Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00676091

Purpose

The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.

Condition	Intervention	Phase
Vaccines, Pneumococcal Conjugate Vaccine	Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)	Phase III

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), Parallel Assignment, Safety Study
Official Title:	A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Brazil

Further study details as provided by Wyeth:

Primary Outcome Measures:

To compare immune response induced by infant series of routine pediatric vaccines when given with 13vPnC compared to the immune response when given with 7vPnC. Also to evaluate safety profile of, and immune response to 13vPnC. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare immune response induced following toddler dose of routine pediatric vaccines when given with 13vPnC compared to the immune response when given with 7vPnC. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	354
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 13vPnC	Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
2: Active Comparator 7vPnc	Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

Eligibility

Ages Eligible for Study:	up to 54 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy 1 month old infants
Available for the duration of the study and reachable by telephone
Able to complete two blood drawing procedures during the study

Exclusion criteria:

Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
Bleeding disorder, immune deficiency or significant chronic or congenital disease
Previous receipt of blood products or immune globulin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676091

Locations

Brazil

Sau Paulo, Brazil, 04038-001

Sau Paulo, Brazil, 04020-060

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:	6096A1-012
Study First Received:	April 8, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00676091
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Pneumococcal conjugate vaccine

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009