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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00574548

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
Vaccines, Pneumococcal Conjugate Vaccine	Biological: 13 valent Pneumoncoccal Conjugate Vaccine Biological: 23vPS	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

To compare the immune response to 23vPS one year after a dose of 13vPnC to the immune response to an initial dose of 23vPS for the 12 common serotypes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	720
Study Start Date:	November 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental arm 1= 13vPnC then 13vPnC	Biological: 13 valent Pneumoncoccal Conjugate Vaccine one dose of vaccine at enrollment and one dose of vaccine at year 1
2: Experimental arm 2 = 13vPnC then 23vPS	Biological: 13 valent Pneumoncoccal Conjugate Vaccine one dose of vaccine at enrollment and one dose of vaccine at year 1 Biological: 23vPS arm 2 = 13vPnC then 23vPS arm 3 = 23vPS then 13vPnC
3: Experimental arm 3 = 23vPS then 13vPnC	Biological: 13 valent Pneumoncoccal Conjugate Vaccine one dose of vaccine at enrollment and one dose of vaccine at year 1 Biological: 23vPS arm 2 = 13vPnC then 23vPS arm 3 = 23vPS then 13vPnC

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

Chandler, Arizona, United States, 85224
United States, Florida

Pembroke Pines, Florida, United States, 33024
United States, Idaho

Boise, Idaho, United States, 83704
United States, North Carolina

Raleigh, North Carolina, United States, 27609
United States, Ohio

Cincinnati, Ohio, United States, 45229
United States, Tennessee

Bristol, Tennessee, United States, 37620

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6115A1-3010
Study First Received:	December 13, 2007
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00574548 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 11, 2009