Trial Outcomes & Findings for PfSPZ Vaccine Trial in Malian Children (NCT NCT04940130)
NCT ID: NCT04940130
Last Updated: 2024-02-07
Results Overview
Proportion of vaccinees compared to controls experiencing related SAEs from V1 to 26 weeks after V3
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
290 participants
Primary outcome timeframe
From day of first vaccination until 26 weeks after 3rd vaccination (study day 1 to day 211)
Results posted on
2024-02-07
Participant Flow
Participant milestones
| Measure |
Arm 1 (PfSPZ Vaccine)
Children ages 6 - 10 will receive three doses of PfSPZ Vaccine (9.0x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, and 29 days
Sanaria® PfSPZ Vaccine: non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).
|
Arm 2 (Normal Saline)
Children ages 6 - 10 will receive normal saline via DVI at 1, 8, and 29 days
Normal Saline: placebo control- saline
|
Enrolled With no Arm Assignment
Children ages 6 -10 were enrolled upon administration of AL treatment, but not assigned to a treatment arm (did not receive PfSPZ Vaccine nor Normal saline)
|
|---|---|---|---|
|
Overall Study
STARTED
|
139
|
138
|
13
|
|
Overall Study
COMPLETED
|
138
|
137
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
13
|
Reasons for withdrawal
| Measure |
Arm 1 (PfSPZ Vaccine)
Children ages 6 - 10 will receive three doses of PfSPZ Vaccine (9.0x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, and 29 days
Sanaria® PfSPZ Vaccine: non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).
|
Arm 2 (Normal Saline)
Children ages 6 - 10 will receive normal saline via DVI at 1, 8, and 29 days
Normal Saline: placebo control- saline
|
Enrolled With no Arm Assignment
Children ages 6 -10 were enrolled upon administration of AL treatment, but not assigned to a treatment arm (did not receive PfSPZ Vaccine nor Normal saline)
|
|---|---|---|---|
|
Overall Study
Travel
|
1
|
0
|
2
|
|
Overall Study
Parent/Guardian withdrew consent
|
0
|
1
|
7
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
|
Overall Study
Disease progression/treatment failure
|
0
|
0
|
1
|
|
Overall Study
Participant refusal
|
0
|
0
|
1
|
Baseline Characteristics
PfSPZ Vaccine Trial in Malian Children
Baseline characteristics by cohort
| Measure |
Arm 1 (PfSPZ Vaccine)
n=139 Participants
Children ages 6 - 10 will receive three doses of PfSPZ Vaccine (9.0x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, and 29 days
Sanaria® PfSPZ Vaccine: non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).
|
Arm 2 (Normal Saline)
n=138 Participants
Children ages 6 - 10 will receive normal saline via DVI at 1, 8, and 29 days
Normal Saline: placebo control- saline
|
Enrolled With no Arm Assignment
n=13 Participants
Children ages 6 -10 were enrolled upon administration of AL treatment, but not assigned to a treatment arm (did not receive PfSPZ Vaccine nor Normal saline)
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
139 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
290 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
139 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
290 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Mali
|
139 participants
n=5 Participants
|
138 participants
n=7 Participants
|
13 participants
n=5 Participants
|
290 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From day of first vaccination until 26 weeks after 3rd vaccination (study day 1 to day 211)Proportion of vaccinees compared to controls experiencing related SAEs from V1 to 26 weeks after V3
Outcome measures
| Measure |
Arm 1 (PfSPZ Vaccine)
n=139 Participants
Children ages 6 - 10 will receive three doses of PfSPZ Vaccine (9.0x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, and 29 days
Sanaria® PfSPZ Vaccine: non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).
|
Arm 2 (Normal Saline)
n=138 Participants
Children ages 6 - 10 will receive normal saline via DVI at 1, 8, and 29 days
Normal Saline: placebo control- saline
|
|---|---|---|
|
Number of Participants With Possibly, Probably, or Definitely Related Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1 (PfSPZ Vaccine)
Serious events: 0 serious events
Other events: 134 other events
Deaths: 0 deaths
Arm 2 (Normal Saline)
Serious events: 0 serious events
Other events: 128 other events
Deaths: 0 deaths
Enrolled With no Arm Assignment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 (PfSPZ Vaccine)
n=139 participants at risk
Children ages 6 - 10 will receive three doses of PfSPZ Vaccine (9.0x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, and 29 days
Sanaria® PfSPZ Vaccine: non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).
|
Arm 2 (Normal Saline)
n=138 participants at risk
Children ages 6 - 10 will receive normal saline via DVI at 1, 8, and 29 days
Normal Saline: placebo control- saline
|
Enrolled With no Arm Assignment
n=13 participants at risk
Children ages 6 -10 were enrolled upon administration of AL treatment, but not assigned to a treatment arm (did not receive PfSPZ Vaccine nor Normal saline)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
7.2%
10/139 • Number of events 10 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
8.0%
11/138 • Number of events 12 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Investigations
Blood creatinine increased
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Bronchiolitis
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Bronchitis
|
8.6%
12/139 • Number of events 12 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
7.2%
10/138 • Number of events 12 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
7.7%
1/13 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Eye disorders
Conjunctivitis
|
3.6%
5/139 • Number of events 5 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.4%
20/139 • Number of events 24 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
11.6%
16/138 • Number of events 18 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
1.4%
2/138 • Number of events 3 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
1.4%
2/138 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Ear infection
|
3.6%
5/139 • Number of events 5 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
2.9%
4/138 • Number of events 4 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
General disorders
Face edema
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Gastrointestinal disorders
Food poisoning
|
2.2%
3/139 • Number of events 3 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
4.3%
6/138 • Number of events 6 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Furuncle
|
2.2%
3/139 • Number of events 3 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
2.9%
4/138 • Number of events 5 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
7.7%
1/13 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Gastroenteritis
|
3.6%
5/139 • Number of events 5 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
4.3%
6/138 • Number of events 6 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Genitourinary tract infection
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Gingivitis
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Nervous system disorders
Headache
|
13.7%
19/139 • Number of events 21 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
15.9%
22/138 • Number of events 23 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Investigations
Hemoglobin decrease
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Investigations
Hemoglobin increased
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
General disorders
Hernia
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
2.2%
3/139 • Number of events 3 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Influenza
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Injury, poisoning and procedural complications
Injury
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
6/139 • Number of events 6 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
5.1%
7/138 • Number of events 8 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Malaria
|
61.9%
86/139 • Number of events 141 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
65.2%
90/138 • Number of events 146 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Mumps
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
2.2%
3/138 • Number of events 3 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
7.7%
1/13 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Nasopharyngitis
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Gastrointestinal disorders
Nausea
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
7/139 • Number of events 7 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
1.4%
2/138 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Investigations
Neutrophil count decreased
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
9/139 • Number of events 11 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
15.9%
22/138 • Number of events 26 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Otitis externa
|
0.72%
1/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Paronychia
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Pharyngitis
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Pyoderma
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
2.9%
4/138 • Number of events 4 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
General disorders
Pyrexia
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Rhinitis
|
44.6%
62/139 • Number of events 96 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
41.3%
57/138 • Number of events 83 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Sinobronchitis
|
15.8%
22/139 • Number of events 29 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
16.7%
23/138 • Number of events 26 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
4/139 • Number of events 4 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Tinea infection
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
7.7%
1/13 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Tonsillitis
|
0.72%
1/139 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/138 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Typhoid fever
|
1.4%
2/139 • Number of events 2 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Varicella
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.72%
1/138 • Number of events 1 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/139 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
2.2%
3/138 • Number of events 3 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Injury, poisoning and procedural complications
Wound
|
14.4%
20/139 • Number of events 20 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
9.4%
13/138 • Number of events 14 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
|
Infections and infestations
Wound infection
|
5.0%
7/139 • Number of events 7 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
2.2%
3/138 • Number of events 3 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
0.00%
0/13 • Receipt of AL treatment to 26 weeks post 3rd vaccination (study day -17 to study day 211) = ~8 months
|
Additional Information
Dr. Patrick Duffy
Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301.761.5089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place