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Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea

NCT01568060 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 645

Last updated 2023-01-27

No results posted yet for this study

Summary

The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.

Conditions

  • Acellular Pertussis
  • Diphtheria
  • Tetanus
  • Poliomyelitis
  • Diphtheria-Tetanus-acellular Pertussis Vaccines

Interventions

OTHER

Infanrix-IPV data collection

Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
2 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-21
Primary Completion
2015-12-15
Completion
2015-12-15

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 NCT01568060 on ClinicalTrials.gov