Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

Study Overview
=================
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.

Official Title
-----------------
Safety of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal-protein D-diphtheria Toxoid-tetanus Toxoid Conjugate (10PN-PD-DiT) Vaccine, Synflorix When Administered According to the Approved Prescribing Information in Korea

Conditions
-----------------
Infections, Streptococcal

Intervention / Treatment
-----------------
* Other: Synflorix™ Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Synflorix Group<br>Infants and children who received at least one dose of Synflorix™ as a part of routine practice at a private clinic or hospital | Other: Synflorix™ Data collection<br>* Safety monitoring: recording of adverse events during using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of unexpected adverse events |  | During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. | 
| Occurrence of expected 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumococcal vaccine, Safety, Synflorix, Pneumococcal diseases