Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00761631

Purpose

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.

Condition	Intervention	Phase
Healthy Subjects	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/Efficacy Study
Official Title:	A Phase 3, Open Label Trial Evaluating the Safety,Tolerability and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States

Further study details as provided by Wyeth:

Primary Outcome Measures:

Measure pneumococcal immune responses 1 month after last dose of 13vPnC in each age groups [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate safety profile of 13vPnC in healthy children enrolled in study [ Time Frame: 8 months total. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	507
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental open label	Biological: 13 valent pneumococcal conjugate vaccine

Eligibility

Ages Eligible for Study:	15 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Male or female subjects >15months to <18years in good health
Available for entire study period and reachable by phone
Parents/legal guardian able and willing to complete all study procedures
Written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

Negative urine pregnancy test for female subjects who are menstruating.

Exclusion criteria:

Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component
Bleeding diathesis
Received blood transfusion or blood related products
Immune deficiency,congenital malformation.

Group 4 only:

Previous vaccination with Prevnar or any other pneumococcal vaccine.
Pregnant or breastfeeding adolescent females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761631

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Illinois
	Recruiting
Dekalb, Illinois, United States, 75235
United States, Ohio
	Recruiting
Cleveland, Ohio, United States, 44121
United States, Virginia
	Recruiting
Vienna, Virginia, United States, 22180

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:	6096A1-3011
Study First Received:	September 25, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00761631
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009