Last updated: 11/07/2018 04:52:51

Safety and reactogenicity of GSK Biologicals’ Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in infants

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GSK study ID
112581
See study documents
Clinicaltrials.gov ID
NCT00937404
See results summary
EudraCT ID
2017-001607-80
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
Biological/vaccine: Poliorix
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
2009-13-11
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:

    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.
    • 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.
Exclusion criteria:

    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.
    • 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Wuzhou, Guangxi, China
Status
Study Complete
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Study documents

Protocol
Available language(s): English
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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
2009-13-11
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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