Phase 3
N=1,053
Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00500266 ↗Enrolled (actual)
1,053
Serious AEs
2.4%
Results posted
Sep 2011
Primary outcome: Primary: Percentage of Participants With Pre-specified Local Reactions — 14.3; 12.6; 6.5; 1.1 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (13vPnC) (Biological)
- Age
- Older Adult · 68+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pre-specified Local Reactions |
14.3; 12.6; 6.5; 1.1; 12.8; 10.9 | — |
| PRIMARY Percentage of Participants With Pre-specified Systemic Events |
2.0; 0.8; 0.0; 0.3; 0.9; 34.4 | — |
| PRIMARY Percentage of Participants Taking Pain or Antipyretic Medication |
17.0; 6.4 | — |
Summary
To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.
Eligibility Criteria
MAIN INCLUSION CRITERIA:
- Male or female aged 68 years or older
- Determined by medical history, physical examination, and clinical judgment to be eligible for the study
- Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment
MAIN EXCLUSION CRITERIA:
- Known history of severe reaction to a vaccine
- Documented S pneumoniae infection within the past 5 years.
- Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids
- Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.
Data sourced from ClinicalTrials.gov (NCT00500266). 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.