Trial Outcomes & Findings for Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine (NCT NCT00223990)

Last Updated: 2021-02-12

Results Overview

Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ITT population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = \>37.5°C with presence of a density of asexual stage P. falciparum \>50K parasites/µL blood Secondary (200) = \>37.5°C with presence of a density of asexual stage P. falciparum \>200K parasites/µL blood Secondary (100) = \>37.5°C with presence of a density of asexual stage P. falciparum \>100K parasites/µL blood Secondary (10) = \>37.5°C with presence of a density of asexual stage P. falciparum \>10K parasites/µL blood Secondary (0) = \>37.5°C with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood Secondary (0\*) = \>37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

400 participants

Primary outcome timeframe

starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240

Results posted on

2021-02-12

Participant Flow

Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine) at the Walter Reed Project Kombewa Clinic in Kombewa Division, Kisumu District, Nyanze Province, Western Kenya (and 12 small field stations within Kombewa Division).

Participant milestones

Participant milestones
Measure	FMP1/AS02A FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Overall Study STARTED	200	200
Overall Study COMPLETED	193	191
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	FMP1/AS02A FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Overall Study Moved from area	2	1
Overall Study Withdrawal by Subject	4	8
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=200 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA: Primary	107 events	121 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA: Secondary (200)	25 events	29 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA: Secondary (100)	68 events	80 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA: Secondary (10)	130 events	143 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA: Secondary (0)	158 events	165 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA: Secondary (0*)	185 events	182 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population MT: Primary	105 events	116 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population MT: Secondary (200)	23 events	27 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population MT: Secondary (100)	64 events	76 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population MT: Secondary (10)	130 events	138 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population MT: Secondary (0)	156 events	161 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population MT: Secondary (0*)	186 events	182 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA MT: Primary	101 events	113 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA MT: Secondary (200)	22 events	27 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA MT: Secondary (100)	60 events	76 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA MT: Secondary (10)	125 events	138 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA MT: Secondary (0)	151 events	160 events
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population SA MT: Secondary (0*)	183 events	182 events

SECONDARY outcome

Timeframe: starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240

Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ATP population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = \>37.5°C with presence of a density of asexual stage P. falciparum \>50K parasites/µL blood Secondary (200) = \>37.5°C with presence of a density of asexual stage P. falciparum \>200K parasites/µL blood Secondary (100) = \>37.5°C with presence of a density of asexual stage P. falciparum \>100K parasites/µL blood Secondary (10) = \>37.5°C with presence of a density of asexual stage P. falciparum \>10K parasites/µL blood Secondary (0) = \>37.5°C with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood Secondary (0\*) = \>37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=200 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA: Primary	85 events	86 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA: Secondary (200)	17 events	13 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA: Secondary (100)	49 events	50 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA: Secondary (10)	103 events	107 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA: Secondary (0)	130 events	138 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA: Secondary (0*)	171 events	168 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population MT: Primary	80 events	79 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population MT: Secondary (200)	16 events	12 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population MT: Secondary (100)	46 events	47 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population MT: Secondary (10)	100 events	101 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population MT: Secondary (0)	127 events	131 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population MT: Secondary (0*)	173 events	168 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA MT: Primary	78 events	76 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA MT: Secondary (200)	15 events	12 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA MT: Secondary (100)	44 events	47 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA MT: Secondary (10)	96 events	100 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA MT: Secondary (0)	122 events	131 events
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population SA MT: Secondary (0*)	168 events	168 events

SECONDARY outcome

Timeframe: vaccination day plus post-vaccination days 1, 2, 3, and 6

Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=200 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I1 - Pain	140 participants	9 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I1 - Swelling	51 participants	1 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I1 - Fever	61 participants	11 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I1 - Drowsiness	1 participants	0 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I1 - Loss of appetite	27 participants	6 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I1 - Irritability/fussiness	14 participants	1 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I2 - Pain	113 participants	6 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I2 - Swelling	28 participants	0 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I2 - Fever	46 participants	3 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I2 - Drowsiness	1 participants	0 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I2 - Loss of appetite	21 participants	4 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I2 - Irritability/fussiness	7 participants	0 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I3 - Pain	66 participants	1 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I3 - Swelling	16 participants	1 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I3 - Fever	17 participants	6 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I3 - Drowsiness	0 participants	0 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I3 - Loss of appetite	5 participants	3 participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population I3 - Irritability/fussiness	3 participants	0 participants

SECONDARY outcome

Timeframe: vaccination day plus post-vaccination days 1, 2, 3, and 6

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=195 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=190 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I1 - Pain	137 Participants	8 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I1 - Swelling	50 Participants	1 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I1 - Fever	61 Participants	10 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I1 - Drowsiness	1 Participants	0 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I1 - Loss of appetite	27 Participants	6 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I1 - Irritability/fussiness	13 Participants	1 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I2 - Pain	113 Participants	5 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I2 - Swelling	28 Participants	0 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I2 - Fever	46 Participants	3 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I2 - Drowsiness	1 Participants	0 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I2 - Loss of appetite	21 Participants	3 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I2 - Irritability/fussiness	7 Participants	0 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I3 - Pain	66 Participants	1 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I3 - Swelling	15 Participants	1 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I3 - Fever	17 Participants	6 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I3 - Drowsiness	0 Participants	0 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I3 - Loss of appetite	5 Participants	3 Participants
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population I3 - Irritability/fussiness	3 Participants	0 Participants

SECONDARY outcome

Timeframe: vaccination day and 29 subsequent days

Population: withdrawals

Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=200 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I1 - Body as a whole general	14 adverse events	7 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I2 - Body as a whole general	7 adverse events	3 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I3 - Body as a whole general	4 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I1 - History of fever	13 adverse events	7 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I2 - History of fever	7 adverse events	3 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I3 - History of fever	4 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I1 - Fever	1 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I2 - Fever	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I3 - Fever	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I1 - Rash maculo-papular	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I2 - Rash maculo-papular	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I3 - Rash maculo-papular	1 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I1 - Gastroenteritis	0 adverse events	1 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I2 - Gastroenteritis	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I3 - Gastroenteritis	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I1 - Headache	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I2 - Headache	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I3 - Headache	1 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I1 - Injection site inflammation	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I2 - Injection site inflammation	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population I3 - Injection site inflammation	0 adverse events	1 adverse events

SECONDARY outcome

Timeframe: vaccination day and 29 subsequent days

Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=195 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=190 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I1 - Body as a whole general	13 adverse events	6 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I2 - Body as a whole general	7 adverse events	2 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I3 - Body as a whole general	4 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I1 - History of Fever	12 adverse events	6 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I2 - History of Fever	7 adverse events	2 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I3 - History ofFever	4 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I1 - Fever	1 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I2 - Fever	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I3 - Fever	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I1 - Rash maculo-papular	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I2 - Rash maculo-papular	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I3 - Rash maculo-papular	1 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I1 - Gastroenteritis	0 adverse events	1 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I2 - Gastroenteritis	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I3 - Gastroenteritis	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I1 - Headache	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I2 - Headache	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I3 - Headache	1 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I1 - Injection site inflammation	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I2 - Injection site inflammation	0 adverse events	0 adverse events
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population I3 - Injection site inflammation	0 adverse events	1 adverse events

SECONDARY outcome

Timeframe: vaccination day plus post-vaccine days 1, 2, 3, and 6; 30 day follow-up for unsolicited events and follow-up for SAEs to continue for duration of study (364 days)

Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). Follow-up of SAEs continued for study duration (364 days)

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=200 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Hearing and vestibular	1 Number of Participants	2 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Endocrine	0 Number of Participants	2 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Reproductive	2 Number of Participants	0 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Red blood cell	176 Number of Participants	167 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Resistance mechanism	167 Number of Participants	160 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Psychiatric	30 Number of Participants	3 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Liver and biliary	10 Number of Participants	12 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Central and peripheral nervous system	12 Number of Participants	9 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization White cell and reticuloendothelial	6 Number of Participants	10 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Urinary	6 Number of Participants	4 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Platelet bleeding and clotting	1 Number of Participants	4 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Musculoskeletal	1 Number of Participants	3 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Body as a whole general	174 Number of Participants	115 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Skin and appendages	132 Number of Participants	132 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Gastroentestinal	128 Number of Participants	116 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Application site	176 Number of Participants	15 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Respiratory	61 Number of Participants	69 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Vision	36 Number of Participants	35 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Any solicited symptom	195 Number of Participants	85 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Any unsolicited AE	197 Number of Participants	197 Number of Participants
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization Any serious adverse event	16 Number of Participants	8 Number of Participants

SECONDARY outcome

Timeframe: vaccination day plus 29 subsequent days

Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=195 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=190 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I1 - Any symptom	157 adverse events	22 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I1 - Local	139 adverse events	9 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I1 - Systemic	82 adverse events	16 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I2 - Any symptom	131 adverse events	10 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I2 - Local	113 adverse events	5 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I2 - Systemic	62 adverse events	6 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I3 - Any symptom	76 adverse events	10 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I3 - Local	66 adverse events	1 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) I3 - Systemic	21 adverse events	9 adverse events

SECONDARY outcome

Timeframe: vaccination day plus 29 subsequent days

Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3

Outcome measures

Outcome measures
Measure	FMP1/AS02A n=200 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I1 - Any symptom	160 adverse events	24 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I1 - Local	142 adverse events	10 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I1 - Systemic	83 adverse events	17 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I2 - Any symptom	131 adverse events	11 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I2 - Local	113 adverse events	5 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I2 - Systemic	62 adverse events	7 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I3 - Any symptom	76 adverse events	10 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I3 - Local	66 adverse events	1 adverse events
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) I3 - Systemic	21 adverse events	9 adverse events

Adverse Events

FMP1/AS02A

Serious events: 15 serious events

Other events: 197 other events

Deaths: 1 deaths

RabAvert (Rabies Vaccine)

Serious events: 8 serious events

Other events: 197 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FMP1/AS02A n=200 participants at risk FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 participants at risk RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine
Infections and infestations Cellulitis	1.0% 2/200 • Number of events 2 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Infections and infestations Cerebral malaria; severe anemia	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Nervous system disorders Convulsions	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Injury, poisoning and procedural complications Foreign body in ear	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Injury, poisoning and procedural complications Foreign body in nostril	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Gastrointestinal disorders Gastroenteritis	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Infections and infestations Pneumonia	1.0% 2/200 • Number of events 2 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Blood and lymphatic system disorders Malaria	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Respiratory, thoracic and mediastinal disorders Hyper-responsive airway disease	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Immune system disorders Allergic reaction	0.00% 0/200 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	0.50% 1/200 • Number of events 1 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3
Investigations Parasitemia >20%	4.5% 9/200 • Number of events 9 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3	2.0% 4/200 • Number of events 4 • 14 months to include follow-up for unsolicited adverse events 30 days post dose-3

Other adverse events

Additional Information

Bernhards R. Ogutu, PhD

Kenya Medical Research Institute

Phone: 254-57-22942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Baseline characteristics by cohort
Measure	FMP1/AS02A n=200 Participants FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine	RabAvert (Rabies Vaccine) n=200 Participants RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine	Total n=400 Participants Total of all reporting groups
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	200 Participants n=200 Participants	200 Participants n=200 Participants	400 Participants n=400 Participants
Age, Continuous Walter Reed Project Field Station	28.6 Months STANDARD_DEVIATION 10.6 • n=43 Participants • Demographics were reported per field station	29.2 Months STANDARD_DEVIATION 10.9 • n=45 Participants • Demographics were reported per field station	28.9 Months STANDARD_DEVIATION 10.7 • n=88 Participants • Demographics were reported per field station
Age, Continuous Abol Field Station	34.3 Months STANDARD_DEVIATION 9.7 • n=14 Participants • Demographics were reported per field station	28.9 Months STANDARD_DEVIATION 10.0 • n=12 Participants • Demographics were reported per field station	31.6 Months STANDARD_DEVIATION 10.0 • n=26 Participants • Demographics were reported per field station
Age, Continuous Bar-Korwa Field Station	22.0 Months STANDARD_DEVIATION 6.2 • n=7 Participants • Demographics were reported per field station	32.8 Months STANDARD_DEVIATION 5.9 • n=5 Participants • Demographics were reported per field station	26.6 Months STANDARD_DEVIATION 8.0 • n=12 Participants • Demographics were reported per field station
Age, Continuous Got-Aglu Field Station	29.1 Months STANDARD_DEVIATION 11.8 • n=15 Participants • Demographics were reported per field station	25.0 Months STANDARD_DEVIATION 8.6 • n=17 Participants • Demographics were reported per field station	26.8 Months STANDARD_DEVIATION 10.2 • n=32 Participants • Demographics were reported per field station
Age, Continuous Kitare Field Station	30.2 Months STANDARD_DEVIATION 10.7 • n=19 Participants • Demographics were reported per field station	29.9 Months STANDARD_DEVIATION 10.0 • n=17 Participants • Demographics were reported per field station	30.1 Months STANDARD_DEVIATION 10.2 • n=36 Participants • Demographics were reported per field station
Age, Continuous Kuoyo-Kowe Field Station	31.1 Months STANDARD_DEVIATION 9.3 • n=17 Participants • Demographics were reported per field station	31.7 Months STANDARD_DEVIATION 9.4 • n=18 Participants • Demographics were reported per field station	31.4 Months STANDARD_DEVIATION 9.2 • n=35 Participants • Demographics were reported per field station
Age, Continuous Manyanda Field Station	30.6 Months STANDARD_DEVIATION 6.4 • n=8 Participants • Demographics were reported per field station	31.1 Months STANDARD_DEVIATION 8.2 • n=8 Participants • Demographics were reported per field station	30.9 Months STANDARD_DEVIATION 7.0 • n=16 Participants • Demographics were reported per field station
Age, Continuous Mirieri Field Station	30.3 Months STANDARD_DEVIATION 10.0 • n=18 Participants • Demographics were reported per field station	26.5 Months STANDARD_DEVIATION 10.1 • n=12 Participants • Demographics were reported per field station	28.8 Months STANDARD_DEVIATION 10.0 • n=30 Participants • Demographics were reported per field station
Age, Continuous Nduru Field Station	26.1 Months STANDARD_DEVIATION 10.2 • n=10 Participants • Demographics were reported per field station	34.6 Months STANDARD_DEVIATION 10.2 • n=15 Participants • Demographics were reported per field station	30.9 Months STANDARD_DEVIATION 10.9 • n=25 Participants • Demographics were reported per field station
Age, Continuous Oruga Field Station	30.5 Months STANDARD_DEVIATION 9.5 • n=19 Participants • Demographics were reported per field station	33.1 Months STANDARD_DEVIATION 9.6 • n=20 Participants • Demographics were reported per field station	31.8 Months STANDARD_DEVIATION 9.5 • n=39 Participants • Demographics were reported per field station
Age, Continuous Osewre Field Station	31.1 Months STANDARD_DEVIATION 11.3 • n=12 Participants • Demographics were reported per field station	30.7 Months STANDARD_DEVIATION 8.4 • n=9 Participants • Demographics were reported per field station	30.9 Months STANDARD_DEVIATION 9.8 • n=21 Participants • Demographics were reported per field station
Age, Continuous Ranen Field Station	26.2 Months STANDARD_DEVIATION 10.9 • n=11 Participants • Demographics were reported per field station	32.2 Months STANDARD_DEVIATION 11.2 • n=12 Participants • Demographics were reported per field station	29.5 Months STANDARD_DEVIATION 11.2 • n=23 Participants • Demographics were reported per field station
Age, Continuous Reru Field Station	26.9 Months STANDARD_DEVIATION 11.0 • n=7 Participants • Demographics were reported per field station	30.3 Months STANDARD_DEVIATION 10.8 • n=10 Participants • Demographics were reported per field station	28.9 Months STANDARD_DEVIATION 10.7 • n=17 Participants • Demographics were reported per field station
Sex: Female, Male WRAIR Field Station · Female	16 Participants n=41 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	17 Participants n=41 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	33 Participants n=82 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male WRAIR Field Station · Male	25 Participants n=41 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	24 Participants n=41 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	49 Participants n=82 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Abol Field Station · Female	7 Participants n=14 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	4 Participants n=12 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	11 Participants n=26 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Abol Field Station · Male	7 Participants n=14 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	8 Participants n=12 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	15 Participants n=26 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Bar-Korwa Field Station · Female	3 Participants n=7 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	3 Participants n=5 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	6 Participants n=12 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Bar-Korwa Field Station · Male	4 Participants n=7 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	2 Participants n=5 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	6 Participants n=12 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Got-Aglu Field Station · Female	6 Participants n=14 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	6 Participants n=17 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	12 Participants n=31 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Got-Aglu Field Station · Male	8 Participants n=14 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	11 Participants n=17 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	19 Participants n=31 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Kitare Field Station · Female	10 Participants n=19 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	5 Participants n=17 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	15 Participants n=36 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Kitare Field Station · Male	9 Participants n=19 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	12 Participants n=17 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	21 Participants n=36 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Kuoyo-Kowe Field Station · Female	8 Participants n=17 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	7 Participants n=18 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	15 Participants n=35 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Kuoyo-Kowe Field Station · Male	9 Participants n=17 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	11 Participants n=18 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	20 Participants n=35 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Manyanda Field Station · Female	5 Participants n=8 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	5 Participants n=7 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	10 Participants n=15 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Manyanda Field Station · Male	3 Participants n=8 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	2 Participants n=7 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	5 Participants n=15 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Mirieri Field Station · Female	13 Participants n=18 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	3 Participants n=11 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	16 Participants n=29 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Mirieri Field Station · Male	5 Participants n=18 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	8 Participants n=11 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	13 Participants n=29 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Nduru Kadero Field Station · Female	8 Participants n=10 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	5 Participants n=13 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	13 Participants n=23 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Nduru Kadero Field Station · Male	2 Participants n=10 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	8 Participants n=13 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	10 Participants n=23 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Oruga Field Station · Female	7 Participants n=19 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	7 Participants n=18 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	14 Participants n=37 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Oruga Field Station · Male	12 Participants n=19 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	11 Participants n=18 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	23 Participants n=37 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Osewre Field Station · Female	3 Participants n=11 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	6 Participants n=9 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	9 Participants n=20 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Osewre Field Station · Male	8 Participants n=11 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	3 Participants n=9 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	11 Participants n=20 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Ranen Field Station · Female	6 Participants n=10 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	5 Participants n=12 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	11 Participants n=22 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Ranen Field Station · Male	4 Participants n=10 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	7 Participants n=12 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	11 Participants n=22 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.
Sex: Female, Male Reru Field Station · Female	5 Participants n=7 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	5 Participants n=10 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.	10 Participants n=17 Participants • Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm.