Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Diphtheria-Tetanus-acellular Pertussis Vaccines

Treatments: Other: Safety data collection; Biological: Boostrix

Study type: Observational

Funder types: Industry

Identifiers

NCT01929291

115374

Details and patient eligibility

About

The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.

Full description

Protocol amendment 3 rationale was as follows:

• Age for analysis set is specified.
• Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
• Pregnancy notifications must be done within 2 weeks

Enrollment: 682 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.

Exclusion criteria

• Those who are not eligible for vaccination according to the local Prescribing Information.
• Child in care.

Trial design

682 participants in 1 patient group

Boostrix Group

Description:

Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.

Treatment:

Biological: Boostrix

Other: Safety data collection