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

NCT ID: NCT01568060

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 645 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-21
• Study Completion Date: 2015-12-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infanrix-IPV group

Infants and children who received at least one dose of Infanrix-IPV as a part of routine practice at a private clinic or hospital in korea

Infanrix-IPV data collection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
• Korean male or female subjects who are eligible for the primary and/or booster doses of Infanrix-IPV according to the Korean Prescribing Information.
• Written or signed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. Where parent(s)/ legally acceptable representatives are illiterate, the consent form will be countersigned by an impartial witness. Prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. And prior to obtaining informed consent form, the investigator will check whether the subject is eligible for vaccination.

Exclusion Criteria

• At the time of post-marketing surveillance (PMS) entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
• Subjects who receive any investigational or non-licensed DTPa-IPV vaccine within 30 days prior to study start will not be enrolled.
• Child in care.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Seoul, , South Korea

Countries

South Korea

References

Lee SM, Kim SJ, Chen J, Song R, Kim JH, Devadiga R, Kim YK. Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children. Hum Vaccin Immunother. 2019;15(5):1145-1153. doi: 10.1080/21645515.2019.1572406. Epub 2019 Mar 19.

Reference Type: BACKGROUND

PMID: 30668217 (View on PubMed)

Other Identifiers

114917

Identifier Type: -

Identifier Source: org_study_id