Last updated: 11/03/2018 12:33:13

Safety study of GSK Biologicals’ DTPa-IPV/Hib (Infanrix™-IPV/Hib)

GSK study ID
112065
See study documents
Clinicaltrials.gov ID
NCT00964028
See results summary
EudraCT ID
2015-001513-27
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib (Infanrix™-IPV/Hib) in infants
Trial description: This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with any solicited local symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after each dose and across doses

Number of subjects with any solicited general symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after each dose and across doses

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) follow-up period after each vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: During the whole study period (from Day 0 until Month 3 or Month 4)

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Infanrix™-IPV/Hib
    • Enrollment:
    50
    Primary completion date:
    2010-12-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Haemophilus influenzae type b, acellular pertussis, Diphtheria, Tetanus, Poliomyelitis
    Product
    SB213503
    Collaborators
    Not applicable
    Study date(s)
    December 2009 to April 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 study visit.
    • Born after a gestation period of 36 to 42 weeks inclusive.
    • Use of any investigational or non-registered product other than the study vaccine 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 study visit.

      • 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 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 the exception of hepatitis B vaccine.
      • 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 diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease.
      • Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.
      • 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.
      • 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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wuzhou, Guangxi, China, 543100
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    2010-12-04
    Actual study completion date
    2010-12-04

    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

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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