MalariaPhase 2NCT07036159
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
A Phase 2 study testing RTS,S/AS01E vaccine in people with Malaria, run by GlaxoSmithKline at 2 sites in Rwanda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- RTS,S/AS01E vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesRwanda
- Study dates
- 6 Aug 2025to 23 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted.
- Participants' parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits).
- Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific procedure.
- Healthy, as established by medical history and clinical examination.
- Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
- With hemoglobin levels >8 g/dL.
- Born after a gestation period of ≥37 weeks.
Who cannot join
- Progressive, unstable, or uncontrolled clinical conditions.
- History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Clinical conditions representing a contraindication to IM vaccination or blood draws.
- Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
- Recurrent history of or uncontrolled neurological disorders or seizures.
Show all 21Show fewer
- Undernutrition, defined as WHO Z-score less than -2 standard deviation.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
- Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- Prior receipt of a malaria vaccine (registered or experimental).
- Use of any investigational 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.
- Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this means prednisone ≥0.5 mg/kg/day or 20 mg/day, whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed.
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device).
- Any study personnel's immediate dependents, family, or household members.
- Child in care.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rwanda2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Kigali
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kigali
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 2a, Open Label, Randomized, Interventional Study to Assess the Safety and Immunogenicity of Alternative Vaccination Regimens and Reduced Antigen Doses of RTS,S/AS01E Vaccine in Healthy Children Aged 5-60 Months in a Malaria-endemic Area
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.
- Conditions
- Malaria
- Being tested
- RTS,S/AS01E vaccine
- Keywords
- Parasitic disease, Plasmodium falciparum, Malaria, Safety, Immunogenicity, Healthy children
- Medical subject headings
- Malaria, Parasitic Diseases, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTS,S/AS01E vaccineBiological
Also called Mosquirix
RTS,S/AS01E vaccine will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Groups 1 to 3 | Experimental | Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 2. Receives: Biological: RTS,S/AS01E vaccine |
| Groups 4 and 5 | Experimental | Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 7. Receives: Biological: RTS,S/AS01E vaccine |
| Groups 6 and 7 | Experimental | Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 2, and Month 7. Receives: Biological: RTS,S/AS01E vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentrations (GMCs) of anti-NANP immunoglobulin G (IgG) antibodies
Measured: 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)
Secondary outcomes (13)
Area under the curve (AUC) of anti-NANP IgG antibodies
Measured: At Month 7 and 19
GMC of anti-NANP IgG antibodies
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first study vaccine administration (Day 1) to the end of the study (Month 19)
Number of participants with SAEs
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: At Month 0, 1, 2, 3, 7, 8, 14, and 19
Geometric mean fold increase over pre-Dose 1 for anti-HBs IgG
Measured: At Month 0, 1, 2, 3, 7, 8, 14, and 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start6 Aug 2025
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien M Nyombayire, MD, MSc, Principal investigator, Center for Family Health ResearchMossi Nzeyimana, MD, Principal investigator, Rinda Ubuzima Gatenga Medicalized Health Center University of Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036159
- Sponsor's protocol ID
- 223247
- Other IDs
- 2024-000563-20
- Status last verified
- Sep 2025
- First submitted
- 16 Jun 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open Label, Randomized, Interventional Study to Assess the Safety and Immunogenicity of Alternative Vaccination Regimens and Reduced Antigen Doses of RTS,S/AS01E Vaccine in Healthy Children Aged 5-60 Months in a Malaria-endemic Area
- ClinicalTrials.gov ID
- NCT07036159
- Acronym / sponsor ID
- 223247
- Conditions
- Malaria
- Keywords
- Parasitic disease, Plasmodium falciparum, Malaria, Safety, Immunogenicity, Healthy children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Groups 1 to 3 | Experimental | Biological: RTS,S/AS01E vaccineParticipants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 2. |
| Groups 4 and 5 | Experimental | Biological: RTS,S/AS01E vaccineParticipants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 7. |
| Groups 6 and 7 | Experimental | Biological: RTS,S/AS01E vaccineParticipants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 2, and Month 7. |
Who may qualify
- Ages
- 5 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted.
- Participants' parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits).
- Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific procedure.
- Healthy, as established by medical history and clinical examination.
- Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
Key exclusion criteria (21 listed)
- Progressive, unstable, or uncontrolled clinical conditions.
- History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Clinical conditions representing a contraindication to IM vaccination or blood draws.
- Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTS,S/AS01E vaccineAlso: MosquirixRTS,S/AS01E vaccine will be administered intramuscularly. | Biological | Groups 1 to 3, Groups 4 and 5, Groups 6 and 7 |
Primary outcome
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)
13 secondary outcomes
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
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
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)
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)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: 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
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien M Nyombayire, MD, MSc principal investigator
Center for Family Health Research
Mossi Nzeyimana, MD principal investigator
Rinda Ubuzima Gatenga Medicalized Health Center University of Rwanda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RTS,S/AS01E vaccine in people with Malaria, run by GlaxoSmithKline at 2 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.