Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
NCT03014206
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Geriatric patients vaccinated with this product (adult not younger than 65 years)
2. 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].
None
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Tokyo,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older- | |||
Official Title | Prevenar13(Registried) Suspension Liquid For Injection Drug Use Investigation - Adults Aged 65 Years Or Older | |||
Brief 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).
| |||
Detailed Description | This study is a multicenter open-label cohort conducted in patients vaccinated with the Product; for which, case report forms will be recorded based on data presented in medical records obtained from day-to-day clinical treatment and diagnosis. "Pneumococcal vaccine health study diary" will be implemented to collect accurate safety data; to which, vaccine recipients will be asked directly to cooperate. | |||
Study Type | Observational [Patient Registry] | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | 28 Days | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Geriatric patients vaccinated with this product (adult not younger than 65 years) | |||
Condition | Adult Not Younger Than 65 Years | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 696 | |||
Original Estimated Enrollment | 660 | |||
Actual Study Completion Date | January 2017 | |||
Actual Primary Completion Date | January 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: None | |||
Sex/Gender |
| |||
Ages | 65 Years and older (Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT03014206 | |||
Other Study ID Numbers | B1851121 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2018 |