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Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01248988
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date November 24, 2010
First Posted Date November 25, 2010
Last Update Posted Date January 13, 2017
Study Start Date December 2010
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 24, 2010)
  • 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. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01248988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Infections, Streptococcal
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.
Study Groups/Cohorts 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
Intervention: Other: Synflorix™ Data collection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 16, 2015)
622
Original Estimated Enrollment
 (submitted: November 24, 2010)
3000
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Weeks to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01248988
Other Study ID Numbers 114469
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2017