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
Study complete
Study complete
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:
Enrollment:
540
Primary completion date:
2007-25-08
Observational study model:
Not applicable
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
Study complete
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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