Phase 3
N=143
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
Pneumococcal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00560950 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
May 2009
Primary outcome: Primary: Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3 — 0.6; 1.4; 0.7; 1.2 gpELISA units/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pneumococcal 23v polysaccharide vaccine (Biological)
- Age
- Adult, Older Adult · 59+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3 |
0.6; 1.4; 0.7; 1.2 | — |
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4 |
1.1; 3.0; 1.7; 3.0 | — |
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B |
2.0; 4.6; 3.0; 5.2 | — |
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8 |
3.0; 9.3; 3.4; 7.4 | — |
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V |
2.7; 7.2; 4.1; 8.0 | — |
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F |
0.4; 1.5; 0.8; 1.5 | — |
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14 |
9.2; 18.0; 10.3; 17.2 | — |
| PRIMARY Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F |
1.8; 4.7; 2.8; 5.6 | — |
Summary
The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal or negative urine pregnancy test if female
- No fever on the day of vaccination
Exclusion Criteria
- History of allergy to vaccine components
- History of pneumococcal disease
- Received any live virus vaccination within 4 weeks prior to study start
- Received any inactivated vaccination within 7 days prior to study start
- Received any blood products within 5 months prior to study start
- Participated in an investigational drug or vaccine study in the past 30 days
- Received immunosuppressive therapy
- Patient has an immune deficiency
Data sourced from ClinicalTrials.gov (NCT00560950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.