Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali

Randomized, Controlled Phase II Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of the AMA-1 Malaria Vaccine FMP2.1/AS02A Versus Rabies Vaccine in 1-6 Year Old Children in Bandiagara, Mali

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00460525

Enrollment

400

Registered

2007-04-16

Start date

2007-05-31

Completion date

2009-07-31

Last updated

2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmodium Falciparum Malaria

Keywords

malaria, Mali, children, Plasmodium falciparum, vaccine

Brief summary

Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of children who get malaria after receiving a vaccine for rabies (an approved vaccine that does not prevent malaria). The children will be assigned to one of the vaccine groups by chance. Participants and doctors will not know which vaccine was given. Study participants will include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3 vaccine doses, by injection, to their upper arm. Study procedures will include physical exams and several blood samples. Participants will be involved in the study for 26 months.

Detailed description

This is a randomized, controlled, phase II clinical trial to evaluate the efficacy, safety and immunogenicity of the apical membrane antigen-1 of Plasmodium (P.) falciparum (AMA-1) malaria vaccine FMP2.1/AS02A using rabies vaccine as a control in healthy children 1-6 years old in Bandiagara, Mali. This study is linked to DMID protocol 05-0146, which is a phase I dose escalation trial at the same site in the same population. In this study, 400 subjects will be randomized in a 1:1 ratio to receive either 50 micrograms of FMP2.1 in 0.5 mL AS02A or rabies vaccine. Immunizations will be given on days 0, 30 and 60. Solicited adverse events will be recorded on the days of immunization and at 1, 2, 3 and 7 days after each immunization. Unsolicited adverse events will be recorded for 30 days after each immunization. Passive case detection will be used to capture clinical malaria episodes and adverse events including serious adverse events, and will occur by continuous availability of clinical care in a population with high utilization of this care. Active surveillance will be used to capture malaria infections and adverse events including serious adverse events. For active case detection, following the third dose, participants will be followed monthly for 6 months and then at 12, 18 and 24 months after randomization, for clinical assessment, malaria smear and hemoglobin. Routine monthly malaria smears will not be read immediately unless symptoms are present. Children will be followed for 2 years after the first immunization. Sera will be collected for anti-FMP2.1 antibody titers on the days of immunization and 1, 3, 6, 8, 12, 18 and 24 months after the first immunization. Peripheral blood mononuclear cells (PBMCs) will be collected on the days of immunization, 30 days after the third immunization and 8, 12, 18 and 24 months after the first immunization. The study Final Report will be based on data collected up to 6 months after the assigned date of the third immunization. A supplemental report will include data from the entire 24-month observation period. Primary study objectives are to: determine the efficacy of FMP2.1/AS02A in children aged 1-6 years against first clinical malaria episodes (axillary temperature of greater than or equal to 37.5 degrees Celsius and parasitemia of greater than or equal to 2500/mm\^3) occurring between randomization and 6 months after the assigned date of the third immunization; and assess the safety of the vaccine in children aged 1-6 years. Secondary study objectives are to: describe the dynamics of anti-AMA-1 antibody responses in recipients of the malaria vaccine compared to natural responses in the control group; determine whether serum anti-AMA-1 IgG titer by enzyme linked immunosorbent assay (ELISA) 1 month after the third immunization correlates with protection against clinical malaria episode; measure allele-specific efficacy against parasites with AMA-1 genotypes homologous to and heterologous to the 3D7 clone of P. falciparum; determine vaccine efficacy against clinical malaria episodes occurring between randomization and 6 months after the assigned date of the third immunization; and if efficacy is observed based on the primary endpoint, to determine vaccine efficacy against first clinical malaria episode and all clinical episodes (using increasing parasitemia thresholds) occurring during 2 years after randomization.

Interventions

BIOLOGICALFMP2.1/AS02A

3 doses administered a month apart: 50 µg recombinant subunit protein FMP2.1 (Plasmodium falciparum Apical Membrane Antigen-1 from strain 3D7 expressed in and purified from Escherichia coli), adjuvanted with 0.5 mL of AS02A (proprietary oil-in-water emulsion and phosphate buffered saline with the immunostimulants monophosphoral lipid A and QS21).

BIOLOGICALRabies Vaccine

White, freeze-dried vaccine for reconstitution with the diluent prior to use; dosage 1.0 mL of rabies vaccine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 1-6 years inclusive at the time of screening * Residing in Bandiagara town * Appear to be in generally good health based on clinical and laboratory investigation * Separate written informed consent obtained from the parent/guardian before screening and study start, respectively * Available to participate in follow-up for the duration of study (26 months)

Exclusion criteria

* Previous vaccination with an investigational vaccine or a rabies vaccine * Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This exclusion includes any dose level of oral steroids or inhaled steroids, but not topical steroids. * Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection * Confirmed or suspected autoimmune disease * History of allergic reactions or anaphylaxis to immunizations or to any vaccine component * History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care * History of allergy to tetracycline, doxycycline, nickel, Imidazole, eggs, neomycin, chlortetracycline or amphotericin B * History of splenectomy * Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than the upper limit of normal of the testing laboratory = 49.6 U/L) * Laboratory evidence of renal disease (serum or plasma creatinine greater than 62 micro mol/L), or more than trace protein or blood on urine dipstick testing) * Laboratory evidence of hematologic disease (absolute leukocyte count \<5,300/mm\^3 or \>15,300/mm\^3, absolute lymphocyte count \<2,300 mm\^3, platelet count \<133,000/mm\^3, or hemoglobin \<9.0 g/dL) * Hepatitis B surface antigen positive * Chronic skin condition that could interfere with vaccine site reactogenicity assessment * Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period * Simultaneous participation in any other interventional clinical trial * Acute or chronic pulmonary, cardiovascular, hepatic (including hepatomegaly), renal or neurological condition, severe malnutrition, or any other clinical findings that in the opinion of the PI may increase the risk of participating in the study * Other condition that in the opinion of the Principal Investigator (PI) would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	0-7 days after first vaccination	Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after each vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately.
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	0-7 days after the second vaccination	Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately.
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	0-7 days after the third vaccination	Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately.
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Day 0-29 after first vaccination	Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Day 0-29 after second vaccination	Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Day 0-29 after third vaccination	Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.
Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Occurring between randomization and 6 months after the assigned date of the 3rd immunization.	Time to first clinical malaria episode is displayed in a life table format to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point.
Number of Subjects Reporting Serious Adverse Events	24 months after initial vaccination	A serious adverse event was defined as any untoward medical occurrence that results in death, is life threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization or is a congenital anomaly/birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above was considered serious.

Secondary

Measure	Time frame	Description
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547	Day 547 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 547.
Incidence Density of Clinical Malaria Episode	Between randomization and 6 months after 3rd immunization.	Clinical malaria episode was defined by significant parasitemia (2500/mm\^3) and temperature of greater than or equal to 37.5 degrees C. Event rate was determined by dividing the number of episodes (150 for the Rabies group and 121 for the FMP2.1/ASO2A group) by the number of Person Years at Risk (PYAR) (126.341 for Rabies group and 127.411 for the FMP2.1/ASO2A group).
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730	Day 730 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 730.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0	Day 0	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 0 prior to the first vaccination.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30.	Day 30 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 30, prior to the second vaccination.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60.	Day 60 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 60, prior to the third vaccination.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90.	Day 90 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 90.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150.	Day 150 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 150.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240.	Day 240 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 240.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364	Day 364 after initial vaccination	Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 364.

Countries

Mali

Participant flow

Recruitment details

Subjects were recruited from the population of healthy children aged 1-6 years residing in the town of Bandiagara.

Participants by arm

Arm	Count
Rabies Vaccine Rabies vaccine administered on Days 0, 30, and 60.	201
FMP2.1/AS02A 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.	199
Total	400

Baseline characteristics

Characteristic	FMP2.1/AS02A	Rabies Vaccine	Total
Age, Categorical <=18 years	199 Participants	201 Participants	400 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	3.4 years STANDARD_DEVIATION 1.6	3.4 years STANDARD_DEVIATION 1.5	3.4 years STANDARD_DEVIATION 1.5
Region of Enrollment Mali	199 participants	201 participants	400 participants
Sex: Female, Male Female	103 Participants	112 Participants	215 Participants
Sex: Female, Male Male	96 Participants	89 Participants	185 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	198 / 201	199 / 199
serious Total, serious adverse events	2 / 201	8 / 199

Outcome results

Primary

Number of Subjects Reporting Serious Adverse Events

A serious adverse event was defined as any untoward medical occurrence that results in death, is life threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization or is a congenital anomaly/birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above was considered serious.

Time frame: 24 months after initial vaccination

Arm	Measure	Value (NUMBER)
Rabies Vaccine	Number of Subjects Reporting Serious Adverse Events	2 Participants
FMP2.1/AS02A	Number of Subjects Reporting Serious Adverse Events	8 Participants

Primary

Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination

Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after each vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately.

Time frame: 0-7 days after first vaccination

Population: All subjects receiving the vaccination are included.

Arm	Measure	Group	Value (NUMBER)
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Loss of Appetite	3 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Erythema	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Vomiting	1 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Drowsiness	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Fever	30 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Reported Limitation of Arm Motion	4 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Site Pain	55 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Irritability/Fussiness	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Swelling	34 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Limitation of Arm Motion	2 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Swelling	153 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Erythema	12 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Limitation of Arm Motion	54 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Drowsiness	5 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Irritability/Fussiness	12 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Loss of Appetite	25 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Vomiting	4 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Fever	61 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Site Pain	157 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination	Reported Limitation of Arm Motion	55 Participants

Primary

Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.

Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately.

Time frame: 0-7 days after the second vaccination

Population: All subjects receiving the vaccination are included.

Arm	Measure	Group	Value (NUMBER)
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Drowsiness	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Irritability/Fussiness	1 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Loss of Appetite	1 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Vomiting	3 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Fever	13 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Site Pain	57 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Swelling	69 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Erythema	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Reported Limitation of Arm Motion	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Limitation of Arm Motion	2 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Erythema	1 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Drowsiness	0 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Site Pain	132 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Irritability/Fussiness	5 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Limitation of Arm Motion	37 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Loss of Appetite	10 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Swelling	151 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Vomiting	3 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Reported Limitation of Arm Motion	31 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.	Fever	64 Participants

Primary

Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.

Time frame: 0-7 days after the third vaccination

Population: All subjects receiving the vaccination are included.

Arm	Measure	Group	Value (NUMBER)
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Drowsiness	1 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Irritability/Fussiness	2 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Loss of Appetite Post	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Vomiting	2 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Fever	18 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Site Pain	48 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Swelling	90 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Erythema	0 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Reported Limitation of Arm Motion	4 Participants
Rabies Vaccine	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Limitation of Arm Motion	2 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Erythema	3 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Drowsiness	0 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Site Pain	134 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Irritability/Fussiness	6 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Limitation of Arm Motion	28 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Loss of Appetite Post	3 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Swelling	159 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Vomiting	2 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Reported Limitation of Arm Motion	26 Participants
FMP2.1/AS02A	Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.	Fever	64 Participants

Primary

Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination

Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.

Time frame: Day 0-29 after first vaccination

Population: All subjects receiving the vaccination are included.

Arm	Measure	Group	Value (NUMBER)
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	General disorders, administrative site conditions	16 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Skin and subcutaneous tissue disorders	5 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Injury, poisoning, and procedural complications	5 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Psychiatric disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Investigations	45 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Blood and lymphatic system disorders	7 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Metabolism and nutrition disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Ear and labyrinth disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Musculoskeletal and connective tissue disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Infections and infestations	56 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Nervous system disorders	3 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Eye disorders	5 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Respiratory, thoracic and mediastinal disorders	23 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Renal and urinary disorders	1 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Gastrointestinal disorders	17 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Reproductive system and breast disorders	1 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Vascular disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Hepatobiliary disorders	2 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Vascular disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Hepatobiliary disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Infections and infestations	53 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Reproductive system and breast disorders	2 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Respiratory, thoracic and mediastinal disorders	28 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Skin and subcutaneous tissue disorders	6 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Ear and labyrinth disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Eye disorders	5 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Gastrointestinal disorders	11 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	General disorders, administrative site conditions	44 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Injury, poisoning, and procedural complications	4 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Investigations	42 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Metabolism and nutrition disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Musculoskeletal and connective tissue disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Nervous system disorders	2 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Psychiatric disorders	4 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Renal and urinary disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination	Blood and lymphatic system disorders	4 Adverse Events

Primary

Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination

Time frame: Day 0-29 after second vaccination

Population: All subjects receiving the vaccination are included.

Arm	Measure	Group	Value (NUMBER)
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Infections and infestations	67 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Vascular disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Blood and lymphatic system disorders	1 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Ear and labyrinth disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Eye disorders	1 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Gastrointestinal disorders	19 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	General disorders, administrative site conditions	9 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Hepatobiliary disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Injury, poisoning, and procedural complications	6 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Investigations	71 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Metabolism and nutrition disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Musculoskeletal and connective tissue disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Nervous system disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Psychiatric disorders	1 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Renal and urinary disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Reproductive system and breast disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Respiratory, thoracic and mediastinal disorders	17 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Skin and subcutaneous tissue disorders	4 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Injury, poisoning, and procedural complications	3 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Skin and subcutaneous tissue disorders	5 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Respiratory, thoracic and mediastinal disorders	16 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Vascular disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Investigations	74 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Blood and lymphatic system disorders	2 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Psychiatric disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Ear and labyrinth disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Metabolism and nutrition disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Eye disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Reproductive system and breast disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Gastrointestinal disorders	11 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Musculoskeletal and connective tissue disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	General disorders, administrative site conditions	26 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Renal and urinary disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Hepatobiliary disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Infections and infestations	68 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination	Nervous system disorders	1 Adverse Events

Primary

Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination

Time frame: Day 0-29 after third vaccination

Population: All subjects receiving the vaccination are included.

Arm	Measure	Group	Value (NUMBER)
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Ear and labyrinth disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Hepatobiliary disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Musculoskeletal and connective tissue disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Infections and infestations	84 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Investigations	110 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Skin and subcutaneous tissue disorders	7 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Nervous system disorders	5 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Eye disorders	8 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Psychiatric disorders	1 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Injury, poisoning, and procedural complications	6 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Renal and urinary disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Gastrointestinal disorders	13 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Reproductive system and breast disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Metabolism and nutrition disorders	2 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Respiratory, thoracic and mediastinal disorders	32 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	General disorders, administrative site conditions	14 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Vascular disorders	0 Adverse Events
Rabies Vaccine	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Blood and lymphatic system disorders	7 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Vascular disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Blood and lymphatic system disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Ear and labyrinth disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Injury, poisoning, and procedural complications	5 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Investigations	109 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Metabolism and nutrition disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Respiratory, thoracic and mediastinal disorders	36 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Eye disorders	7 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Gastrointestinal disorders	16 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	General disorders, administrative site conditions	29 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Hepatobiliary disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Infections and infestations	73 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Musculoskeletal and connective tissue disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Nervous system disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Psychiatric disorders	1 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Renal and urinary disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Reproductive system and breast disorders	0 Adverse Events
FMP2.1/AS02A	Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination	Skin and subcutaneous tissue disorders	9 Adverse Events

Primary

Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.

Time to first clinical malaria episode is displayed in a life table format to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point.

Time frame: Occurring between randomization and 6 months after the assigned date of the 3rd immunization.

Arm	Measure	Group	Value (NUMBER)
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 181 - 210, Number with First Episode	5 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 121 - 150, Number Censored	1 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 151 - 180, Number at Risk	101 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 151 - 180, Number with First Episode	5 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 151 - 180, Number Censored	2 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 181 - 210, Number at Risk	94 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 121 - 150, Number with First Episode	16 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 181 - 210, Number Censored	0 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 211 - 240, Number at Risk	89 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 211 - 240, Number with First Episode	2 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 0 - 30, Number at Risk	201 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 0 - 30, Number with First Episode	1 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 0 -30, Number Censored	4 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 31 - 60, Number at Risk	196 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 31 - 60, Number with First Episode	9 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 31 - 60, Number Censored	1 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 61 - 90 Number at Risk	186 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 61 - 90, Number with First Episode	40 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 61 - 90, Number Censored	0 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 91 - 120, Number at Risk	146 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 91 - 120, Number with First Episode	28 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 91 - 120, Number Censored	0 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 121 - 150, Number at Risk	118 Participants
Rabies Vaccine	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 211 - 240, Number Censored	87 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 121 - 150, Number at Risk	129 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 121 - 150, Number with First Episode	10 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 0 -30, Number Censored	1 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 121 - 150, Number Censored	1 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 61 - 90, Number Censored	1 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 151 - 180, Number at Risk	118 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 31 - 60, Number at Risk	198 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 151 - 180, Number with First Episode	9 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 91 - 120, Number Censored	0 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 151 - 180, Number Censored	1 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 31 - 60, Number with First Episode	10 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 181 - 210, Number at Risk	108 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 91 - 120, Number at Risk	162 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 181 - 210, Number with First Episode	5 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 31 - 60, Number Censored	0 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 181 - 210, Number Censored	0 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 211 - 240, Number Censored	100 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 211 - 240, Number at Risk	103 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 61 - 90 Number at Risk	188 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 211 - 240, Number with First Episode	3 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 91 - 120, Number with First Episode	33 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 0 - 30, Number at Risk	199 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 61 - 90, Number with First Episode	25 Participants
FMP2.1/AS02A	Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.	Days 0 - 30, Number with First Episode	0 Participants

Comparison: Time to first clinical malaria episode with significant parasitemia (2500/mm\^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.p-value: 0.17595% CI: [-0.09, 0.37]Regression, Cox

Secondary