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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kumasi | Ghana | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38723650 | Background | 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. |
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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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As pre-specified in the analysis plan, efficacy outcome measures corresponding to vaccine efficacy against first new infection (ATP Cohort) and vaccine efficacy against all new infections (ATP Cohort), presented data for the R012-20 + R012-14-mD Pooled Group because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1, 3rd dose at Month 2) was the same for both the R012-20 Group and the R012-14-mD Group until Month 14.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2017 | Aug 8, 2024 |
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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.
| 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. | 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. | 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. | 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. | 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 |
| Kisumu |
| 40100 |
| Kenya |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Blood samples collected |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | Weeks | Up to 20 months post Dose 1 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | Weeks | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | Weeks | Up to 32 months post Dose 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | Weeks | 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 |
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| Primary | 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. | 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. | Posted | Number | Infections | Up to 20 months post Dose 1 |
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| Primary | 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. | The analysis was performed on the ATP cohort which included all participants who received the first 3 vaccinations according to the Malaria-094 protocol and who were observed to be at risk for a molecularly confirmed malaria infection at 14 days post-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. | Posted | Number | Infections | 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 |
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| Primary | 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. | 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. | Posted | Number | Infections | Up to 32 months post Dose 1 |
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| Primary | 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. | 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 are observed to be at risk for a molecularly confirmed malaria infection at 14 days post-Dose 3. | Posted | Number | Infections | 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 |
|
All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were not monitored/assessed.
As pre-specified in the protocol, the adverse events were collected under the Malaria-094 (204889/NCT03276962) study. Therefore, no safety assessment was conducted for the Malaria-095 (206213/NCT03281291) study. Since no safety data was assessed, the total number of participants at risk and affected by All-Cause Mortality, Serious Adverse Events, and Other Adverse Events is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. | 0 | 0 | 0 | 0 | 0 | 0 |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2023 | Aug 27, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| Male |
|
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Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group. |
| Regression, Cox |
| Vaccine Efficacy |
| 31.2 |
| 2-Sided |
| 95 |
| 16.4 |
| 43.3 |
VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group. |
| Other |
| Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group. | Regression, Cox | Vaccine Efficacy | 24.6 | 2-Sided | 95 | 9.0 | 37.6 | VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group. | Other |
| Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group. | Regression, Cox | Vaccine Efficacy | 28.8 | 2-Sided | 95 | 13.9 | 41.1 | VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group. | Other |
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.
| OG002 | 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. |
| OG003 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
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| OG003 | 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. |
| OG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
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| OG002 |
| 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. |
| OG003 | 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. |
| OG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
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| 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. |
| OG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
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| OG002 | 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. |
| OG003 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
|
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| 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. |
| OG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
|
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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.
| OG003 | 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. |
| OG004 | Control Group | Participants received rabies vaccine at Month 0, Month 1 and Month 2 of study NCT03276962. |
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