Trial Outcomes & Findings for Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B (NCT NCT02458092)
NCT ID: NCT02458092
Last Updated: 2023-06-28
Results Overview
Vaccinations were given at 0-, 1-, 2-month interval, occurrence and intensity of solicited symptoms on day of vaccination (Day 0) and Days 1-7 after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7
Results posted on
2023-06-28
Participant Flow
30 healthy, malaria-experienced adults were enrolled and randomized into 2 groups at Walter Reed Project/Kenya Medical Research Institute (KEMRI) Kisumu, Kenya.
Participant milestones
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
Rabies Vaccine Rabipur
Rabipur: Rabipur is a licensed rabies vaccine (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
19
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
Rabies Vaccine Rabipur
Rabipur: Rabipur is a licensed rabies vaccine (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
Baseline characteristics by cohort
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
n=20 Participants
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
|
Rabies Vaccine Rabipur
n=10 Participants
Rabipur: Rabipur is a licensed rabies vaccine.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Luo
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Lulya
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7Vaccinations were given at 0-, 1-, 2-month interval, occurrence and intensity of solicited symptoms on day of vaccination (Day 0) and Days 1-7 after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe
Outcome measures
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
n=20 Participants
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
Rabies Vaccine Rabipur
n=10 Participants
Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
|---|---|---|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fever · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Gastrointestinal (nausea) · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Gastrointestinal (nausea) · No experiences
|
17 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Headache · Grade 1
|
8 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Headache · Grade 2
|
4 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Headache · No experiences
|
8 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Malaise · Grade 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Malaise · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Myalgia · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Myalgia · No experiences
|
19 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Joint pain · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Joint pain · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local pain · Grade 1
|
14 Participants
|
6 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local pain · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization: Local redness · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization: Local redness · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fever · No experiences
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fatigue · Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fatigue · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Malaise · No experiences
|
15 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Myalgia · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local redness · Grade 1
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local swelling · No experiences
|
17 Participants
|
8 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fatigue · Grade 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fatigue · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Gastrointestinal (nausea) · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Malaise · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Malaise · No experiences
|
18 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Myalgia · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Myalgia · No experiences
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Joint pain · Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Joint pain · No experiences
|
19 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local pain · Grade 1
|
10 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local swelling · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local swelling · No experiences
|
18 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local pain · Grade 2
|
6 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local pain · No experiences
|
0 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization: Local redness · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization: Local redness · No experiences
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local swelling · Grade 1
|
6 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local swelling · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local swelling · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Local swelling · No experiences
|
14 Participants
|
8 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fever · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fever · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fever · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fatigue · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Fatigue · No experiences
|
18 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Gastrointestinal (nausea) · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Gastrointestinal (nausea) · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Gastrointestinal (nausea) · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Gastrointestinal (nausea) · No experiences
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Headache · Grade 1
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Headache · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Headache · Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Headache · No experiences
|
16 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Malaise · Grade 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Malaise · Grade 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Malaise · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Myalgia · Grade 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Myalgia · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Myalgia · No experiences
|
17 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Joint pain · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Joint pain · Grade 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Joint pain · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Joint pain · No experiences
|
17 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local pain · Grade 1
|
12 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local pain · Grade 2
|
7 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local pain · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local pain · No experiences
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local redness · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local redness · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local redness · No experiences
|
17 Participants
|
8 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local swelling · Grade 1
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local swelling · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 2: Local swelling · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fever · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fever · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fever · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fever · No experiences
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fatigue · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Fatigue · No experiences
|
18 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Gastrointestinal (nausea) · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Gastrointestinal (nausea) · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Gastrointestinal (nausea) · No experiences
|
20 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Headache · Grade 1
|
4 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Headache · Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Headache · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Headache · No experiences
|
14 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Malaise · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Malaise · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fever · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fever · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fever · No experiences
|
20 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fatigue · Grade 1
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fatigue · Grade 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fatigue · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Fatigue · No experiences
|
15 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Gastrointestinal (nausea) · Grade 1
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Gastrointestinal (nausea) · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Headache · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Malaise · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Malaise · No experiences
|
17 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Myalgia · Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Myalgia · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Joint pain · Grade 1
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 1: Joint pain · No experiences
|
17 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Myalgia · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Myalgia · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Joint pain · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Joint pain · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local pain · Grade 2
|
4 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local pain · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local pain · No experiences
|
6 Participants
|
6 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local redness · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local redness · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local redness · Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local redness · No experiences
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local swelling · Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Immunization 3: Local swelling · Grade 3
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: After each vaccination (Day 0), 30 day f/u period post vaccinationVaccinations were given at 0-, 1-, 2-month interval, number of subjects reporting unsolicited symptoms at specified grades over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe
Outcome measures
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
n=20 Participants
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
Rabies Vaccine Rabipur
n=10 Participants
Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events at Specified Grades
Grade 1
|
20 Participants
|
10 Participants
|
|
Number of Subjects With Unsolicited Adverse Events at Specified Grades
Grade 2
|
15 Participants
|
9 Participants
|
|
Number of Subjects With Unsolicited Adverse Events at Specified Grades
Grade 3
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccinationVaccinations were given at 0-, 1-, 2-month interval, number of subjects with the occurrence of serious adverse events at days 0-7 post vaccination
Outcome measures
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
n=20 Participants
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
Rabies Vaccine Rabipur
n=10 Participants
Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
|---|---|---|
|
Number of Subjects With the Occurrence of Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) (not presented in results), at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Outcome measures
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
n=20 Participants
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
Rabies Vaccine Rabipur
Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
|---|---|---|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00906: Day14
|
7961.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00423: Day14
|
54644.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00423: Day28
|
51390.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00423: Day42
|
97930.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00423: Day56
|
90560.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00906: Day0
|
7055.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02507: Day 112
|
240330.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02708: Day0
|
4905.9 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02708: Day14
|
7577.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03401: Day28
|
6060.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03401: Day42
|
62353.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03401: Day56
|
30647.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03401: Day70
|
70680.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03814: Day0
|
15190.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03814: Day14
|
45280.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03814: Day56
|
137740.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03814: Day70
|
80160.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 05029: Day70
|
74950.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 05029: Day112
|
41140.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06020: Day0
|
45960.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06020: Day14
|
45690.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06020: Day112
|
54958.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06627: Day0
|
3926.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06627: Day28
|
8919.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06627: Day42
|
12677.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 07722: Day0
|
399.6 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 07722: Day56
|
39952.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09105: Day70
|
121030.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09105: Day112
|
30260.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09621: Day14
|
15889.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09621: Day28
|
15213.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09621: Day42
|
32252.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09621: Day56
|
19676.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09621: Day70
|
53608.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09621: Day112
|
26482.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09913: Day0
|
29480.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09913: Day14
|
32260.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09913: Day72
|
76470.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09913: Day112
|
114600.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10015: Day56
|
311250.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10916: Day28
|
61407.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10916: Day42
|
68040.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10916: Day56
|
71610.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10916: Day70
|
60950.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10916: Day112
|
81650.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12217: Day42
|
48342.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12217: Day112
|
45929.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12518: Day42
|
78680.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12518: Day56
|
27675.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12612: Day0
|
1852.4 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 13209: Day14
|
2506.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 13209: Day28
|
2988.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 13209: Day112
|
38390.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06020: Day70
|
68280.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06627: Day14
|
10662.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06627: Day56
|
10673.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06020: Day28
|
48483.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06020: Day42
|
65830.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06020: Day56
|
79880.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 05029: Day56
|
58170.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00423: Day0
|
44720.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00423: Day70
|
99530.0 Geometric Mean Titers
CICI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00423: Day112
|
91040.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00906: Day28
|
11322.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00906: Day42
|
36532.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00906: Day56
|
21780.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00906: Day70
|
36438.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 00906: Day112
|
14994.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02507: Day0
|
84830.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02507: Day14
|
261320.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02507: Day28
|
172340.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02507: Day42
|
224560.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02507: Day56
|
396580.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02507: Day70
|
275580.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02708: Day28
|
10519.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02708: Day42
|
61350.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02708: Day56
|
40838.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subect 02708: Day70
|
66650.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 02708: Day112
|
57170.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03401: Day0
|
2215.7 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03401: Day14
|
10186.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03401: Day112
|
45400.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03814: Day28
|
44100.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03814: Day42
|
83150.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 03814: Day112
|
99760.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 05029: Day0
|
4151.5 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 05029: Day14
|
15949.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 05029: Day28
|
21873.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 05029: Day42
|
92010.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06627: Day70
|
12201.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 06627: Day112
|
NA Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 07722: Day14
|
1500.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 07722: Day28
|
970.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 07722: Day42
|
55140.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 07722: Day70
|
127770.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 07722: Day112
|
40950.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 08904: Day0
|
1751.8 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 08904: Day14
|
2656.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 08904: Day28
|
2176.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 08904: Day42
|
19760.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 08904: Day56
|
11798.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 08904: Day70
|
16158.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 08904: Day112
|
13393.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09105: Day0
|
37.7 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09105: Day14
|
567.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09105: Day28
|
1318.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09105: Day42
|
132810.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09105: Day56
|
37366.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09621: Day0
|
6147.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09913: Day28
|
27302.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09913: Day42
|
80040.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 09913: Day56
|
NA Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10015: Day0
|
2007.5 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10015: Day14
|
6241.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10015: Day28
|
6617.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10015: Day42
|
53650.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10015: Day70
|
205460.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10015: Day112
|
149250.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10916: Day0
|
28200.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 10916: Day14
|
53252.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12217: Day0
|
6603.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12217: Day14
|
11804.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12217: Day28
|
10355.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12217: Day56
|
24537.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12217: Day70
|
78190.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12518: Day0
|
2051.6 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12518: Day14
|
4403.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12518: Day28
|
2214.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12518: Day70
|
126160.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12518: Day112
|
38900.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12612: Day14
|
1545.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12612: Day28
|
979.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12612: Day42
|
7536.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12612: Day56
|
4067.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12612: Day70
|
23216.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 12612: Day112
|
11960.0 Geometric Mean Titers
CCI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 13209: Day0
|
940.8 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 13209: Day42
|
153550.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 13209: Day 56
|
900000.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Subject 13209: Day70
|
110650.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
SECONDARY outcome
Timeframe: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Outcome measures
| Measure |
50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant
n=10 Participants
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
Rabies Vaccine Rabipur
Rabipur: Rabipur is a licensed rabies vaccine. Vaccinations were performed intramuscularly in the deltoid muscle of the non-dominant arm, 3 doses were given at 0-, 1-, 2-month interval.
|
|---|---|---|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01603: Day0
|
20580.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01702: Day42
|
57.8 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01702: Day56
|
65.1 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01702: Day112
|
42.1 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04026: Day0
|
122.6 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04328: Day42
|
3788.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04328: Day56
|
2914.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 08725: Day0
|
27240.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 08725: Day42
|
17866.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 09211: Day28
|
2794.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 09211: Day42
|
1952.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 09211: Day70
|
1232.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10324: Day14
|
4493.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10810: Day112
|
36962.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 11819: Day42
|
9381.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 11819: Day56
|
6355.0 Geometric Mean Titers
CCI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 11819: Day70
|
5276.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 11819: Day112
|
5921.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 12330: Day0
|
1117.6 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 12330: Day14
|
1291.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 12330: Day28
|
1392.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 12330: Day42
|
1105.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 12330: Day112
|
852.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01603: Day14
|
23707.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01603: Day28
|
22537.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01603: Day42
|
24090.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01603: Day56
|
42005.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01603: Day70
|
43723.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01603: Day112
|
32104.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01702: Day0
|
71.5 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01702: Day14
|
84.3 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01702: Day28
|
53.2 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 01702: Day70
|
73.6 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04026: Day14
|
103.2 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04026: Day28
|
109.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04026: Day42
|
77.5 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04026: Day56
|
1000.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04026: Day70
|
544.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04026: Day112
|
125.8 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04328: Day0
|
5226.3 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04328: Day14
|
3782.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04328: Day28
|
4560.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04328: Day70
|
1920.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 04328: Day112
|
1802.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 08725: Day14
|
29477.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 08725: Day28
|
26786.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 08725: Day56
|
13819.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 08725: Day70
|
9601.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 08725: Day112
|
9898.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 09211: Day0
|
2347.1 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 09211: Day14
|
2250.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 09211: Day56
|
1378.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 09211: Day112
|
1991.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10324: Day0
|
3970.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10324: Day28
|
3781.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10324: Day42
|
2891.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10324: Day56
|
3849.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10324: Day70
|
1901.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10324: Day112
|
1381.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10810: Day0
|
49410.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10810: Day14
|
41500.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10810: Day28
|
45920.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10810: Day42
|
49386.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10810: Day56
|
32158.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 10810: Day70
|
39979.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 11819: Day0
|
9669.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 11819: Day14
|
11155.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 11819: Day28
|
10008.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 12330: Day56
|
734.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
|
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Subject 12330: Day70
|
858.0 Geometric Mean Titers
CI was not included in the tables section of the final clinical study report that corresponds to this outcome measure
|
—
|
Adverse Events
50 µg of FMP010 Antigen in 0.5 mL AS01B Adjuvant
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Rabies Vaccine Rabipur
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 µg of FMP010 Antigen in 0.5 mL AS01B Adjuvant
n=20 participants at risk
50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant given intramuscularly in the deltoid muscle of the non-dominant arm.
Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
|
Rabies Vaccine Rabipur
n=10 participants at risk
Rabies Vaccine Rabipur given intramuscularly in the deltoid muscle of the non-dominant arm.
Rabipur: Rabipur is a licensed rabies vaccine.
|
|---|---|---|
|
General disorders
Generalized malaise
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Giardiasis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Nervous system disorders
Headache
|
40.0%
8/20 • Number of events 14 • Day 0 - 146
|
30.0%
3/10 • Number of events 4 • Day 0 - 146
|
|
Infections and infestations
Herpes labialis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Infections and infestations
Hordeolum
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Vascular disorders
Hot flushes
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Vascular disorders
Hotness of body
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Skin and subcutaneous tissue disorders
Itchiness of ears (mild)
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Skin and subcutaneous tissue disorders
Itchiness of injection site
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Investigations
Leukopenia
|
10.0%
2/20 • Number of events 2 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Metabolism and nutrition disorders
Loss of appetite
|
5.0%
1/20 • Number of events 2 • Day 0 - 146
|
20.0%
2/10 • Number of events 3 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Lumbosacral back pain
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Blood and lymphatic system disorders
Malaria
|
45.0%
9/20 • Number of events 9 • Day 0 - 146
|
30.0%
3/10 • Number of events 3 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Mild cough
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Investigations
Mild drop in neutrophils
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Muscular neck pain
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Muscular pain lower back
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Neck pains
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
20.0%
2/10 • Number of events 2 • Day 0 - 146
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Nervous system disorders
Numbness left upper limb
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Numbness of left arm
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Numbness of left arm (muscular)
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
General disorders
Pain at circumcision site
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Eye disorders
Pain both eyes
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
General disorders
Pain left face
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Pain on the left elbow joint
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Pain right shin
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • Number of events 3 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
10.0%
2/20 • Number of events 2 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Skin and subcutaneous tissue disorders
Pruritus of the interphalangeal spaces, both feet
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Skin and subcutaneous tissue disorders
Pruritus all over body
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Investigations
Raised WBC count
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Metabolism and nutrition disorders
Reduced appetite
|
10.0%
2/20 • Number of events 2 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Investigations
Reduced neutrophil count
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Blood and lymphatic system disorders
Relative eosinophilia
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
10.0%
2/20 • Number of events 3 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
15.0%
3/20 • Number of events 3 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Right chest pain
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Right joint (hip) pain
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
10.0%
2/20 • Number of events 2 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Infections and infestations
Small abscess left foot
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Injury, poisoning and procedural complications
Soft tissue injury left foot
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Injury, poisoning and procedural complications
Soft tissue injury left heel
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Injury, poisoning and procedural complications
Soft tissue injury left shoulder
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Injury, poisoning and procedural complications
Soft tissue injury right foot
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Injury, poisoning and procedural complications
Soft tissue injury right hand
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Injury, poisoning and procedural complications
Soft tissue injury right wrist joint
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Sore mouth
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Gastrointestinal disorders
Sore throat
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
General disorders
Subjective fever
|
10.0%
2/20 • Number of events 2 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Nervous system disorders
Subjective weakness of the left upper limb
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Psychiatric disorders
Suidical ideations
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Gastrointestinal disorders
Tooth pain secodnary to dental caries
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Gastrointestinal disorders
Tooth sensitivity
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • Number of events 2 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Nervous system disorders
Torticollis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
35.0%
7/20 • Number of events 9 • Day 0 - 146
|
70.0%
7/10 • Number of events 10 • Day 0 - 146
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Nervous system disorders
Weakness of left arm
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Gastrointestinal disorders
Abdominal hernia
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Infections and infestations
Abscesses on lower limbs
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Infections and infestations
Abscesses right medial malleolus
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Acute colitis (infective)
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Gastrointestinal disorders
Acute gastroenteritis (amoebiasis)
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Infections and infestations
Allergic conjunctivitis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Infections and infestations
Allergic conjunctivitis (both eyes)
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
20.0%
2/10 • Number of events 2 • Day 0 - 146
|
|
Immune system disorders
Allergic cough
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Immune system disorders
Allergic rhinitis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Immune system disorders
Allergic skin reaction
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Arthritis in both knee joints
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Number of events 4 • Day 0 - 146
|
20.0%
2/10 • Number of events 4 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Chest pain (musculoskeletal)
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Chills
|
20.0%
4/20 • Number of events 5 • Day 0 - 146
|
20.0%
2/10 • Number of events 2 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Chills and rigors
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Infections and infestations
Conjunctivitis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Infections and infestations
Conjunctivitis (both eyes)
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Infections and infestations
Conjunctivitis (left eye)
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Number of events 3 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Investigations
Decreased neutrophil count
|
15.0%
3/20 • Number of events 3 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Investigations
Decreased white blood cell count
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • Number of events 6 • Day 0 - 146
|
20.0%
2/10 • Number of events 3 • Day 0 - 146
|
|
Investigations
Drop in hemoglobin
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Investigations
Drop in neutrophil count
|
25.0%
5/20 • Number of events 5 • Day 0 - 146
|
50.0%
5/10 • Number of events 7 • Day 0 - 146
|
|
Investigations
Drop in platelet count
|
0.00%
0/20 • Day 0 - 146
|
20.0%
2/10 • Number of events 2 • Day 0 - 146
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Elbow joint pain bilateral
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Investigations
Elevated ALT
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/20 • Day 0 - 146
|
20.0%
2/10 • Number of events 2 • Day 0 - 146
|
|
Gastrointestinal disorders
Entrocolitis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Epigastric pain
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Eye disorders
Eye strain both eyes
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Fullness of chest related heartburn
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Infections and infestations
Fungal dermatitis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
General disorders
General body aches
|
0.00%
0/20 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
|
General disorders
General body weakness
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
0.00%
0/10 • Day 0 - 146
|
|
Musculoskeletal and connective tissue disorders
Generalized joint pains
|
5.0%
1/20 • Number of events 1 • Day 0 - 146
|
10.0%
1/10 • Number of events 1 • Day 0 - 146
|
Additional Information
Nekoye Otsyula
US Army Medical Research Unit - Kenya
Phone: 254-722-239-828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place