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Post-marketing Safety Evaluation of Pneumococcal Vaccines Among Children and Elderly Adults.

NCT04551248 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000000

Last updated 2020-09-16

No results posted yet for this study

Summary

The purpose of this observational study is to examine the risk of adverse events following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age \<59 months and 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older.

Conditions

  • Pneumococcal Vaccine Adverse Reaction

Interventions

BIOLOGICAL

10 or 13-valent pneumococcal conjugate vaccine

a four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age.

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Single 0.5-mL dose administered intramuscularly or subcutaneously only.

BIOLOGICAL

Influenza vaccine

One dose of trivalent influenza vaccine in flu seasons.

Sponsors & Collaborators

  • Government-wide R&D Fund project for infectious disease research

    collaborator UNKNOWN

  • Sungkyunkwan University

    lead OTHER

Principal Investigators

  • Ju-Young Shin, PhD · Sungkyunkwan University

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT04551248 on ClinicalTrials.gov