N/A
Completed N=696
Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
Adult Not Younger Than 65 Years
Source: ClinicalTrials.gov NCT03014206 ↗
Enrolled (actual)
696
Serious AEs
0.9%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Adverse Reactions — 80; 1 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Reactions |
80; 1 | — |
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. Informational only — not medical advice.