N/A
N=696
Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
Adult Not Younger Than 65 Years
Bottom Line
View on ClinicalTrials.gov: NCT03014206 ↗Enrolled (actual)
696
Serious AEs
0.9%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With Adverse Reactions — 80; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Reactions |
80; 1 | — |
Summary
This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older).
1. To confirm the use in actual clinical settings
2. To confirm the occurrence of adverse events
Eligibility Criteria
Inclusion Criteria
- Geriatric patients vaccinated with this product (adult not younger than 65 years)
- Consent of vaccine recipients [Vaccine recipient (or his/her legally acceptable representative) must sign and date the consent form warranting that the relevant information concerning this Study was appropriately communicated to the recipient].
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT03014206). 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.