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
- Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).
- Infants and children who are not indicated and/or contraindicated for the Prevenar13
usage will not be included.
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Descriptive Information | ||||
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Brief Title | Prevenar13 Post Market Surveillance | |||
Official Title | Post Marketing Surveillance To Observe Safety Of Prevenar 13 | |||
Brief Summary | It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA. | |||
Detailed Description | non-randomization, non-probability sampling | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage | |||
Condition | Healthy | |||
Intervention | Biological: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule Other Name: Prevenar 13 | |||
Study Groups/Cohorts | Group1
Intervention: Biological: 13-valent pneumococcal vaccine | |||
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 | 649 | |||
Original Estimated Enrollment | 600 | |||
Actual Study Completion Date | January 2016 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 6 Weeks to 17 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01509105 | |||
Other Study ID Numbers | 6096A1-4029 B1851057 ( Other Identifier: Alias Study Number ) | |||
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 | December 2016 |