Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

NCT01248988 | Completed

• 1 other identifier: 114469
• Study Type: observational
• Target: 622
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infections, Streptococcal

Keywords

Pneumococcal vaccine; Safety; Synflorix; Pneumococcal diseases

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

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

Interventions

Synflorix™ Data collection 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.

Synflorix Group

Eligibility Criteria

• Age: 6 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30084702 DERIVED

MeSH Terms

Conditions

Streptococcal Infections; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

KR (1)