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Prevenar13 Post Market Surveillance

NCT01509105 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 649

Last updated 2017-02-13

Study results available
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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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

13-valent pneumococcal vaccine

0.5mL IM (Intramuscular administration) as per recommended schedule

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
6 Weeks
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509105 on ClinicalTrials.gov