Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| pPCV-002 | Other Identifier | Merck | |
| jRCT2071200094 | Registry Identifier | jRCT | |
| V116-002 | Other Identifier | Merck |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAXâ„¢23 in healthy Japanese adults.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V116 | Experimental | Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. |
|
| PNEUMOVAXâ„¢23 | Active Comparator | Participants receive a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V116 | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 days postvaccination |
| 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. | Up to 5 days postvaccination |
| 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. | Up to 62 days postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAXâ„¢23 | The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAXâ„¢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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai PS Clinic ( Site 0201) | Fukuoka | 812-0025 | Japan | |||
| Souseikai Nishikumamoto Hospital ( Site 0202) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37389808 | Result | Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | V116 | Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. |
| FG001 | PNEUMOVAXâ„¢23 | Participants received a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V116 | Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. |
| BG001 | PNEUMOVAXâ„¢23 | Participants received a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 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 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. | All randomized participants who received study vaccination | Posted | Number | Percentage of Participants | Up to 5 days postvaccination |
|
Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
Not provided
| 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 received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| 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 | Oct 20, 2020 | Aug 4, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PNEUMOVAX™23 | Biological | 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 |
|
|
| Day 30 postvaccination |
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAXâ„¢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. | Day 30 postvaccination |
| 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. | Day 30 postvaccination |
| 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. | Day 30 postvaccination |
| Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | GMTs for the serotypes in V116 and PNEUMOVAXâ„¢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. | Baseline (Day 1) and Day 30 postvaccination |
| GMFR From Baseline in Serotype-specific IgG GMCs | GMCs for the serotypes in V116 and PNEUMOVAXâ„¢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. | Baseline (Day 1) and Day 30 postvaccination |
| 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 |
|
Participants received a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 on Day 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. | All randomized participants who received study vaccination | Posted | Number | Percentage of participants | Up to 5 days postvaccination |
|
|
|
|
| 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. | All randomized participants who received study vaccination | Posted | Number | Percentage of participants | Up to 62 days postvaccination |
|
|
|
|
| Secondary | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAXâ„¢23 | The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAXâ„¢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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 postvaccination |
|
|
|
|
| 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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Day 30 postvaccination |
|
|
|
|
| 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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 postvaccination |
|
|
|
|
| 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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Day 30 postvaccination |
|
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | GMTs for the serotypes in V116 and PNEUMOVAXâ„¢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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and Day 30 postvaccination |
|
|
|
| Secondary | GMFR From Baseline in Serotype-specific IgG GMCs | GMCs for the serotypes in V116 and PNEUMOVAXâ„¢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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and Day 30 postvaccination |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 30 |
| 51 |
| EG001 | PNEUMOVAXâ„¢23 | Participants received a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 on Day 1. | 0 | 51 | 0 | 51 | 35 | 51 |
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. 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 |
| Myalgia |
|
| Headache |
|
Arthralgia
| Difference in percentage |
| 0.0 |
| 2-Sided |
| 95 |
| -9.9 |
| 9.9 |
V116 minus PNEUMOVAXâ„¢23 |
| Other |
Estimated difference and CI are calculated based on the Miettinen & Nurminen method |
| Myalgia | Difference in percentage | -2.0 | 2-Sided | 95 | -17.5 | 13.6 | V116 minus PNEUMOVAXâ„¢23 | Other | Estimated difference and CI are calculated based on the Miettinen & Nurminen method |
| Headache | Difference in percentage | 0.0 | 2-Sided | 95 | -12.7 | 12.7 | V116 minus PNEUMOVAXâ„¢23 | Other | Estimated difference and CI are calculated based on the Miettinen & Nurminen method |
| Serotype 19A |
|
| Serotype 22F |
|
| Serotype 33F |
|
| Serotype 8 |
|
| Serotype 9N |
|
| Serotype 10A |
|
| Serotype 11A |
|
| Serotype 12F |
|
| Serotype 17F |
|
| Serotype 20A |
|
Serotype 7F
| GMT Ratio |
| 1.21 |
| 2-Sided |
| 95 |
| 0.69 |
| 2.11 |
V116/PNEUMOVAXâ„¢23 |
| Other |
GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 19A | GMT Ratio | 2.00 | 2-Sided | 95 | 1.24 | 3.24 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 22F | GMT Ratio | 1.92 | 2-Sided | 95 | 1.04 | 3.57 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 33F | GMT Ratio | 1.15 | 2-Sided | 95 | 0.71 | 1.86 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 8 | GMT Ratio | 1.78 | 2-Sided | 95 | 1.24 | 2.58 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 9N | GMT Ratio | 1.89 | 2-Sided | 95 | 1.19 | 3.00 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 10A | GMT Ratio | 2.71 | 2-Sided | 95 | 1.47 | 5.00 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 11A | GMT Ratio | 2.43 | 2-Sided | 95 | 1.52 | 3.89 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 12F | GMT Ratio | 2.40 | 2-Sided | 95 | 1.20 | 4.83 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 17F | GMT Ratio | 2.57 | 2-Sided | 95 | 1.59 | 4.17 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 20A | GMT Ratio | 2.28 | 2-Sided | 95 | 1.46 | 3.56 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% confidence interval CI are estimated from a cLDA model. |
| Serotype 19A |
|
| Serotype 22F |
|
| Serotype 33F |
|
| Serotype 8 |
|
| Serotype 9N |
|
| Serotype 10A |
|
| Serotype 11A |
|
| Serotype 12F |
|
| Serotype 17F |
|
| Serotype 20A |
|
Serotype 7F
| GMC Ratio |
| 2.21 |
| 2-Sided |
| 95 |
| 1.36 |
| 3.60 |
V116/PNEUMOVAXâ„¢23 |
| Other |
GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 19A | GMC Ratio | 2.16 | 2-Sided | 95 | 1.45 | 3.23 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 22F | GMC Ratio | 2.33 | 2-Sided | 95 | 1.36 | 3.99 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 33F | GMC Ratio | 1.52 | 2-Sided | 95 | 0.97 | 2.37 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 8 | GMC Ratio | 1.88 | 2-Sided | 95 | 1.32 | 2.68 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 9N | GMC Ratio | 2.37 | 2-Sided | 95 | 1.49 | 3.74 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 10A | GMC Ratio | 2.16 | 2-Sided | 95 | 1.28 | 3.65 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 11A | GMC Ratio | 1.92 | 2-Sided | 95 | 1.28 | 2.89 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 12F | GMC Ratio | 3.49 | 2-Sided | 95 | 1.94 | 6.27 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 17F | GMC Ratio | 2.88 | 2-Sided | 95 | 1.92 | 4.31 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 20A | GMC Ratio | 2.05 | 2-Sided | 95 | 1.30 | 3.25 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 15C |
|
| Serotype 16F |
|
| Serotype 23A |
|
| Serotype 23B |
|
| Serotype 24F |
|
| Serotype 31 |
|
| Serotype 35B |
|
Serotype 15A
| GMT Ratio |
| 6.23 |
| 2-Sided |
| 95 |
| 3.54 |
| 10.98 |
V116/PNEUMOVAXâ„¢23 |
| Other |
GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 15C | GMT Ratio | 2.33 | 2-Sided | 95 | 1.23 | 4.39 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 16F | GMT Ratio | 10.06 | 2-Sided | 95 | 5.39 | 18.78 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 23A | GMT Ratio | 42.09 | 2-Sided | 95 | 19.67 | 90.03 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 23B | GMT Ratio | 12.37 | 2-Sided | 95 | 6.97 | 21.94 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 24F | GMT Ratio | 24.82 | 2-Sided | 95 | 11.65 | 52.86 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 31 | GMT Ratio | 25.66 | 2-Sided | 95 | 14.65 | 44.93 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 35B | GMT Ratio | 14.30 | 2-Sided | 95 | 8.72 | 23.47 | V116/PNEUMOVAXâ„¢23 | Other | GMT ratio and 95% CI are estimated from a cLDA model. |
| Serotype 15C |
|
| Serotype 16F |
|
| Serotype 23A |
|
| Serotype 23B |
|
| Serotype 24F |
|
| Serotype 31 |
|
| Serotype 35B |
|
Serotype 15A
| GMC Ratio |
| 8.03 |
| 2-Sided |
| 95 |
| 4.61 |
| 13.98 |
V116/PNEUMOVAXâ„¢23 |
| Other |
GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 15C | GMC Ratio | 3.14 | 2-Sided | 95 | 1.77 | 5.58 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 16F | GMC Ratio | 13.06 | 2-Sided | 95 | 8.45 | 20.19 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 23A | GMC Ratio | 8.55 | 2-Sided | 95 | 5.19 | 14.09 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 23B | GMC Ratio | 4.15 | 2-Sided | 95 | 2.72 | 6.36 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 24F | GMC Ratio | 28.68 | 2-Sided | 95 | 16.59 | 49.58 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 31 | GMC Ratio | 10.27 | 2-Sided | 95 | 6.71 | 15.73 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 35B | GMC Ratio | 15.95 | 2-Sided | 95 | 11.62 | 21.90 | V116/PNEUMOVAXâ„¢23 | Other | GMC ratio and 95% CI are estimated from a cLDA model. |
| Serotype 7F |
|
|
| Serotype 19A |
|
|
| Serotype 22F |
|
|
| Serotype 33F |
|
|
| Serotype 8 |
|
|
| Serotype 9N |
|
|
| Serotype 10A |
|
|
| Serotype 11A |
|
|
| Serotype 12F |
|
|
| Serotype 17F |
|
|
| Serotype 20A |
|
|
| Serotype 6A |
|
|
| Serotype 15A |
|
|
| Serotype 15C |
|
|
| Serotype 16F |
|
|
| Serotype 23A |
|
|
| Serotype 23B |
|
|
| Serotype 24F |
|
|
| Serotype 31 |
|
|
| Serotype 35B |
|
|
| Serotype 6C |
|
|
| Serotype 15B |
|
|
| Serotype 20B |
|
|
| Serotype 7F |
|
|
| Serotype 19A |
|
|
| Serotype 22F |
|
|
| Serotype 33F |
|
|
| Serotype 8 |
|
|
| Serotype 9N |
|
|
| Serotype 10A |
|
|
| Serotype 11A |
|
|
| Serotype 12F |
|
|
| Serotype 17F |
|
|
| Serotype 20A |
|
|
| Serotype 6A |
|
|
| Serotype 15A |
|
|
| Serotype 15C |
|
|
| Serotype 16F |
|
|
| Serotype 23A |
|
|
| Serotype 23B |
|
|
| Serotype 24F |
|
|
| Serotype 31 |
|
|
| Serotype 35B |
|
|
| Serotype 6C |
|
|
| Serotype 15B |
|
|