Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Adults - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00744263

Purpose

The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.

Condition	Intervention	Phase
Vaccines, Pneumococcal	Biological: VACCINE: 13-valent pneumococcal conjugate vaccine Biological: VACCINE: placebo	Phase IV

MedlinePlus related topics: Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase 4, Randomized, Placebo-Controlled Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease

Further study details as provided by Wyeth:

Primary Outcome Measures:

Compare number of cases of first episode vaccine-type pneumococcal community-acquired pneumonia in each study arm. [ Time Frame: No specific time; rather as long as necessary to gather sufficient data to make the protocol-required outcome assessments. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the number of cases of vaccine-type invasive pneumococcal disease in each arm. Evaluate the acceptability of the safety profile of 13-valent as measured by the incidence rates of serious adverse events in each arm. [ Time Frame: No specific time; rather as long as necessary to gather sufficient data to make the protocol-required outcome assessments. Occurrence of serious adverse events will be assessed for 28 days following vaccination. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	85000
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Placebo	Biological: VACCINE: placebo
13-valent: Experimental 13-valent	Biological: VACCINE: 13-valent pneumococcal conjugate vaccine

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Male or female adults aged 65 years or older on 01 Sep 2008 and able to fulfill study requirements.

Exclusion criteria:

Previous vaccination with any licensed or experimental pneumococcal vaccine Residence in a nursing home, long-term care facility, or similar facility Known hypersensitivity to vaccination Immune deficiency or suppression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744263

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 57 Study Locations

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:	6115A1-3006
Study First Received:	August 27, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00744263
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration

Study placed in the following topic categories:

Pneumonia

ClinicalTrials.gov processed this record on January 16, 2009