Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

Infections, Streptococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248988
• Other study ID #: 114469
• Status: Completed
• Phase: N/A
• First received: November 24, 2010
• Last updated: January 12, 2017
• Start date: December 2010
• Est. completion date: September 2015

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Streptococcal
• Streptococcal Infections

Intervention

Other:
• Synflorix™ Data collection
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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Suwon, Kyonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of unexpected adverse events		During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Primary	Occurrence of expected adverse events		During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Primary	Occurrence of serious adverse events		From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose.