drugset / Trial / NCT00169234
Pneumococcal Adult-dose Ranging Immunization Study
Phase 1/2
Completed
220 enrolled
Kaiser Permanente
Centers for Disease Control and Prevention · collab
RandomizedSingle-groupSingle-blindOther
Summary
The purpose of this study is to give seniors different doses of a new pneumococcal vaccine called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out which amount gives the best immune response. The PCV7 vaccine is currently licensed by the FDA for use in infants and toddlers only.
Timeline
- Start
- 2003-05
- Primary completion
- 2005-02
- Completion
- 2005-02
Publications
- Results Jackson LA, Neuzil KM, Nahm MH, Whitney CG, Yu O, Nelson JC, Starkovich PT, Dunstan M, Carste B, Shay DK, Baggs J, Carlone GM. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2007 May 16;25(20):4029-37. doi: 10.1016/j.vaccine.2007.02.062. Epub 2007 Mar 12.
- Results Jackson LA, Neuzil KM, Whitney CG, Starkovich P, Dunstan M, Yu O, Nelson JC, Feikin DR, Shay DK, Baggs J, Carste B, Nahm MH, Carlone G. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2005 May 25;23(28):3697-703. doi: 10.1016/j.vaccine.2005.02.017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pneumovax 23 | Vaccine | 0.5 ml | — |
| Subject | Prevnar 13 | Vaccine | 0.1 ml | — |
| Subject | Prevnar 13 | Vaccine | 0.5 ml | — |
| Subject | Prevnar 13 | Vaccine | 1 ml | — |
| Subject | Prevnar 13 | Vaccine | 2 ml | — |