Trial Outcomes & Findings for Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria (NCT NCT03503058)
NCT ID: NCT03503058
Last Updated: 2026-05-04
Results Overview
1. The proportion of participants experiencing solicited AEs occurring within 7 days (PfSPZ Vaccine) or 14 days (PfSPZ-CVac) of each administration of investigational product (IP). 2. The proportion of participants experiencing serious adverse events (SAEs) deemed related to IP during active participation in the trial. 3. The proportion of participants experiencing unsolicited AEs occurring within 14 days of each administration of IP deemed related to vaccination or placebo administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
345 participants
Primary outcome timeframe
PfSPZ Vaccine: 7 days after each vaccination (2 days for local solicited AEs); PfSPZ-CVac: 14 days after each administration; SAEs for both products: from day of immunization until end of study (20 months-immunizations started ~2 months after FSFV).
Results posted on
2026-05-04
Participant Flow
The study lasted about 22 months (May 2022 to Feb 2024).
Participant milestones
| Measure |
Group 1 (PfSPZ Vaccine)
PfSPZ Vaccine: N=124; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) on day 1, 8 and 29.
PfSPZ Vaccine: Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine).
|
Group 2 (NS Placebo)
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 8 and 29.
Normal Saline: 0.9% Sodium chloride
|
Group 3 (PfSPZ Challenge + CQ)
PfSPZ-CVac (PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis): N=124; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ.
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on PfSPZ-CVac Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of PfSPZ Challenge).
PfSPZ-CVac: PfSPZ Challenge (infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites) under CQ chemoprophylaxis
|
Group 4 (NS Placebo + CQ)
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 29 and 57, with weekly CQ.
Normal Saline: 0.9% Sodium chloride
CQ chemoprophylaxis alone:
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on NS Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of NS).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
57
|
116
|
57
|
|
Overall Study
COMPLETED
|
110
|
55
|
113
|
56
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
Baseline characteristics by cohort
| Measure |
Group 1 (PfSPZ Vaccine)
n=115 Participants
PfSPZ Vaccine: N=124; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) on day 1, 8 and 29.
PfSPZ Vaccine: Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine).
|
Group 2 (NS Placebo)
n=57 Participants
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 8 and 29.
Normal Saline: 0.9% Sodium chloride
|
Group 3 (PfSPZ Challenge + CQ)
n=116 Participants
PfSPZ-CVac (PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis): N=124; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ.
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on PfSPZ-CVac Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of PfSPZ Challenge).
PfSPZ-CVac: PfSPZ Challenge (infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites) under CQ chemoprophylaxis.
|
Group 4 (NS Placebo + CQ)
n=57 Participants
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 29 and 57, with weekly CQ.
Normal Saline: 0.9% Sodium chloride
CQ chemoprophylaxis alone:
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on NS Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of NS).
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=54 Participants
|
57 Participants
n=60 Participants
|
116 Participants
n=114 Participants
|
57 Participants
n=1 Participants
|
345 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
23 Years
n=54 Participants
|
24 Years
n=60 Participants
|
23 Years
n=114 Participants
|
23 Years
n=1 Participants
|
23 Years
n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=54 Participants
|
57 Participants
n=60 Participants
|
116 Participants
n=114 Participants
|
57 Participants
n=1 Participants
|
345 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
115 Participants
n=54 Participants
|
57 Participants
n=60 Participants
|
116 Participants
n=114 Participants
|
57 Participants
n=1 Participants
|
345 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Indonesia
|
115 participants
n=54 Participants
|
57 participants
n=60 Participants
|
116 participants
n=114 Participants
|
57 participants
n=1 Participants
|
345 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: PfSPZ Vaccine: 7 days after each vaccination (2 days for local solicited AEs); PfSPZ-CVac: 14 days after each administration; SAEs for both products: from day of immunization until end of study (20 months-immunizations started ~2 months after FSFV).Population: The safety population - 1. All subjects who received at least 1 dose of investigational product or placebo (all 345 randomized) and for whom any safety data were available 2. Used for all safety evaluations (AEs, solicited and unsolicited reactogenicity and SAEs) 3. Subjects were classified according to the treatment they actually received 4. If received at least 1 immunization were not excluded because of ineligibility, missed follow-up immunizations, or protocol deviations
1. The proportion of participants experiencing solicited AEs occurring within 7 days (PfSPZ Vaccine) or 14 days (PfSPZ-CVac) of each administration of investigational product (IP). 2. The proportion of participants experiencing serious adverse events (SAEs) deemed related to IP during active participation in the trial. 3. The proportion of participants experiencing unsolicited AEs occurring within 14 days of each administration of IP deemed related to vaccination or placebo administration.
Outcome measures
| Measure |
Group 1 (PfSPZ Vaccine)
n=115 Participants
PfSPZ Vaccine: N=124; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) on day 1, 8 and 29.
PfSPZ Vaccine: Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine).
|
Group 2 (NS Placebo)
n=57 Participants
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 8 and 29.
Normal Saline: 0.9% Sodium chloride
|
Group 3 (PfSPZ Challenge + CQ)
n=116 Participants
PfSPZ-CVac (PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis): N=124; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ.
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on PfSPZ-CVac Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of PfSPZ Challenge).
PfSPZ-CVac: PfSPZ Challenge (infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites) under CQ chemoprophylaxis.
|
Group 4 (NS Placebo + CQ)
n=57 Participants
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 29 and 57, with weekly CQ.
Normal Saline: 0.9% Sodium chloride
CQ chemoprophylaxis alone:
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on NS Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of NS).
|
|---|---|---|---|---|
|
Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) Administration
No. of subjects with systemic solicited AEs in 7 days (Vaccine) or 14 days (CVac) of each dose.
|
77 participants
|
36 participants
|
115 participants
|
55 participants
|
|
Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) Administration
No. of subjects with local solicited AEs in 2 days (Vaccine) or 14 days (CVac) of each dose.
|
6 participants
|
5 participants
|
8 participants
|
3 participants
|
|
Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) Administration
No. of subjects with SAEs deemed related to IP during active participation in the trial.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) Administration
No. of subjects with unsolicited AEs in14 days of each dose of IP deemed related (IP/placebo).
|
23 participants
|
13 participants
|
69 participants
|
30 participants
|
PRIMARY outcome
Timeframe: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).Population: The modified intention-to-treat population (or mITT Population) was defined as all randomized participants who received all 3 intended doses of vaccine or placebo, even if doses were administered out of window or were less than 80% of intended volume. Those completing 3 doses and also completing 24 weeks of surveillance during deployment (primary endpoint) were included in the efficacy analysis. For efficacy analysis, the placebo groups, Group 2 and Group 4, were combined into one group.
The deployment surveillance period was from 10 days after arriving in Papua to 2 days before departure (which was the last day that the clinical team had access to the study population). Primary endpoint: number of first clinical malaria cases caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Clinical malaria caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test) plus * measured axillary temperature ≥ 37.5 degrees Celsius or history of fever in the last 24 hours; or * at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; or * meeting criteria for severe malaria (this third option was not used).
Outcome measures
| Measure |
Group 1 (PfSPZ Vaccine)
n=109 Participants
PfSPZ Vaccine: N=124; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) on day 1, 8 and 29.
PfSPZ Vaccine: Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine).
|
Group 2 (NS Placebo)
n=113 Participants
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 8 and 29.
Normal Saline: 0.9% Sodium chloride
|
Group 3 (PfSPZ Challenge + CQ)
n=111 Participants
PfSPZ-CVac (PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis): N=124; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ.
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on PfSPZ-CVac Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of PfSPZ Challenge).
PfSPZ-CVac: PfSPZ Challenge (infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites) under CQ chemoprophylaxis.
|
Group 4 (NS Placebo + CQ)
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 29 and 57, with weekly CQ.
Normal Saline: 0.9% Sodium chloride
CQ chemoprophylaxis alone:
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on NS Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of NS).
|
|---|---|---|---|---|
|
Primary Efficacy Endpoint - Number of Participants With First Clinical Pf Malaria Cases
First clinical malaria cases caused by Pf (first 24 weeks of deployment).
|
24 participants
|
27 participants
|
47 participants
|
—
|
|
Primary Efficacy Endpoint - Number of Participants With First Clinical Pf Malaria Cases
First clinical malaria cases caused by Pf (entire deployment).
|
39 participants
|
44 participants
|
59 participants
|
—
|
SECONDARY outcome
Timeframe: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).The deployment surveillance period extended from 10 days after arriving in Papua to two days before departure (which was the last day that the clinical team had access to the study population). Secondary endpoint: number of first infections caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Malaria infection caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test).
Outcome measures
| Measure |
Group 1 (PfSPZ Vaccine)
n=109 Participants
PfSPZ Vaccine: N=124; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) on day 1, 8 and 29.
PfSPZ Vaccine: Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine).
|
Group 2 (NS Placebo)
n=113 Participants
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 8 and 29.
Normal Saline: 0.9% Sodium chloride
|
Group 3 (PfSPZ Challenge + CQ)
n=111 Participants
PfSPZ-CVac (PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis): N=124; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ.
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on PfSPZ-CVac Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of PfSPZ Challenge).
PfSPZ-CVac: PfSPZ Challenge (infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites) under CQ chemoprophylaxis.
|
Group 4 (NS Placebo + CQ)
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 29 and 57, with weekly CQ.
Normal Saline: 0.9% Sodium chloride
CQ chemoprophylaxis alone:
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on NS Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of NS).
|
|---|---|---|---|---|
|
Secondary Efficacy Endpoint - Number of Confirmed First Infections Caused by Pf
First infections caused by Pf (first 24 weeks of deployment).
|
25 participants
|
27 participants
|
47 participants
|
—
|
|
Secondary Efficacy Endpoint - Number of Confirmed First Infections Caused by Pf
First infections caused by Pf (entire deployment).
|
39 participants
|
44 participants
|
60 participants
|
—
|
Adverse Events
Group 1 (PfSPZ Vaccine)
Serious events: 9 serious events
Other events: 85 other events
Deaths: 0 deaths
Group 2 (NS Placebo)
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Group 3 (PfSPZ Challenge + CQ)
Serious events: 7 serious events
Other events: 115 other events
Deaths: 0 deaths
Group 4 (NS Placebo + CQ)
Serious events: 4 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (PfSPZ Vaccine)
n=115 participants at risk
PfSPZ Vaccine: N=124; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) on day 1, 8 and 29.
PfSPZ Vaccine: Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine).
|
Group 2 (NS Placebo)
n=57 participants at risk
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 8 and 29.
Normal Saline: 0.9% Sodium chloride
|
Group 3 (PfSPZ Challenge + CQ)
n=116 participants at risk
PfSPZ-CVac (PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis): N=124; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ.
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on PfSPZ-CVac Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of PfSPZ Challenge).
PfSPZ-CVac: PfSPZ Challenge (infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites) under CQ chemoprophylaxis.
|
Group 4 (NS Placebo + CQ)
n=57 participants at risk
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 29 and 57, with weekly CQ.
Normal Saline: 0.9% Sodium chloride
CQ chemoprophylaxis alone:
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on NS Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of NS).
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Appendicitis non-infective
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Bronchities
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Cystitis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Furuncle
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Gastroenteritis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Malaria
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Orchitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Plasmodium malariae infection
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Pneumonia
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Systemic viral infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Gastritis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Gastro-esophageal reflux disease
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Pyrexia
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
Other adverse events
| Measure |
Group 1 (PfSPZ Vaccine)
n=115 participants at risk
PfSPZ Vaccine: N=124; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) on day 1, 8 and 29.
PfSPZ Vaccine: Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine).
|
Group 2 (NS Placebo)
n=57 participants at risk
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 8 and 29.
Normal Saline: 0.9% Sodium chloride
|
Group 3 (PfSPZ Challenge + CQ)
n=116 participants at risk
PfSPZ-CVac (PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis): N=124; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ.
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on PfSPZ-CVac Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of PfSPZ Challenge).
PfSPZ-CVac: PfSPZ Challenge (infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites) under CQ chemoprophylaxis.
|
Group 4 (NS Placebo + CQ)
n=57 participants at risk
Normal saline (NS) placebo: N=62; three doses of NS administered by DVI on day 1, 29 and 57, with weekly CQ.
Normal Saline: 0.9% Sodium chloride
CQ chemoprophylaxis alone:
Loading Dose: 10 mg/kg of CQ base (orally administered as a single loading dose via directly observed therapy on NS Day -2).
Weekly Dose: 5 mg/kg of CQ base (subsequent maintenance doses of CQ given weekly as a single dose, with the last dose no earlier than 5 days after the last dose of NS).
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Chills
|
33.0%
38/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
22.8%
13/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
69.0%
80/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
47.4%
27/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Fatigue
|
26.1%
30/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
21.1%
12/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
76.7%
89/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
59.6%
34/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Hyperhidrosis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
23.3%
27/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
10.5%
6/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Injection site bruising
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Injection site erythema
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Injection site extravasation
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Injection site pain
|
1.7%
2/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Injection site pruritus
|
2.6%
3/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Malaise
|
20.9%
24/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
15.8%
9/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
64.7%
75/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
36.8%
21/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Edema
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
General disorders
Pyrexia
|
40.0%
46/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
21.1%
12/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
78.4%
91/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
49.1%
28/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Dizziness
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
48.3%
56/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
45.6%
26/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Headache
|
42.6%
49/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
35.1%
20/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
78.4%
91/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
66.7%
38/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Migraine
|
3.5%
4/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
5.2%
6/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
10.5%
6/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Syncope
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Nervous system disorders
Migraine without aura
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.7%
25/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
15.8%
9/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
55.2%
64/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
29.8%
17/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.0%
38/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
24.6%
14/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
62.9%
73/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
38.6%
22/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.4%
4/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Ear infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Ecthyma
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Gastroenteritis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
6.0%
7/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
7.0%
4/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Gingivitis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Hordeolum
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Influenza
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Nasopharyngitis
|
13.9%
16/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
10.5%
6/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
71.6%
83/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
64.9%
37/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Otitis media
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Paronychia
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Rhinitis
|
4.3%
5/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
5.2%
6/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Tonsillitis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
13.8%
16/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
14.0%
8/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Viral infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Wound infection
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Infections and infestations
COVID-19
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
5.3%
3/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
69.8%
81/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
64.9%
37/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
4.3%
5/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
19.0%
22/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
17.5%
10/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Dental caries
|
2.6%
3/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
21.6%
25/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
28.1%
16/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
3/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
5.2%
6/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
5.3%
3/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Food poisoning
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
7/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
44.0%
51/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
26.3%
15/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
3/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
19.0%
22/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
12.3%
7/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
6.1%
7/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
10.3%
12/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Cold urticaria
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
7/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
12.1%
14/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
10.5%
6/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
7/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
10.3%
12/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.1%
7/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
10.3%
12/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
2.6%
3/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Psychiatric disorders
Insomnia
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
16.4%
19/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
12.3%
7/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Eye disorders
Keratitis
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.7%
2/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Eye disorders
Vision blurred
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
12.1%
14/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
7.0%
4/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
8.6%
10/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
5.3%
3/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
6.0%
7/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
3.5%
2/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
5.2%
6/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Surgical and medical procedures
Tooth extraction
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.87%
1/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
1.8%
1/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
|
Vascular disorders
Hypertension
|
0.00%
0/115 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.86%
1/116 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
0.00%
0/57 • The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.
The SAE table below includes the 26 participants who experienced SAEs, all of which were deemed unrelated to investigational product. One participant experienced 3 SAEs and five more each experienced 2 SAEs. Of these 33 SAEs, three had 3 diagnoses and two had 2 diagnoses. Each diagnosis is listed in a different row, resulting in 41 SAE entries.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee (1) The principal investigator and associated institution are restricted from using the results of the study for commercial purposes; (2) the principal investigator is obligated to provide the Sponsor an opportunity to review planned disseminations of the data for "confidential information" that if present must be removed on Sponsor's request; (3) it is stipulated that communications such as publications and presentations should be "joint."
- Publication restrictions are in place
Restriction type: OTHER