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NCT00546572 Clinical Trial

Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

Pneumococcal Infections Clinical Trial

Official title:
A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00546572
Other study ID # 6115A1-3005
Secondary ID B1851024
Status Completed
Phase Phase 3
First received October 18, 2007
Last updated July 12, 2011
Start date November 2007
Est. completion date July 2010

Study information
Verified date July 2011
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.

Recruitment information / eligibility
Status Completed
Enrollment 938
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Male or Female aged 70 years or older.

- Documented vaccination with 1 dose of 23vPS at least 5 years previous.

- Healthy.

Exclusion Criteria:

- Receipt of more than one dose of 23vPS prior to enrollment.

- History of severe adverse reaction to a vaccine.

- Immunodeficiency.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• 13 valent Pneumococcal Conjugate Vaccine
0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
• 23vPS
0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1

Locations
Country Name City State
Sweden Pfizer Investigational Site Arlov
Sweden Pfizer Investigational Site Boden
Sweden Pfizer Investigational Site Degeberga
Sweden Pfizer Investigational Site Gothenburg
Sweden Pfizer Investigational Site Malmoe
Sweden Pfizer Investigational Site Umea
Sweden Pfizer Investigational Site Uppsala
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Bristol Tennessee
United States Pfizer Investigational Site Butte Montana
United States Pfizer Investigational Site Carnegie Pennsylvania
United States Pfizer Investigational Site Cary North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Coral Gables Florida
United States Pfizer Investigational Site Corvallis Oregon
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Downington Pennsylvania
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Fargo North Dakota
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Grove City Pennsylvania
United States Pfizer Investigational Site Hickory North Carolina
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Mt. Pleasant South Carolina
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Penndel Pennsylvania
United States Pfizer Investigational Site Pinellas Park Florida
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site Salisbury North Carolina
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Shawnee Mission Kansas
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Stockbridge Georgia
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Upper St. Clair Pennsylvania
United States Pfizer Investigational Site Waterbury Connecticut
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common 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 Vax 1 / Year 0 No
Primary Percentage of Participants Achieving a = 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0) OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants. Baseline, 1 month after Vax 1 / Year 0 No
Secondary Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0) Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer. 1 month after Vax 1 / Year 0 Yes
Secondary Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 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 Vax 1 / Year 0, 1 month after Vax 2 / Year 1 No
Secondary Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) Antibody geometric mean titers as measured by OPA assays for the 12 common 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 Vax 1 / Year 0, 1 month after Vax 2 / Year 1 No
Secondary Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer. 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 No
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