Last updated: 07/17/2024 15:23:29
Immunogenicity and safety study of GlaxoSmithKline Biologicals’ Poliorix™ vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity and safety of GSK Biologicals’ IPV (Poliorix™) in infants
Trial description: The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects against poliovirus types 1, 2 and 3
Timeframe: At Month 3, one month after the third vaccine dose
Secondary outcomes:
Number of seroprotected subjects against poliovirus types 1, 2 and 3
Timeframe: At Day 0, prior to the first vaccine dose
Anti-poliovirus types 1, 2 and 3 antibody titers
Timeframe: Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Within 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 3)
Interventions:
Biological/vaccine: Poliorix™
Biological/vaccine: Oral Poliovirus vaccine
Enrollment:
1101
Observational study model:
Not applicable
Primary completion date:
2010-05-07
Time perspective:
Not applicable
Clinical publications:
Li R et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, The Australia, 16-19 November 2011.
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)
November 2009 to July 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
60 - 90 days
Accepts healthy volunteers
Yes
- A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Inclusion and exclusion criteria
Inclusion criteria:
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR) (s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
Exclusion criteria:
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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, Hib and/or hepatitis B vaccine(s).
- 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 or intercurrent poliomyelitis disease or vaccination.
- 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(s).
- Major congenital defects or serious chronic illness.
- Child in care. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if 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(s) within 30 days preceding the first 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
2010-05-07
Actual study completion date
2010-05-07
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.
Additional information about the trial
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