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

Completed

• Conditions: Acellular Pertussis; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines; Tetanus; Poliomyelitis
• Interventions: Other: Infanrix-IPV data collection

• Registration Number: NCT01568060
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-04-02
• Study Start: 2012-05-21
• Primary Completion: 2015-12-15
• Study Completion: 2015-12-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 645

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infanrix-IPV group	Infanrix-IPV data collection	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

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of serious adverse events	Starting at Visit 1 in the post-marketing surveillance (PMS) up to 30 days (Day 0 to Day 29) after the last dose is administered in the PMS

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of