Last updated: 11/03/2018 08:47:45
Partially-blind (observer-blind) study of safety and immunogenicity of two malaria vaccines in Ghanaian Children
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A partially-blind (observer-blind) study to evaluate the safety and immunogenicity of 3 different vaccination schedules with 2 GSK Biologicals' candidate Plasmodium falciparum vaccines in children aged 5 to 17 months living in Ghana
Trial description: This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with serious adverse events (SAEs)
Timeframe: From Day 0 to Month 10
Secondary outcomes:
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
Titers for anti-Circumsporozoite protein of Plasmodium falciparum (anti-CS)
Timeframe: At Day 0, at Month 2, at Month 7 and at Month 10
Titers for anti-Hepatitis B (anti-HBs)
Timeframe: At Day 0 and at Month 2
Interventions:
Biological/vaccine: GSK Biologicals’ candidate Plasmodium falciparum malaria vaccine 257049
Biological/vaccine: Rabipur
Enrollment:
540
Observational study model:
Not applicable
Primary completion date:
2007-25-08
Time perspective:
Not applicable
Clinical publications:
Ansong D et al. (2011) T Cell Responses to the RTS,S/AS01E and RTS,S/AS02D Malaria Candidate Vaccines Administered According to Different Schedules to Ghanaian Children. PLoS One. 6(4):e18891.
Owusu-Agyei S et al. (2009) Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 4(10):e7302.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
August 2006 to May 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
5 - 17 months
Accepts healthy volunteers
Yes
- A male or female child between 5 months and 17 months of age 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.
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female child between 5 months and 17 months of age 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.
- Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
Exclusion criteria:
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
- Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Simultaneous participation in any other clinical trial;
- Previous participation in any other malaria vaccine trial;
- Any twins
- 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.
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
Completed
Actual primary completion date
2007-25-08
Actual study completion date
2008-30-05
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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