An observational study in Malaria, sponsored by GlaxoSmithKline. Completed at 2 sites in 2 countries. Open to participants aged 5 Months to 17 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by GlaxoSmithKline · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 41 studies in Malaria by GlaxoSmithKline — 3 open to participants now, 3 under way, none of them phase 3. Malaria · GlaxoSmithKline.
Among the 41 studies in Malaria by GlaxoSmithKline, this one is the only one that started in 2018, is one of 3 observational ones, and was the 36th registered.
1,185 studies on the registry are indexed under Malaria; 80 are open to participants now.
Browse Malaria studies →3 of the 41 studies in Malaria by GlaxoSmithKline are open now, in 4 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Gabon, Uganda
Ages 18–65
GlaxoSmithKline · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
GlaxoSmithKline · Sites in Rwanda
Ages 5 mo–60 mo · Healthy volunteers
By country, each count listing its studies:
Of the 52 Malaria studies recruiting now, 15 (29%) set no upper age limit and 34 (65%) stop at 75 or younger; 38 take children under 18; 32 take healthy volunteers.
This study: 5 Months to 17 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,500 is above the median of 582 across 204 observational studies indexed under Malaria.
Median enrollment 207 across the 38 interventional studies, 36,366 across the 3 observational. Of the 38 that completed or were terminated, 23 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
2 of the studies in Malaria by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07036159GlaxoSmithKlineA Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months | 2027-04-23 |
| NCT07545681GlaxoSmithKlineA Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria | 2027-10-08 |
Add all 2 to your calendar (.ics) → With an account.
Among the 41 studies in Malaria by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this study was to evaluate the effectiveness of the RTS,S/AS01E malaria vaccine against both clinical and asymptomatic malaria infections by detecting Plasmodium falciparum (P. falciparum) parasites in blood samples collected from children who received the primary and yearly booster doses of the RTS,S/AS01E vaccine, as part of their participation in the Malaria-094 parent clinical study. The genomic analysis was conducted on parasites found in blood spot samples from children aged 5-17 months, who were vaccinated according to different dosage and schedule regimens as part of the Malaria-094 parent clinical study.
This genotyping study of malaria parasites, collected from serial blood samples following RTS,S/AS01E immunization, assessed vaccine efficacy using molecular genetic data. The study aimed to identify the first infections post-vaccination and distinguish new infections from existing ones through an amplicon sequencing-based strategy. This involved deep sequencing of small, highly variable regions of the parasite genome, enabling both: 1. Highly sensitive detection of parasitemia (similar to conventional polymerase chain reaction [PCR]-based detection), and 2. Identification of genetically distinct parasite populations within or between affected individuals.
Community sample
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:
Chronic administration (defined as more than 14 days in total) of or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For , this meant prednisone (0.5 mg/kg/day (for pediatric participants) or equivalent. Inhaled and topical steroids are allowed.
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.
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.
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.
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.
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.
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 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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and Month 20 of study NCT03276962.
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2, Month 14, Month 26 and Month 38 of study NCT03276962.
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2, Month 14, Month 26 and Month 38 of study NCT03276962.
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7, Month 20 and Month 32 of study NCT03276962.
Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962.
Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 20 Study Visit
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: Up to 20 months post Dose 1
Time From First Vaccination to the Detection of the First New Malaria Infection From 14 Days Post-Dose 3 Through to 12 Months Post-Dose 3
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: From Month 2.5 to Month 14 for the R012-20 + R012-14-mD Pooled Group, the Fx012-14-mFxD Group and the Control Group, and from Month 7.5 to Month 19 for the Fx017-mFxD Group
Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 32 Study Visit
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: Up to 32 months post Dose 1
Time From First Vaccination to the Detection of the First New Malaria Infection From 14 Days Post-Dose 3 Through to 24 Months Post-Dose 3
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: From Month 2.5 to Month 26 for the R012-20 Group, the R012-14-mD Group, the Fx012-14-mFxD Group and the Control Group, and from Month 7.5 to Month 31 for the Fx017-mFxD Group
Number of Molecularly Confirmed New Malaria Infections Through to the Month 20 Study Visit
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: Up to 20 months post Dose 1
Number of Molecularly Confirmed New Malaria Infections From 14 Days Post-Dose 3 Through to 12 Months Post-Dose 3
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: From Month 2.5 to Month 14 for the R012-20 + R012-14-mD Pooled Group, the Fx012-14-mFxD Group and the Control Group, and from Month 7.5 to Month 19 for the Fx017-mFxD Group
Number of Molecularly Confirmed New Malaria Infections Through to the Month 32 Study Visit
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: Up to 32 months post Dose 1
Number of Molecularly Confirmed New Malaria Infections From 14 Days Post-Dose 3 Through to 24 Months Post-Dose 3
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
Time frame: From Month 2.5 to Month 26 for the R012-20 Group, the R012-14-mD Group, the Fx012-14-mFxD Group and the Control Group, and from Month 7.5 to Month 31 for the Fx017-mFxD Group
This is an ancillary study of the Malaria-094 study (204889/NCT03276962). Consequently, the data reported in the Participant Flow and Baseline Characteristics sections were collected from participants from that study.
| Milestone | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Started | 298 | 294 | 304 | 311 | 293 |
| Completed | 229 | 232 | 242 | 247 | 237 |
| Not completed | 69 | 62 | 62 | 64 | 56 |
| Withdrew: Serious adverse event and/or pimd | 2 | 1 | 0 | 4 | 1 |
| Withdrew: Protocol deviation | 2 | 0 | 1 | 2 | 1 |
| Withdrew: Consent withdrawal, not due to an adverse event/a serious adverse event | 29 | 21 | 13 | 21 | 16 |
| Withdrew: Migrated / moved from the study area | 26 | 28 | 44 | 29 | 27 |
| Withdrew: Lost to follow-up | 10 | 10 | 4 | 6 | 10 |
| Withdrew: Other | 0 | 2 | 0 | 2 | 1 |
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Weeks | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 20 Study Visit | 43.1 (15.1 to 85.9) | 43.9 (17.4 to 86.4) | 39 (19.4 to 79.3) | 39 (15.7 to 87.7) | 31.9 (10.4 to 64.9) |
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Weeks | R012-20 + R012-14-mD Pooled Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|
| Time From First Vaccination to the Detection of the First New Malaria Infection From 14 Days Post-Dose 3 Through to 12 Months Post-Dose 3 | 40.6 (20.4 to NA) | 36.7 (21.9 to NA) | 38.6 (12.6 to NA) | 28.7 (10.6 to NA) |
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Weeks | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 32 Study Visit | 42.4 (12.6 to 97.1) | 42.7 (12.7 to 97.7) | 38.9 (19.6 to 79.3) | 37.7 (14.7 to 94) | 31 (10.3 to 64) |
The number of days from the time origin in each analysis to the visit date associated with the first molecular detection of a new malaria infection. A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Weeks | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Time From First Vaccination to the Detection of the First New Malaria Infection From 14 Days Post-Dose 3 Through to 24 Months Post-Dose 3 | 40.3 (20 to NA) | 42 (20.3 to NA) | 36.7 (21.9 to 83.7) | 38.4 (12.6 to NA) | 28.7 (10.4 to NA) |
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Infections | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Molecularly Confirmed New Malaria Infections Through to the Month 20 Study Visit | 758 | 558 | 605 | 673 | 996 |
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Infections | R012-20 + R012-14-mD Pooled Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|
| Number of Molecularly Confirmed New Malaria Infections From 14 Days Post-Dose 3 Through to 12 Months Post-Dose 3 | 1825 | 337 | 368 | 477 |
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Infections | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Molecularly Confirmed New Malaria Infections Through to the Month 32 Study Visit | 1105 | 940 | 910 | 1029 | 1420 |
A new molecularly confirmed malaria infection was defined by a detected new infection from genomic analysis of dried blood spot samples originating either from active monthly screening for infection or from unscheduled visits intended for the assessment of clinical malaria.
| Infections | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Molecularly Confirmed New Malaria Infections From 14 Days Post-Dose 3 Through to 24 Months Post-Dose 3 | 804 | 728 | 704 | 836 | 1071 |
Collected over All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| R012-20 Group | — | — | — |
| R012-14-mD Group | — | — | — |
| Fx012-14-mFxD Group | — | — | — |
| Fx017-mFxD Group | — | — | — |
| Control Group | — | — | — |
| Age, Continuous(Months) | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Mean | 10.2 ± 3.9 | 10.3 ± 3.8 | 10.5 ± 4.0 | 10.2 ± 3.8 | 10.5 ± 3.9 | 10.3 ± 3.9 |
| Sex: Female, Male(Participants) | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Female | 119 | 155 | 172 | 163 | 152 | 761 |
| Male | 179 | 139 | 132 | 148 | 141 | 739 |
| Race/Ethnicity, Customized(Participants) | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Black Or African American | 298 | 294 | 304 | 311 | 293 | 1500 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — GSK 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.
Ran from Nov 2018 to primary completion in Apr 2022, 41 months.
Results were first posted in Jan 2025, 2 years 9 months after primary completion.
Of 93 observational studies under Malaria, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.