Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

NCT ID: NCT01248988

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 622 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

Infections, Streptococcal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Synflorix™ Data collection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Suwon, Kyonggi-do, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30084702 (View on PubMed)

Other Identifiers

114469

Identifier Type: -

Identifier Source: org_study_id