Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

Study Overview
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Brief Summary
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The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

Official Title
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A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS

Conditions
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Pneumococcal Vaccines

Intervention / Treatment
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* Biological: 13 valent Pneumococcal Conjugate Vaccine
* Biological: 13 valent Pneumococcal Conjugate Vaccine
* Biological: 13 valent Pneumococcal Conjugate Vaccine
* Biological: 23-valent Pneumococcal Polysaccharide Vaccine
* Biological: 23-valent Pneumococcal Polysaccharide Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, aged 60 to 64 years. Healthy. Exclusion Criteria: Previous vaccination with any licensed or experimental pneumococcal vaccine. History of severe adverse reaction associated with a vaccine. Immunodeficiency.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1.1<br>Group 1.1 = 13vPnC then 13vPnC | Biological: 13 valent Pneumococcal Conjugate Vaccine<br>* 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1<br>|
| Experimental: Group 1.2<br>Group 1.2 = 13vPnC then 23vPS | Biological: 13 valent Pneumococcal Conjugate Vaccine<br>* 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1<br>Biological: 23-valent Pneumococcal Polysaccharide Vaccine<br>* 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1<br>|
| Experimental: Group 2<br>Group 2 = 23vPS then 13vPnC | Biological: 13 valent Pneumococcal Conjugate Vaccine<br>* 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1<br>Biological: 23-valent Pneumococcal Polysaccharide Vaccine<br>* 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0) | Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1) | 
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1) | Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0) | Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1) | 
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0) | Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1) | 

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