Last updated: 11/07/2018 07:35:47
Immunogenicity and safety of booster dose of PoliorixTM vaccine in previously vaccinated toddlers
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ IPV (PoliorixTM) in healthy Chinese toddlers
Trial description: This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value
Timeframe: One month after Poliorix™ booster vaccination.
Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value
Timeframe: Before booster vaccination.
Antibody titers against poliovirus type 1, 2 and 3
Timeframe: One month after Poliorix™ booster vaccination.
Antibody titers against poliovirus type 1, 2 and 3.
Timeframe: Before booster vaccination.
Secondary outcomes:
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of subjects with any, grade 3 and related solicited general symptoms.
Timeframe: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of subjects reporting any unsolicited adverse events (AEs)
Timeframe: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (Day 0 to Month 1).
Interventions:
Enrollment:
957
Primary completion date:
2011-19-09
Observational study model:
Not applicable
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)
April 2011 to September 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 24 months
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
- Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
Exclusion criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
- Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) 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.
- Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrolment.
Child in care.
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
Study complete
Actual primary completion date
2011-19-09
Actual study completion date
2011-19-09
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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