Last updated: 11/07/2018 04:59:04
Safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ IPV vaccine (PoliorixTM) in toddlers
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ Inactivated Poliomyelitis Vaccine Poliorix administered as a booster dose at 18-24 months of age in healthy toddlers in China.
Trial description: The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Day 0 to Month 1)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: PoliorixTM
Enrollment:
26
Observational study model:
Not applicable
Primary completion date:
2009-03-08
Time perspective:
Not applicable
Clinical publications:
Li R et al. (2016) Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 34(12):1436-1443.
Medical condition
Poliomyelitis
Product
SB208132
Collaborators
Not applicable
Study date(s)
June 2009 to August 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 24 months
Accepts healthy volunteers
Yes
- A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
Exclusion criteria:
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP and/or Hib vaccine(s).
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Previous booster vaccination against poliomyelitis since the end of the primary vaccination series.
- History of poliomyelitis disease.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-03-08
Actual study completion date
2009-03-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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