=37, 122, 159) | 12.23 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6B (n=38, 124, 162) | 12.13 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 9V (n=37, 124, 161) | 5.09 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 14 (n=37, 124, 161) | 12.24 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 18C (n=38, 122, 160) | 6.69 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19A (n=37, 124, 161) | 12.99 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19F (n=38, 123, 161) | 13.69 mcg/mL |
| 13vPnC, 23vPS (Adult Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 23F (n=38, 123, 161) | 12.68 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 14 (n=37, 124, 161) | 13.02 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 5 (n=38, 122, 160) | 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 4 in Pediatric, Adult and All Participants | Serotype 19F (n=38, 123, 161) | 14.96 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 18C (n=38, 122, 160) | 6.65 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 4 (n=36, 124, 160) | 5.23 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 1 (n=38, 123, 161) | 5.41 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19A (n=37, 124, 161) | 13.81 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 7F (n=38, 124, 162) | 8.71 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6B (n=38, 124, 162) | 13.33 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 3 (n=38, 123, 161) | 0.97 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 9V (n=37, 124, 161) | 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 4 in Pediatric, Adult and All Participants | Serotype 6A (n=37, 122, 159) | 13.08 mcg/mL |
| 13vPnC, 23vPS (All Participants) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 23F (n=38, 123, 161) | 13.52 mcg/mL |
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 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 13vPnC Dose 4 were computed using the logarithmically transformed assay results. 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 after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.
Time frame: 1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4
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 Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 23F (n=37, 120, 157) | 2.49 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 18C (n=37, 118, 155) | 1.64 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6B (n=37, 120, 157) | 2.96 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 4 (n=35, 121, 156) | 2.19 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 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 14 (n=36, 121, 157) | 2.50 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 7F (n=36, 121, 157) | 1.51 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 3 (n=37, 119, 156) | 0.88 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 9V (n=36, 121, 157) | 2.08 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19F (n=37, 120, 157) | 3.50 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 5 (n=37, 119, 156) | 2.25 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 1 (n=37, 119, 156) | 2.80 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19A (n=36, 121, 157) | 2.25 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6A (n=36, 119, 155) | 2.36 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 23F (n=37, 120, 157) | 2.59 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 1 (n=37, 119, 156) | 2.16 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 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 3 (n=37, 119, 156) | 1.32 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 4 (n=35, 121, 156) | 2.32 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 5 (n=37, 119, 156) | 2.43 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6A (n=36, 119, 155) | 3.06 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6B (n=37, 120, 157) | 3.10 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 7F (n=36, 121, 157) | 1.83 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 9V (n=36, 121, 157) | 1.82 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 14 (n=36, 121, 157) | 1.68 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 18C (n=37, 118, 155) | 1.87 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19A (n=36, 121, 157) | 2.33 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19F (n=37, 120, 157) | 3.65 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 14 (n=36, 121, 157) | 1.84 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6A (n=36, 119, 155) | 2.88 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 3 (n=37, 119, 156) | 1.20 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 18C (n=37, 118, 155) | 1.81 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 5 (n=37, 119, 156) | 2.39 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 23F (n=37, 120, 157) | 2.57 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19A (n=36, 121, 157) | 2.31 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 4 (n=35, 121, 156) | 2.29 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 7F (n=36, 121, 157) | 1.75 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 1 (n=37, 119, 156) | 2.30 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 9V (n=36, 121, 157) | 1.88 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 6B (n=37, 120, 157) | 3.07 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 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19F (n=37, 120, 157) | 3.61 fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 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 before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. 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 1 and after 13vPnC Dose 3 blood draws.
Time frame: Before 13vPnC Dose 1 (pre-vaccination), 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 Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | Serotype 4 (n=49, 144) | 40.83 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 3 in Pediatric and Adult Participants | Serotype 9V (n=48, 148) | 7.64 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 3 in Pediatric and Adult Participants | Serotype 6A (n=48, 147) | 7.49 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 3 in Pediatric and Adult Participants | Serotype 14 (n=49, 148) | 5.01 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 3 in Pediatric and Adult Participants | Serotype 3 (n=48, 144) | 7.58 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 3 in Pediatric and Adult Participants | Serotype 18C (n=49, 147) | 12.59 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 3 in Pediatric and Adult Participants | Serotype 6B (n=47, 145) | 6.02 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 3 in Pediatric and Adult Participants | Serotype 19A (n=49, 147) | 5.04 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 3 in Pediatric and Adult Participants | Serotype 5 (n=47, 147) | 4.11 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 3 in Pediatric and Adult Participants | Serotype 19F (n=49, 146) | 7.66 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 3 in Pediatric and Adult Participants | Serotype 7F (n=48, 147) | 14.65 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 3 in Pediatric and Adult Participants | Serotype 23F (n=49, 148) | 9.73 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 3 in Pediatric and Adult Participants | Serotype 1 (n=48, 143) | 27.64 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 3 in Pediatric and Adult Participants | Serotype 23F (n=49, 148) | 7.52 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 3 in Pediatric and Adult Participants | Serotype 1 (n=48, 143) | 15.54 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 3 in Pediatric and Adult Participants | Serotype 3 (n=48, 144) | 4.43 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 3 in Pediatric and Adult Participants | Serotype 4 (n=49, 144) | 19.86 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 3 in Pediatric and Adult Participants | Serotype 5 (n=47, 147) | 2.70 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 3 in Pediatric and Adult Participants | Serotype 6A (n=48, 147) | 4.79 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 3 in Pediatric and Adult Participants | Serotype 6B (n=47, 145) | 4.94 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 3 in Pediatric and Adult Participants | Serotype 7F (n=48, 147) | 9.15 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 3 in Pediatric and Adult Participants | Serotype 9V (n=48, 148) | 5.26 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 3 in Pediatric and Adult Participants | Serotype 14 (n=49, 148) | 4.92 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 3 in Pediatric and Adult Participants | Serotype 18C (n=49, 147) | 7.13 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 3 in Pediatric and Adult Participants | Serotype 19A (n=49, 147) | 3.58 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 3 in Pediatric and Adult Participants | Serotype 19F (n=49, 146) | 6.44 fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 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 4 were computed using the logarithmically transformed assay results. 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 1 and after 13vPnC Dose 4 blood draws.
Time frame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4
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 Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Serotype 19F (n=38, 120, 158) | 29.31 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 4 in Pediatric, Adult and All Participants | Serotype 14 (n=37, 123, 160) | 12.61 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 4 in Pediatric, Adult and All Participants | Serotype 6B (n=37, 122, 159) | 16.90 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 4 in Pediatric, Adult and All Participants | Serotype 4 (n=36, 121, 157) | 90.31 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 4 in Pediatric, Adult and All Participants | Serotype 9V (n=36, 122, 158) | 14.90 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 4 in Pediatric, Adult and All Participants | Serotype 7F (n=38, 123, 161) | 19.18 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 4 in Pediatric, Adult and All Participants | Serotype 1 (n=37, 120, 157) | 70.66 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 4 in Pediatric, Adult and All Participants | Serotype 3 (n=37, 120, 157) | 5.88 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 4 in Pediatric, Adult and All Participants | Serotype 19A (n=37, 123, 160) | 11.46 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 4 in Pediatric, Adult and All Participants | Serotype 5 (n=37, 119, 156) | 7.76 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 4 in Pediatric, Adult and All Participants | Serotype 23F (n=38, 122, 160) | 25.37 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 4 in Pediatric, Adult and All Participants | Serotype 18C (n=38, 121, 159) | 21.22 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 4 in Pediatric, Adult and All Participants | Serotype 6A (n=36, 121, 157) | 15.62 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 4 in Pediatric, Adult and All Participants | Serotype 7F (n=38, 123, 161) | 18.69 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 4 in Pediatric, Adult and All Participants | Serotype 1 (n=37, 120, 157) | 35.81 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 4 in Pediatric, Adult and All Participants | Serotype 3 (n=37, 120, 157) | 6.41 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 4 in Pediatric, Adult and All Participants | Serotype 4 (n=36, 121, 157) | 47.47 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 4 in Pediatric, Adult and All Participants | Serotype 5 (n=37, 119, 156) | 7.29 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 4 in Pediatric, Adult and All Participants | Serotype 6A (n=36, 121, 157) | 17.02 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 4 in Pediatric, Adult and All Participants | Serotype 6B (n=37, 122, 159) | 20.09 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 4 in Pediatric, Adult and All Participants | Serotype 9V (n=36, 122, 158) | 11.13 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 4 in Pediatric, Adult and All Participants | Serotype 14 (n=37, 123, 160) | 9.69 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 4 in Pediatric, Adult and All Participants | Serotype 18C (n=38, 121, 159) | 14.40 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 4 in Pediatric, Adult and All Participants | Serotype 19A (n=37, 123, 160) | 9.52 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 4 in Pediatric, Adult and All Participants | Serotype 19F (n=38, 120, 158) | 25.63 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 4 in Pediatric, Adult and All Participants | Serotype 23F (n=38, 122, 160) | 23.02 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 4 in Pediatric, Adult and All Participants | Serotype 14 (n=37, 123, 160) | 10.30 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 4 in Pediatric, Adult and All Participants | Serotype 5 (n=37, 119, 156) | 7.40 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 4 in Pediatric, Adult and All Participants | Serotype 19F (n=38, 120, 158) | 26.47 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 4 in Pediatric, Adult and All Participants | Serotype 18C (n=38, 121, 159) | 15.80 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 4 in Pediatric, Adult and All Participants | Serotype 4 (n=36, 121, 157) | 55.02 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 4 in Pediatric, Adult and All Participants | Serotype 1 (n=37, 120, 157) | 42.03 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 4 in Pediatric, Adult and All Participants | Serotype 19A (n=37, 123, 160) | 9.94 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 4 in Pediatric, Adult and All Participants | Serotype 7F (n=38, 123, 161) | 18.81 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 4 in Pediatric, Adult and All Participants | Serotype 6B (n=37, 122, 159) | 19.29 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 4 in Pediatric, Adult and All Participants | Serotype 3 (n=37, 120, 157) | 6.28 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 4 in Pediatric, Adult and All Participants | Serotype 9V (n=36, 122, 158) | 11.90 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 4 in Pediatric, Adult and All Participants | Serotype 6A (n=36, 121, 157) | 16.90 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 4 in Pediatric, Adult and All Participants | Serotype 23F (n=38, 122, 160) | 23.56 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 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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 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: mild (n = 38, 130, 168) | 15.8 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 = 38, 130, 168) | 21.1 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 = 37, 128, 165) | 10.8 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 = 37, 128, 165) | 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 = 40, 130, 170) | 25.0 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 = 39, 130, 169) | 10.3 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 = 39, 128, 167) | 20.5 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 = 37, 128, 165) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: any (n = 51, 171, 222) | 78.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: mild (n = 48, 169, 217) | 68.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: moderate (n = 42, 138, 180) | 45.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: severe (n = 37, 129, 166) | 5.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: severe (n = 37, 129, 166) | 2.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: any (n = 51, 171, 222) | 73.1 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 = 38, 130, 168) | 11.5 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 = 39, 128, 167) | 0.8 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 = 38, 130, 168) | 10.8 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 = 39, 130, 169) | 10.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: moderate (n = 42, 138, 180) | 22.5 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 = 37, 128, 165) | 1.6 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 = 37, 128, 165) | 0.8 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 = 40, 130, 170) | 11.5 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 = 37, 128, 165) | 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: mild (n = 48, 169, 217) | 69.8 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 = 37, 128, 165) | 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 = 40, 130, 170) | 14.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: mild (n = 48, 169, 217) | 69.6 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 = 39, 130, 169) | 10.7 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 = 39, 128, 167) | 5.4 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 = 37, 128, 165) | 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: moderate (n = 42, 138, 180) | 27.8 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 = 38, 130, 168) | 13.7 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 = 38, 130, 168) | 11.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: any (n = 51, 171, 222) | 74.3 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 = 37, 128, 165) | 3.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1 | Pain: severe (n = 37, 129, 166) | 3.0 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 centimeters \[cm\] for participants aged 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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 = 28, 109, 137) | 42.9 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 = 26, 108, 134) | 34.6 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 = 26, 103, 129) | 26.9 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 = 24, 103, 127) | 4.2 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 = 28, 105, 133) | 35.7 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 = 26, 105, 131) | 15.4 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 = 26, 102, 128) | 26.9 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 = 24, 102, 126) | 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: any (n = 40, 154, 194) | 77.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: mild (n = 36, 148, 184) | 66.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: moderate (n = 32, 116, 148) | 53.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: severe (n = 27, 104, 131) | 14.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: severe (n = 27, 104, 131) | 1.9 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 = 28, 109, 137) | 16.5 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 = 26, 102, 128) | 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: any (n = 40, 154, 194) | 74.7 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 = 26, 108, 134) | 15.7 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 = 26, 105, 131) | 14.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: moderate (n = 32, 116, 148) | 27.6 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 = 26, 103, 129) | 1.9 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 = 24, 102, 126) | 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 = 28, 105, 133) | 14.3 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 = 24, 103, 127) | 1.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: mild (n = 36, 148, 184) | 70.9 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 = 24, 103, 127) | 1.6 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 = 28, 105, 133) | 18.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: mild (n = 36, 148, 184) | 70.1 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 = 26, 105, 131) | 14.5 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 = 26, 102, 128) | 5.5 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 = 24, 102, 126) | 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: moderate (n = 32, 116, 148) | 33.1 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 = 28, 109, 137) | 21.9 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 = 26, 108, 134) | 19.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: any (n = 40, 154, 194) | 75.3 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 = 26, 103, 129) | 7.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2 | Pain: severe (n = 27, 104, 131) | 4.6 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 centimeters \[cm\] for participants aged 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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 = 25, 95, 120) | 32.0 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 = 24, 94, 118) | 20.8 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 = 28, 93, 121) | 35.7 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 = 24, 93, 117) | 20.8 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 = 23, 93, 116) | 4.3 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 = 27, 93, 120) | 25.9 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 = 25, 92, 117) | 20.0 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 = 23, 92, 115) | 4.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: any (n = 37, 138, 175) | 70.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: mild (n = 31, 132, 163) | 64.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: moderate (n = 34, 107, 141) | 38.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: severe (n = 24, 93, 117) | 8.3 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 = 23, 93, 116) | 1.1 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 = 28, 93, 121) | 8.6 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 = 27, 93, 120) | 8.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: severe (n = 24, 93, 117) | 3.2 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 = 25, 92, 117) | 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: moderate (n = 34, 107, 141) | 27.1 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 = 23, 92, 115) | 0.0 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 = 25, 95, 120) | 9.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: any (n = 37, 138, 175) | 73.2 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 = 24, 94, 118) | 8.5 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 = 24, 93, 117) | 1.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: mild (n = 31, 132, 163) | 67.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: moderate (n = 34, 107, 141) | 29.8 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 = 24, 94, 118) | 11.0 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 = 28, 93, 121) | 14.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: mild (n = 31, 132, 163) | 66.9 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 = 25, 95, 120) | 14.2 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 = 27, 93, 120) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: severe (n = 24, 93, 117) | 4.3 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 = 23, 93, 116) | 1.7 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 = 25, 92, 117) | 4.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | Pain: any (n = 37, 138, 175) | 72.6 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 = 24, 93, 117) | 5.1 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 = 23, 92, 115) | 0.9 percentage of participants |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
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 2 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 2 to \<12 years and 5.5 to 10.0 cm for participants aged \>= 12 years); Severe (greater than \[\>\] 7.0 cm for participants aged 2 to \<12 years and \>10.0 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 4
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 4 | Redness: mild (n = 20, 77, 97) | 50.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: any (n = 27, 81, 108) | 66.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: moderate (n = 24, 85, 109) | 62.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: any (n = 21, 79, 100) | 71.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: mild (n = 21, 79, 100) | 38.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: any (n = 30, 113, 143) | 86.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: severe (n = 16, 74, 90) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: moderate (n = 23, 72, 95) | 52.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: severe (n = 16, 73, 89) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: moderate (n = 18, 72, 90) | 50.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: severe (n = 15, 73, 88) | 6.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: mild (n = 25, 105, 130) | 76.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: severe (n = 15, 73, 88) | 4.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: any (n = 30, 113, 143) | 77.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: mild (n = 25, 105, 130) | 71.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: moderate (n = 24, 85, 109) | 31.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: severe (n = 16, 73, 89) | 4.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: severe (n = 16, 74, 90) | 5.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: any (n = 27, 81, 108) | 28.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: mild (n = 20, 77, 97) | 15.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: mild (n = 21, 79, 100) | 21.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: any (n = 21, 79, 100) | 22.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: moderate (n = 23, 72, 95) | 6.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: moderate (n = 18, 72, 90) | 9.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: severe (n = 16, 74, 90) | 6.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: any (n = 21, 79, 100) | 33.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: mild (n = 20, 77, 97) | 22.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: moderate (n = 18, 72, 90) | 17.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Redness: severe (n = 16, 73, 89) | 5.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: any (n = 27, 81, 108) | 38.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: mild (n = 21, 79, 100) | 25.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: moderate (n = 23, 72, 95) | 17.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Swelling: severe (n = 15, 73, 88) | 4.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: any (n = 30, 113, 143) | 79.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: mild (n = 25, 105, 130) | 72.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | Pain: moderate (n = 24, 85, 109) | 38.5 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).
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 | Vomiting: Severe (n = 37, 128, 165) | 5.4 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= 41, 133, 174) | 24.4 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 = 38, 134, 172) | 18.4 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 = 41, 145, 186) | 39.0 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 = 44, 142, 186) | 31.8 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 = 41, 149, 190) | 36.6 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 = 43, 148, 191) | 46.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Moderate (n = 44, 139, 183) | 36.4 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 = 45, 159, 204) | 53.3 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 = 37, 128, 165) | 0.0 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 = 39, 130, 169) | 12.8 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 = 37, 131, 168) | 0.0 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 = 39, 128, 167) | 7.7 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 = 37, 130, 167) | 5.4 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 = 39, 134, 173) | 20.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Fever: >=38.5, <39 degrees C (n = 37, 128, 165) | 5.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Severe (n = 37, 131, 168) | 5.4 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 = 38, 133, 171) | 5.3 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 = 37, 130, 167) | 2.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Any (n = 38, 143, 181) | 26.3 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 = 38, 128, 166) | 2.6 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 = 40, 134, 174) | 20.0 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 = 37, 139, 176) | 18.9 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 = 47, 154, 201) | 55.3 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 = 42, 147, 189) | 45.2 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 = 38, 137, 175) | 15.8 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 = 44, 145, 189) | 31.8 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 = 37, 136, 173) | 10.8 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 = 37, 130, 167) | 2.7 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 = 44, 148, 192) | 36.4 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= 40, 136, 176) | 25.0 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 = 44, 145, 189) | 35.9 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 = 44, 142, 186) | 33.8 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 = 38, 133, 171) | 9.0 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 = 37, 131, 168) | 3.8 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 = 47, 154, 201) | 50.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Mild (n = 43, 148, 191) | 42.6 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 = 44, 139, 183) | 21.6 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 = 37, 131, 168) | 5.3 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 = 38, 143, 181) | 26.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Joint Pain: Mild (n = 37, 139, 176) | 19.4 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 = 38, 137, 175) | 14.6 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= 40, 136, 176) | 13.2 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= 41, 133, 174) | 14.3 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 = 37, 130, 167) | 3.1 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 = 39, 130, 169) | 6.2 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 = 37, 130, 167) | 6.2 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 = 37, 128, 165) | 0.0 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 = 39, 128, 167) | 0.0 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 = 37, 128, 165) | 0.0 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 = 45, 159, 204) | 59.7 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 = 41, 149, 190) | 49.0 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 = 44, 148, 192) | 35.8 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 = 37, 136, 173) | 11.8 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 = 42, 147, 189) | 44.2 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 = 41, 145, 186) | 37.9 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 = 40, 134, 174) | 17.2 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 = 37, 130, 167) | 2.3 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 = 39, 134, 173) | 20.9 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 = 38, 134, 172) | 17.9 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 = 38, 128, 166) | 3.9 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 = 37, 128, 165) | 0.0 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 = 37, 130, 167) | 3.0 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 = 37, 128, 165) | 1.2 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 = 44, 148, 192) | 35.9 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 = 38, 137, 175) | 14.9 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 = 38, 134, 172) | 18.0 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 = 37, 136, 173) | 11.6 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 = 37, 139, 176) | 19.3 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 = 37, 131, 168) | 3.0 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 = 42, 147, 189) | 44.4 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 = 44, 142, 186) | 33.3 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 = 41, 145, 186) | 38.2 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 = 38, 143, 181) | 26.5 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 = 38, 128, 166) | 3.6 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 = 40, 134, 174) | 17.8 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 = 37, 131, 168) | 5.4 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 = 38, 133, 171) | 8.2 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 = 37, 130, 167) | 6.0 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 = 37, 130, 167) | 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 = 37, 128, 165) | 1.2 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 = 39, 130, 169) | 7.7 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 = 44, 139, 183) | 25.1 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 = 39, 128, 167) | 1.8 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= 41, 133, 174) | 16.7 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 = 44, 145, 189) | 34.9 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 = 37, 128, 165) | 0.0 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= 40, 136, 176) | 15.9 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 = 39, 134, 173) | 20.8 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 = 45, 159, 204) | 58.3 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 = 47, 154, 201) | 51.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Muscle Pain: Mild (n = 43, 148, 191) | 43.5 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 = 41, 149, 190) | 46.3 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).
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 | Muscle Pain: Mild (n = 32, 118, 150) | 31.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Severe (n = 25, 104, 129) | 4.0 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 = 24, 104, 128) | 0.0 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 = 25, 109, 134) | 8.0 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 = 25, 106, 131) | 8.0 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 = 28, 107, 135) | 21.4 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 = 24, 102, 126) | 0.0 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 = 29, 121, 150) | 31.0 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 = 27, 107, 134) | 18.5 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= 27, 107, 134) | 33.3 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 = 26, 110, 136) | 7.7 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 = 28, 103, 131) | 14.3 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 = 38, 133, 171) | 60.5 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 = 29, 120, 149) | 31.0 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 = 24, 102, 126) | 0.0 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 = 36, 124, 160) | 44.4 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= 28, 105, 133) | 25.0 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 = 31, 125, 156) | 45.2 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 = 24, 102, 126) | 8.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Moderate (n = 30, 106, 136) | 30.0 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 = 33, 122, 155) | 45.5 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 = 26, 105, 131) | 19.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Fever: >=38 degrees C (n = 26, 105, 131) | 23.1 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 = 24, 107, 131) | 12.5 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 = 24, 103, 127) | 0.0 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 = 27, 115, 142) | 18.5 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 = 31, 121,152) | 32.3 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 = 31, 116, 147) | 32.3 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 = 30, 117, 147) | 30.0 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 = 24, 102, 126) | 8.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Moderate (n = 32, 111, 143) | 37.5 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 = 27, 115, 142) | 21.7 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 = 26, 105, 131) | 6.7 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 = 26, 105, 131) | 5.7 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 = 24, 102, 126) | 1.0 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 = 24, 102, 126) | 1.0 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 = 38, 133, 171) | 56.4 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 = 31, 125, 156) | 39.2 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 = 33, 122, 155) | 37.7 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 = 24, 107, 131) | 9.3 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 = 30, 117, 147) | 29.9 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 = 26, 110, 136) | 16.4 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 = 24, 104, 128) | 1.9 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 = 28, 107, 135) | 13.1 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 = 27, 107, 134) | 10.3 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 = 28, 103, 131) | 4.9 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 = 24, 102, 126) | 1.0 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 = 29, 121, 150) | 28.9 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 = 29, 120, 149) | 26.7 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 = 24, 102, 126) | 0.0 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 = 31, 121,152) | 35.5 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 = 32, 118, 150) | 37.3 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 = 32, 111, 143) | 25.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Severe (n = 25, 106, 131) | 5.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Any (n = 31, 116, 147) | 23.3 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 = 30, 106, 136) | 10.4 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 = 25, 104, 129) | 1.9 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= 28, 105, 133) | 7.6 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= 27, 107, 134) | 10.3 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 = 25, 109, 134) | 10.1 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 = 24, 103, 127) | 1.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Any (n = 36, 124, 160) | 45.2 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 = 24, 102, 126) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Moderate (n = 32, 111, 143) | 28.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Fever: >=38 degrees C (n = 26, 105, 131) | 9.9 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 = 25, 106, 131) | 6.1 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 = 31, 121,152) | 34.9 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 = 25, 109, 134) | 9.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Any (n = 31, 116, 147) | 25.2 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 = 24, 107, 131) | 9.9 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 = 33, 122, 155) | 39.4 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 = 27, 115, 142) | 21.1 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 = 31, 125, 156) | 40.4 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 = 24, 102, 126) | 2.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Joint Pain: Moderate (n = 30, 106, 136) | 14.7 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 = 36, 124, 160) | 45.0 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 = 25, 104, 129) | 2.3 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 = 38, 133, 171) | 57.3 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 = 24, 102, 126) | 0.8 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 = 24, 103, 127) | 1.6 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 = 29, 121, 150) | 29.3 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 = 28, 103, 131) | 6.9 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 = 24, 102, 126) | 0.0 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 = 26, 105, 131) | 8.4 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= 27, 107, 134) | 14.9 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 = 27, 107, 134) | 11.9 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 = 28, 107, 135) | 14.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Muscle Pain: Mild (n = 32, 118, 150) | 36.0 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 = 24, 104, 128) | 1.6 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 = 26, 110, 136) | 14.7 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 Pain (n= 28, 105, 133) | 11.3 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 = 29, 120, 149) | 27.5 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 = 30, 117, 147) | 29.9 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).
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 | Fatigue: Mild (n = 32, 116, 148) | 40.6 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 = 26, 102, 128) | 15.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Fever: >=38 degrees C (n = 27, 93, 120) | 14.8 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 = 26, 93, 119) | 11.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Fever: >=38.5, <39 degrees C (n = 24, 93, 117) | 4.2 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 = 24, 92, 116) | 4.2 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 = 23, 92, 115) | 0.0 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 = 35, 122, 157) | 48.6 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 = 30, 107, 137) | 33.3 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 = 24, 96, 120) | 4.2 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 = 32, 110,142) | 37.5 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 = 30, 108, 138) | 30.0 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 = 27, 95, 122) | 22.2 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 = 25, 94, 119) | 8.0 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 = 25, 95, 120) | 8.0 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 = 24, 95, 119) | 4.2 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 = 24, 93, 117) | 4.2 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 = 23, 92, 115) | 0.0 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 = 26, 104, 130) | 15.4 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 = 24, 95, 119) | 4.2 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 = 23, 94, 117) | 0.0 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 = 35, 117, 152) | 45.7 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 = 30, 112, 142) | 33.3 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 = 31, 101, 132) | 32.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Severe (n = 24, 94, 118) | 4.2 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 = 28, 104, 132) | 25.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Mild (n = 26, 102, 128) | 19.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Moderate (n = 27, 95, 122) | 18.5 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 = 25, 94, 119) | 8.0 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= 28, 97, 125) | 21.4 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= 30, 101, 131) | 26.7 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 = 23, 94, 117) | 2.1 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 = 32, 110,142) | 37.3 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= 30, 101, 131) | 15.8 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= 28, 97, 125) | 12.4 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 = 31, 101, 132) | 16.8 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 = 24, 93, 117) | 7.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Fever: >=38 degrees C (n = 27, 93, 120) | 4.3 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 = 25, 94, 119) | 2.1 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 = 35, 117, 152) | 38.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Fever: >=38, <38.5 degrees C (n = 26, 93, 119) | 3.2 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 = 26, 102, 128) | 17.6 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 = 23, 92, 115) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Fever: >=38.5, <39 degrees C (n = 24, 93, 117) | 3.2 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 = 24, 94, 118) | 3.2 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 = 28, 104, 132) | 20.2 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 = 24, 92, 116) | 1.1 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 = 26, 104, 130) | 25.0 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 = 30, 112, 142) | 33.0 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 = 23, 92, 115) | 0.0 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 = 25, 95, 120) | 11.6 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 = 35, 122, 157) | 49.2 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 = 26, 102, 128) | 21.6 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 = 30, 108, 138) | 32.4 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 = 32, 116, 148) | 38.8 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 = 27, 95, 122) | 15.8 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 = 25, 94, 119) | 2.1 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 = 30, 107, 137) | 29.9 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 = 24, 95, 119) | 5.3 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 = 24, 95, 119) | 5.3 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 = 24, 96, 120) | 7.3 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 = 27, 95, 122) | 8.4 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 = 24, 96, 120) | 6.7 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 = 32, 110,142) | 37.3 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 = 30, 108, 138) | 31.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Muscle Pain: Severe (n = 24, 94, 118) | 3.4 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 = 25, 94, 119) | 3.4 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 = 25, 95, 120) | 10.8 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 = 28, 104, 132) | 21.2 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 = 24, 95, 119) | 5.0 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 = 24, 93, 117) | 6.8 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 = 23, 92, 115) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Joint Pain: Mild (n = 26, 102, 128) | 18.0 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 = 26, 104, 130) | 23.1 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 = 26, 102, 128) | 20.3 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= 28, 97, 125) | 14.4 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 = 24, 95, 119) | 5.0 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 = 27, 95, 122) | 17.2 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 = 23, 94, 117) | 1.7 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 = 27, 95, 122) | 10.7 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 = 27, 93, 120) | 6.7 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 = 26, 93, 119) | 5.0 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 = 35, 117, 152) | 40.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Fever: >=38.5, <39 degrees C (n = 24, 93, 117) | 3.4 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= 30, 101, 131) | 18.3 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 = 24, 92, 116) | 1.7 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 = 23, 92, 115) | 0.0 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 = 35, 122, 157) | 49.0 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 = 30, 112, 142) | 33.1 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 = 32, 116, 148) | 39.2 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 = 30, 107, 137) | 30.7 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 = 31, 101, 132) | 20.5 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 = 25, 94, 119) | 3.4 percentage of participants |
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
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).
Time frame: Within 14 days after 13vPnC Dose 4
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 4 | Muscle Pain: Moderate (n = 19, 80, 99) | 36.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Mild (n = 26, 95, 121) | 61.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Moderate (n = 20, 86, 106) | 45.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Severe (n = 16, 77, 93) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Any (n = 21, 93, 114) | 52.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Mild (n = 21, 88, 109) | 47.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Moderate (n = 16, 82, 98) | 18.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Severe (n = 16, 74, 90) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Any (n = 16, 73, 89) | 6.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Mild (n = 16, 73, 89) | 6.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38 degrees C (n= 18, 78, 96) | 27.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38, <38.5 degrees C (n = 16, 76, 92) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38.5, <39 degrees C (n = 17, 73, 90) | 17.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=39, =<40 degrees C (n = 15, 72, 87) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >40 degrees C (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Any (n = 28, 100, 128) | 67.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Moderate (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Severe (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Any (n = 18, 83, 101) | 22.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Mild (n = 18, 82, 100) | 22.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Moderate (n = 15, 72, 87) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Severe (n = 15, 72, 87) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Any (n = 24, 99, 123) | 58.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Mild (n = 22, 92, 114) | 50.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Severe (n = 16, 75, 91) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Any (n = 16, 83, 99) | 25.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Mild (n = 15, 78, 93) | 13.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Moderate (n = 16, 75, 91) | 12.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Severe (n = 16, 74, 90) | 6.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Use of Medication to Treat Pain (n= 16, 77, 93) | 18.8 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Use of Medication to Treat Fever (n= 17, 77, 94) | 23.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Severe (n = 15, 72, 87) | 1.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Use of Medication to Treat Pain (n= 16, 77, 93) | 16.9 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Moderate (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Severe (n = 16, 75, 91) | 6.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Moderate (n = 20, 86, 106) | 45.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Mild (n = 15, 78, 93) | 24.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Any (n = 24, 99, 123) | 60.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Severe (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=39, =<40 degrees C (n = 15, 72, 87) | 2.8 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38.5, <39 degrees C (n = 17, 73, 90) | 2.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Mild (n = 26, 95, 121) | 54.7 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Severe (n = 16, 77, 93) | 13.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Any (n = 18, 83, 101) | 30.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Any (n = 16, 73, 89) | 5.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Use of Medication to Treat Fever (n= 17, 77, 94) | 15.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Any (n = 21, 93, 114) | 45.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >40 degrees C (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Severe (n = 16, 74, 90) | 4.1 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Mild (n = 21, 88, 109) | 38.6 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Mild (n = 18, 82, 100) | 29.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Mild (n = 22, 92, 114) | 50.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Moderate (n = 16, 82, 98) | 28.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Any (n = 16, 83, 99) | 32.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Moderate (n = 16, 75, 91) | 17.3 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Severe (n = 16, 74, 90) | 5.4 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Moderate (n = 15, 72, 87) | 4.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Any (n = 28, 100, 128) | 67.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Moderate (n = 19, 80, 99) | 30.0 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Mild (n = 16, 73, 89) | 5.5 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38, <38.5 degrees C (n = 16, 76, 92) | 13.2 percentage of participants |
| 13vPnC, 23vPS (Adult Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38 degrees C (n= 18, 78, 96) | 15.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Mild (n = 22, 92, 114) | 50.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Severe (n = 16, 74, 90) | 4.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38, <38.5 degrees C (n = 16, 76, 92) | 13.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38.5, <39 degrees C (n = 17, 73, 90) | 5.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Severe (n = 16, 75, 91) | 7.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=39, =<40 degrees C (n = 15, 72, 87) | 2.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Any (n = 28, 100, 128) | 67.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Moderate (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Severe (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Mild (n = 15, 78, 93) | 22.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Any (n = 18, 83, 101) | 28.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Use of Medication to Treat Pain (n= 16, 77, 93) | 17.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Mild (n = 18, 82, 100) | 28.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Moderate (n = 15, 72, 87) | 3.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Moderate (n = 16, 75, 91) | 16.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Diarrhea: Severe (n = 15, 72, 87) | 1.1 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Mild (n = 26, 95, 121) | 56.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Use of Medication to Treat Fever (n= 17, 77, 94) | 17.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Moderate (n = 20, 86, 106) | 45.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fatigue: Severe (n = 16, 77, 93) | 12.9 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Any (n = 24, 99, 123) | 60.2 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >40 degrees C (n = 15, 71, 86) | 0.0 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Severe (n = 16, 74, 90) | 6.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Joint Pain: Any (n = 16, 83, 99) | 31.3 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Any (n = 21, 93, 114) | 46.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Mild (n = 21, 88, 109) | 40.4 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Headache: Moderate (n = 16, 82, 98) | 26.5 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Fever: >=38 degrees C (n= 18, 78, 96) | 17.7 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Mild (n = 16, 73, 89) | 5.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Vomiting: Any (n = 16, 73, 89) | 5.6 percentage of participants |
| 13vPnC, 23vPS (All Participants) | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Muscle Pain: Moderate (n = 19, 80, 99) | 31.3 percentage of participants |