Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
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|ClinicalTrials.gov Identifier: NCT00269672|
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : August 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Vaccines, Pneumococcal Conjugate Vaccine||Biological: 13-valent Pneumococcal Conjugate Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||915 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
- Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
- Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
- Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269672
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|