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.
- 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.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| 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 | |||
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
