Last updated: 11/07/2018 04:52:51
Safety and reactogenicity of GSK Biologicals’ Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ Inactivated Poliomyelitis vaccine Poliorix administered as a three-dose primary vaccination course at 2, 3 and 4 months of age in healthy infants in China.
Trial description: The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects reporting solicited local symptoms
Timeframe: During the 4-day follow-up period after each dose of study vaccine.
Number of subjects reporting solicited general symptoms
Timeframe: During the 4-day follow-up period after each dose of study vaccine.
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: During the 31-days follow-up period after each dose of the study vaccine.
Number of subjects reporting serious adverse events (SAEs)
Timeframe: During the entire study period (from Dose 1 up to one month following last vaccine dose).
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
25
Primary completion date:
2009-13-11
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)
August 2009 to November 2009
Type
Interventional
Phase
1
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 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 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
Protocol
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
2009-13-11
Actual study completion date
2009-13-11
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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Additional information
Results for study 112581 can be found on the GSK Clinical Study Register
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