MalariaNCT03281291

Study to Assess the Vaccine Efficacy Against Malaria Infection, in Children Immunized With the Primary and Yearly Booster of the RTS,S/AS01E Vaccine, as Part of Their Participation in the Malaria-094 (204889/NCT03276962) Study.

An observational study of Malaria, run by GlaxoSmithKline at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 17 monthsHealthy volunteers can take part
Conditions the study is for: Malaria
Type of treatment: Vaccines
How many people: 1,500 participants
Where: 2 sitesin 2 countries
Study dates: 19 Nov 2018to 23 Oct 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 months
All sexes
Healthy volunteers accepted
Child

Study population: Community sample

Who may be able to join

Participants' parent(s)/LAR(s) who, in the opinion of the investigator, complied with the requirements of the protocol (e.g. return for follow-up visits).
Signed or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. Where parent(s)/LAR(s) were illiterate, the consent form was countersigned by an independent witness.
A male or female between, and including, five and 17 months of age at the time of the first vaccination.
Healthy participants as established by medical history and clinical examination before entering into the study.
Previously received three documented doses of diphtheria, tetanus, pertussis, hepatitis B vaccine (DTPHepB), and at least three doses of oral polio vaccine.

Who cannot join

Child in care.
Use of a drug or vaccine that is not approved for that indication (by one of the following regulatory authorities: Food and Drug Administration [FDA; USA] or European Union member state or WHO [with respect to prequalification]) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
Any medical condition that in the judgment of the investigator would have made the intramuscular injection unsafe.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this meant prednisone (0.5 mg/kg/day (for pediatric participants) or equivalent. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before each dose and ending seven days after each dose of vaccine administration.
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or was to be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).

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Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
History of anaphylaxis post-vaccination.
History of any, or documented, serious adverse reaction to rabies vaccination.
Contraindication to rabies vaccination (Rabipur is contraindicated in participants with a history of a severe hypersensitivity to any of the ingredients in the vaccine. Note that the vaccine contains polygeline and residues of chicken proteins, and may contain traces of neomycin, chlortetracycline and amphotericin B).
Major congenital defects.
Serious chronic illness.
Children with a past history of a neurological disorder or atypical febrile seizure (a febrile seizure is atypical if it meets one of the following criteria: not associated with fever; lasts > 5 minutes; focal (not generalized); followed by transient or persistent neurological abnormality; occurs in a child < 6 months of age).
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may have been enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
Moderate or severe malnutrition at screening defined as weight for age or weight for height Z-score < -2.
Hemoglobin concentration < 8 g/dl at screening.
Same sex twins (to avoid misidentification).
Maternal death.
Prior receipt of an investigational malaria vaccine.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Ghana1 site

GSK Investigational Site
Kumasi

Other trials in Ghana

Kenya1 site

GSK Investigational Site
Kisumu, 40100

Other trials in Kenya

About this study

Official title: Molecular Detection and Genotyping of Plasmodium Falciparum Parasites in Young African Children After Immunization With RTS,S/AS01E Malaria Vaccine. An Ancillary Study Protocol to GlaxoSmithKline Phase IIb RTS,S/AS01E Malaria Vaccine Trial (Study Number 204889) Entitled, "Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age.

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.

Read the detailed description

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.

Conditions: Malaria
Keywords: malaria vaccine, infants, malaria, RTS,S/AS01, falciparum, genomics, efficacy
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03281291
Study group	Role	What they receive
R012-20 Group		Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and Month 20 of study NCT03276962.
R012-14-mD Group		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.
Fx012-14-mFxD Group		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.
Fx017-mFxD Group		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.
Control Group		Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201823 Oct 2023

First posted13 Sep 2017
Study start19 Nov 2018
Primary completion22 Apr 2022
Study completion23 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03281291
Sponsor's protocol ID: 206213
Status last verified: Dec 2024
First submitted: 11 Sep 2017
Last updated: 23 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Juraska M, Early AM, Li L, Schaffner SF, Lievens M, Khorgade A, Simpkins B, Hejazi NS, Benkeser D, Wang Q, Mercer LD, Adjei S, Agbenyega T, Anderson S, Ansong D, Bii DK, Buabeng PBY, English S, Fitzgerald N, Grimsby J, Kariuki SK, Otieno K, Roman F, Samuels AM, Westercamp N, Ockenhouse CF, Ofori-Anyinam O, Lee CK, MacInnis BL, Wirth DF, Gilbert PB, Neafsey DE. Genotypic analysis of RTS,S/AS01E malaria vaccine efficacy against parasite infection as a function of dosage regimen and baseline malaria infection status in children aged 5-17 months in Ghana and Kenya: a longitudinal phase 2b randomised controlled trial. Lancet Infect Dis. 2024 Sep;24(9):1025-1036. doi: 10.1016/S1473-3099(24)00179-8. Epub 2024 May 6.
PubMed 38723650

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Molecular Detection and Genotyping of Plasmodium Falciparum Parasites in Young African Children After Immunization With RTS,S/AS01E Malaria Vaccine. An Ancillary Study Protocol to GlaxoSmithKline Phase IIb RTS,S/AS01E Malaria Vaccine Trial (Study Number 204889) Entitled, "Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age.
ClinicalTrials.gov ID: NCT03281291
Acronym / sponsor ID: 206213
Conditions: Malaria
Keywords: malaria vaccine, infants, malaria, RTS,S/AS01, falciparum, genomics, efficacy
Study type: Observational
Recruitment status: Completed
Enrolment: 1,500 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Nov 2018 (actual)
Primary completion: 22 Apr 2022 (actual)
Study completion: 23 Oct 2023 (actual)
First posted: 13 Sep 2017 (actual)
Results: Posted 23 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 5

Arm	Type	Receives
R012-20 Group	–	–Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and Month 20 of study NCT03276962.
R012-14-mD Group	–	–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.
Fx012-14-mFxD Group	–	–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.
Fx017-mFxD Group	–	–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.
Control Group	–	–Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962.

Who may qualify

Ages: 5 to 17 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Community sample

Key inclusion criteria (5 listed)

Participants' parent(s)/LAR(s) who, in the opinion of the investigator, complied with the requirements of the protocol (e.g. return for follow-up visits).
Signed or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. Where parent(s)/LAR(s) were illiterate, the consent form was countersigned by an independent witness.
A male or female between, and including, five and 17 months of age at the time of the first vaccination.
Healthy participants as established by medical history and clinical examination before entering into the study.
Previously received three documented doses of diphtheria, tetanus, pertussis, hepatitis B vaccine (DTPHepB), and at least three doses of oral polio vaccine.

Key exclusion criteria (24 listed)

Child in care.
Use of a drug or vaccine that is not approved for that indication (by one of the following regulatory authorities: Food and Drug Administration [FDA; USA] or European Union member state or WHO [with respect to prequalification]) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
Any medical condition that in the judgment of the investigator would have made the intramuscular injection unsafe.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this meant prednisone (0.5 mg/kg/day (for pediatric participants) or equivalent. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before each dose and ending seven days after each dose of vaccine administration.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 20 Study Visit
Time frame: Up to 20 months post Dose 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.
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
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
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 From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 32 Study Visit
Time frame: Up to 32 months post Dose 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.
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
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
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.
Number of Molecularly Confirmed New Malaria Infections Through to the Month 20 Study Visit
Time frame: Up to 20 months post Dose 1
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.
Number of Molecularly Confirmed New Malaria Infections From 14 Days Post-Dose 3 Through to 12 Months Post-Dose 3
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
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.
Number of Molecularly Confirmed New Malaria Infections Through to the Month 32 Study Visit
Time frame: Up to 32 months post Dose 1
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.
Number of Molecularly Confirmed New Malaria Infections From 14 Days Post-Dose 3 Through to 24 Months Post-Dose 3
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
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.

Results and safety

Results posted to the registry on 23 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R012-20 Group	298	229
R012-14-mD Group	294	232
Fx012-14-mFxD Group	304	242
Fx017-mFxD Group	311	247
Control Group	293	237

Primary outcome: Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 20 Study Visit

Time frame: Up to 20 months post Dose 1. Median (Inter-Quartile Range). Unit: Weeks

Measure	R012-20 Group n = 298	R012-14-mD Group n = 294	Fx012-14-mFxD Group n = 304	Fx017-mFxD Group n = 311	Control Group n = 293
Value	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)

R012-20 Group vs Control Group: Vaccine Efficacy: 29.7 (95% CI 14.7 to 42.1), Regression, Cox
R012-14-mD Group vs Control Group: Vaccine Efficacy: 31.2 (95% CI 16.4 to 43.3), Regression, Cox
Fx012-14-mFxD Group vs Control Group: Vaccine Efficacy: 24.6 (95% CI 9.0 to 37.6), Regression, Cox

Population analysed: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all the participants who received at least one dose of study vaccine per Malaria-094 protocol.

Primary outcome: 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

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. Median (Inter-Quartile Range). Unit: Weeks

Measure	R012-20 + R012-14-mD Pooled Group n = 523	Fx012-14-mFxD Group n = 271	Fx017-mFxD Group n = 273	Control Group n = 265
Value	40.6 (20.4 to NA)	36.7 (21.9 to NA)	38.6 (12.6 to NA)	28.7 (10.6 to NA)

R012-20 + R012-14-mD Pooled Group vs Control Group: Vaccine Efficacy: 42.8 (95% CI 30.7 to 52.8), Regression, Cox
Fx012-14-mFxD Group vs Control Group: Vaccine Efficacy: 36.7 (95% CI 21.2 to 49.2), Regression, Cox
Fx017-mFxD Group vs Control Group: Vaccine Efficacy: 41.4 (95% CI 26.7 to 53.1), Regression, Cox

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort, including participants who received the first three vaccinations per Malaria-094 protocol and were at risk for a molecularly confirmed infection 14 days after Dose 3. As pre-specified in the analysis plan, this outcome measure was reported for the R012-20 + R012-14-mD Pooled Group because both the R012-20 Group and R012-14-mD Group followed the same interventional strategy until Month 14.

Primary outcome: Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 32 Study Visit

Time frame: Up to 32 months post Dose 1. Median (Inter-Quartile Range). Unit: Weeks

Measure	R012-20 Group n = 298	R012-14-mD Group n = 294	Fx012-14-mFxD Group n = 304	Fx017-mFxD Group n = 311	Control Group n = 293
Value	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)

R012-20 Group vs Control Group: Vaccine Efficacy: 29.6 (95% CI 15.4 to 41.5), Regression, Cox
R012-14-mD Group vs Control Group: Vaccine Efficacy: 30.6 (95% CI 16.6 to 42.2), Regression, Cox
Fx012-14-mFxD Group vs Control Group: Vaccine Efficacy: 27.4 (95% CI 13.1 to 39.4), Regression, Cox

Population analysed: The analysis was performed on the TVC which included all the participants who received at least one dose of study vaccine per Malaria-094 protocol.

Primary outcome: 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

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. Median (Inter-Quartile Range). Unit: Weeks

Measure	R012-20 Group n = 259	R012-14-mD Group n = 264	Fx012-14-mFxD Group n = 271	Fx017-mFxD Group n = 273	Control Group n = 265
Value	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)

R012-20 Group vs Control Group: Vaccine Efficacy: 41.8 (95% CI 28.6 to 52.5), Regression, Cox
R012-14-mD Group vs Control Group: Vaccine Efficacy: 39.9 (95% CI 26.8 to 50.6), Regression, Cox
Fx012-14-mFxD Group vs Control Group: Vaccine Efficacy: 33.6 (95% CI 19.3 to 45.3), Regression, Cox

Population analysed: The analysis was performed on the ATP cohort which included all participants who received the first three vaccinations according to the Malaria-094 protocol procedures and who were observed to be at risk for a molecularly confirmed malaria infection at 14 days post-Dose 3.

Adverse events

Time frame: All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
R012-20 Group	0 of 0	0 of 0
R012-14-mD Group	0 of 0	0 of 0
Fx012-14-mFxD Group	0 of 0	0 of 0
Fx017-mFxD Group	0 of 0	0 of 0
Control Group	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38723650Juraska M, Early AM, Li L, Schaffner SF, Lievens M, Khorgade A, Simpkins B, Hejazi NS, Benkeser D, Wang Q, Mercer LD, Adjei S, Agbenyega T, Anderson S, Ansong D, Bii DK, Buabeng PBY, English S, Fitzgerald N, Grimsby J, Kariuki SK, Otieno K, Roman F, Samuels AM, Westercamp N, Ockenhouse CF, Ofori-Anyinam O, Lee CK, MacInnis BL, Wirth DF, Gilbert PB, Neafsey DE. Genotypic analysis of RTS,S/AS01E malaria vaccine efficacy against parasite infection as a function of dosage regimen and baseline malaria infection status in children aged 5-17 months in Ghana and Kenya: a longitudinal phase 2b randomised controlled trial. Lancet Infect Dis. 2024 Sep;24(9):1025-1036. doi: 10.1016/S1473-3099(24)00179-8. Epub 2024 May 6.
Individual participant dataSharing planned: 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.

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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. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Malaria, run by GlaxoSmithKline at 2 sites in 2 countries.

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 5 inclusion and 24 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: finished, as of the sponsor's last update on 23 Jan 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 Ghana, Kenya. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From First Vaccination to the Detection of the First New Malaria Infection Through to the Month 20 Study Visit (time frame: Up to 20 months post Dose 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03281291, which also lists 1 linked publication.

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 23 Jan 2025.