Trial Outcomes & Findings for Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali (NCT NCT00460525)

NCT ID: NCT00460525

Last Updated: 2018-11-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 400 participants
• Primary outcome timeframe: 0-7 days after first vaccination
• Results posted on: 2018-11-09

Participant Flow

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

Participant milestones

Measure	Rabies Vaccine Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Study STARTED	201	199
Overall Study COMPLETED	190	194
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Rabies Vaccine n=201 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.	Total n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	201 Participants n=5 Participants	199 Participants n=7 Participants	400 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	3.4 years STANDARD_DEVIATION 1.5 • n=5 Participants	3.4 years STANDARD_DEVIATION 1.6 • n=7 Participants	3.4 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	103 Participants n=7 Participants	215 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	96 Participants n=7 Participants	185 Participants n=5 Participants
Region of Enrollment Mali	201 participants n=5 Participants	199 participants n=7 Participants	400 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-7 days after first vaccination

Population: All subjects receiving the vaccination are included.

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.

Outcome measures

Measure	Rabies Vaccine n=201 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Drowsiness	0 Participants	5 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Irritability/Fussiness	0 Participants	12 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Loss of Appetite	3 Participants	25 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Vomiting	1 Participants	4 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Fever	30 Participants	61 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Site Pain	55 Participants	157 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Swelling	34 Participants	153 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Erythema	0 Participants	12 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Reported Limitation of Arm Motion	4 Participants	55 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination Limitation of Arm Motion	2 Participants	54 Participants

PRIMARY outcome

Timeframe: 0-7 days after the second vaccination

Population: All subjects receiving the vaccination are included.

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.

Outcome measures

Measure	Rabies Vaccine n=193 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=193 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Erythema	0 Participants	1 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Reported Limitation of Arm Motion	0 Participants	31 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Limitation of Arm Motion	2 Participants	37 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Drowsiness	0 Participants	0 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Irritability/Fussiness	1 Participants	5 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Loss of Appetite	1 Participants	10 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Vomiting	3 Participants	3 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Fever	13 Participants	64 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Site Pain	57 Participants	132 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. Swelling	69 Participants	151 Participants

PRIMARY outcome

Timeframe: 0-7 days after the third vaccination

Population: All subjects receiving the vaccination are included.

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.

Outcome measures

Measure	Rabies Vaccine n=187 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=184 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Fever	18 Participants	64 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Site Pain	48 Participants	134 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Swelling	90 Participants	159 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Erythema	0 Participants	3 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Reported Limitation of Arm Motion	4 Participants	26 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Drowsiness	1 Participants	0 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Irritability/Fussiness	2 Participants	6 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Loss of Appetite Post	0 Participants	3 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Vomiting	2 Participants	2 Participants
Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. Limitation of Arm Motion	2 Participants	28 Participants

PRIMARY outcome

Timeframe: Day 0-29 after first vaccination

Population: All subjects receiving the vaccination are included.

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.

Outcome measures

Measure	Rabies Vaccine n=201 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
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	4 Adverse Events
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	0 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Eye disorders	5 Adverse Events	5 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Gastrointestinal disorders	17 Adverse Events	11 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Nervous system disorders	3 Adverse Events	2 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Psychiatric disorders	0 Adverse Events	4 Adverse Events
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	1 Adverse Events
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	2 Adverse Events
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	28 Adverse Events
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	6 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Vascular disorders	0 Adverse Events	0 Adverse Events
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	44 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Hepatobiliary disorders	2 Adverse Events	0 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Infections and infestations	56 Adverse Events	53 Adverse Events
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	4 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination Investigations	45 Adverse Events	42 Adverse Events
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	0 Adverse Events
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	0 Adverse Events

PRIMARY outcome

Timeframe: Day 0-29 after second vaccination

Population: All subjects receiving the vaccination are included.

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.

Outcome measures

Measure	Rabies Vaccine n=193 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=193 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
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	2 Adverse Events
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	1 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Eye disorders	1 Adverse Events	1 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Gastrointestinal disorders	19 Adverse Events	11 Adverse Events
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	26 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Hepatobiliary disorders	0 Adverse Events	0 Adverse Events
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	3 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Investigations	71 Adverse Events	74 Adverse Events
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	1 Adverse Events
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	1 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Nervous system disorders	0 Adverse Events	1 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Psychiatric disorders	1 Adverse Events	1 Adverse Events
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	1 Adverse Events
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	1 Adverse Events
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	16 Adverse Events
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	5 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Vascular disorders	0 Adverse Events	0 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination Infections and infestations	67 Adverse Events	68 Adverse Events

PRIMARY outcome

Timeframe: Day 0-29 after third vaccination

Population: All subjects receiving the vaccination are included.

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.

Outcome measures

Measure	Rabies Vaccine n=187 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=184 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
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	1 Adverse Events
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	0 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Eye disorders	8 Adverse Events	7 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Gastrointestinal disorders	13 Adverse Events	16 Adverse Events
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	29 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Hepatobiliary disorders	0 Adverse Events	0 Adverse Events
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	36 Adverse Events
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	9 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Infections and infestations	84 Adverse Events	73 Adverse Events
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	5 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Investigations	110 Adverse Events	109 Adverse Events
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	0 Adverse Events
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	0 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Nervous system disorders	5 Adverse Events	1 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Psychiatric disorders	1 Adverse Events	1 Adverse Events
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	0 Adverse Events
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	0 Adverse Events
Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination Vascular disorders	0 Adverse Events	1 Adverse Events

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Rabies Vaccine n=201 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
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	1 Participants
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	108 Participants
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	5 Participants
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	0 Participants
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	103 Participants
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	3 Participants
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	100 Participants
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	199 Participants
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	0 Participants
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	33 Participants
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	0 Participants
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	129 Participants
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	1 Participants
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	198 Participants
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	10 Participants
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	0 Participants
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	188 Participants
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	25 Participants
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	1 Participants
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	162 Participants
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	10 Participants
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	1 Participants
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	118 Participants
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	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Rabies Vaccine n=201 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Number of Subjects Reporting Serious Adverse Events	2 Participants	8 Participants

SECONDARY outcome

Timeframe: Between randomization and 6 months after 3rd immunization.

Population: Analyses are ITT.

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).

Outcome measures

Measure	Rabies Vaccine n=201 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Incidence Density of Clinical Malaria Episode	1.187263 Events Per PYAR	0.949683 Events Per PYAR

SECONDARY outcome

Timeframe: Day 0

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 0 prior to the first vaccination.

Outcome measures

Measure	Rabies Vaccine n=201 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0	430.4 Titer Interval 298.0 to 621.4	393.1 Titer Interval 273.2 to 565.5

SECONDARY outcome

Timeframe: Day 30 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 30, prior to the second vaccination.

Outcome measures

Measure	Rabies Vaccine n=195 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=194 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30.	403.7 Titer Interval 275.8 to 591.0	21248.7 Titer Interval 17616.8 to 25629.5

SECONDARY outcome

Timeframe: Day 60 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 60, prior to the third vaccination.

Outcome measures

Measure	Rabies Vaccine n=194 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=195 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60.	512.2 Titer Interval 350.1 to 749.3	98199.0 Titer Interval 86574.6 to 111384.1

SECONDARY outcome

Timeframe: Day 90 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 90.

Outcome measures

Measure	Rabies Vaccine n=191 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=194 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90.	781.8 Titer Interval 524.8 to 1164.5	188449.1 Titer Interval 165625.5 to 214417.8

SECONDARY outcome

Timeframe: Day 150 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 150.

Outcome measures

Measure	Rabies Vaccine n=188 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=194 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150.	1202.9 Titer Interval 813.3 to 1779.0	100746.5 Titer Interval 85163.0 to 119181.5

SECONDARY outcome

Timeframe: Day 240 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 240.

Outcome measures

Measure	Rabies Vaccine n=189 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=193 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240.	774.6 Titer Interval 525.5 to 1141.8	65031.7 Titer Interval 54999.2 to 76894.4

SECONDARY outcome

Timeframe: Day 364 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 364.

Outcome measures

Measure	Rabies Vaccine n=185 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=192 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364	505.0 Titer Interval 353.9 to 720.5	42596.8 Titer Interval 36549.9 to 49644.1

SECONDARY outcome

Timeframe: Day 547 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 547.

Outcome measures

Measure	Rabies Vaccine n=183 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=183 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547	1589.3 Titer Interval 1075.0 to 2349.7	81205.1 Titer Interval 66166.2 to 99662.1

SECONDARY outcome

Timeframe: Day 730 after initial vaccination

Population: Analyses are ITT. No imputation techniques were used.

Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 730.

Outcome measures

Measure	Rabies Vaccine n=168 Participants Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=179 Participants 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730	636.5 Titer Interval 431.4 to 939.0	40605.3 Titer Interval 33946.8 to 48569.8

Adverse Events

Rabies Vaccine

Serious events: 2 serious events

Other events: 198 other events

Deaths: 0 deaths

FMP2.1/AS02A

Serious events: 8 serious events

Other events: 199 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rabies Vaccine n=201 participants at risk Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 participants at risk 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Infections and infestations Malaria	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	1.0% 2/199 • Number of events 2 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
General disorders Pyrexia	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.50% 1/199 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Nervous system disorders Febrile Convulsion	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.50% 1/199 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Nervous system disorders Status epilepticus	0.50% 1/201 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.00% 0/199 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Cerebral malaria	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.50% 1/199 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Nervous system disorders Febrile convulsion	0.50% 1/201 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.00% 0/199 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.50% 1/199 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Metabolism and nutrition disorders Dehydration	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.50% 1/199 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Gastrointestinal disorders Ileus paralytic	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	0.50% 1/199 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.

Other adverse events

Measure	Rabies Vaccine n=201 participants at risk Rabies vaccine administered on Days 0, 30, and 60.	FMP2.1/AS02A n=199 participants at risk 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Eye disorders Conjunctivitis	27.4% 55/201 • Number of events 71 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	24.6% 49/199 • Number of events 61 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Gastrointestinal disorders Abdominal Pain	19.4% 39/201 • Number of events 57 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	22.6% 45/199 • Number of events 74 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Gastrointestinal disorders Diarrhoea	31.8% 64/201 • Number of events 96 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	24.1% 48/199 • Number of events 81 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Gastrointestinal disorders Vomiting	8.5% 17/201 • Number of events 20 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	12.1% 24/199 • Number of events 30 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
General disorders Pyrexia	22.9% 46/201 • Number of events 52 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	52.3% 104/199 • Number of events 133 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Bronchitis	62.7% 126/201 • Number of events 273 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	60.8% 121/199 • Number of events 259 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Ear infection	23.4% 47/201 • Number of events 65 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	23.1% 46/199 • Number of events 55 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Fungal skin infection	13.4% 27/201 • Number of events 31 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	12.1% 24/199 • Number of events 27 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Furuncle	9.0% 18/201 • Number of events 18 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	8.5% 17/199 • Number of events 20 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Mumps	9.5% 19/201 • Number of events 19 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	6.0% 12/199 • Number of events 12 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Nasopharyngitis	21.4% 43/201 • Number of events 59 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	20.6% 41/199 • Number of events 54 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Pharyngitis	15.4% 31/201 • Number of events 32 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	16.6% 33/199 • Number of events 40 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Pneumonia	15.4% 31/201 • Number of events 37 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	16.6% 33/199 • Number of events 42 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Pyoderma	26.9% 54/201 • Number of events 71 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	30.2% 60/199 • Number of events 89 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Rhinitis	63.2% 127/201 • Number of events 244 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	61.8% 123/199 • Number of events 251 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Salmonellosis	5.5% 11/201 • Number of events 13 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	2.5% 5/199 • Number of events 5 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Staphylococcal infection	6.0% 12/201 • Number of events 12 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	5.5% 11/199 • Number of events 11 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Tinea capitis	14.9% 30/201 • Number of events 36 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	13.1% 26/199 • Number of events 27 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Tonsillitis	9.5% 19/201 • Number of events 22 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	9.0% 18/199 • Number of events 22 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Trichomoniasis intestinal	6.0% 12/201 • Number of events 13 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	9.5% 19/199 • Number of events 21 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Infections and infestations Varicella	28.4% 57/201 • Number of events 57 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	24.6% 49/199 • Number of events 50 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Injury, poisoning and procedural complications Wound	19.4% 39/201 • Number of events 51 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	20.6% 41/199 • Number of events 49 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations Alanine aminotransferase increased	6.0% 12/201 • Number of events 13 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	5.0% 10/199 • Number of events 11 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations Granulocyte count increased	17.9% 36/201 • Number of events 37 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	12.1% 24/199 • Number of events 24 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations Haemoglobin increased	46.8% 94/201 • Number of events 145 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	46.2% 92/199 • Number of events 143 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations Lymphocyte count decreased	6.0% 12/201 • Number of events 12 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	6.5% 13/199 • Number of events 14 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations Lymphocyte count increased	5.0% 10/201 • Number of events 12 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	8.0% 16/199 • Number of events 16 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations Platelet count increased	23.4% 47/201 • Number of events 60 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	29.6% 59/199 • Number of events 80 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations Red blood cell count increased	7.5% 15/201 • Number of events 16 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	2.0% 4/199 • Number of events 5 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations White blood cell count decreased	9.0% 18/201 • Number of events 21 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	8.5% 17/199 • Number of events 19 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Investigations White blood cell count increased	8.5% 17/201 • Number of events 19 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	9.0% 18/199 • Number of events 19 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Metabolism and nutrition disorders Anorexia	2.0% 4/201 • Number of events 4 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	16.1% 32/199 • Number of events 35 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Nervous system disorders Headache	12.4% 25/201 • Number of events 34 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	15.1% 30/199 • Number of events 36 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Respiratory, thoracic and mediastinal disorders Cough	54.2% 109/201 • Number of events 166 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	52.3% 104/199 • Number of events 190 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	19.4% 39/201 • Number of events 46 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	14.1% 28/199 • Number of events 30 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Skin and subcutaneous tissue disorders Rash papular	3.5% 7/201 • Number of events 8 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	5.5% 11/199 • Number of events 13 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Skin and subcutaneous tissue disorders Skin lesion	3.0% 6/201 • Number of events 8 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	5.5% 11/199 • Number of events 11 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
General disorders Injection site erythema	0.00% 0/201 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	6.5% 13/199 • Number of events 13 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
General disorders Injection site pain	45.8% 92/201 • Number of events 114 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	90.5% 180/199 • Number of events 324 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
General disorders Injection site swelling	64.2% 129/201 • Number of events 167 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	96.5% 192/199 • Number of events 438 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
General disorders Irritability	0.50% 1/201 • Number of events 1 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.	8.5% 17/199 • Number of events 19 • Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.

Additional Information

Mahamadou A. Thera, MD, MPH

Department of Epidemiology of Parasitic Diseases, University of Bamako

Phone: 223-222-8109

Email: mthera@mrtcbko.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60