Last updated: 11/03/2018 12:10:24
Feasibility study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 3, 5 and 11 months of age.
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: Feasibility study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 3, 5 and 11 months of age.
Trial description: This study will evaluate the safety and immunogenicity of GSK Biologicals’ GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Anti-PRP antibody concentrations ≥ 0.15 mg/mL
Timeframe: At Month 3
Secondary outcomes:
Number of subjects with any, grade 3 and related solicited local symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of subjects with unsolicited adverse events AE(s)
Timeframe: During the 31-day (Days 0-30) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Month 0 to Month 9)
Interventions:
Biological/vaccine: GSK2202083A vaccine
Biological/vaccine: Infanrix hexa
Biological/vaccine: Menjugate
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
2009-25-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus influenzae type b, Diphtheria, acellular pertussis, Hepatitis B
Product
GSK2202083A
Collaborators
Not applicable
Study date(s)
April 2009 to June 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
8 - 16 weeks
Accepts healthy volunteers
Yes
- A male or female infant between, and including, 8 and 16 weeks 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.
- 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, 8 and 16 weeks 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 randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
- 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, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
- 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 if no other exclusion criteria is met:
- Current febrile illness or axillary temperature >= 38.5 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
Terminated (halted prematurely)
Actual primary completion date
2009-25-06
Actual study completion date
2009-25-06
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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