Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

Completed

• Conditions: Infections, Streptococcal
• Interventions: Other: Synflorix™ Data collection

• Registration Number: NCT01248988
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Start: 2010-12
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 622

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Occurrence of expected adverse events	During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of unexpected adverse events	During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of serious adverse events	From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose.

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Suwon, Kyonggi-do, Korea, Republic of