Last updated: 09/12/2019 12:10:12
Post-marketing surveillance to assess the safety of Boostrix vaccine given according to prescribing information in Korea
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Assessment of safety of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine (dTPa), Boostrix when administered according to the approved Prescribing Information in Korea
Trial description: The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with unexpected adverse events (AEs)
Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Number of subjects with expected AEs.
Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Number of subjects with Serious Adverse Events (SAEs)
Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Boostrix
Other: Safety data collection
Enrollment:
682
Observational study model:
Cohort
Primary completion date:
2016-11-01
Time perspective:
Prospective
Clinical publications:
Park HJ et al. (2019) A 6-year prospective, observational, multi-center post-marketing surveillance of the safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in Korea. J Korean Med Sci. 34(12):e105.
Medical condition
Diphtheria-Tetanus-acellular Pertussis Vaccines
Product
SB263855
Collaborators
Not applicable
Study date(s)
September 2013 to January 2016
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
10+ years
Accepts healthy volunteers
Yes
- Written or signed informed consent obtained from the subject/ subject’s parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.
- Those who are not eligible for vaccination according to the local Prescribing Information.
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- Written or signed informed consent obtained from the subject/ subject’s parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.
Exclusion criteria:
- Those who are not eligible for vaccination according to the local Prescribing Information.
- Child in care.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
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
2016-11-01
Actual study completion date
2016-11-01
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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