Study Evaluating Pneumococcal Vaccine in Healthy Infants - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00205803

Purpose

The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.

Condition	Intervention	Phase
Healthy Subjects Pneumococcal Infections	Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)	Phase I Phase II

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Official Title:	A Phase I/II, 2-Stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety as assessed by adverse events, fever and other systemic reactions and local injection site reactions.
Immunogenicity assessed by serum IgG antibody levels.

Secondary Outcome Measures:

Safety and immunogenicity after the toddler dose, as well as immune response to concomitant vaccines.

Estimated Enrollment:	240
Study Start Date:	September 2004
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	42 Days to 98 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy 2-month-old infants.
Born at full term.
Available for the study period.

Exclusion Criteria:

Previous vaccination with pneumococcal vaccine.
Previous vaccination with Hib conjugate, DTaP or IPV vaccines
Contraindication to immunization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205803

Locations

United States, New York

New York, New York, United States, 10045

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	6096A1-003
Study First Received:	September 19, 2005
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00205803
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Infant Vaccine

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Healthy
Pneumococcal Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009