A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

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 a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.

Official Title
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A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine

Conditions
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Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine

Intervention / Treatment
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* Biological: 13-valent pneumococcal conjugate vaccine
* Biological: 23-valent pneumococcal polysaccharide vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer. Exclusion Criteria: History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component. Previous vaccination with any licensed or experimental pneumococcal vaccine. Documented Streptococcus pneumoniae infection within the past 5 years. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.

Ages Eligible for Study
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Minimum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: >= 65-year age group-13vPnC<br> | Biological: 13-valent pneumococcal conjugate vaccine<br>* A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.<br>* Other names: 13vPnC;|
| Active Comparator: >= 65-year age group-23vPS<br> | Biological: 23-valent pneumococcal polysaccharide vaccine<br>* A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.<br>* Other names: 23VPS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). | One month after vaccination | 
| Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination | For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | One month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). | One month after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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13VPNC, 23VPS