Pneumococcal Disease
Conditions
Brief summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Interventions
BIOLOGICAL20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
BIOLOGICAL13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* Japanese male or female infants ≥2 months to ≤6 months at the time of consent. * Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) * Major known congenital malformation or serious chronic disorder. * History of microbiologically proven invasive disease caused by S pneumoniae. * Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | 1 Month after Dose 3 | Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. The predefined levels, \>=0.35 micrograms/mL for all serotypes except for serotypes 5 (\>=0.23 micrograms/mL), 6B (\>=0.10 micrograms/mL) and 19A (\>=0.12 micrograms/mL). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Within 7 Days After Dose 2 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature \>=37.5 degree C and categorized as \>=37.5 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Within 7 Days After Dose 3 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature \>=37.5 degree C and categorized as \>=37.5 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Within 7 Days After Dose 4 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature \>=37.5 degree C and categorized as \>=37.5 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
| Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | Day 1 of Dose 1 to 1 Month after Dose 3 | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | From Dose 4 to 1 Month after Dose 4 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 | From Dose 1 to 1 Month after Dose 4 | A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 | From Dose 1 to 1 Month after Dose 4 | An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects. |
| Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Within 7 Days after Dose 1 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Within 7 Days after Dose 2 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Within 7 Days after Dose 3 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Within 7 Days after Dose 4 | Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Within 7 Days After Dose 1 | Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (\>=) 37.5 degree Celsius (C), and categorized as \>=37.5 to 38.4 degree C, greater than (\>)38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | 1 Month after Dose 4 | Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. |
| Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | 1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4 | 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group. |
| Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | 1 Month after Dose 4 | Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, \>=0.35 micrograms/mL for all serotypes except for serotypes 5 (\>=0.23 micrograms/mL), 6B (\>=0.10 micrograms/mL) and 19A (\>=0.12 micrograms/mL). |
| Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | 1 Month after Dose 3 to before Dose 4 | GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population. |
| GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | From 1 Month after Dose 3 to 1 Month after Dose 4 | GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population. |
| GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | From before Dose 4 to 1 Month after Dose 4 | GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population. |
| Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | 1 Month after Dose 3 | Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5\*LLOQ. |
Countries
Japan
Participant flow
Pre-assignment details
A total of 668 participants were enrolled and randomized in the study. One participant did not receive any study vaccine. One participant receive vaccination through route which was not as per randomization. Hence, data of these participants were excluded from analysis.
Participants by arm
| Arm | Count |
|---|---|
| 20vPnC (SC) Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | 225 |
| 13vPnC (SC) Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | 224 |
| 20vPnC (IM) Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3. | 217 |
| Total | 666 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | No longer meets eligibility criteria | 1 | 0 | 2 |
| Overall Study | Other | 2 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by parent/guardian | 5 | 2 | 2 |
Baseline characteristics
| Characteristic | 20vPnC (SC) | 13vPnC (SC) | 20vPnC (IM) | Total |
|---|---|---|---|---|
| Age, Continuous | 2.4 Months STANDARD_DEVIATION 0.33 | 2.4 Months STANDARD_DEVIATION 0.4 | 2.4 Months STANDARD_DEVIATION 0.42 | 2.4 Months STANDARD_DEVIATION 0.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants | 224 Participants | 217 Participants | 666 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 225 Participants | 224 Participants | 217 Participants | 666 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 117 Participants | 114 Participants | 106 Participants | 337 Participants |
| Sex: Female, Male Male | 108 Participants | 110 Participants | 111 Participants | 329 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 225 | 0 / 224 | 1 / 217 |
| other Total, other adverse events | 222 / 225 | 223 / 224 | 211 / 217 |
| serious Total, serious adverse events | 14 / 225 | 9 / 224 | 16 / 217 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Day 1 of Dose 1 to 1 Month after Dose 3
Population: Safety population included all the participants who received at least 1 dose of the IP and had safety data after any dose.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | 47.6 Percentage of participants | 95% Confidence Interval 40.9 |
| 13vPnC (SC) | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | 55.4 Percentage of participants | 95% Confidence Interval 48.6 |
| 20vPnC (IM) | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | 58.5 Percentage of participants | 95% Confidence Interval 51.7 |
Primary
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: From Dose 4 to 1 Month after Dose 4
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, Number of Participants Analyzed = number of participants who received Dose 4.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | 40.4 Percentage of participants | 95% Confidence Interval 33.8 |
| 13vPnC (SC) | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | 43.2 Percentage of participants | 95% Confidence Interval 36.5 |
| 20vPnC (IM) | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | 43.9 Percentage of participants | 95% Confidence Interval 37.1 |
Primary
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm.
Time frame: Within 7 Days after Dose 1
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 1.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Mild | 48.9 Percentage of participants | 95% Confidence Interval 42.2 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Moderate | 19.6 Percentage of participants | 95% Confidence Interval 14.6 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Mild | 58.2 Percentage of participants | 95% Confidence Interval 51.5 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Moderate | 1.8 Percentage of participants | 95% Confidence Interval 0.5 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Moderate | 20.0 Percentage of participants | 95% Confidence Interval 15 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Mild | 15.6 Percentage of participants | 95% Confidence Interval 11.1 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Moderate | 23.2 Percentage of participants | 95% Confidence Interval 17.9 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Mild | 51.3 Percentage of participants | 95% Confidence Interval 44.6 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Moderate | 23.7 Percentage of participants | 95% Confidence Interval 18.3 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Mild | 42.9 Percentage of participants | 95% Confidence Interval 36.3 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Mild | 13.4 Percentage of participants | 95% Confidence Interval 9.2 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Moderate | 2.7 Percentage of participants | 95% Confidence Interval 1 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Mild | 26.3 Percentage of participants | 95% Confidence Interval 20.5 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Mild | 12.4 Percentage of participants | 95% Confidence Interval 8.4 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Redness: Moderate | 11.1 Percentage of participants | 95% Confidence Interval 7.2 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Severe | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Moderate | 11.1 Percentage of participants | 95% Confidence Interval 7.2 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Mild | 17.5 Percentage of participants | 95% Confidence Interval 12.7 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Pain at the injection site: Moderate | 3.2 Percentage of participants | 95% Confidence Interval 1.3 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm.
Time frame: Within 7 Days after Dose 2
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 2. Here, Number of Participants Analyzed = number of participants with any e-diary data reported after Dose 2.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Mild | 46.2 Percentage of participants | 95% Confidence Interval 39.5 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Moderate | 22.4 Percentage of participants | 95% Confidence Interval 17.1 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Mild | 52.9 Percentage of participants | 95% Confidence Interval 46.1 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Moderate | 3.6 Percentage of participants | 95% Confidence Interval 1.6 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Moderate | 23.3 Percentage of participants | 95% Confidence Interval 17.9 |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Mild | 13.0 Percentage of participants | 95% Confidence Interval 8.9 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Moderate | 26.6 Percentage of participants | 95% Confidence Interval 20.9 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Mild | 53.2 Percentage of participants | 95% Confidence Interval 46.4 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Moderate | 31.1 Percentage of participants | 95% Confidence Interval 25.1 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Mild | 46.8 Percentage of participants | 95% Confidence Interval 40.1 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Mild | 16.7 Percentage of participants | 95% Confidence Interval 12 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Moderate | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Mild | 24.7 Percentage of participants | 95% Confidence Interval 19 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Mild | 9.3 Percentage of participants | 95% Confidence Interval 5.8 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness: Moderate | 7.0 Percentage of participants | 95% Confidence Interval 4 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Moderate | 7.9 Percentage of participants | 95% Confidence Interval 4.7 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Mild | 18.1 Percentage of participants | 95% Confidence Interval 13.2 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at the injection site: Moderate | 2.3 Percentage of participants | 95% Confidence Interval 0.8 |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm.
Time frame: Within 7 Days after Dose 3
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 3. Here, Overall Number of Participants Analyzed = number of participants with any e-diary data reported after Dose 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Mild | 38.7 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Severe | 0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Severe | 0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Moderate | 30.2 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Mild | 45.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Moderate | 3.6 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Severe | 0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Moderate | 33.8 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Mild | 10.8 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Moderate | 35.3 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Mild | 51.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Moderate | 34.8 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Severe | 0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Mild | 39.8 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Severe | 0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Mild | 14.5 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Moderate | 1.4 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Severe | 0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Severe | 0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Mild | 23.3 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Mild | 8.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness: Moderate | 8.4 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Severe | 0.5 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Moderate | 9.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Mild | 17.7 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at the injection site: Moderate | 0.9 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling: Severe | 0 Percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm.
Time frame: Within 7 Days after Dose 4
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 4. Here, Number of Participants Analyzed = number of participants with any e-diary data reported after Dose 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Mild | 19.7 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Mild | 37.6 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Moderate | 49.1 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Severe | 0.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Moderate | 42.2 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Mild | 37.2 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Moderate | 1.4 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Severe | 0.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Severe | 0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Moderate | 3.2 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Mild | 36.4 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Moderate | 49.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Severe | 0.5 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Mild | 35.9 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Moderate | 41.8 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Severe | 0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Mild | 19.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Severe | 0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Severe | 0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Severe | 0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Severe | 0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Mild | 10.4 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Moderate | 11.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Pain at the injection site: Moderate | 3.3 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Moderate | 10.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Swelling: Mild | 13.2 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Redness: Mild | 20.8 Percentage of participants |
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4
An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.
Time frame: From Dose 1 to 1 Month after Dose 4
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 | 10.7 Percentage of participants | 95% Confidence Interval 7 |
| 13vPnC (SC) | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 | 8.9 Percentage of participants | 95% Confidence Interval 5.5 |
| 20vPnC (IM) | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 | 8.3 Percentage of participants | 95% Confidence Interval 5 |
Primary
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. The predefined levels, \>=0.35 micrograms/mL for all serotypes except for serotypes 5 (\>=0.23 micrograms/mL), 6B (\>=0.10 micrograms/mL) and 19A (\>=0.12 micrograms/mL).
Time frame: 1 Month after Dose 3
Population: Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, had no other major protocol deviations per clinician.Here, N = participants with an IgG concentration greater than or equal to(\>=)predefined level for given serotype,n =participants with valid assay results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 7F | 95.9 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 23F | 89.6 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 8 | 99.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 9V | 95.9 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 33F | 95.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 19F | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 14 | 96.8 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 4 | 96.8 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 19A | 99.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 18C | 96.8 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 10A | 60.2 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 22F | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 5 | 92.3 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 1 | 97.7 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 15B | 99.1 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 6A | 90.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 12F | 74.7 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 6B | 87.8 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 3 | 96.4 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 11A | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 15B | 8.2 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 1 | 99.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 3 | 99.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 4 | 99.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 5 | 97.3 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 6A | 98.2 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 6B | 96.4 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 7F | 99.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 9V | 98.6 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 14 | 97.7 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 18C | 99.1 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 19A | 99.5 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 19F | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 23F | 93.6 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 8 | 0.9 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 10A | 1.8 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 11A | 2.7 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 12F | 0.9 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 22F | 0.9 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 33F | 3.2 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 7F | 94.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 4 | 94.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 8 | 99.5 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 33F | 92.5 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 10A | 59.6 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 6B | 82.2 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 22F | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 11A | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 6A | 94.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 3 | 95.3 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 12F | 74.6 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 18C | 94.8 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 14 | 96.2 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 5 | 93.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 19A | 99.1 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 9V | 93.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 1 | 92.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 19F | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 15B | 98.6 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Serotype: 23F | 88.7 Percentage of participants |
Comparison: Serotype 1: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.95% CI: [-4.4, 1.3]
Comparison: Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-6.2, 0.1]
Comparison: Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-5.6, 0.5]
Comparison: Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-9.6, -0.9]
Comparison: Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-13, -4]
Comparison: Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-14, -3.7]
Comparison: Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-6.8, -0.3]
Comparison: Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-6.4, 0.4]
Comparison: Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-4.4, 2.4]
Comparison: Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-5.6, 0.5]
Comparison: Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-2.1, 2.1]
Comparison: Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-1.7, 1.7]
Comparison: Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-9.5, 1.2]
Comparison: Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [3, 10]
Comparison: Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-40.7, -26.2]
Comparison: Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [3.8, 10.4]
Comparison: Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-25.7, -12.5]
Comparison: Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [2.2, 9.6]
Comparison: Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [3.8, 10.4]
Comparison: Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-3.2, 6]
Comparison: Serotype 1: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-10.4, -1.7]
Comparison: Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-5.2, 2.9]
Comparison: Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-6.2, 1.9]
Comparison: Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-4.5, 5.8]
Comparison: Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-0.2, 10]
Comparison: Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-12.5, 1.1]
Comparison: Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-5.4, 3.1]
Comparison: Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-7.7, 1.4]
Comparison: Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-4.4, 3.2]
Comparison: Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-6.2, 1.9]
Comparison: Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-3, 1.7]
Comparison: Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-1.8, 1.7]
Comparison: Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-6.9, 5.1]
Comparison: Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-2.2, 2.1]
Comparison: Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-9.8, 8.6]
Comparison: Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-1.8, 1.7]
Comparison: Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-8.2, 8.2]
Comparison: Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-3.3, 2]
Comparison: Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-1.8, 1.7]
Comparison: Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.95% CI: [-7.5, 2.2]
Primary
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4
A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.
Time frame: From Dose 1 to 1 Month after Dose 4
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 | 6.2 Percentage of participants | 95% Confidence Interval 3.4 |
| 13vPnC (SC) | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 | 4.0 Percentage of participants | 95% Confidence Interval 1.9 |
| 20vPnC (IM) | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 | 7.4 Percentage of participants | 95% Confidence Interval 4.3 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (\>=) 37.5 degree Celsius (C), and categorized as \>=37.5 to 38.4 degree C, greater than (\>)38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 1
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up Dose 1.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Mild | 3.6 Percentage of participants | 95% Confidence Interval 1.5 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >38.4°C to 38.9 degree C | 0.4 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Moderate | 0.9 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Moderate | 1.8 Percentage of participants | 95% Confidence Interval 0.5 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >=37.5°C to 38.4 degree C | 9.3 Percentage of participants | 95% Confidence Interval 5.9 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Mild | 40.4 Percentage of participants | 95% Confidence Interval 34 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Mild | 13.8 Percentage of participants | 95% Confidence Interval 9.6 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >38.9 to 40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Severe | 1.3 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >=37.5 degree C | 9.8 Percentage of participants | 95% Confidence Interval 6.2 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Moderate | 12.0 Percentage of participants | 95% Confidence Interval 8.1 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Severe | 0.4 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >=37.5 degree C | 12.9 Percentage of participants | 95% Confidence Interval 8.8 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >=37.5°C to 38.4 degree C | 12.5 Percentage of participants | 95% Confidence Interval 8.5 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >38.4°C to 38.9 degree C | 0.4 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >38.9 to 40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Mild | 7.1 Percentage of participants | 95% Confidence Interval 4.1 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Moderate | 3.1 Percentage of participants | 95% Confidence Interval 1.3 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Severe | 0.4 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Mild | 42.0 Percentage of participants | 95% Confidence Interval 35.4 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Moderate | 2.2 Percentage of participants | 95% Confidence Interval 0.7 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Mild | 11.2 Percentage of participants | 95% Confidence Interval 7.4 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Moderate | 13.4 Percentage of participants | 95% Confidence Interval 9.2 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Severe | 1.8 Percentage of participants | 95% Confidence Interval 0.5 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Moderate | 11.5 Percentage of participants | 95% Confidence Interval 7.6 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Moderate | 4.1 Percentage of participants | 95% Confidence Interval 1.9 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >38.9 to 40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >38.4°C to 38.9 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >=37.5 degree C | 9.7 Percentage of participants | 95% Confidence Interval 6.1 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Mild | 12.9 Percentage of participants | 95% Confidence Interval 8.7 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever: >=37.5°C to 38.4 degree C | 9.7 Percentage of participants | 95% Confidence Interval 6.1 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Moderate | 3.2 Percentage of participants | 95% Confidence Interval 1.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Irritability: Severe | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Drowsiness: Mild | 42.9 Percentage of participants | 95% Confidence Interval 36.2 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Decreased appetite: Mild | 3.2 Percentage of participants | 95% Confidence Interval 1.3 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature \>=37.5 degree C and categorized as \>=37.5 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 2
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 2. Here, Overall Number of Participants Analyzed = number of participants with any e-diary data reported after Dose 2.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Mild | 4.5 Percentage of participants | 95% Confidence Interval 2.2 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >38.4 to 38.9 degree C | 3.1 Percentage of participants | 95% Confidence Interval 1.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Moderate | 3.1 Percentage of participants | 95% Confidence Interval 1.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Moderate | 5.8 Percentage of participants | 95% Confidence Interval 3.1 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >=37.5 to 38.4 degree C | 15.2 Percentage of participants | 95% Confidence Interval 10.8 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Mild | 39.9 Percentage of participants | 95% Confidence Interval 33.4 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Mild | 12.6 Percentage of participants | 95% Confidence Interval 8.5 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >38.9 to 40.0 degree C | 1.8 Percentage of participants | 95% Confidence Interval 0.5 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Severe | 1.3 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >=37.5 degree C | 20.2 Percentage of participants | 95% Confidence Interval 15.1 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Moderate | 12.1 Percentage of participants | 95% Confidence Interval 8.1 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >=37.5 degree C | 21.2 Percentage of participants | 95% Confidence Interval 16 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >=37.5 to 38.4 degree C | 17.6 Percentage of participants | 95% Confidence Interval 12.8 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >38.4 to 38.9 degree C | 2.3 Percentage of participants | 95% Confidence Interval 0.7 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >38.9 to 40.0 degree C | 1.4 Percentage of participants | 95% Confidence Interval 0.3 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Mild | 6.8 Percentage of participants | 95% Confidence Interval 3.8 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Moderate | 5.0 Percentage of participants | 95% Confidence Interval 2.5 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Mild | 48.6 Percentage of participants | 95% Confidence Interval 41.9 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Moderate | 4.1 Percentage of participants | 95% Confidence Interval 1.9 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Mild | 16.7 Percentage of participants | 95% Confidence Interval 12 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Moderate | 14.9 Percentage of participants | 95% Confidence Interval 10.5 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Severe | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Moderate | 15.3 Percentage of participants | 95% Confidence Interval 10.8 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Moderate | 2.3 Percentage of participants | 95% Confidence Interval 0.8 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >38.9 to 40.0 degree C | 1.4 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >38.4 to 38.9 degree C | 1.9 Percentage of participants | 95% Confidence Interval 0.5 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >=37.5 degree C | 18.1 Percentage of participants | 95% Confidence Interval 13.2 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Mild | 10.2 Percentage of participants | 95% Confidence Interval 6.5 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever: >=37.5 to 38.4 degree C | 14.9 Percentage of participants | 95% Confidence Interval 10.4 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Moderate | 4.7 Percentage of participants | 95% Confidence Interval 2.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Irritability: Severe | 1.4 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Drowsiness: Mild | 39.5 Percentage of participants | 95% Confidence Interval 33 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Decreased appetite: Mild | 5.1 Percentage of participants | 95% Confidence Interval 2.6 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature \>=37.5 degree C and categorized as \>=37.5 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 3
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 3. Here, Overall Number of Participants Analyzed = number of participants with any e-diary data reported after Dose 3
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Mild | 5.0 Percentage of participants | 95% Confidence Interval 2.5 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >38.4 to 38.9 degree C | 1.4 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Moderate | 1.4 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Moderate | 2.7 Percentage of participants | 95% Confidence Interval 1 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >=37.5 to 38.4 degree C | 13.5 Percentage of participants | 95% Confidence Interval 9.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Mild | 24.8 Percentage of participants | 95% Confidence Interval 19.2 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Severe | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Mild | 16.7 Percentage of participants | 95% Confidence Interval 12 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >38.9 to 40.0 degree C | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Severe | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >=37.5 degree C | 15.3 Percentage of participants | 95% Confidence Interval 10.8 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Moderate | 8.6 Percentage of participants | 95% Confidence Interval 5.2 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >=37.5 degree C | 19.9 Percentage of participants | 95% Confidence Interval 14.9 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >=37.5 to 38.4 degree C | 16.3 Percentage of participants | 95% Confidence Interval 11.7 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >38.4 to 38.9 degree C | 2.7 Percentage of participants | 95% Confidence Interval 1 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >38.9 to 40.0 degree C | 0.9 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Mild | 7.2 Percentage of participants | 95% Confidence Interval 4.2 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Moderate | 3.6 Percentage of participants | 95% Confidence Interval 1.6 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Mild | 32.6 Percentage of participants | 95% Confidence Interval 26.4 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Moderate | 1.8 Percentage of participants | 95% Confidence Interval 0.5 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Mild | 10.9 Percentage of participants | 95% Confidence Interval 7.1 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Moderate | 9.0 Percentage of participants | 95% Confidence Interval 5.6 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Moderate | 13.0 Percentage of participants | 95% Confidence Interval 8.8 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Moderate | 1.4 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >38.9 to 40.0 degree C | 0.9 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >38.4 to 38.9 degree C | 1.9 Percentage of participants | 95% Confidence Interval 0.5 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >=37.5 degree C | 15.3 Percentage of participants | 95% Confidence Interval 10.8 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Mild | 14.0 Percentage of participants | 95% Confidence Interval 9.6 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever: >=37.5 to 38.4 degree C | 12.6 Percentage of participants | 95% Confidence Interval 8.4 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Moderate | 3.7 Percentage of participants | 95% Confidence Interval 1.6 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Irritability: Severe | 0.9 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Drowsiness: Mild | 32.6 Percentage of participants | 95% Confidence Interval 26.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Decreased appetite: Mild | 4.2 Percentage of participants | 95% Confidence Interval 1.9 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature \>=37.5 degree C and categorized as \>=37.5 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 4
Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 4. Here, Overall Number of Participants Analyzed = number of participants with any e-diary data reported after Dose 4.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >38.9 to 40.0 degree C | 6.4 Percentage of participants | 95% Confidence Interval 3.6 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Moderate | 7.3 Percentage of participants | 95% Confidence Interval 4.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Moderate | 1.4 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >40.0 degree C | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Mild | 24.3 Percentage of participants | 95% Confidence Interval 18.8 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Mild | 6.4 Percentage of participants | 95% Confidence Interval 3.6 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >=37.5 to 38.4 degree C | 25.7 Percentage of participants | 95% Confidence Interval 20 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Moderate | 7.3 Percentage of participants | 95% Confidence Interval 4.3 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Severe | 0.9 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Mild | 14.2 Percentage of participants | 95% Confidence Interval 9.9 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >38.4 to 38.9 degree C | 10.1 Percentage of participants | 95% Confidence Interval 6.4 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >=37.5 degree C | 42.7 Percentage of participants | 95% Confidence Interval 36 |
| 20vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Mild | 15.5 Percentage of participants | 95% Confidence Interval 10.9 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Moderate | 11.4 Percentage of participants | 95% Confidence Interval 7.5 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >=37.5 degree C | 39.5 Percentage of participants | 95% Confidence Interval 33 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >=37.5 to 38.4 degree C | 29.1 Percentage of participants | 95% Confidence Interval 23.2 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >38.4 to 38.9 degree C | 5.9 Percentage of participants | 95% Confidence Interval 3.2 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >38.9 to 40.0 degree C | 4.5 Percentage of participants | 95% Confidence Interval 2.2 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Mild | 6.8 Percentage of participants | 95% Confidence Interval 3.9 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Moderate | 7.7 Percentage of participants | 95% Confidence Interval 4.6 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Mild | 23.6 Percentage of participants | 95% Confidence Interval 18.2 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Moderate | 2.3 Percentage of participants | 95% Confidence Interval 0.7 |
| 13vPnC (SC) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Severe | 0.9 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Severe | 0.9 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Mild | 29.7 Percentage of participants | 95% Confidence Interval 23.7 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >38.9 to 40.0 degree C | 8.0 Percentage of participants | 95% Confidence Interval 4.7 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Severe | 0.5 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Drowsiness: Moderate | 1.9 Percentage of participants | 95% Confidence Interval 0.5 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >38.4 to 38.9 degree C | 6.1 Percentage of participants | 95% Confidence Interval 3.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >=37.5 to 38.4 degree C | 24.1 Percentage of participants | 95% Confidence Interval 18.5 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >=37.5 degree C | 38.2 Percentage of participants | 95% Confidence Interval 31.6 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Mild | 6.1 Percentage of participants | 95% Confidence Interval 3.3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Mild | 15.1 Percentage of participants | 95% Confidence Interval 10.6 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Decreased appetite: Moderate | 5.7 Percentage of participants | 95% Confidence Interval 3 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Fever: >40.0 degree C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC (IM) | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Irritability: Moderate | 9.4 Percentage of participants | 95% Confidence Interval 5.9 |
Secondary
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5\*LLOQ.
Time frame: 1 Month after Dose 3
Population: Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, and had no other major protocol deviations per clinician. Here, N = participants with an IgG concentration \>= predefined level for given serotype and n =participants with valid assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 12F | 0.79 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 7F | 1.58 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 6A | 1.38 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 1 | 1.37 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 9V | 1.46 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 3 | 1.29 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 4 | 1.76 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 14 | 2.79 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 15B | 6.77 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 18C | 1.67 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 6B | 0.42 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 22F | 4.94 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 19A | 2.41 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 11A | 5.63 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 10A | 0.50 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 19F | 2.81 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 33F | 1.70 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 5 | 1.01 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 23F | 1.32 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 8 | 3.32 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 23F | 2.05 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 8 | 0.01 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 15B | 0.04 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 10A | 0.01 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 11A | 0.02 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 6A | 2.34 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 12F | 0.01 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 22F | 0.01 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 6B | 0.83 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 33F | 0.02 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 3 | 1.81 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 7F | 2.19 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 9V | 2.11 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 14 | 3.31 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 18C | 2.52 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 4 | 2.96 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 19A | 3.19 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 1 | 2.21 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 19F | 3.73 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 5 | 1.72 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 19F | 2.76 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 33F | 1.62 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 1 | 1.17 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 3 | 1.10 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 4 | 1.73 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 5 | 1.00 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 6A | 1.64 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 6B | 0.39 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 7F | 1.52 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 9V | 1.45 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 18C | 1.54 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 19A | 2.36 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 14 | 2.43 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 23F | 1.29 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 8 | 3.29 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 10A | 0.47 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 11A | 5.22 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 12F | 0.72 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 15B | 6.80 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 | Serotype 22F | 4.41 Micrograms per milliliter |
Comparison: Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.54, 0.72]
Comparison: Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.63, 0.81]
Comparison: Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.51, 0.7]
Comparison: Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.49, 0.71]
Comparison: Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.5, 0.7]
Comparison: Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.4, 0.64]
Comparison: Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.62, 0.84]
Comparison: Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.6, 0.8]
Comparison: Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.7, 1.01]
Comparison: Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.57, 0.77]
Comparison: Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.65, 0.87]
Comparison: Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.67, 0.85]
Comparison: Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.53, 0.78]
Comparison: Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [3.36, 4.79]
Comparison: Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.48, 0.76]
Comparison: Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [5.69, 8.13]
Comparison: Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.76, 1.2]
Comparison: Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [6.75, 9.92]
Comparison: Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [5, 7.12]
Comparison: Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [1.69, 2.51]
Comparison: Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.73, 0.99]
Comparison: Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.74, 0.98]
Comparison: Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.83, 1.16]
Comparison: Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.81, 1.19]
Comparison: Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.98, 1.44]
Comparison: Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.72, 1.21]
Comparison: Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.82, 1.12]
Comparison: Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.85, 1.16]
Comparison: Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.72, 1.04]
Comparison: Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.79, 1.07]
Comparison: Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.84, 1.13]
Comparison: Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.87, 1.1]
Comparison: Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.81, 1.19]
Comparison: Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.87, 1.13]
Comparison: Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.73, 1.2]
Comparison: Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.81, 1.06]
Comparison: Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.71, 1.15]
Comparison: Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.85, 1.18]
Comparison: Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.78, 1.02]
Comparison: Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.95% CI: [0.79, 1.15]
Secondary
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Time frame: 1 Month after Dose 4
Population: Dose 4 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at Dose 1 and 12 to 15 months of age at Dose 4, received all 4 doses as randomized, had at least 1 valid assay result from the blood collection within 27 to 56 days after Dose 4, and had no other major protocol deviations per clinician. Here,N = participants with an IgG concentration \>= predefined level for given serotype and n=participants with valid assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 3 | 0.97 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 19F | 8.74 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 5 | 2.96 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 11A | 5.73 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 6A | 11.90 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 15B | 18.45 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 6B | 7.18 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 23F | 7.01 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 7F | 4.46 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 22F | 14.07 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 9V | 4.54 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 10A | 6.98 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 12F | 2.73 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 14 | 8.23 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 33F | 10.29 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 8 | 5.84 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 18C | 3.95 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 1 | 2.79 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 4 | 6.93 Micrograms per milliliter |
| 20vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 19A | 7.62 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 4 | 10.01 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 5 | 4.64 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 19F | 11.02 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 8 | 0.02 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 6B | 10.48 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 10A | 0.01 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 1 | 4.62 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 15B | 0.03 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 22F | 0.00 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 33F | 0.02 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 19A | 8.97 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 23F | 11.76 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 6A | 17.25 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 3 | 1.44 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 11A | 0.02 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 7F | 6.62 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 9V | 6.62 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 14 | 10.30 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 12F | 0.01 Micrograms per milliliter |
| 13vPnC (SC) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 18C | 5.97 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 33F | 11.13 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 7F | 4.85 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 23F | 7.39 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 12F | 2.69 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 15B | 21.83 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 22F | 14.21 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 1 | 2.78 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 3 | 1.08 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 4 | 7.31 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 5 | 2.94 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 6A | 13.92 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 6B | 7.50 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 9V | 5.38 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 14 | 9.19 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 18C | 3.81 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 19A | 7.92 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 19F | 8.56 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 8 | 5.88 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 10A | 8.02 Micrograms per milliliter |
| 20vPnC (IM) | Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 | Serotype 11A | 5.78 Micrograms per milliliter |
Secondary
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population.
Time frame: 1 Month after Dose 3 to before Dose 4
Population: Dose 3 evaluable immunogenicity population was included. Here, Overall Number of Participants Analyzed= participants evaluable for this outcome measure and Number Analyzed= participants with valid IgG concentration at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 4 | 0.3 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 19A | 0.1 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 6B | 0.8 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 3 | 0.1 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 12F | 0.4 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 11A | 0.1 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 1 | 0.2 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 15B | 0.4 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 23F | 0.2 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 33F | 1.1 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 22F | 0.4 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 7F | 0.5 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 10A | 2.2 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 6A | 0.5 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 19F | 0.2 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 14 | 0.7 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 5 | 0.3 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 9V | 0.3 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 18C | 0.2 Fold rise |
| 20vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 8 | 0.2 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 8 | 1.4 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 5 | 0.2 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 6A | 0.4 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 6B | 0.5 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 7F | 0.4 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 9V | 0.3 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 14 | 0.7 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 18C | 0.2 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 19A | 0.1 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 12F | 1.0 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 15B | 0.6 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 22F | 0.6 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 33F | 0.6 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 1 | 0.2 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 3 | 0.1 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 19F | 0.1 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 23F | 0.3 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 4 | 0.2 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 10A | 0.8 Fold rise |
| 13vPnC (SC) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 11A | 0.8 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 5 | 0.2 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 3 | 0.1 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 18C | 0.2 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 7F | 0.5 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 14 | 0.7 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 9V | 0.3 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 11A | 0.1 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 19F | 0.2 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 6B | 0.7 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 10A | 2.3 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 23F | 0.3 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 6A | 0.4 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 22F | 0.4 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 15B | 0.4 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 4 | 0.3 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 33F | 1.0 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 12F | 0.4 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 8 | 0.2 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 1 | 0.2 Fold rise |
| 20vPnC (IM) | Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 | Serotype 19A | 0.1 Fold rise |
Secondary
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group.
Time frame: 1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4
Population: For 1 month after Dose 3 and before Dose 4: Dose 3 evaluable immunogenicity population set were analyzed and for 1 month after Dose 4: Dose 4 evaluable immunogenicity population for 1 month after Dose 4 OPA GMTs were analyzed. Here, Overall Number of Participants Analyzed= participants evaluable for this outcome measure and Number Analyzed= participants with valid results for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3:1 Month after Dose 3 | 107 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:1 Month after Dose 4 | 1673 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:1 Month after Dose 3 | 6981 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:1 Month after Dose 4 | 162 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:1 Month after Dose 3 | 5124 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:1 Month after Dose 3 | 1807 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:Before Dose. 4 | 11 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:1 Month after Dose 4 | 4477 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:1 Month after Dose 4 | 15611 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:1 Month after Dose 3 | 55 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:1 Month after Dose 3 | 638 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:Before Dose 4 | 3984 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A:Before Dose 4 | 416 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:Before Dose 4 | 13 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:1 Month after Dose 4 | 18997 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A:1 Month after Dose 3 | 1894 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:1 Month after Dose 4 | 1860 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:1 Month after Dose 3 | 35278 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:1 Month after Dose 4 | 9030 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:1 Month after Dose 3 | 449 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:Before Dose 4 | 122 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:Before Dose 4 | 1985 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:Before Dose 4 | 26 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:1 Month after Dose 3 | 1580 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:1 Month after Dose 3 | 1532 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:1 Month after Dose 4 | 1071 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:Before Dose 4 | 166 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:1 Month after Dose 4 | 2609 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:1 Month after Dose 3 | 20162 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:Before Dose 4 | 42 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A: 1 Month after Dose 4 | 3958 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:1 Month after Dose 4 | 2970 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:Before Dose 4 | 83 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:1 Month after Dose 4 | 172 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:1 Month after Dose 3 | 6977 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4: Before Dose 4 | 25 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:Before Dose 4 | 16 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:1 Month after Dose 4 | 3249 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:1 Month after Dose 4 | 28435 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:Before Dose 4 | 40 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:Before Dose 4 | 2562 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:1 Month after Dose 3 | 95 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:1 Month after Dose 4 | 2304 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:1 Month after Dose 3 | 1548 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:1 Month after Dose 3 | 4160 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:Before Dose 4 | 5678 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4:1 Month after Dose 4 | 1627 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:1 Month after Dose 4 | 4735 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:1 Month after Dose 3 | 21864 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:1 Month after Dose 4 | 7280 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4:1 Month after Dose 3 | 1864 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:Before Dose 4 | 183 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:1 Month after Dose 4 | 4199 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:Before Dose 4 | 578 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3: 1 Month after Dose 4 | 131 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:1 Month after Dose 3 | 1922 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:Before Dose 4 | 626 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3:Before Dose 4 | 16 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:Before Dose 4 | 426 Titers |
| 20vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:1 Month after Dose 3 | 2709 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:Before Dose 4 | 204 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:Before Dose. 4 | 13 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3:1 Month after Dose 3 | 170 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:1 Month after Dose 3 | 3339 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:Before Dose 4 | 173 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:1 Month after Dose 3 | 2489 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:Before Dose 4 | 761 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:1 Month after Dose 3 | 5355 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:Before Dose 4 | 20 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:1 Month after Dose 4 | 27 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:Before Dose 4 | 35 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:1 Month after Dose 4 | 5455 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:Before Dose 4 | 75 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:1 Month after Dose 4 | 4319 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:1 Month after Dose 3 | 4428 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:1 Month after Dose 4 | 6361 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:1 Month after Dose 3 | 2388 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:1 Month after Dose 4 | 5162 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:1 Month after Dose 3 | 2593 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:Before Dose 4 | 469 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:1 Month after Dose 4 | 1706 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:Before Dose 4 | 173 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:1 Month after Dose 4 | 6315 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:1 Month after Dose 3 | 676 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:Before Dose 4 | 20 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:1 Month after Dose 4 | 2534 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:1 Month after Dose 3 | 624 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:Before Dose 4 | 25 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:1 Month after Dose 4 | 1783 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:1 Month after Dose 3 | 1849 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:Before Dose 4 | 62 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:1 Month after Dose 4 | 3772 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:1 Month after Dose 3 | 16 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:1 Month after Dose 3 | 40 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:Before Dose 4 | 78 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:1 Month after Dose 4 | 87 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A:1 Month after Dose 3 | 58 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:1 Month after Dose 3 | 126 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:1 Month after Dose 4 | 386 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3:Before Dose 4 | 20 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3: 1 Month after Dose 4 | 193 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4:1 Month after Dose 3 | 1768 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4: Before Dose 4 | 44 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4:1 Month after Dose 4 | 2038 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:1 Month after Dose 3 | 154 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:Before Dose 4 | 18 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:1 Month after Dose 4 | 248 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A:Before Dose 4 | 95 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A: 1 Month after Dose 4 | 90 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:1 Month after Dose 3 | 24 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:1 Month after Dose 4 | 43 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:1 Month after Dose 3 | 17 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:Before Dose 4 | 26 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:1 Month after Dose 4 | 32 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:1 Month after Dose 3 | 10 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:Before Dose 4 | 16 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:1 Month after Dose 4 | 18 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:1 Month after Dose 3 | 177 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:Before Dose 4 | 539 Titers |
| 13vPnC (SC) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:1 Month after Dose 4 | 658 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:1 Month after Dose 4 | 2552 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3:Before Dose 4 | 16 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:1 Month after Dose 4 | 4201 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:1 Month after Dose 3 | 15931 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3: 1 Month after Dose 4 | 150 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:1 Month after Dose 3 | 1929 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:1 Month after Dose 4 | 7770 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4:1 Month after Dose 3 | 1617 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:1 Month after Dose 3 | 1563 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4: Before Dose 4 | 21 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:Before Dose 4 | 689 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:1 Month after Dose 4 | 141 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 4:1 Month after Dose 4 | 1544 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6B:Before Dose 4 | 44 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:1 Month after Dose 3 | 19276 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:1 Month after Dose 3 | 91 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:Before Dose 4 | 4904 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:1 Month after Dose 4 | 3489 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 5:Before Dose 4 | 15 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:1 Month after Dose 4 | 3208 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:1 Month after Dose 4 | 26963 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:Before Dose 4 | 2014 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A:Before Dose 4 | 247 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:Before Dose 4 | 147 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:Before Dose 4 | 95 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A: 1 Month after Dose 4 | 4200 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:1 Month after Dose 3 | 4908 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 33F:Before Dose 4 | 6835 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:1 Month after Dose 3 | 21475 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 9V:Before Dose 4 | 212 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:1 Month after Dose 3 | 1402 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:1 Month after Dose 3 | 56 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:Before Dose 4 | 24 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:1 Month after Dose 4 | 962 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 22F:1 Month after Dose 4 | 23480 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 23F:1 Month after Dose 4 | 2052 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:Before Dose 4 | 26 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 12F:1 Month after Dose 4 | 18899 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 8:1 Month after Dose 3 | 1541 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:1 Month after Dose 4 | 4703 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:1 Month after Dose 3 | 6780 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19F:1 Month after Dose 3 | 488 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 6A:1 Month after Dose 3 | 3120 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:Before Dose 4 | 2066 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:1 Month after Dose 4 | 1722 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:1 Month after Dose 3 | 5707 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 10A:1 Month after Dose 4 | 8269 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:Before Dose 4 | 12 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 7F:1 Month after Dose 3 | 4491 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 11A:1 Month after Dose 3 | 1838 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 19A:1 Month after Dose 3 | 553 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:1 Month after Dose 4 | 4249 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:1 Month after Dose 4 | 194 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 18C:Before Dose 4 | 89 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 1:Before Dose. 4 | 10 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:1 Month after Dose 4 | 2005 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 15B:Before Dose 4 | 609 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:Before Dose 4 | 357 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 3:1 Month after Dose 3 | 120 Titers |
| 20vPnC (IM) | Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 | Serotype 14:1 Month after Dose 3 | 2103 Titers |
Secondary
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population.
Time frame: From 1 Month after Dose 3 to 1 Month after Dose 4
Population: Dose 3 and Dose 4 evaluable immunogenicity populations were included. Here, Overall Number of Participants Analyzed= participants evaluable for this outcome measure and Number Analyzed= participants with valid IgG concentrations at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 3 | 0.7 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 23F | 5.3 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 7F | 2.8 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 22F | 2.9 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 19F | 3.1 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 9V | 3.1 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 12F | 3.4 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 19A | 3.2 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 14 | 2.9 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 4 | 3.9 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 18C | 2.3 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 1 | 2.0 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 11A | 1.0 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 5 | 2.9 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 33F | 6.0 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 10A | 14.0 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 6A | 8.6 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 15B | 2.7 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 8 | 1.8 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 6B | 17.1 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 15B | 0.9 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 19F | 2.9 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 1 | 2.1 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 3 | 0.8 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 4 | 3.4 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 5 | 2.7 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 6A | 7.3 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 6B | 12.6 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 7F | 3.0 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 9V | 3.1 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 14 | 3.1 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 18C | 2.4 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 23F | 5.7 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 8 | 1.7 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 10A | 0.8 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 11A | 0.8 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 12F | 1.0 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 19A | 2.8 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 22F | 0.7 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 33F | 0.7 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 15B | 3.3 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 8 | 1.8 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 5 | 3.0 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 19F | 3.1 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 10A | 17.5 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 4 | 4.3 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 33F | 7.1 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 11A | 1.1 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 3 | 1.0 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 22F | 3.2 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 12F | 3.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 14 | 3.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 1 | 2.4 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 18C | 2.5 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 9V | 3.8 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 7F | 3.3 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 6B | 19.5 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 19A | 3.4 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 23F | 5.8 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 | Serotype 6A | 8.6 Fold rise |
Secondary
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population.
Time frame: From before Dose 4 to 1 Month after Dose 4
Population: Dose 4 evaluable immunogenicity population was included. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure and Number Analyzed =participants with valid IgG concentrations at both timepoints for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 10A | 6.3 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 9V | 11.8 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 1 | 10.7 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 8 | 10.8 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 14 | 4.3 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 5 | 10.8 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 23F | 22.6 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 18C | 11.7 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 33F | 5.7 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 19F | 18.8 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 19A | 34.2 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 15B | 6.8 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 6A | 17.6 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 22F | 7.9 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 12F | 8.5 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 6B | 22.3 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 4 | 15.0 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 11A | 7.0 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 7F | 6.0 Fold rise |
| 20vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 3 | 7.5 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 15B | 1.5 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 1 | 12.1 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 3 | 7.9 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 4 | 14.3 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 5 | 11.8 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 6A | 18.4 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 6B | 24.3 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 7F | 7.2 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 9V | 12.0 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 14 | 4.4 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 18C | 14.0 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 19A | 37.6 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 19F | 21.4 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 23F | 22.6 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 8 | 1.3 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 10A | 1.1 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 11A | 1.1 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 12F | 1.0 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 22F | 1.2 Fold rise |
| 13vPnC (SC) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 33F | 1.2 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 3 | 8.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 8 | 11.2 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 7F | 6.8 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 33F | 6.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 10A | 7.4 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 6B | 26.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 22F | 8.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 11A | 8.1 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 6A | 22.1 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 1 | 12.6 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 12F | 9.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 5 | 12.2 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 19A | 38.3 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 18C | 12.7 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 4 | 16.5 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 19F | 19.9 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 14 | 5.7 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 15B | 8.7 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 23F | 22.7 Fold rise |
| 20vPnC (IM) | GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 | Serotype 9V | 13.9 Fold rise |
Secondary
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, \>=0.35 micrograms/mL for all serotypes except for serotypes 5 (\>=0.23 micrograms/mL), 6B (\>=0.10 micrograms/mL) and 19A (\>=0.12 micrograms/mL).
Time frame: 1 Month after Dose 4
Population: Dose 4 evaluable immunogenicity population included participants who were eligible randomized aged 2 to 6 months of age at first dose, received all 4 randomized doses with Dose 4 received within defined window 12 to 15 months of age, had at least 1 immunogenicity results within 27 to 56 days, inclusive, after Dose 4,and had no other major protocol deviations per clinician. Here, N=participants evaluable for this outcome measure and n=participants with valid results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 19F | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 23F | 99.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 11A | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 4 | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 10A | 99.1 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 12F | 98.2 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 15B | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 5 | 99.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 33F | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 6A | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 6B | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 8 | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 7F | 99.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 22F | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 9V | 99.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 1 | 99.1 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 14 | 99.1 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 18C | 99.5 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 19A | 100.0 Percentage of participants |
| 20vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 3 | 91.7 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 6A | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 19F | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 3 | 98.6 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 9V | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 23F | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 18C | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 6B | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 8 | 3.2 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 10A | 0.9 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 4 | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 14 | 99.5 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 12F | 0.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 11A | 5.9 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 7F | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 15B | 8.6 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 22F | 1.8 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 1 | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 19A | 100.0 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 33F | 2.7 Percentage of participants |
| 13vPnC (SC) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 5 | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 33F | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 11A | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 15B | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 1 | 98.6 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 3 | 91.5 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 4 | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 6A | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 6B | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 7F | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 9V | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 14 | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 18C | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 19A | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 19F | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 23F | 99.5 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 8 | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 10A | 99.5 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 12F | 98.6 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 22F | 100.0 Percentage of participants |
| 20vPnC (IM) | Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 | Serotype 5 | 99.5 Percentage of participants |