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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2015-24-09
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
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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
Finalized
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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