Pneumococcal Infection
Conditions
Brief summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.
Interventions
BIOLOGICALV116
Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICALPNEUMOVAX™23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* is a healthy Japanese male or female ≥20 years of age at time of randomization * male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention * female participants must not be pregnant or breastfeeding, and is either: * not a woman of childbearing potential (WOCBP) or * a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
Exclusion criteria
* has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1 * has a known hypersensitivity to any vaccine components * has impaired immunological function * has a coagulation disorder * had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1 * has a known malignancy that is progressing/requiring treatment * has received, or is expected to receive, a pneumococcal vaccine outside the study protocol * has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1 * is receiving immunosuppressive therapy * has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine * has received any live vaccine from 30 days prior to Day 1 * has received a blood transfusion or blood products * has participated in another clinical trial within 2 months of this study * has clinically relevant drug or alcohol abuse * has any condition that, in the opinion of the investigator, precludes participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Up to 5 days postvaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm. |
| Percentage of Participants With a Solicited Systemic AE | Up to 5 days postvaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | Up to 62 days postvaccination | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Day 30 postvaccination | The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated. |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Day 30 postvaccination | The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated. |
| GMFR From Baseline in Serotype-specific IgG GMCs | Baseline (Day 1) and Day 30 postvaccination | GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated. |
| Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Baseline (Day 1) and Day 30 postvaccination | GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated. |
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Day 30 postvaccination | The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated. |
| Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Day 30 postvaccination | The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V116 Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. | 51 |
| PNEUMOVAX™23 Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1. | 51 |
| Total | 102 |
Baseline characteristics
| Characteristic | V116 | PNEUMOVAX™23 | Total |
|---|---|---|---|
| Age, Continuous | 63.1 Years STANDARD_DEVIATION 13.7 | 64.0 Years STANDARD_DEVIATION 12.7 | 63.6 Years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 51 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 51 Participants | 51 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 24 Participants | 52 Participants |
| Sex: Female, Male Male | 23 Participants | 27 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 30 / 51 | 35 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.
Time frame: Up to 5 days postvaccination
Population: All randomized participants who received study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site erythema | 9.8 Percentage of Participants |
| V116 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site pain | 54.9 Percentage of Participants |
| V116 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site swelling | 13.7 Percentage of Participants |
| PNEUMOVAX™23 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site erythema | 9.8 Percentage of Participants |
| PNEUMOVAX™23 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site pain | 66.7 Percentage of Participants |
| PNEUMOVAX™23 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site swelling | 13.7 Percentage of Participants |
Comparison: Injection Site Erythema95% CI: [-12.7, 12.7]
Comparison: Injection Site Pain95% CI: [-30, 7.3]
Comparison: Injection Site Swelling95% CI: [-14.1, 14.1]
Primary
Percentage of Participants With a Solicited Systemic AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.
Time frame: Up to 5 days postvaccination
Population: All randomized participants who received study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With a Solicited Systemic AE | Fatigue | 13.7 Percentage of participants |
| V116 | Percentage of Participants With a Solicited Systemic AE | Myalgia | 17.6 Percentage of participants |
| V116 | Percentage of Participants With a Solicited Systemic AE | Arthralgia | 3.9 Percentage of participants |
| V116 | Percentage of Participants With a Solicited Systemic AE | Headache | 9.8 Percentage of participants |
| PNEUMOVAX™23 | Percentage of Participants With a Solicited Systemic AE | Headache | 9.8 Percentage of participants |
| PNEUMOVAX™23 | Percentage of Participants With a Solicited Systemic AE | Fatigue | 9.8 Percentage of participants |
| PNEUMOVAX™23 | Percentage of Participants With a Solicited Systemic AE | Arthralgia | 3.9 Percentage of participants |
| PNEUMOVAX™23 | Percentage of Participants With a Solicited Systemic AE | Myalgia | 19.6 Percentage of participants |
Comparison: Fatigue95% CI: [-9.4, 17.5]
Comparison: Arthralgia95% CI: [-9.9, 9.9]
Comparison: Myalgia95% CI: [-17.5, 13.6]
Comparison: Headache95% CI: [-12.7, 12.7]
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.
Time frame: Up to 62 days postvaccination
Population: All randomized participants who received study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0.0 Percentage of participants |
| PNEUMOVAX™23 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0.0 Percentage of participants |
95% CI: [-7.1, 7.1]
Secondary
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 7F | 19.79 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6A | 22.76 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 9N | 55.49 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15A | 10.70 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 22F | 15.14 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15C | 36.53 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 10A | 31.29 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 16F | 14.74 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 3 | 9.86 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23A | 46.69 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 11A | 42.06 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23B | 43.21 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 33F | 11.47 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 24F | 9.21 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 12F | 94.74 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 19A | 10.80 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 35B | 7.39 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 17F | 23.63 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6C | 5.63 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 8 | 102.33 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15B | 35.68 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20A | 11.69 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20B | 6.08 Ratio |
| V116 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 31 | 27.99 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20B | 8.89 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 3 | 6.35 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 7F | 21.53 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 19A | 6.74 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 22F | 18.13 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 33F | 11.62 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 8 | 48.14 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 9N | 40.11 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 10A | 21.93 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 11A | 20.68 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 12F | 44.70 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 17F | 11.40 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20A | 5.94 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6A | 8.31 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15A | 3.02 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15C | 16.72 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 16F | 1.84 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23A | 1.93 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23B | 4.43 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 24F | 0.75 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 31 | 1.22 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 35B | 0.56 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6C | 4.00 Ratio |
| PNEUMOVAX™23 | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15B | 23.54 Ratio |
Secondary
GMFR From Baseline in Serotype-specific IgG GMCs
GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 9N | 24.26 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 11A | 9.31 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 3 | 5.92 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 7F | 23.86 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 19A | 7.58 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 22F | 14.68 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 33F | 21.61 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 8 | 31.58 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 10A | 15.70 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 12F | 23.87 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 17F | 20.71 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 20A | 11.68 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 6A | 14.01 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 15A | 32.11 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 15C | 42.20 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 16F | 21.00 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 23A | 18.42 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 23B | 14.04 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 24F | 31.58 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 31 | 17.97 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 35B | 16.93 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 6C | 5.94 Ratio |
| V116 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 15B | 11.14 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 20A | 6.19 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 9N | 10.56 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 23B | 3.22 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 6A | 4.67 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 3 | 4.47 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 35B | 1.10 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 7F | 10.51 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 15A | 3.34 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 19A | 3.52 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 24F | 1.15 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 22F | 6.57 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 15C | 11.50 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 33F | 11.52 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 15B | 8.61 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 8 | 16.71 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 16F | 1.52 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 10A | 7.19 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 11A | 4.64 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 31 | 1.64 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 12F | 6.53 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 23A | 2.26 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 17F | 7.37 Ratio |
| PNEUMOVAX™23 | GMFR From Baseline in Serotype-specific IgG GMCs | Serotype 6C | 2.21 Ratio |
Secondary
Serotype-specific IgG GMCs for the Unique Serotypes in V116
The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Time frame: Day 30 postvaccination
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 15A | 16.39 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 23B | 8.56 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 16F | 5.57 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 24F | 13.99 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 15C | 21.42 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 31 | 5.25 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 23A | 4.14 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 35B | 24.61 μg/mL |
| V116 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 6A | 6.38 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 35B | 1.54 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 6A | 2.13 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 15A | 2.04 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 15C | 6.81 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 16F | 0.43 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 23A | 0.48 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 23B | 2.06 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 24F | 0.49 μg/mL |
| PNEUMOVAX™23 | Serotype-specific IgG GMCs for the Unique Serotypes in V116 | Serotype 31 | 0.51 μg/mL |
Comparison: Serotype 6A95% CI: [1.73, 5.19]
Comparison: Serotype 15A95% CI: [4.61, 13.98]
Comparison: Serotype 15C95% CI: [1.77, 5.58]
Comparison: Serotype 16F95% CI: [8.45, 20.19]
Comparison: Serotype 23A95% CI: [5.19, 14.09]
Comparison: Serotype 23B95% CI: [2.72, 6.36]
Comparison: Serotype 24F95% CI: [16.59, 49.58]
Comparison: Serotype 3195% CI: [6.71, 15.73]
Comparison: Serotype 35B95% CI: [11.62, 21.9]
Secondary
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Time frame: Day 30 postvaccination
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 8 | 19.38 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 9N | 14.17 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 3 | 1.13 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 7F | 10.29 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 19A | 10.75 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 22F | 3.94 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 33F | 22.00 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 10A | 11.13 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 11A | 9.07 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 12F | 2.87 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 17F | 19.46 μg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 20A | 23.53 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 22F | 1.69 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 8 | 10.33 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 11A | 4.71 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 9N | 5.99 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 20A | 11.46 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 33F | 14.48 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 3 | 0.73 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 17F | 6.77 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 7F | 4.66 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 10A | 5.16 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 19A | 4.97 μg/mL |
| PNEUMOVAX™23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 12F | 0.82 μg/mL |
Comparison: Serotype 395% CI: [1.08, 2.21]
Comparison: Serotype 7F95% CI: [1.36, 3.6]
Comparison: Serotype 19A95% CI: [1.45, 3.23]
Comparison: Serotype 22F95% CI: [1.36, 3.99]
Comparison: Serotype 33F95% CI: [0.97, 2.37]
Comparison: Serotype 895% CI: [1.32, 2.68]
Comparison: Serotype 9N95% CI: [1.49, 3.74]
Comparison: Serotype 10A95% CI: [1.28, 3.65]
Comparison: Serotype 11A95% CI: [1.28, 2.89]
Comparison: Serotype 12F95% CI: [1.94, 6.27]
Comparison: Serotype 17F95% CI: [1.92, 4.31]
Comparison: Serotype 20A95% CI: [1.3, 3.25]
Secondary
Serotype-specific OPA GMTs for the Unique Serotypes in V116
The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Time frame: Day 30 postvaccination
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15A | 5030.66 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23B | 2065.39 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 16F | 2459.26 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 24F | 2742.93 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15C | 3641.84 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 31 | 1699.54 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23A | 2620.19 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 35B | 4992.58 Titers |
| V116 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 6A | 1663.20 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 35B | 349.07 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 6A | 464.65 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15A | 807.16 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15C | 1565.56 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 16F | 244.49 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23A | 62.26 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23B | 167.03 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 24F | 110.53 Titers |
| PNEUMOVAX™23 | Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 31 | 66.24 Titers |
Comparison: Serotype 6A95% CI: [1.86, 6.88]
Comparison: Serotype 15A95% CI: [3.54, 10.98]
Comparison: Serotype 15C95% CI: [1.23, 4.39]
Comparison: Serotype 16F95% CI: [5.39, 18.78]
Comparison: Serotype 23A95% CI: [19.67, 90.03]
Comparison: Serotype 23B95% CI: [6.97, 21.94]
Comparison: Serotype 24F95% CI: [11.65, 52.86]
Comparison: Serotype 3195% CI: [14.65, 44.93]
Comparison: Serotype 35B95% CI: [8.72, 23.47]
Secondary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated.
Time frame: Day 30 postvaccination
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 33F | 33187.25 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 22F | 5768.79 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 12F | 1356.20 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 8 | 1287.66 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 3 | 161.08 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 10A | 3608.34 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 9N | 6555.82 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 7F | 5327.67 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 17F | 8470.21 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 11A | 1467.66 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 20A | 3542.90 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 19A | 1479.82 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 20A | 1553.99 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 8 | 721.85 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 11A | 603.00 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 3 | 100.76 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 7F | 4406.11 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 19A | 738.52 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 33F | 28831.77 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 9N | 3466.72 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 10A | 1330.75 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 12F | 563.99 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 17F | 3293.31 Titers |
| PNEUMOVAX™23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | Serotype 22F | 3000.50 Titers |
Comparison: Serotype 395% CI: [1.07, 2.4]
Comparison: Serotype 7F95% CI: [0.69, 2.11]
Comparison: Serotype 19A95% CI: [1.24, 3.24]
Comparison: Serotype 22F95% CI: [1.04, 3.57]
Comparison: Serotype 33F95% CI: [0.71, 1.86]
Comparison: Serotype 895% CI: [1.24, 2.58]
Comparison: Serotype 9N95% CI: [1.19, 3]
Comparison: Serotype 10A95% CI: [1.47, 5]
Comparison: Serotype 11A95% CI: [1.52, 3.89]
Comparison: Serotype 12F95% CI: [1.2, 4.83]
Comparison: Serotype 17F95% CI: [1.59, 4.17]
Comparison: Serotype 20A95% CI: [1.46, 3.56]