Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50 years.

Official Title
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A Phase 3, Open-Label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a 13vPnC When Administered to Healthy Japanese Adults Aged >= 65 Years and 50 to 64 Years in Japan Who Have Not Received a Previous Dose of 23-Valent Pneumococcal Polysaccharide Vaccine

Conditions
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Healthy

Intervention / Treatment
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* Biological: 13vPnC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese descent male and female adults who do not have the potential to bear children >= 50 years of age. Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible. Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination. Exclusion Criteria: History of severe adverse reaction associated with a vaccine. Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine. Documented S pneumoniae infection within the past 5 years before study vaccination.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stratum 1: >= 65 years of age | Biological: 13vPnC<br>* 13vPnC for both stratum<br>|
| Experimental: 2<br>Stratum 2: 50 to 64 years of age | Biological: 13vPnC<br>* 13vPnC for both stratum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. | 1 month after vaccination | 
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. | 1 month after vaccination | 
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. | Prevaccination (Day 1), 1 month after vaccination | 
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. | Prevaccination (Day 1), 1 month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. | 1 month after vaccination | 
| Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | 1 month after vaccination | 
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. | 1 month after vaccination | 
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. | 1 month after vaccination | 
| Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. | 1 month after vaccination | 
| Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. | 1 month after vaccination | 
| Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. | 1 month after vaccination | 
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder). | Day 1 through 14 | 
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder). | Day 1 through 14 | 
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain. | Day 1 through 14 | 
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain. | Day 1 through 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines, Pneumococcal Conjugate Vaccine