Last updated: 09/26/2019 09:20:14
A post-marketing safety study of GSK Bio IPV vaccine (PoliorixTM) in Korean children
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, multicentric, PMS study to monitor safety and reactogenicity of GlaxoSmithKline Biologicals’ Poliomyelitis vaccine (inactivated)-Poliorix, administered in Korean children as a primary vaccination in healthy subjects aged 2 to 6 months or as a booster vaccination in subjects aged 4 to 6 years
Trial description: Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of unsolicited adverse events.
Timeframe: During 7 days (Day 0 - 6) following vaccination.
Occurrence of serious adverse events (SAEs).
Timeframe: During the entire study period.
Secondary outcomes:
Occurrence of solicited local and general adverse events.
Timeframe: During 7 days (Day 0 to 6) after vaccination
Interventions:
Enrollment:
349
Primary completion date:
2011-12-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Sin JB et al. (2013) Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (Poliorix™ ) in Korea (2006-2012). Korean J Pediatr Infect Dis. 20(3):139-146.
Medical condition
Poliomyelitis
Product
SB208132
Collaborators
Not applicable
Study date(s)
July 2007 to July 2011
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
2 months - 6 years
Accepts healthy volunteers
Yes
- A healthy male or female child between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards)
- At the time of study entry, the contraindications and precautions of use indicated in the Korean Label should be checked and the subject must not be included in the study if there is any contraindication or risk
Inclusion and exclusion criteria
Inclusion criteria:
- A healthy male or female child between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards)
- Written informed consent obtained from the parent/ guardian of the subject
Exclusion criteria:
- At the time of study entry, the contraindications and precautions of use indicated in the Korean Label should be checked and the subject must not be included in the study if there is any contraindication or risk
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
Study complete
Actual primary completion date
2011-12-07
Actual study completion date
2011-12-07
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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