Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Streptococcal

Treatments: Other: Synflorix™ Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01248988

114469

Details and patient eligibility

About

The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.

Full description

Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has been updated. The protocol is being amended to reflect this update.

Enrollment: 622 patients

Sex: All

Ages: 6 weeks to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
• Korean male or female subjects whose age while receiving the first vaccination with Synflorix is 6 weeks - 5 years.
• Written, signed or thumb-printed 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 a witness.

Exclusion criteria

• At the time of Post Marketing Surveillance entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the infant must not be included in the Post Marketing Surveillance if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
• Subjects who receive any investigational or non-registered pneumococcal vaccine 30 days prior to the study start will not be enrolled. Subjects who had previous administration of a pneumococcal vaccine other than Synforix will not be enrolled into the study.
• A male or female children >= 5 years of age at study entry.

Trial design

622 participants in 1 patient group

Synflorix Group

Description:

Infants and children who received at least one dose of Synflorix™ as a part of routine practice at a private clinic or hospital

Treatment:

Other: Synflorix™ Data collection