Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
6-17 weeks
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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).
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Infants and children who are not indicated and/or contraindicated for the Prevenar13
usage will not be included.
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
HealthyStudy To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept
NCT04543344
- Brussels, Bruxelles-capitale, Région DE
ALL GENDERS
21 Years+
years
MULTIPLE SITES
HealthyStudy To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)
NCT01114568
ALL GENDERS
21 Years+
years
MULTIPLE SITES
HealthyTrial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children
NCT00192244
- Hong Kong,
ALL GENDERS
6 Months+
years
MULTIPLE SITES
HealthyThe Effects of Prazosin on Dopamine in Healthy Humans: A PET Pilot Study
NCT01999530
- Toronto, Ontario
ALL GENDERS
19 Years+
years
MULTIPLE SITES
Advanced Information
| 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 | |||