Study Evaluating the Safety and Tolerability of a Pneumococcal Vaccine in People 18-49 Years of Age - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00774410

Purpose

This study will assess the safety and tolerability of this 13v Pneumococcal vaccine (13vPnC) in 18-49 years old people. The results of the immune response in this age group will be compared to the immune response in people 60-64 years old.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: 13 valent pneumococcal conjugate vaccine	Phase III

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vs. a 23vPS in Adults Aged 60 to 64 Years and 13vPnC in Adults Aged 18-59 Years Who Are Naive to 23vPS Vaccine.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Evaluation of immune response to the 13vPnC in the 18-49 year-old age group against the immune response to 13vPnC in the 60-64 year-old age group. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	370
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
C: Experimental	Biological: 13 valent pneumococcal conjugate vaccine

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male and female adults 18-49 years of age at time of enrollment. Negative urine pregnancy test for all female subjects in cohort 3.

Exclusion Criteria:

Previous immunization with any licensed or experimental pneumococcal vaccine. Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD), end stage renal disease, clinically unstable cardiac disease.

Known or suspected impairment of immunological function Pregnant or breastfeeding women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774410

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6115A1-004 Cohort 3
Study First Received:	October 16, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00774410
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Pneumococcal Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009