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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-12-04
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
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Location
GSK Investigational Site
Wuzhou, Guangxi, China, 543100
Status
Study Complete
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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
Completed
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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