Malaria
Conditions
Keywords
falciparum, efficacy, RTS,S/AS01, malaria vaccine, safety, Malaria, immunogenicity, infants
Brief summary
The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.
Detailed description
The current study intends to establish proof of concept (POC) for a fractional dose schedule under conditions of natural exposure. The study will be conducted in children 5-17 months old at first vaccination living in areas of mid to high malaria transmission, in line with the age group recommended by the World Health Organization (WHO) for the implementation of the RTS,S/AS01E vaccine. Results from this study will be critical in informing future possibilities for the development of vaccine-based strategies which, in combination with other interventions, may contribute to the malaria elimination agenda.
Interventions
BIOLOGICALRTS,S/AS01E (Full dose)
Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).
BIOLOGICALRTS,S/AS01E (1/5th dose)
Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).
BIOLOGICALRabies vaccine
Participants will receive intramuscular injection of rabies vaccine (0.1 ml).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Months to 17 Months
Healthy volunteers
Yes
Inclusion criteria
* Participants' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply 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) are illiterate, the consent form will be 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.
Exclusion criteria
* 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 make 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 will mean 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 will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * 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 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, be 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Clinical Malaria Meeting the Primary Case Definition | From Month 2.5 to Month 14 | The primary case definition is: Plasmodium (P.) falciparum asexual parasitemia greater than (\>)5000 parasites/microliters (μl) and presence of fever (axillary temperature greater than or equal to \[≥\]37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). The objective of this endpoint was to demonstrate the superiority of a Fx012-14-mFxD Group compared to a standard schedule of RTS,S/AS01E with three full doses (R012-20+R012-14 Group) in terms of vaccine efficacy. This analysis was reported for the R012-20+R012-14 Group (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 group until Month 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group | From Month 0 to Month 50 | The primary case definition is P. falciparum asexual parasitemia \> 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The secondary case definition is P. falciparum asexual parasitemia \> 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T. |
| The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Monthly from Month 0 to Month 20 and every 3 months thereafter until Study End (Month 50) | Prevalence of P. falciparum infections of each RTS,S/AS01E schedule at cross-sectional visits. As specified in the statistical analysis plan, a graphical presentation of the prevalence over time was analyzed for this outcome measure and only the percentage values were reported to depict the prevalence of P. falciparum infections. |
| Incidence of P. Falciparum Infections Defined by Positive Blood Slide | Month 0 to Month 14 | The incidence of P. falciparum infections is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T. Assessment of vaccine efficacy (VE) against first or only episodes of incident P. falciparum infections defined by positive blood slide over the entire study period (Month 0 to Month 50) was not done after the Month 21 Interim analysis since it was assumed that almost all children would have already contracted malaria at least once. |
| Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50) | A seropositive participant is defined as a participant with antibody concentrations ≥ 0.5 ELISA units per milliliter (EU/mL). |
| Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50) | A seropositive participant is defined as a participant with antibody concentrations ≥ 10 milli-international units per milliliter (mIU/mL). |
| Antibody Concentrations for Anti-CS | Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50) | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as EU/mL. |
| Antibody Concentrations for Anti-HB | Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50) | The antibody concentrations were calculated as GMCs and expressed as mlU/mL. |
| Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | From Day 0 to Month 50 | SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to death. |
| Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination | From Day 0 to Month 50 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Participants With Cerebral Malaria and Severe Malaria | From Day 0 to Month 50 | Cerebral malaria is defined as Severe P. falciparum malaria with coma (Blantyre coma score less than \[\<\] 3); and if malaria with seizure: coma persisting for \> 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis). Severe malaria is defined as P. falciparum parasitemia \> 0 detected by microscopy and/or rapid diagnostic test (RDT) and one or more of the following, occurring in the absence of an identified alternative cause: Impaired consciousness, Prostration, Multiple convulsions, Acidosis, Hypoglycemia, Severe malarial anemia, Renal impairment, Jaundice, Pulmonary edema, Significant bleeding: including recurrent or prolonged bleeding from the nose, gums or venipuncture sites, hematemesis or melaena, Shock, Hyperparasitemia. |
| Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group | From Month 0 to Month 50 | The primary case definition is P. falciparum asexual parasitemia \> 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The secondary case definition is P. falciparum asexual parasitemia \> 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T. |
| Number of Participants With Meningitis | From Day 0 to Month 50 | Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. |
| Number of Participants With Seizures | During the 30-day (Day 0 to Day 29) follow-up period after any dose of study vaccine | Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. |
| Number of Participants With Generalized Convulsive Seizures | During the 7-day (Day 0 to Day 6) follow-up period after any dose of study vaccine | Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. |
| Number of Participants With Any Unsolicited AEs | During the 30-day (Day 0 to Day 29) follow-up period following the 1st 3 doses and post dose 4, 5 and 6 of study vaccine | An unsolicited AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. |
| Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Before Dose 3 (at Month 2) | The assessed parameters (alanine aminotransferase \[ALT\], creatinine, haemoglobin, white blood cells \[WBC\], platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN (Upper limit of normal), creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure. |
| Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | At 7 days post-Dose 3 | The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN, creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure. |
| Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | At 30 days post-Dose 3 | The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN, creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure. |
| Number of Participants With Any Solicited Local Symptoms | During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination | Assessed solicited local AEs are: redness, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter \> 0 millimeters. |
| Number of Participants With Any Solicited General Symptoms | During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination | Assessed solicited general AEs are: drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. |
| Number of Participants With Potential Immune Mediated Diseases (pIMDs) | From Day 0 to Month 50 | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. |
Countries
Ghana, Kenya
Participant flow
Recruitment details
As pre-specified in statistical analysis plan, data reported in Participant Flow, Baseline Characteristics and Adverse Events were presented for individual groups (R012-20 Group, R012-14-mD Group, R012-14-mD Group, Fx017-mFxD Group and Control Group).
Pre-assignment details
As pre-specified in protocol, efficacy outcome measures corresponding to clinical malaria (primary case definition) and Plasmodium (P.) falciparum infection, presented data for R012-20+R012-14 Group (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 group until Month 14.
Participants by arm
| Arm | Count |
|---|---|
| R012-20 Group Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20. | 298 |
| R012-14-mD Group Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38. | 294 |
| 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 and yearly fractional doses at Month 14, Month 26 and Month 38. | 304 |
| 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 and yearly fractional doses at Month 20 and Month 32. | 311 |
| Control Group Participants received rabies vaccine at Month 0, Month 1 and Month 2. | 293 |
| Total | 1,500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Consent Withdrawal, Not Due To An Adverse Event/A Serious Adverse Event | 29 | 21 | 13 | 21 | 16 |
| Overall Study | Lost to Follow-up | 10 | 10 | 4 | 6 | 10 |
| Overall Study | Migrated / Moved From The Study Area | 26 | 28 | 44 | 29 | 27 |
| Overall Study | Other | 0 | 2 | 0 | 2 | 1 |
| Overall Study | Protocol Deviation | 2 | 0 | 1 | 2 | 1 |
| Overall Study | Serious Adverse Event And/Or Pimd | 2 | 1 | 0 | 4 | 1 |
Baseline characteristics
| Characteristic | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 10.2 Months STANDARD_DEVIATION 3.9 | 10.3 Months STANDARD_DEVIATION 3.8 | 10.5 Months STANDARD_DEVIATION 4 | 10.2 Months STANDARD_DEVIATION 3.8 | 10.5 Months STANDARD_DEVIATION 3.9 | 10.3 Months STANDARD_DEVIATION 3.9 |
| Race/Ethnicity, Customized Black Or African American | 298 Participants | 294 Participants | 304 Participants | 311 Participants | 293 Participants | 1500 Participants |
| Sex: Female, Male Female | 119 Participants | 155 Participants | 172 Participants | 163 Participants | 152 Participants | 761 Participants |
| Sex: Female, Male Male | 179 Participants | 139 Participants | 132 Participants | 148 Participants | 141 Participants | 739 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 298 | 1 / 294 | 0 / 304 | 4 / 311 | 1 / 293 |
| other Total, other adverse events | 230 / 298 | 243 / 294 | 253 / 304 | 253 / 311 | 234 / 293 |
| serious Total, serious adverse events | 73 / 298 | 65 / 294 | 64 / 304 | 84 / 311 | 92 / 293 |
Outcome results
Primary
Incidence of Clinical Malaria Meeting the Primary Case Definition
The primary case definition is: Plasmodium (P.) falciparum asexual parasitemia greater than (\>)5000 parasites/microliters (μl) and presence of fever (axillary temperature greater than or equal to \[≥\]37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). The objective of this endpoint was to demonstrate the superiority of a Fx012-14-mFxD Group compared to a standard schedule of RTS,S/AS01E with three full doses (R012-20+R012-14 Group) in terms of vaccine efficacy. This analysis was reported for the R012-20+R012-14 Group (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 group until Month 14.
Time frame: From Month 2.5 to Month 14
Population: This analysis was performed on Per Protocol Set (PPS) for efficacy, which included all participants from Exposed Set (ES) who fulfilled eligibility criteria and received all interventions as per study plan, within the protocol specified intervals that contribute to the time at risk in the follow-up period starting Month 2.5 to Month 14. As pre-specified in the analysis plan, the analysis of this outcome measure was reported for the R012-20+R012-14 Group and the Fx012-14-mFxD Group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fx012-14-mFxD Group | Incidence of Clinical Malaria Meeting the Primary Case Definition | 0.45 events per person-year |
| R012-20 + R012-14 Group | Incidence of Clinical Malaria Meeting the Primary Case Definition | 0.36 events per person-year |
Comparison: To demonstrate the superiority of a 3-dose schedule of GSK Biologicals' malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 (Fx012-14-mFxD Group) compared to a standard schedule of RTS,S/AS01E with 3 full doses (R012-20 + R012-14 Group) in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.p-value: 0.15495% CI: [-57, 7]Regression, Cox
Secondary
Antibody Concentrations for Anti-CS
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as EU/mL.
Time frame: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Population: The analysis was performed on the immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Before Dose 1, Pre-Vaccination (Day 1) | 1.0 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | End of Study (Month 50) | 25.1 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Pre-Dose 4 (Month 20) | 26.6 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 4 (Month 21) | 288.1 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 2 (Month 2) | 359.9 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 3 (Month 3) | 472.6 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Post Dose 2 (Month 2) | 320.0 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Before Dose 1, Pre-Vaccination (Day 1) | 1.0 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Pre-Dose 5 (Month 26) | 37.3 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Post Dose 5 (Month 27) | 185.2 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Pre-Dose 6 (Month 38) | 45.7 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Post Dose 6 (Month 39) | 181.8 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | End of Study (Month 50) | 49.7 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Post Dose 3 (Month 3) | 342.5 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Pre-Dose 4 (Month 14) | 26.9 EU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-CS | Post Dose 4 (Month 15) | 234.8 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Pre-Dose 6 (Month 38) | 40.5 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Pre-Dose 4 (Month 14) | 22.6 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 3 (Month 3) | 251.1 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 6 (Month 39) | 115.2 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 4 (Month 15) | 196.4 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 5 (Month 27) | 145.6 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Pre-Dose 5 (Month 26) | 38.0 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 2 (Month 2) | 378.8 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | End of Study (Month 50) | 35.5 EU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-CS | Before Dose 1, Pre-Vaccination (Day 1) | 1.0 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Pre-Dose 3 (Month 7) | 25.3 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Pre-Dose 4 (Month 20) | 33.3 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Pre-Dose 5 (Month 32) | 38.9 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 5 (Month 33) | 133.9 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Before Dose 1, Pre-Vaccination (Day 1) | 1.0 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 2 (Month 2) | 253.6 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 3 (Month 8) | 142.3 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | Post Dose 4 (Month 21) | 187.1 EU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-CS | End of Study (Month 50) | 30.9 EU/mL |
| Control Group | Antibody Concentrations for Anti-CS | Post Dose 2 (Month 2) | 1.3 EU/mL |
| Control Group | Antibody Concentrations for Anti-CS | Before Dose 1, Pre-Vaccination (Day 1) | 1.0 EU/mL |
| Control Group | Antibody Concentrations for Anti-CS | Pre-Dose 4 (Month 20) | 1.0 EU/mL |
| Control Group | Antibody Concentrations for Anti-CS | End of Study (Month 50) | 1.0 EU/mL |
| Control Group | Antibody Concentrations for Anti-CS | Post Dose 3 (Month 3) | 1.0 EU/mL |
Secondary
Antibody Concentrations for Anti-HB
The antibody concentrations were calculated as GMCs and expressed as mlU/mL.
Time frame: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Population: The analysis was performed on immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Pre-Dose 4 (Month 20) | 5189.6 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 4 (Month 21) | 210277.6 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Before Dose 1, Pre-Vaccination (Day 1) | 162.8 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 2 (Month 2) | 39990.7 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | End of Study (Month 50) | 10714.9 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 3 (Month 3) | 45665.7 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Pre-Dose 6 (Month 38) | 24027.2 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Post Dose 6 (Month 39) | 114277.1 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Before Dose 1, Pre-Vaccination (Day 1) | 224.7 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Post Dose 4 (Month 15) | 137582.9 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Post Dose 2 (Month 2) | 39336.5 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Pre-Dose 5 (Month 26) | 18767.8 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | End of Study (Month 50) | 24353.9 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Post Dose 5 (Month 27) | 126992.7 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Pre-Dose 4 (Month 14) | 5700.6 mlU/mL |
| R012-20 + R012-14 Group | Antibody Concentrations for Anti-HB | Post Dose 3 (Month 3) | 37592.9 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 6 (Month 39) | 60669.1 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Pre-Dose 6 (Month 38) | 16776.6 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Pre-Dose 4 (Month 14) | 4856.5 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 4 (Month 15) | 81612.1 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Before Dose 1, Pre-Vaccination (Day 1) | 124.6 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 3 (Month 3) | 21641.4 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | End of Study (Month 50) | 13240.2 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Pre-Dose 5 (Month 26) | 14130.8 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 5 (Month 27) | 63683.7 mlU/mL |
| Fx012-14-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 2 (Month 2) | 34301.2 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 3 (Month 8) | 53700.6 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | End of Study (Month 50) | 10013.0 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Before Dose 1, Pre-Vaccination (Day 1) | 98.4 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 2 (Month 2) | 29015.8 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Pre-Dose 3 (Month 7) | 6296.7 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Pre-Dose 4 (Month 20) | 9700.1 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 4 (Month 21) | 74185.9 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Pre-Dose 5 (Month 32) | 13212.6 mlU/mL |
| Fx017-mFxD Group | Antibody Concentrations for Anti-HB | Post Dose 5 (Month 33) | 57655.7 mlU/mL |
| Control Group | Antibody Concentrations for Anti-HB | Pre-Dose 4 (Month 20) | 45.6 mlU/mL |
| Control Group | Antibody Concentrations for Anti-HB | Post Dose 3 (Month 3) | 100.4 mlU/mL |
| Control Group | Antibody Concentrations for Anti-HB | Post Dose 2 (Month 2) | 159.1 mlU/mL |
| Control Group | Antibody Concentrations for Anti-HB | Before Dose 1, Pre-Vaccination (Day 1) | 152.5 mlU/mL |
| Control Group | Antibody Concentrations for Anti-HB | End of Study (Month 50) | 18.5 mlU/mL |
Secondary
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group
The primary case definition is P. falciparum asexual parasitemia \> 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The secondary case definition is P. falciparum asexual parasitemia \> 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
Time frame: From Month 0 to Month 50
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine. As per statistical analysis plan, the analysis of this outcome measure was reported only for the Fx012-14-mFxD Group and the R012-14-mD Group since the objective of this endpoint was to assess the vaccine efficacy in terms of incident rate against Fx012-14-mFxD Group versus R012-14-mD Group..
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fx012-14-mFxD Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group | Primary case definition | 0.69 events per person-year |
| Fx012-14-mFxD Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group | Secondary case definition | 1.18 events per person-year |
| R012-20 + R012-14 Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group | Primary case definition | 0.67 events per person-year |
| R012-20 + R012-14 Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group | Secondary case definition | 1.22 events per person-year |
Secondary
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group
The primary case definition is P. falciparum asexual parasitemia \> 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The secondary case definition is P. falciparum asexual parasitemia \> 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
Time frame: From Month 0 to Month 50
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine. As per statistical analysis plan, the analysis of this outcome measure was reported only for the Fx012-14-mFxD Group and the R012-20 Group since the objective of this endpoint was to assess the vaccine efficacy in terms of incident rate against Fx012-14-mFxD Group versus R012-20 Group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fx012-14-mFxD Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group | Primary case definition | 0.69 events per person-year |
| Fx012-14-mFxD Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group | Secondary case definition | 1.18 events per person-year |
| R012-20 + R012-14 Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group | Primary case definition | 0.86 events per person-year |
| R012-20 + R012-14 Group | Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group | Secondary case definition | 1.62 events per person-year |
Secondary
Incidence of P. Falciparum Infections Defined by Positive Blood Slide
The incidence of P. falciparum infections is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T. Assessment of vaccine efficacy (VE) against first or only episodes of incident P. falciparum infections defined by positive blood slide over the entire study period (Month 0 to Month 50) was not done after the Month 21 Interim analysis since it was assumed that almost all children would have already contracted malaria at least once.
Time frame: Month 0 to Month 14
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine and for whom data were collected from Month 0 to Month 14. As pre-specified in the analysis plan, the analysis of the outcome measure was reported for the R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1 and 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fx012-14-mFxD Group | Incidence of P. Falciparum Infections Defined by Positive Blood Slide | 0.50 events per person-year |
| R012-20 + R012-14 Group | Incidence of P. Falciparum Infections Defined by Positive Blood Slide | 0.60 events per person-year |
| Fx012-14-mFxD Group | Incidence of P. Falciparum Infections Defined by Positive Blood Slide | 0.59 events per person-year |
| Fx017-mFxD Group | Incidence of P. Falciparum Infections Defined by Positive Blood Slide | 0.80 events per person-year |
Secondary
Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 to Month 50
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination | 2 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination | 4 Participants |
| Control Group | Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination | 1 Participants |
Secondary
Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to death.
Time frame: From Day 0 to Month 50
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Related SAE | 3 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Any SAE | 73 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Fatal SAE | 2 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Any SAE | 65 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Fatal SAE | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Related SAE | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Fatal SAE | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Any SAE | 64 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Related SAE | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Fatal SAE | 4 Participants |
| Fx017-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Related SAE | 2 Participants |
| Fx017-mFxD Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Any SAE | 84 Participants |
| Control Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Any SAE | 92 Participants |
| Control Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Fatal SAE | 1 Participants |
| Control Group | Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs) | Related SAE | 0 Participants |
Secondary
Number of Participants With Any Solicited General Symptoms
Assessed solicited general AEs are: drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
Time frame: During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination
Population: The analysis was performed on SSRS which included all participants who received at least one dose of study vaccine and had solicited general data during specific duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 4 | 2 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 4 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 4 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 3 | 2 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 4 | 5 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 5 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 6 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 6 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 3 | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 3 | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 5 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 4 | 6 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 6 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 5 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 4 | 2 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 6 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 3 | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 4 | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 5 | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 6 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 4 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 5 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 6 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 4 | 2 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 5 | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 3 | 3 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 5 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 3 | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 4 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 5 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 4 | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 5 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 4 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 3 | 2 Participants |
| Control Group | Number of Participants With Any Solicited General Symptoms | Any Loss of appetite, after Dose 3 | 0 Participants |
| Control Group | Number of Participants With Any Solicited General Symptoms | Any Drowsiness, after Dose 3 | 0 Participants |
| Control Group | Number of Participants With Any Solicited General Symptoms | Any Irritability/Fussiness, after Dose 3 | 0 Participants |
Secondary
Number of Participants With Any Solicited Local Symptoms
Assessed solicited local AEs are: redness, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter \> 0 millimeters.
Time frame: During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination
Population: The analysis was performed on Solicited Safety Set reactogenicity sub-cohort (SSRS) which included all participants who received at least one dose of study vaccine and had solicited local data during specific duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 4 | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 3 | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 4 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 4 | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 3 | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 4 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 5 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 3 | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 5 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 4 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 6 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 3 | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 5 | 4 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 4 | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 6 | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 6 | 3 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 4 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 5 | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 4 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 5 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 6 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 6 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 3 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 4 | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 5 | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 6 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 3 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 3 | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 4 | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 5 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 4 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 5 | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 4 | 4 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 5 | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 3 | 0 Participants |
| Control Group | Number of Participants With Any Solicited Local Symptoms | Any Swelling, after Dose 3 | 0 Participants |
| Control Group | Number of Participants With Any Solicited Local Symptoms | Any Erythema, after Dose 3 | 0 Participants |
| Control Group | Number of Participants With Any Solicited Local Symptoms | Any Pain, after Dose 3 | 0 Participants |
Secondary
Number of Participants With Any Unsolicited AEs
An unsolicited AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 30-day (Day 0 to Day 29) follow-up period following the 1st 3 doses and post dose 4, 5 and 6 of study vaccine
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine and who had safety data available for the specific duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Any Unsolicited AEs | Post 1st 3 doses | 223 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Unsolicited AEs | Post Dose 4 | 74 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Unsolicited AEs | Post Dose 4 | 94 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Unsolicited AEs | Post 1st 3 doses | 221 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Unsolicited AEs | Post Dose 5 | 67 Participants |
| R012-20 + R012-14 Group | Number of Participants With Any Unsolicited AEs | Post Dose 6 | 64 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Unsolicited AEs | Post Dose 6 | 76 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Unsolicited AEs | Post 1st 3 doses | 240 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Unsolicited AEs | Post Dose 4 | 101 Participants |
| Fx012-14-mFxD Group | Number of Participants With Any Unsolicited AEs | Post Dose 5 | 65 Participants |
| Fx017-mFxD Group | Number of Participants With Any Unsolicited AEs | Post Dose 5 | 88 Participants |
| Fx017-mFxD Group | Number of Participants With Any Unsolicited AEs | Post 1st 3 doses | 242 Participants |
| Fx017-mFxD Group | Number of Participants With Any Unsolicited AEs | Post Dose 4 | 79 Participants |
| Control Group | Number of Participants With Any Unsolicited AEs | Post 1st 3 doses | 238 Participants |
Secondary
Number of Participants With Cerebral Malaria and Severe Malaria
Cerebral malaria is defined as Severe P. falciparum malaria with coma (Blantyre coma score less than \[\<\] 3); and if malaria with seizure: coma persisting for \> 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis). Severe malaria is defined as P. falciparum parasitemia \> 0 detected by microscopy and/or rapid diagnostic test (RDT) and one or more of the following, occurring in the absence of an identified alternative cause: Impaired consciousness, Prostration, Multiple convulsions, Acidosis, Hypoglycemia, Severe malarial anemia, Renal impairment, Jaundice, Pulmonary edema, Significant bleeding: including recurrent or prolonged bleeding from the nose, gums or venipuncture sites, hematemesis or melaena, Shock, Hyperparasitemia.
Time frame: From Day 0 to Month 50
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Cerebral Malaria and Severe Malaria | Cerebral malaria | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Cerebral Malaria and Severe Malaria | Severe malaria | 29 Participants |
| R012-20 + R012-14 Group | Number of Participants With Cerebral Malaria and Severe Malaria | Severe malaria | 22 Participants |
| R012-20 + R012-14 Group | Number of Participants With Cerebral Malaria and Severe Malaria | Cerebral malaria | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Cerebral Malaria and Severe Malaria | Cerebral malaria | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Cerebral Malaria and Severe Malaria | Severe malaria | 25 Participants |
| Fx017-mFxD Group | Number of Participants With Cerebral Malaria and Severe Malaria | Cerebral malaria | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Cerebral Malaria and Severe Malaria | Severe malaria | 31 Participants |
| Control Group | Number of Participants With Cerebral Malaria and Severe Malaria | Severe malaria | 51 Participants |
| Control Group | Number of Participants With Cerebral Malaria and Severe Malaria | Cerebral malaria | 1 Participants |
Secondary
Number of Participants With Generalized Convulsive Seizures
Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
Time frame: During the 7-day (Day 0 to Day 6) follow-up period after any dose of study vaccine
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Generalized Convulsive Seizures | 4 Participants |
| R012-20 + R012-14 Group | Number of Participants With Generalized Convulsive Seizures | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Generalized Convulsive Seizures | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Generalized Convulsive Seizures | 4 Participants |
| Control Group | Number of Participants With Generalized Convulsive Seizures | 2 Participants |
Secondary
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN, creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure.
Time frame: At 30 days post-Dose 3
Population: The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | ALT | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Creatine | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Platelets | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | WBC | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | ALT | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | WBC | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Platelets | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Creatine | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | WBC | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Platelets | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | ALT | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Creatine | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Creatine | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | ALT | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | WBC | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Platelets | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | WBC | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | ALT | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Creatine | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3 | Platelets | 0 Participants |
Secondary
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN, creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure.
Time frame: At 7 days post-Dose 3
Population: The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | ALT | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Creatine | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Platelets | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | WBC | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | ALT | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | WBC | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Platelets | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Creatine | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | WBC | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Platelets | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | ALT | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Creatine | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Creatine | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | ALT | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | WBC | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Platelets | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | WBC | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | ALT | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Haemoglobin | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Creatine | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3 | Platelets | 0 Participants |
Secondary
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
The assessed parameters (alanine aminotransferase \[ALT\], creatinine, haemoglobin, white blood cells \[WBC\], platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN (Upper limit of normal), creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure.
Time frame: Before Dose 3 (at Month 2)
Population: The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | ALT | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Platelets | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Creatine | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | WBC | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | ALT | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | WBC | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Platelets | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Haemoglobin | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Creatine | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | WBC | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Haemoglobin | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Platelets | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | ALT | 0 Participants |
| Fx012-14-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Creatine | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Creatine | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Haemoglobin | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | ALT | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | WBC | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Platelets | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | WBC | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | ALT | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Haemoglobin | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Creatine | 0 Participants |
| Control Group | Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3 | Platelets | 0 Participants |
Secondary
Number of Participants With Meningitis
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
Time frame: From Day 0 to Month 50
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Meningitis | 1 Participants |
| R012-20 + R012-14 Group | Number of Participants With Meningitis | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Meningitis | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Meningitis | 3 Participants |
| Control Group | Number of Participants With Meningitis | 3 Participants |
Secondary
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From Day 0 to Month 50
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | 0 Participants |
| R012-20 + R012-14 Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | 2 Participants |
| Fx012-14-mFxD Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | 1 Participants |
| Fx017-mFxD Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | 0 Participants |
| Control Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | 0 Participants |
Secondary
Number of Participants With Seizures
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
Time frame: During the 30-day (Day 0 to Day 29) follow-up period after any dose of study vaccine
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fx012-14-mFxD Group | Number of Participants With Seizures | 5 Participants |
| R012-20 + R012-14 Group | Number of Participants With Seizures | 1 Participants |
| Fx012-14-mFxD Group | Number of Participants With Seizures | 0 Participants |
| Fx017-mFxD Group | Number of Participants With Seizures | 4 Participants |
| Control Group | Number of Participants With Seizures | 4 Participants |
Secondary
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
A seropositive participant is defined as a participant with antibody concentrations ≥ 0.5 ELISA units per milliliter (EU/mL).
Time frame: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Population: The analysis was performed on immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 3 (Month 3) | 36 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 4 (Month 20) | 37 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | End of Study (Month 50) | 30 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 2 (Month 2) | 43 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 2 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 4 (Month 21) | 35 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 4 (Month 14) | 41 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 5 (Month 27) | 30 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 4 (Month 15) | 37 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 1 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 2 (Month 2) | 48 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 3 (Month 3) | 44 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 6 (Month 38) | 34 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 6 (Month 39) | 33 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 5 (Month 26) | 37 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | End of Study (Month 50) | 34 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 4 (Month 15) | 38 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 6 (Month 38) | 31 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 5 (Month 27) | 26 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 0 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 5 (Month 26) | 34 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 2 (Month 2) | 42 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | End of Study (Month 50) | 29 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 6 (Month 39) | 28 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 3 (Month 3) | 40 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 4 (Month 14) | 40 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 3 (Month 7) | 44 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | End of Study (Month 50) | 25 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 2 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 2 (Month 2) | 47 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 4 (Month 21) | 39 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 3 (Month 8) | 43 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 4 (Month 20) | 42 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 5 (Month 32) | 37 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 5 (Month 33) | 32 Participants |
| Control Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Pre-Dose 4 (Month 20) | 2 Participants |
| Control Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 3 (Month 3) | 2 Participants |
| Control Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Post Dose 2 (Month 2) | 4 Participants |
| Control Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 2 Participants |
| Control Group | Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies | End of Study (Month 50) | 2 Participants |
Secondary
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
A seropositive participant is defined as a participant with antibody concentrations ≥ 10 milli-international units per milliliter (mIU/mL).
Time frame: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Population: The analysis was performed on the immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 3 (Month 3) | 35 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 4 (Month 20) | 37 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | End of Study (Month 50) | 30 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 42 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 2 (Month 2) | 43 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 4 (Month 21) | 33 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 5 (Month 26) | 38 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | End of Study (Month 50) | 34 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 2 (Month 2) | 48 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 48 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 6 (Month 38) | 34 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 5 (Month 27) | 30 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 4 (Month 15) | 37 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 4 (Month 14) | 41 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 3 (Month 3) | 44 Participants |
| R012-20 + R012-14 Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 6 (Month 39) | 33 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 2 (Month 2) | 41 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 6 (Month 39) | 28 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 39 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 3 (Month 3) | 40 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 4 (Month 14) | 40 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 4 (Month 15) | 37 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 5 (Month 26) | 34 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 5 (Month 27) | 26 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 6 (Month 38) | 31 Participants |
| Fx012-14-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | End of Study (Month 50) | 28 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 3 (Month 8) | 43 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | End of Study (Month 50) | 25 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 3 (Month 7) | 44 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 4 (Month 20) | 42 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 40 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 4 (Month 21) | 38 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 5 (Month 32) | 37 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 5 (Month 33) | 32 Participants |
| Fx017-mFxD Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 2 (Month 2) | 48 Participants |
| Control Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Pre-Dose 4 (Month 20) | 30 Participants |
| Control Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Before Dose 1, Pre-Vaccination (Day 1) | 43 Participants |
| Control Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | End of Study (Month 50) | 22 Participants |
| Control Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 2 (Month 2) | 42 Participants |
| Control Group | Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies | Post Dose 3 (Month 3) | 39 Participants |
Secondary
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Prevalence of P. falciparum infections of each RTS,S/AS01E schedule at cross-sectional visits. As specified in the statistical analysis plan, a graphical presentation of the prevalence over time was analyzed for this outcome measure and only the percentage values were reported to depict the prevalence of P. falciparum infections.
Time frame: Monthly from Month 0 to Month 20 and every 3 months thereafter until Study End (Month 50)
Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine and for whom data were assessed during specific timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 15 | 8.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 8 | 4.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 14 | 12.6 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 44 | 12.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 2 | 4.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 47 | 13.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 7 | 6.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 12 | 9.7 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 6 | 4.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 3 | 3.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 16 | 7.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 5 | 3.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 41 | 5.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 11 | 8.4 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 4 | 3.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 32 | 10.5 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 23 | 11.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 38 | 11.5 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 19 | 6.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 18 | 9.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 29 | 10.6 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 20 | 7.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 35 | 10.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 50 | 13.1 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 17 | 10.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 0 | 10.1 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 10 | 6.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 9 | 6.7 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 13 | 7.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 26 | 12.2 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 1 | 3.8 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 12 | 6.5 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 47 | 5.7 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 13 | 6.9 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 29 | 6.9 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 19 | 7.9 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 16 | 6.7 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 18 | 9.9 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 0 | 6.1 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 50 | 10.8 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 44 | 10.2 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 1 | 5.9 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 2 | 4.6 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 14 | 2.0 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 3 | 4.1 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 41 | 7.5 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 4 | 4.7 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 15 | 3.7 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 5 | 3.6 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 6 | 4.4 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 11 | 5.7 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 38 | 6.5 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 7 | 7.7 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 8 | 7.2 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 35 | 11.0 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 9 | 6.6 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 20 | 8.3 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 17 | 9.8 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 32 | 7.9 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 23 | 7.3 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 26 | 2.8 Percentage of participants |
| R012-20 + R012-14 Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 10 | 5.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 7 | 6.5 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 35 | 10.1 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 1 | 3.1 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 16 | 6.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 8 | 5.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 47 | 8.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 19 | 8.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 0 | 4.6 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 29 | 9.2 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 9 | 6.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 50 | 13.6 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 44 | 9.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 32 | 7.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 18 | 7.1 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 26 | 6.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 20 | 8.1 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 4 | 2.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 12 | 6.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 14 | 5.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 3 | 3.2 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 10 | 7.4 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 5 | 1.9 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 15 | 5.1 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 38 | 7.3 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 41 | 6.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 17 | 7.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 6 | 3.0 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 13 | 7.7 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 23 | 11.2 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 2 | 2.8 Percentage of participants |
| Fx012-14-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 11 | 6.9 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 2 | 5.5 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 10 | 6.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 11 | 7.8 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 16 | 5.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 26 | 9.5 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 19 | 9.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 0 | 5.1 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 1 | 5.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 7 | 5.3 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 3 | 6.5 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 4 | 4.9 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 5 | 4.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 6 | 6.2 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 8 | 4.4 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 9 | 7.1 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 20 | 3.4 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 23 | 7.5 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 12 | 6.6 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 13 | 9.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 14 | 7.1 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 15 | 6.4 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 17 | 5.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 18 | 6.5 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 29 | 8.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 32 | 5.8 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 35 | 10.4 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 38 | 8.4 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 41 | 6.5 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 44 | 8.7 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 47 | 8.3 Percentage of participants |
| Fx017-mFxD Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 50 | 12.6 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 23 | 10.7 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 20 | 7.5 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 19 | 10.1 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 26 | 10.9 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 32 | 10.6 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 9 | 9.7 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 8 | 9.4 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 7 | 4.8 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 16 | 6.7 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 6 | 7.2 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 5 | 8.5 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 50 | 13.5 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 38 | 17.0 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 4 | 5.6 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 3 | 5.4 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 2 | 3.9 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 11 | 12.5 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 41 | 11.0 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 1 | 5.7 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 0 | 7.2 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 47 | 16.2 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 10 | 12.7 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 44 | 11.9 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 18 | 12.2 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 17 | 11.7 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 15 | 9.0 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 14 | 12.9 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 13 | 13.5 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 12 | 13.1 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 35 | 13.7 Percentage of participants |
| Control Group | The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey | Month 29 | 13.4 Percentage of participants |