Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00574548
First received: December 13, 2007
Last updated: July 18, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Vaccines |
Biological: 13 valent Pneumococcal Conjugate Vaccine Biological: 13 valent Pneumococcal Conjugate Vaccine Biological: 23-valent Pneumococcal Polysaccharide Vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0) [ Time Frame: 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) ] [ Designated as safety issue: No ]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.
- Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1) [ Time Frame: 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0) [ Time Frame: 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) ] [ Designated as safety issue: No ]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.
- Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0) [ Time Frame: 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) ] [ Designated as safety issue: No ]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.
| Enrollment: | 720 |
| Study Start Date: | November 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1.1
Group 1.1 = 13vPnC then 13vPnC
|
Biological: 13 valent Pneumococcal Conjugate Vaccine
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
|
|
Experimental: Group 1.2
Group 1.2 = 13vPnC then 23vPS
|
Biological: 13 valent Pneumococcal Conjugate Vaccine
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
Biological: 23-valent Pneumococcal Polysaccharide Vaccine
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
|
|
Experimental: Group 2
Group 2 = 23vPS then 13vPnC
|
Biological: 13 valent Pneumococcal Conjugate Vaccine
0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
Biological: 23-valent Pneumococcal Polysaccharide Vaccine
0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
|
Eligibility| Ages Eligible for Study: | 60 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574548
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Chandler, Arizona, United States, 85224 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, Idaho | |
| Pfizer Investigational Site | |
| Boise, Idaho, United States, 83704 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Bristol, Tennessee, United States, 37620 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| ClinicalTrials.gov Identifier: | NCT00574548 History of Changes |
| Other Study ID Numbers: | 6115A1-3010, B1851027 |
| Study First Received: | December 13, 2007 |
| Results First Received: | February 1, 2011 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Vaccines, Pneumococcal Conjugate Vaccine |
ClinicalTrials.gov processed this record on May 22, 2013