Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
NCT03014206
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Adult Trials: 18+ Years
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].
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| 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 |
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| 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 | |||