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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Poliomyelitis; Diphtheria; Tetanus; Diphtheria-Tetanus-acellular Pertussis Vaccines; Acellular Pertussis

Treatments: Other: Infanrix-IPV data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01568060

114917

Details and patient eligibility

About

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

Enrollment: 645 patients

Sex: All

Ages: 2 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

645 participants in 1 patient group

Infanrix-IPV group

Description:

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

Treatment:

Other: Infanrix-IPV data collection