The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
238
RTS,S/AS01E vaccine will be administered intramuscularly.
GSK Investigational Site
Kigali, Rwanda
RECRUITINGGSK Investigational Site
Kigali, Rwanda
RECRUITINGGeometric Mean Concentrations (GMCs) of anti-NANP immunoglobulin G (IgG) antibodies
Time frame: 12 months post-Dose 3 (Month 14 for Groups 1 to 3 and Month 19 for Groups 4 and 5 and Groups 6 and 7)
Area under the curve (AUC) of anti-NANP IgG antibodies
Time frame: At Month 7 and 19
GMC of anti-NANP IgG antibodies
Time frame: At Month 0, 1, 2, 3, 7, 8, 14, and 19
Number of participants with a greater than or equal to (>=) 2-fold and a (>=) 4-fold increase from pre-Dose 1 in IgG antibody concentration
Time frame: At Month 0, 1, 2, 3, 7, 8, 14, and 19
Number of participants with solicited administration site events
Solicited administration site events include pain, redness, and swelling at administration site.
Time frame: Up to 7 days after each vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7)
Number of participants with solicited systemic events
Solicited systemic events include fever, irritability/fussiness, loss of appetite, sleepiness/drowsiness, and vomiting.
Time frame: Up to 7 days after each vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7)
Number of participants with unsolicited adverse events (AEs)
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame: Within 30 days after each study vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7)
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Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity, or other medically significant events.
Time frame: From first study vaccine administration (Day 1) to the end of the study (Month 19)
Number of participants with SAEs
Time frame: From first study vaccine administration (Day 1) to 12 months after the last study vaccine administration (Month 14 for Groups 1 to 3 and Month 19 for Groups 4 and 5 and Groups 6 and 7)
Number of participants with adverse events of special interest (AESIs)
AESIs include febrile convulsion that are defined as seizures that occur in febrile children between the ages of 6 and 60 months who do not have an intracranial infection, metabolic disturbance, or history of afebrile seizures.
Time frame: Up to 7 days after each vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7)
Number of participants with AEs/SAEs leading to withdrawal from the study and/or discontinuation of study vaccine
Time frame: From first study vaccine administration (Day 1) to the end of the study (Month 19)
GMC of anti-hepatitis B surface antigens (HBs) antibody concentrations (IgG)
Time frame: At Month 0, 1, 2, 3, 7, 8, 14, and 19
Number of participants achieving anti-HBs IgG levels above 6.2 International Units per liter (IU/L) and 10.0 IU/L
Time frame: At Month 0, 1, 2, 3, 7, 8, 14, and 19
Geometric mean fold increase over pre-Dose 1 for anti-HBs IgG
Time frame: At Month 0, 1, 2, 3, 7, 8, 14, and 19