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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00774410 |
This study will assess the safety and tolerability of this 13v Pneumococcal vaccine (13vPnC) in 18-49 years old people. The results of the immune response in this age group will be compared to the immune response in people 60-64 years old.
Condition | Intervention | Phase |
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Pneumococcal Infections |
Biological: 13 valent pneumococcal conjugate vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vs. a 23vPS in Adults Aged 60 to 64 Years and 13vPnC in Adults Aged 18-59 Years Who Are Naive to 23vPS Vaccine. |
Estimated Enrollment: | 370 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
C: Experimental | Biological: 13 valent pneumococcal conjugate vaccine |
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female adults 18-49 years of age at time of enrollment. Negative urine pregnancy test for all female subjects in cohort 3.
Exclusion Criteria:
Previous immunization with any licensed or experimental pneumococcal vaccine. Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD), end stage renal disease, clinically unstable cardiac disease.
Known or suspected impairment of immunological function Pregnant or breastfeeding women.
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 6115A1-004 Cohort 3 |
Study First Received: | October 16, 2008 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00774410 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Gram-Positive Bacterial Infections Streptococcal Infections Pneumococcal Infections |
Infection |