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Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 24, 2010
Last updated: January 12, 2017
Last verified: January 2017
The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.

Condition Intervention
Infections, Streptococcal Other: Synflorix™ Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of unexpected adverse events [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. ]
  • Occurrence of expected adverse events [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. ]
  • Occurrence of serious adverse events [ Time Frame: From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose. ]

Enrollment: 622
Study Start Date: December 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

Ages Eligible for Study:   6 Weeks to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01248988

Korea, Republic of
GSK Investigational Site
Suwon, Kyonggi-do, Korea, Republic of, 443-721
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01248988     History of Changes
Other Study ID Numbers: 114469
Study First Received: November 24, 2010
Last Updated: January 12, 2017

Keywords provided by GlaxoSmithKline:
Pneumococcal vaccine
Pneumococcal diseases

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017