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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 23, 2014