Phase 4
N=84,496
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
Pneumonia, Pneumococcal · Pneumococcal Infections · 13-valent Pneumococcal Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT00744263 ↗Enrolled (actual)
84,496
Serious AEs
0.9%
Results posted
Oct 2014
Primary outcome: Primary: Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP) — 49; 90 participants — p=0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- VACCINE: placebo (Biological); VACCINE: 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP) |
49; 90 | 0.0006 sig |
| SECONDARY Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP) |
33; 60 | 0.0067 sig |
| SECONDARY Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases |
7; 28 | 0.0005 sig |
Summary
The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.
Exclusion Criteria
- Previous vaccination with any licensed or experimental pneumococcal vaccine
- Residence in a nursing home, long-term care facility, or similar facility
- Known hypersensitivity to vaccination
- Immune deficiency or suppression
Data sourced from ClinicalTrials.gov (NCT00744263). 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.