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.
This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
540
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
3-dose intramuscular injection.
GSK Investigational Site
Kintampo, Ghana
GSK Investigational Site
Kumasi, Ghana
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 to Month 10
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: 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
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: 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)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
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Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)
Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Day 0, at Month 2, at Month 7 and at Month 10
Titers for Anti-Hepatitis B (Anti-HBs)
Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Day 0 and at Month 2