Last updated: 03/20/2019 11:50:12

Post Marketing Surveillance of Synflorix vaccine safety among infants in Korea

GSK study ID
114469
See study documents
Clinicaltrials.gov ID
NCT01248988
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of unexpected adverse events

Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.

Occurrence of expected adverse events

Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.

Occurrence of serious adverse events

Timeframe: From the first dose in the study up to 30 days (Day 0 – Day 29) after the last dose.

Secondary outcomes:
Not applicable
Interventions:
  • Other: Synflorix™ Data collection
    • Enrollment:
    622
    Primary completion date:
    2015-24-09
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Lee SM et al. (2018) 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. 14(12):3019-3025.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A, GSK2647154A
    Collaborators
    Not applicable
    Study date(s)
    December 2010 to September 2015
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6 weeks - 5 years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Suwon, Kyonggi-do, South Korea, 443-721
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-24-09
    Actual study completion date
    2015-24-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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