Study Evaluating the Safety, Tolerability and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00546572

Purpose

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.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: 13 valent Pneumococcal Conjugate Vaccine Biological: 23vPS	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To measure (or assess) the immunogenicity of 13vPnC as compared with 23vPS for the 12 common serotypes. [ Time Frame: 1 month after vaccination at year 0 and 1 month after vaccination at year 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	924
Study Start Date:	November 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Receives 13vPnC at year 0 and 13vPnC at year 1	Biological: 23vPS
2: Active Comparator	Biological: 13 valent Pneumococcal Conjugate Vaccine

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion:

Male or Female aged 70 years or older
Documented vaccination with 1 dose of 23vPS at least 5 years previous
Healthy

Exclusion:

Receipt of more than one dose of 23vPS prior to enrollment
History of severe adverse reaction to a vaccine
Immunodeficiency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546572

Show 58 Study Locations

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:	6115A1-3005
Study First Received:	October 18, 2007
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00546572 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Infection
Pneumococcal Infections

ClinicalTrials.gov processed this record on February 08, 2010