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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031220551 | Registry Identifier | jRCT |
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This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V116 | Experimental | Participants receive a single intramuscular (IM) injection of V116 on Day 1. |
|
| PPSV23 | Active Comparator | Participants receive a single IM injection of PPSV23 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V116 | Biological | Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | 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. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. | Up to 5 days postvaccination |
| Percentage of Participants With Solicited Systemic AEs | 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. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue. | Up to 5 days postvaccination |
| Percentage of Participants With Vaccine-related Serious AEs (SAEs) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized. | Up to 30 days postvaccination |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA). | Day 30 postvaccination |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined. |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific OPA GMTs (Unique Serotypes) | The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA. | Day 30 postvaccination |
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital ( Site 1008) | Osaka | Osaka | 532-0003 | Japan | ||
| Medical Corporation Heishinkai OCROM Clinic ( Site 1003) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40763490 | Derived | Kishino H, Inoue S, Matsuoka O, Yagi M, Igarashi R, Oshima N, Sawata M, Platt HL. A phase 3 randomized trial (STRIDE-9) to evaluate the safety, tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in pneumococcal vaccine-naive Japanese adults >/=65 years of age. Vaccine. 2025 Aug 30;62:127456. doi: 10.1016/j.vaccine.2025.127456. Epub 2025 Aug 5. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | V116 | Participants receive a single intramuscular (IM) injection of V116 on Day 1. |
| FG001 | PPSV23 | Participants receive a single IM injection of PPSV23 on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V116 | Participants receive a single intramuscular (IM) injection of V116 on Day 1. |
| BG001 | PPSV23 | Participants receive a single IM injection of PPSV23 on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | 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. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. | The analysis population includes all participants who received ≥1 dose of study treatment. | Posted | Number | Percentage of participants | Up to 5 days postvaccination |
|
Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V116 | Participants receive a single intramuscular (IM) injection of V116 on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacunar infarction | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2022 | May 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
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|
| PPSV23 | Biological | Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each 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. |
|
|
| Baseline (Day 1) and Day 30 postvaccination |
The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL). |
| Day 30 postvaccination |
| Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. | Baseline (Day 1) and Day 30 postvaccination |
| Serotype-specific GMFR in IgG GMCs | The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. | Baseline (Day 1) and Day 30 postvaccination |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | Baseline (Day 1) and Day 30 postvaccination |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination. | Baseline (Day 1) and Day 30 postvaccination |
| Suita-shi |
| Osaka |
| 565-0853 |
| Japan |
| P-One Clinic ( Site 1001) | Hachiōji | Tokyo | 192-0071 | Japan |
| Heishinkai Medical Group ToCROM Clinic ( Site 1004) | Shinjuku-ku | Tokyo | 160-0008 | Japan |
| Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006) | Shinjuku-ku | Tokyo | 160-0017 | Japan |
| Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005) | Toshima City | Tokyo | 171-0014 | Japan |
| PS Clinic ( Site 1002) | Fukuoka | 812-0025 | Japan |
| Nishikumamoto Hospital ( Site 1007) | Kumamoto | 861-4157 | Japan |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) | OPA GMT for each serotype in V116, estimated using a constrained longitudinal data analysis (cLDA) model. | The analysis population consists of all randomized participants who had available baseline data. | Geometric Mean | Full Range | Titers |
|
Participants receive a single IM injection of PPSV23 on Day 1.
|
|
| Primary | Percentage of Participants With Solicited Systemic AEs | 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. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue. | The analysis population includes all participants who received ≥1 dose of study treatment. | Posted | Number | Percentage of participants | Up to 5 days postvaccination |
|
|
|
| Primary | Percentage of Participants With Vaccine-related Serious AEs (SAEs) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized. | The analysis population includes all participants who received ≥1 dose of study treatment. | Posted | Number | Percentage of participants | Up to 30 days postvaccination |
|
|
|
| Primary | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA). | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 postvaccination |
|
|
|
|
| Primary | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined. | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points. | Posted | Number | Percentage of Participants | Baseline (Day 1) and Day 30 postvaccination |
|
|
|
|
| Secondary | Serotype-specific OPA GMTs (Unique Serotypes) | The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA. | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 postvaccination |
|
|
|
| Secondary | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL). | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day 30 postvaccination |
|
|
|
| Secondary | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and Day 30 postvaccination |
|
|
|
| Secondary | Serotype-specific GMFR in IgG GMCs | The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and Day 30 postvaccination |
|
|
|
| Secondary | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and Day 30 postvaccination |
|
|
|
| Secondary | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination. | The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and Day 30 postvaccination |
|
|
|
| 0 |
| 225 |
| 1 |
| 225 |
| 77 |
| 225 |
| EG001 | PPSV23 | Participants receive a single IM injection of PPSV23 on Day 1. | 0 | 225 | 0 | 225 | 96 | 225 |
| Injection site erythema | General disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA Version 26.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| D007239 | Infections |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Day 30, Serotype 7F |
|
|
| Day 30, Serotype 8 |
|
|
| Day 30, Serotype 9N |
|
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| Day 30, Serotype 10A |
|
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| Day 30, Serotype 11A |
|
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| Day 30, Serotype 12F |
|
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| Day 30, Serotype 17F |
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| Day 30, Serotype 19A |
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| Day 30, Serotype 20A |
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| Day 30, Serotype 22F |
|
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| Day 30, Serotype 33F |
|
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| Day 30, Serotype 15C |
|
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| Day 30, Serotype 15B |
|
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| Baseline, Serotype 3 |
|
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| Baseline, Serotype 7F |
|
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| Baseline, Serotype 8 |
|
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| Baseline, Serotype 9N |
|
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| Baseline, Serotype 10A |
|
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| Baseline, Serotype 11A |
|
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| Baseline, Serotype 12F |
|
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| Baseline, Serotype 17F |
|
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| Baseline, Serotype 19A |
|
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| Baseline, Serotype 20A |
|
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| Baseline, Serotype 22F |
|
|
| Baseline, Serotype 33F |
|
|
| Baseline, Serotype 15C |
|
|
| Baseline, Serotype 15B |
|
|
For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025).
| Serotype 7F | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.08 | 2-Sided | 95 | 0.88 | 1.33 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 8 | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.12 | 2-Sided | 95 | 0.93 | 1.36 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 9N | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.05 | 2-Sided | 95 | 0.86 | 1.29 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 10A | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.65 | 2-Sided | 95 | 1.28 | 2.14 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 11A | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.52 | 2-Sided | 95 | 1.20 | 1.92 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 12F | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.97 | 2-Sided | 95 | 1.43 | 2.72 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 17F | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.60 | 2-Sided | 95 | 1.28 | 2.00 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 19A | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.16 | 2-Sided | 95 | 0.93 | 1.45 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 20A | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.44 | 2-Sided | 95 | 1.18 | 1.77 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 22F | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.39 | 2-Sided | 95 | 1.10 | 1.76 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 33F | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 0.87 | 2-Sided | 95 | 0.68 | 1.12 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 15B | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 1.43 | 2-Sided | 95 | 1.07 | 1.89 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Non-Inferiority | For serotype 15B, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >0.5 (one-sided p-value <0.025). |
| Serotype 15C | Constrained Longitudinal Data Analysis | cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum | <0.001 | Day 30 GMT Ratio | 2.05 | 2-Sided | 95 | 1.56 | 2.70 | Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement. | Superiority | For serotype 15C, a conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be >1.0 (one-sided p-value <0.025). |
| Serotype 15A |
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| Serotype 16F |
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| Serotype 23A |
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| Serotype 23B |
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| Serotype 24F |
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| Serotype 31 |
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| Serotype 35B |
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| Serotype 15A | Stratified Miettinen & Nurminen | <0.001 | Difference in Percent | 33.7 | 2-Sided | 95 | 23.6 | 43.0 | Estimated difference and confidence interval are based on the Miettinen & Nurminen method. | Superiority | A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be >0 percentage points (one-sided p-value <0.025). |
| Serotype 16F | Stratified Miettinen & Nurminen | <0.001 | Difference in Percent | 38.3 | 2-Sided | 95 | 29.8 | 46.4 | Estimated difference and confidence interval are based on the Miettinen & Nurminen method. | Superiority | A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be >0 percentage points (one-sided p-value <0.025). |
| Serotype 23A | Stratified Miettinen & Nurminen | <0.001 | Difference in Percent | 29.5 | 2-Sided | 95 | 17.4 | 40.6 | Estimated difference and confidence interval are based on the Miettinen & Nurminen method. | Superiority | A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be >0 percentage points (one-sided p-value <0.025). |
| Serotype 23B | Stratified Miettinen & Nurminen | <0.001 | Difference in Percent | 38.3 | 2-Sided | 95 | 29.3 | 46.7 | Estimated difference and confidence interval are based on the Miettinen & Nurminen method. | Superiority | A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be >0 percentage points (one-sided p-value <0.025). |
| Serotype 24F | Stratified Miettinen & Nurminen | <0.001 | Difference in Percent | 27.1 | 2-Sided | 95 | 18.3 | 35.6 | Estimated difference and confidence interval are based on the Miettinen & Nurminen method. | Superiority | A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be >0 percentage points (one-sided p-value <0.025). |
| Serotype 31 | Stratified Miettinen & Nurminen | <0.001 | Difference in Percent | 57.3 | 2-Sided | 95 | 49.3 | 64.4 | Estimated difference and confidence interval are based on the Miettinen & Nurminen method. | Superiority | A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be >0 percentage points (one-sided p-value <0.025). |
| Serotype 35B | Stratified Miettinen & Nurminen | <0.001 | Difference in Percent | 47.0 | 2-Sided | 95 | 39.5 | 54.1 | Estimated difference and confidence interval are based on the Miettinen & Nurminen method. | Superiority | A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be >0 percentage points (one-sided p-value <0.025). |
| Serotype 15A |
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| Serotype 16F |
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| Serotype 23A |
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| Serotype 23B |
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| Serotype 24F |
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| Serotype 31 |
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| Serotype 35B |
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| Serotype 7F |
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| Serotype 8 |
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| Serotype 9N |
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| Serotype 10A |
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| Serotype 11A |
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| Serotype 12F |
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| Serotype 17F |
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| Serotype 19A |
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| Serotype 20A |
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| Serotype 22F |
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| Serotype 33F |
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| Serotype 6A |
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| Serotype 15A |
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| Serotype 15C |
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| Serotype 16F |
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| Serotype 23A |
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| Serotype 23B |
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| Serotype 24F |
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| Serotype 31 |
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| Serotype 35B |
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| Serotype 6C |
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| Serotype 15B |
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| Serotype 7F |
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| Serotype 8 |
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| Serotype 9N |
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| Serotype 10A |
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| Serotype 11A |
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| Serotype 12F |
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| Serotype 17F |
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| Serotype 19A |
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| Serotype 20A |
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| Serotype 22F |
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| Serotype 33F |
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| Serotype 6A |
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| Serotype 15A |
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| Serotype 15C |
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| Serotype 16F |
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| Serotype 23A |
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| Serotype 23B |
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| Serotype 24F |
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| Serotype 31 |
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| Serotype 35B |
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| Serotype 6C |
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| Serotype 15B |
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| Serotype 7F |
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| Serotype 8 |
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| Serotype 9N |
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| Serotype 10A |
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| Serotype 11A |
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| Serotype 12F |
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| Serotype 17F |
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| Serotype 19A |
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| Serotype 20A |
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| Serotype 22F |
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| Serotype 33F |
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| Serotype 6A |
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| Serotype 15A |
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| Serotype 15C |
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| Serotype 16F |
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| Serotype 23A |
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| Serotype 23B |
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| Serotype 24F |
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| Serotype 31 |
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| Serotype 35B |
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| Serotype 6C |
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| Serotype 15B |
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| Serotype 7F |
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| Serotype 8 |
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| Serotype 9N |
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| Serotype 10A |
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| Serotype 11A |
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| Serotype 12F |
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| Serotype 17F |
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| Serotype 19A |
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| Serotype 20A |
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| Serotype 22F |
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| Serotype 33F |
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| Serotype 6A |
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| Serotype 15A |
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| Serotype 15C |
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| Serotype 16F |
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| Serotype 23A |
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| Serotype 23B |
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| Serotype 24F |
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| Serotype 31 |
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| Serotype 35B |
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| Serotype 6C |
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| Serotype 15B |
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| Serotype 7F |
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| Serotype 8 |
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| Serotype 9N |
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| Serotype 10A |
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| Serotype 11A |
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| Serotype 12F |
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| Serotype 17F |
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| Serotype 19A |
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| Serotype 20A |
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| Serotype 22F |
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| Serotype 33F |
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| Serotype 6A |
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| Serotype 15A |
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| Serotype 15C |
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| Serotype 16F |
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| Serotype 23A |
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| Serotype 23B |
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| Serotype 24F |
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| Serotype 31 |
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| Serotype 35B |
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| Serotype 6C |
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| Serotype 15B |
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