Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

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

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

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Other: Synflorix™ Data collection

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 Type: Observational
• Enrollment (Actual): 622

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Kyonggi-do, Korea, Republic of, 443-721
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Synflorix Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Lee SM, Lee JH, Song ES, Kim SJ, Kim JH, Jakes RW, Devadiga R, Park MS. A 6-year safety surveillance of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in South Korea. Hum Vaccin Immunother. 2018;14(12):3019-3025. doi: 10.1080/21645515.2018.1502525. Epub 2018 Aug 29.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 24, 2010
• First Submitted That Met QC Criteria: November 24, 2010
• First Posted (Estimate): November 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Pneumococcal vaccine; Synflorix; Pneumococcal diseases
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: 114469