A Phase 2 interventional study of RTS,S/AS01E vaccine in Malaria, sponsored by GlaxoSmithKline. Recruiting at 2 sites in Rwanda. Open to participants aged 5 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 238 is close to the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Use of any or non-registered product (drug, vaccine, or medical device)* other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -30 to Day 1), or planned use during the study period.
*Use of herbs and traditional treatments is not considered an exclusion criterion.
Planned administration of a vaccine not foreseen by the study protocol or the country EPI in the period starting 14 days before each dose and ending 28 days after the last dose of study vaccine administration*, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign*.
*If emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided the vaccination is used according to the local governmental recommendations and the Sponsor is notified.
Under such circumstances, a participant may be considered eligible for study enrollment and/or study vaccine administration after the appropriate window for delay has passed, if the participant is confirmed to be eligible after inclusion/exclusion criteria have been re checked.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 2.
Biological: RTS,S/AS01E vaccine
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 7.
Biological: RTS,S/AS01E vaccine
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 2, and Month 7.
Biological: RTS,S/AS01E vaccine
RTS,S/AS01E vaccine will be administered intramuscularly.
Also known as: Mosquirix
Geometric 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)
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
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
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