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Sponsored by: |
Wyeth |
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00205803 |
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 |
ChemIDplus related topics: | Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | September 2004 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 42 Days to 98 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 6096A1-003 |
First Received: | September 19, 2005 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00205803 |
Health Authority: | United States: Food and Drug Administration |
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