Description:

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Eligibility) is to be filled out at Visit 1 (Day -28 to day 0).

Link:

https://clinicaltrials.gov/ct2/show/NCT00307021

Keywords:
Versions (2) ▾
  1. 12/1/20
  2. 12/5/20
Copyright Holder:
GlaxoSmithKline
Uploaded on:

December 1, 2020

DOI:
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License:
Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Eligibility

  1. StudyEvent: ODM
    1. Eligibility
Administrative Data
Eligibility Check
Did the subject meet all the entry criteria?
Inclusion Criteria
A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination.
Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
Exclusion Criteria
Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infection without fever, i.e. axillary temperature < 37,5°C.
Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to: any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required); a family history of congenital or hereditary immunodeficiency; history of splenectomy; major congenital defects; history of any neurologic disorders or seizures; moderate malnutrition at screening defined as weight for age Z-score less than -2
Laboratory screening tests out of range, specifically hemoglobin, total white cell count, platelets, ALT and creatinine.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during study period
Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Previous participation in any other malaria vaccine trial
Simultaneous participation in any other clinical trial
Same sex twin
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial