A Phase 2 interventional study of RTS,S/AS01E (Full dose) and RTS,S/AS01E (1/5th dose) in Malaria, sponsored by GlaxoSmithKline. Completed at 2 sites in 2 countries. Open to participants aged 5 Months to 17 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
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Among 41 studies in Malaria by GlaxoSmithKline — 3 open to participants now, 3 under way, none of them phase 3. Malaria · GlaxoSmithKline.
Among the 41 studies in Malaria by GlaxoSmithKline, this one is the 8th largest by enrollment of the 38 interventional ones that give a count, is one of 3 that started in 2017, is one of 18 in phase 2, and was the 35th registered.
1,185 studies on the registry are indexed under Malaria; 80 are open to participants now.
Browse Malaria studies →3 of the 41 studies in Malaria by GlaxoSmithKline are open now, in 4 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Gabon, Uganda
Ages 18–65
GlaxoSmithKline · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
GlaxoSmithKline · Sites in Rwanda
Ages 5 mo–60 mo · Healthy volunteers
By country, each count listing its studies:
Of the 52 Malaria studies recruiting now, 15 (29%) set no upper age limit and 34 (65%) stop at 75 or younger; 38 take children under 18; 32 take healthy volunteers.
This study: 5 Months to 17 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,500 is above the median of 252 across 938 interventional studies indexed under Malaria.
Median enrollment 207 across the 38 interventional studies, 36,366 across the 3 observational. Of the 38 that completed or were terminated, 23 (61%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
2 of the studies in Malaria by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07036159GlaxoSmithKlineA Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months | 2027-04-23 |
| NCT07545681GlaxoSmithKlineA Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria | 2027-10-08 |
Add all 2 to your calendar (.ics) → With an account.
Among the 41 studies in Malaria by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The 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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
Biological: RTS,S/AS01E (Full dose)
Participants will receive 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.
Biological: RTS,S/AS01E (Full dose)
Participants will receive 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.
Biological: RTS,S/AS01E (Full dose) · Biological: RTS,S/AS01E (1/5th dose)
Participants will receive 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.
Biological: RTS,S/AS01E (Full dose) · Biological: RTS,S/AS01E (1/5th dose)
Participants will receive rabies vaccine at Month 0, Month 1 and Month 2.
Biological: Rabies vaccine
Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).
Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).
Participants will receive intramuscular injection of rabies vaccine (0.1 ml).
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
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
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
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)
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
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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)
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
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
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
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
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).
| Milestone | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Started | 298 | 294 | 304 | 311 | 293 |
| Completed | 229 | 232 | 242 | 247 | 237 |
| Not completed | 69 | 62 | 62 | 64 | 56 |
| Withdrew: Serious adverse event and/or pimd | 2 | 1 | 0 | 4 | 1 |
| Withdrew: Protocol deviation | 2 | 0 | 1 | 2 | 1 |
| Withdrew: Consent withdrawal, not due to an adverse event/a serious adverse event | 29 | 21 | 13 | 21 | 16 |
| Withdrew: Migrated / moved from the study area | 26 | 28 | 44 | 29 | 27 |
| Withdrew: Lost to follow-up | 10 | 10 | 4 | 6 | 10 |
| Withdrew: Other | 0 | 2 | 0 | 2 | 1 |
The 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.
| events per person-year | Fx012-14-mFxD Group | R012-20 + R012-14 Group |
|---|---|---|
| Incidence of Clinical Malaria Meeting the Primary Case Definition | 0.45 | 0.36 |
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.
| events per person-year | Fx012-14-mFxD Group | R012-20 Group |
|---|---|---|
| Primary case definition | 0.69 | 0.86 |
| Secondary case definition | 1.18 | 1.62 |
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.
| events per person-year | Fx012-14-mFxD Group | R012-14-mD Group |
|---|---|---|
| Primary case definition | 0.69 | 0.67 |
| Secondary case definition | 1.18 | 1.22 |
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.
| Percentage of participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Month 0 | 10.1 | 6.1 | 4.6 | 5.1 | 7.2 |
| Month 1 | 3.8 | 5.9 | 3.1 | 5.7 | 5.7 |
| Month 2 | 4.3 | 4.6 | 2.8 | 5.5 | 3.9 |
| Month 3 | 3.0 | 4.1 | 3.2 | 6.5 | 5.4 |
| Month 4 | 3.9 | 4.7 | 2.3 | 4.9 | 5.6 |
| Month 5 | 3.9 | 3.6 | 1.9 | 4.7 | 8.5 |
| Month 6 | 4.8 | 4.4 | 3.0 | 6.2 | 7.2 |
| Month 7 | 6.0 | 7.7 | 6.5 | 5.3 | 4.8 |
| Month 8 | 4.0 | 7.2 | 5.0 | 4.4 | 9.4 |
| Month 9 | 6.7 | 6.6 | 6.8 | 7.1 | 9.7 |
| Month 10 | 6.0 | 5.3 | 7.4 | 6.7 | 12.7 |
| Month 11 | 8.4 | 5.7 | 6.9 | 7.8 | 12.5 |
| Month 12 | 9.7 | 6.5 | 6.9 | 6.6 | 13.1 |
| Month 13 | 7.3 | 6.9 | 7.7 | 9.7 | 13.5 |
| Month 14 | 12.6 | 2.0 | 5.3 | 7.1 | 12.9 |
| Month 15 | 8.3 | 3.7 | 5.1 | 6.4 | 9.0 |
| Month 16 | 7.9 | 6.7 | 6.8 | 5.7 | 6.7 |
| Month 17 | 10.8 | 9.8 | 7.0 | 5.7 | 11.7 |
| Month 18 | 9.3 | 9.9 | 7.1 | 6.5 | 12.2 |
| Month 19 | 6.8 | 7.9 | 8.8 | 9.7 | 10.1 |
| Month 20 | 7.0 | 8.3 | 8.1 | 3.4 | 7.5 |
| Month 23 | 11.3 | 7.3 | 11.2 | 7.5 | 10.7 |
| Month 26 | 12.2 | 2.8 | 6.0 | 9.5 | 10.9 |
| Month 29 | 10.6 | 6.9 | 9.2 | 8.7 | 13.4 |
| Month 32 | 10.5 | 7.9 | 7.9 | 5.8 | 10.6 |
| Month 35 | 10.9 | 11.0 | 10.1 | 10.4 | 13.7 |
| Month 38 | 11.5 | 6.5 | 7.3 | 8.4 | 17.0 |
| Month 41 | 5.8 | 7.5 | 6.8 | 6.5 | 11.0 |
| Month 44 | 12.3 | 10.2 | 9.8 | 8.7 | 11.9 |
| Month 47 | 13.8 | 5.7 | 8.9 | 8.3 | 16.2 |
| Month 50 | 13.1 | 10.8 | 13.6 | 12.6 | 13.5 |
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.
| events per person-year | R012-20 + R012-14 Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|
| Incidence of P. Falciparum Infections Defined by Positive Blood Slide | 0.50 | 0.60 | 0.59 | 0.80 |
A seropositive participant is defined as a participant with antibody concentrations ≥ 0.5 ELISA units per milliliter (EU/mL).
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Before Dose 1, Pre-Vaccination (Day 1) | 2 | 1 | 0 | 2 | 2 |
| Post Dose 2 (Month 2) | 43 | 48 | 42 | 47 | 4 |
| Post Dose 3 (Month 3) | 36 | 44 | 40 | — | 2 |
| Pre-Dose 3 (Month 7) | — | — | — | 44 | — |
| Post Dose 3 (Month 8) | — | — | — | 43 | — |
| Pre-Dose 4 (Month 14) | — | 41 | 40 | — | — |
| Post Dose 4 (Month 15) | — | 37 | 38 | — | — |
| Pre-Dose 4 (Month 20) | 37 | — | — | 42 | 2 |
| Post Dose 4 (Month 21) | 35 | — | — | 39 | — |
| Pre-Dose 5 (Month 26) | — | 37 | 34 | — | — |
| Post Dose 5 (Month 27) | — | 30 | 26 | — | — |
| Pre-Dose 5 (Month 32) | — | — | — | 37 | — |
| Post Dose 5 (Month 33) | — | — | — | 32 | — |
| Pre-Dose 6 (Month 38) | — | 34 | 31 | — | — |
| Post Dose 6 (Month 39) | — | 33 | 28 | — | — |
| End of Study (Month 50) | 30 | 34 | 29 | 25 | 2 |
A seropositive participant is defined as a participant with antibody concentrations ≥ 10 milli-international units per milliliter (mIU/mL).
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Before Dose 1, Pre-Vaccination (Day 1) | 42 | 48 | 39 | 40 | 43 |
| Post Dose 2 (Month 2) | 43 | 48 | 41 | 48 | 42 |
| Post Dose 3 (Month 3) | 35 | 44 | 40 | — | 39 |
| Pre-Dose 3 (Month 7) | — | — | — | 44 | — |
| Post Dose 3 (Month 8) | — | — | — | 43 | — |
| Pre-Dose 4 (Month 14) | — | 41 | 40 | — | — |
| Post Dose 4 (Month 15) | — | 37 | 37 | — | — |
| Pre-Dose 4 (Month 20) | 37 | — | — | 42 | 30 |
| Post Dose 4 (Month 21) | 33 | — | — | 38 | — |
| Pre-Dose 5 (Month 26) | — | 38 | 34 | — | — |
| Post Dose 5 (Month 27) | — | 30 | 26 | — | — |
| Pre-Dose 5 (Month 32) | — | — | — | 37 | — |
| Post Dose 5 (Month 33) | — | — | — | 32 | — |
| Pre-Dose 6 (Month 38) | — | 34 | 31 | — | — |
| Post Dose 6 (Month 39) | — | 33 | 28 | — | — |
| End of Study (Month 50) | 30 | 34 | 28 | 25 | 22 |
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as EU/mL.
| EU/mL | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Before Dose 1, Pre-Vaccination (Day 1) | 1.0 (0.9 to 1.0) | 1.0 (0.9 to 1.0) | 1.0 (1.0 to 1.0) | 1.0 (0.9 to 1.0) | 1.0 (0.9 to 1.0) |
| Post Dose 2 (Month 2) | 359.9 (284.3 to 455.5) | 320.0 (248.2 to 412.6) | 378.8 (279.3 to 513.9) | 253.6 (182.2 to 353.0) | 1.3 (0.9 to 1.9) |
| Post Dose 3 (Month 3) | 472.6 (371.0 to 602.0) | 342.5 (275.6 to 425.6) | 251.1 (170.6 to 369.6) | — | 1.0 (0.9 to 1.1) |
| Pre-Dose 3 (Month 7) | — | — | — | 25.3 (19.1 to 33.5) | — |
| Post Dose 3 (Month 8) | — | — | — | 142.3 (113.9 to 177.8) | — |
| Pre-Dose 4 (Month 14) | — | 26.9 (19.2 to 37.7) | 22.6 (17.9 to 28.5) | — | — |
| Post Dose 4 (Month 15) | — | 234.8 (184.2 to 299.5) | 196.4 (150.4 to 256.7) | — | — |
| Pre-Dose 4 (Month 20) | 26.6 (19.1 to 37.0) | — | — | 33.3 (23.5 to 47.3) | 1.0 (0.9 to 1.2) |
| Post Dose 4 (Month 21) | 288.1 (227.7 to 364.4) | — | — | 187.1 (139.9 to 250.1) | — |
| Pre-Dose 5 (Month 26) | — | 37.3 (26.7 to 52.3) | 38.0 (27.7 to 52.1) | — | — |
| Post Dose 5 (Month 27) | — | 185.2 (140.4 to 244.3) | 145.6 (106.6 to 198.9) | — | — |
| Pre-Dose 5 (Month 32) | — | — | — | 38.9 (27.6 to 54.9) | — |
| Post Dose 5 (Month 33) | — | — | — | 133.9 (103.4 to 173.4) | — |
| Pre-Dose 6 (Month 38) | — | 45.7 (33.5 to 62.2) | 40.5 (31.0 to 52.9) | — | — |
| Post Dose 6 (Month 39) | — | 181.8 (137.2 to 241.0) | 115.2 (86.4 to 153.6) | — | — |
| End of Study (Month 50) | 25.1 (18.8 to 33.6) | 49.7 (37.0 to 66.6) | 35.5 (27.2 to 46.5) | 30.9 (19.9 to 47.9) | 1.0 (0.9 to 1.2) |
The antibody concentrations were calculated as GMCs and expressed as mlU/mL.
| mlU/mL | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Before Dose 1, Pre-Vaccination (Day 1) | 162.8 (98.7 to 268.5) | 224.7 (142.3 to 354.7) | 124.6 (72.0 to 215.5) | 98.4 (55.7 to 173.8) | 152.5 (93.4 to 249.0) |
| Post Dose 2 (Month 2) | 39990.7 (23198.3 to 68938.5) | 39336.5 (26109.5 to 59264.5) | 34301.2 (19896.6 to 59134.2) | 29015.8 (17445.6 to 48259.4) | 159.1 (83.8 to 302.2) |
| Post Dose 3 (Month 3) | 45665.7 (26775.1 to 77884.4) | 37592.9 (27463.3 to 51458.8) | 21641.4 (12408.6 to 37743.9) | — | 100.4 (57.3 to 175.7) |
| Pre-Dose 3 (Month 7) | — | — | — | 6296.7 (3817.3 to 10386.7) | — |
| Post Dose 3 (Month 8) | — | — | — | 53700.6 (38222.8 to 75446.0) | — |
| Pre-Dose 4 (Month 14) | — | 5700.6 (4033.4 to 8057.1) | 4856.5 (3129.3 to 7537.0) | — | — |
| Post Dose 4 (Month 15) | — | 137582.9 (108671.7 to 174185.8) | 81612.1 (60532.7 to 110032.1) | — | — |
| Pre-Dose 4 (Month 20) | 5189.6 (3061.3 to 8797.4) | — | — | 9700.1 (6732.0 to 13977.0) | 45.6 (26.6 to 78.3) |
| Post Dose 4 (Month 21) | 210277.6 (160964.7 to 274697.9) | — | — | 74185.9 (55296.5 to 99528.0) | — |
| Pre-Dose 5 (Month 26) | — | 18767.8 (14581.3 to 24156.3) | 14130.8 (9985.9 to 19996.1) | — | — |
| Post Dose 5 (Month 27) | — | 126992.7 (101650.7 to 158652.5) | 63683.7 (42424.1 to 95596.9) | — | — |
| Pre-Dose 5 (Month 32) | — | — | — | 13212.6 (9396.3 to 18579.0) | — |
| Post Dose 5 (Month 33) | — | — | — | 57655.7 (44884.3 to 74060.9) | — |
| Pre-Dose 6 (Month 38) | — | 24027.2 (18417.3 to 31345.9) | 16776.6 (11990.4 to 23473.1) | — | — |
| Post Dose 6 (Month 39) | — | 114277.1 (88950.0 to 146815.7) | 60669.1 (42343.5 to 86925.7) | — | — |
| End of Study (Month 50) | 10714.9 (7199.2 to 15947.3) | 24353.9 (18411.6 to 32214.0) | 13240.2 (9550.0 to 18356.2) | 10013.0 (6511.4 to 15397.7) | 18.5 (10.4 to 32.8) |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Any SAE | 73 | 65 | 64 | 84 | 92 |
| Fatal SAE | 2 | 1 | 0 | 4 | 1 |
| Related SAE | 3 | 0 | 0 | 2 | 0 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination | 2 | 1 | 0 | 4 | 1 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Cerebral malaria | 0 | 0 | 0 | 0 | 1 |
| Severe malaria | 29 | 22 | 25 | 31 | 51 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Participants With Potential Immune Mediated Diseases (pIMDs) | 0 | 2 | 1 | 0 | 0 |
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Participants With Meningitis | 1 | 1 | 1 | 3 | 3 |
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Participants With Seizures | 5 | 1 | 0 | 4 | 4 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Number of Participants With Generalized Convulsive Seizures | 4 | 1 | 0 | 4 | 2 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Post 1st 3 doses | 223 | 221 | 240 | 242 | 238 |
| Post Dose 4 | 74 | 94 | 101 | 79 | — |
| Post Dose 5 | — | 67 | 65 | 88 | — |
| Post Dose 6 | — | 64 | 76 | — | — |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Haemoglobin | 0 | 0 | 0 | 0 | 0 |
| Platelets | 0 | 0 | 0 | 0 | 0 |
| WBC | 0 | 0 | 0 | 0 | 0 |
| ALT | 0 | 0 | 0 | 0 | 0 |
| Creatine | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Haemoglobin | 0 | 0 | 0 | 0 | 0 |
| Platelets | 0 | 0 | 0 | 0 | 0 |
| WBC | 0 | 0 | 0 | 0 | 0 |
| ALT | 0 | 0 | 0 | 0 | 0 |
| Creatine | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Haemoglobin | 0 | 0 | 0 | 0 | 0 |
| Platelets | 0 | 0 | 0 | 0 | 0 |
| WBC | 0 | 0 | 0 | 0 | 0 |
| ALT | 0 | 0 | 0 | 0 | 0 |
| Creatine | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Any Erythema, after Dose 3 | 0 | 1 | 0 | 0 | 0 |
| Any Erythema, after Dose 4 | 0 | 0 | 0 | 0 | — |
| Any Erythema, after Dose 5 | — | 0 | 0 | 0 | — |
| Any Erythema, after Dose 6 | — | 0 | 0 | — | — |
| Any Pain, after Dose 3 | 1 | 1 | 0 | 0 | 0 |
| Any Pain, after Dose 4 | 1 | 1 | 0 | 4 | — |
| Any Pain, after Dose 5 | — | 4 | 1 | 0 | — |
| Any Pain, after Dose 6 | — | 3 | 0 | — | — |
| Any Swelling, after Dose 3 | 0 | 1 | 0 | 1 | 0 |
| Any Swelling, after Dose 4 | 1 | 0 | 0 | 1 | — |
| Any Swelling, after Dose 5 | — | 0 | 1 | 1 | — |
| Any Swelling, after Dose 6 | — | 0 | 0 | — | — |
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.
| Participants | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Any Drowsiness, after Dose 3 | 2 | 0 | 1 | 2 | 0 |
| Any Drowsiness, after Dose 4 | 0 | 2 | 1 | 0 | — |
| Any Drowsiness, after Dose 5 | — | 0 | 1 | 0 | — |
| Any Drowsiness, after Dose 6 | — | 0 | 0 | — | — |
| Any Irritability/Fussiness, after Dose 3 | 0 | 1 | 0 | 3 | 0 |
| Any Irritability/Fussiness, after Dose 4 | 0 | 6 | 0 | 1 | — |
| Any Irritability/Fussiness, after Dose 5 | — | 0 | 0 | 0 | — |
| Any Irritability/Fussiness, after Dose 6 | — | 0 | 0 | — | — |
| Any Loss of appetite, after Dose 3 | 0 | 1 | 0 | 1 | 0 |
| Any Loss of appetite, after Dose 4 | 2 | 5 | 2 | 0 | — |
| Any Loss of appetite, after Dose 5 | — | 0 | 1 | 0 | — |
| Any Loss of appetite, after Dose 6 | — | 0 | 0 | — | — |
Collected over Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| R012-20 Group | 2/298 (0.7%) | 73/298 (24.5%) | 230/298 (77.2%) |
| R012-14-mD Group | 1/294 (0.3%) | 65/294 (22.1%) | 243/294 (82.7%) |
| Fx012-14-mFxD Group | 0/304 (0%) | 64/304 (21.1%) | 253/304 (83.2%) |
| Fx017-mFxD Group | 4/311 (1.3%) | 84/311 (27%) | 253/311 (81.4%) |
| Control Group | 1/293 (0.3%) | 92/293 (31.4%) | 234/293 (79.9%) |
| Event | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Plasmodium falciparum infectionInfections and infestations | 28/298 | 22/294 | 29/304 | 32/311 | 48/293 |
| PneumoniaInfections and infestations | 15/298 | 15/294 | 12/304 | 10/311 | 21/293 |
| GastroenteritisInfections and infestations | 12/298 | 9/294 | 9/304 | 15/311 | 13/293 |
| MalariaInfections and infestations | 8/298 | 7/294 | 6/304 | 10/311 | 12/293 |
| Febrile convulsionNervous system disorders | 10/298 | 4/294 | 6/304 | 12/311 | 11/293 |
| AnaemiaBlood and lymphatic system disorders | 5/298 | 4/294 | 4/304 | 4/311 | 11/293 |
| Otitis mediaInfections and infestations | 4/298 | 3/294 | 4/304 | 4/311 | 5/293 |
| Urinary tract infectionInfections and infestations | 3/298 | 1/294 | 2/304 | 3/311 | 5/293 |
| Thermal burnInjury, poisoning and procedural complications | 1/298 | 3/294 | 1/304 | 2/311 | 5/293 |
| Meningitis viralInfections and infestations | 1/298 | 1/294 | 1/304 | 2/311 | 3/293 |
| Event | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 161/298 | 187/294 | 198/304 | 194/311 | 164/293 |
| MalariaInfections and infestations | 76/298 | 86/294 | 98/304 | 94/311 | 63/293 |
| GastroenteritisInfections and infestations | 56/298 | 87/294 | 76/304 | 70/311 | 68/293 |
| PyrexiaGeneral disorders | 35/298 | 69/294 | 36/304 | 43/311 | 13/293 |
| PneumoniaInfections and infestations | 19/298 | 41/294 | 38/304 | 26/311 | 33/293 |
| DiarrhoeaGastrointestinal disorders | 30/298 | 25/294 | 40/304 | 26/311 | 35/293 |
| ConjunctivitisInfections and infestations | 24/298 | 32/294 | 35/304 | 22/311 | 27/293 |
| Otitis mediaInfections and infestations | 23/298 | 25/294 | 33/304 | 21/311 | 33/293 |
| Rash papularSkin and subcutaneous tissue disorders | 26/298 | 30/294 | 27/304 | 22/311 | 24/293 |
| Skin bacterial infectionInfections and infestations | 18/298 | 25/294 | 29/304 | 16/311 | 16/293 |
| Age, Continuous(Months) | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Mean | 10.2 ± 3.9 | 10.3 ± 3.8 | 10.5 ± 4.0 | 10.2 ± 3.8 | 10.5 ± 3.9 | 10.3 ± 3.9 |
| Sex: Female, Male(Participants) | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Female | 119 | 155 | 172 | 163 | 152 | 761 |
| Male | 179 | 139 | 132 | 148 | 141 | 739 |
| Race/Ethnicity, Customized(Participants) | R012-20 Group | R012-14-mD Group | Fx012-14-mFxD Group | Fx017-mFxD Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Black Or African American | 298 | 294 | 304 | 311 | 293 | 1500 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Sep 2017 to primary completion in Nov 2019, 25 months.
Results were first posted in May 2024, 4 years 6 months after primary completion.
Of 39 phase 2 interventional studies under Malaria, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 27. This study's 25 months is above that.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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